Commission Implementing Decision (EU) 2018/945 of 22 June 2018 on the communicable diseases and related special health issues to be covered by epidemiological surveillance as well as relevant case definitions (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/decision/2018/945@2018-06-22/en
Contents
- Preamble
- ANNEX
- ANNEX I Communicable diseases and related special health issues to be covered by the epidemiological surveillance network
- 2.
- ANNEX II
- 1. CLINICAL CRITERIA
- 3.
- 3.1. Clinical Criteria
- A.
- B.
- C.
- 3.2. Clinical Criteria
- A.
- B.
- C.
- 3.3. Clinical Criteria
- A.
- B.
- C.
- 3.4. Clinical Criteria
- A.
- B.
- C.
- 3.5. Laboratory Criteria
- A.
- B.
- C.
- 3.6. Clinical Criteria
- Chlamydial infection non-LGV
- LGV
- A.
- B.
- C.
- 3.7. Clinical Criteria
- A.
- B.
- C.
- 3.8. Clinical Criteria
- A.
- B.
- C.
- 3.9. Clinical Criteria
- A.
- B.
- C.
- 3.10. Laboratory Criteria
- A.
- B.
- C.
- 3.11. Clinical Criteria
- A.
- B.
- C.
- 3.12. Clinical Criteria
- A.
- B.
- C.
- 3.13. Clinical Criteria
- A.
- B.
- C.
- 3.14. Clinical Criteria
- A.
- B.
- C.
- 3.15. Clinical Criteria
- A.
- B.
- C.
- 3.16. Clinical Criteria
- A.
- B.
- C.
- 3.17. Clinical Criteria
- A.
- B.
- C.
- 3.18. Clinical Criteria
- A.
- B.
- C.
- 3.19. Clinical Criteria (AIDS)
- A.
- B.
- C.
- 3.20. Clinical Criteria
- A.
- B.
- C.
- 3.21. Clinical Criteria
- A.
- B.
- C.
- D.
- 3.22. Clinical Criteria
- Laboratory criteria for case confirmation
- Laboratory criteria for a probable case
- A.
- B.
- C.
- 3.23. Clinical Criteria
- A.
- B.
- C.
- 3.24. Clinical Criteria
- Listeriosis in pregnancy:
- A.
- B.
- C.
- 3.25. Laboratory Criteria
- A.
- B.
- C.
- 3.26. Clinical Criteria
- A.
- B.
- C.
- 3.27. Clinical Criteria
- A.
- B.
- C.
- 3.28. Clinical Criteria
- A.
- B.
- C.
- 3.29. Clinical Criteria
- A.
- B.
- C.
- 3.30. Clinical Criteria Notes:
- A.
- B.
- C.
- 3.31. Clinical Criteria
- A.
- B.
- C.
- 3.32. Clinical Criteria
- A.
- B.
- C.
- Antimicrobial resistance:
- 3.33. Clinical Criteria
- A.
- B.
- C.
- 3.34. Clinical Criteria
- A.
- B.
- C.
- 3.35. Clinical Criteria
- A.
- B.
- C.
- 3.36. Clinical Criteria
- A.
- B.
- C.
- 3.37. Clinical Criteria
- Congenital rubella infection (CRI)
- Congenital rubella syndrome (CRS)
- A.
- B.
- C.
- 3.38. Clinical Criteria
- A.
- B.
- C.
- 3.39. Clinical Criteria
- Laboratory criteria for case confirmation
- Laboratory criteria for a probable case
- A.
- B.
- C.
- D.
- 3.40. Clinical Criteria
- STEC/VTEC diarrhoea
- HUS
- A.
- B.
- C.
- 3.41. Clinical Criteria
- A.
- B.
- C.
- 3.42. Clinical Criteria
- Laboratory criteria for case confirmation
- A.
- B.
- C.
- 3.43. Clinical Criteria
- Primary syphilis
- Secondary syphilis
- Early latent syphilis (< 1 year)
- Primary/secondary syphilis
- Early latent syphilis
- A.
- B.
- C.
- 3.44. Clinical Criteria
- Laboratory criteria for case confirmation
- Laboratory criteria for a probable case
- A.
- B.
- C.
- 3.45. Clinical Criteria
- A.
- B.
- C.
- 3.46. Clinical Criteria
- Laboratory criteria for case confirmation:
- Laboratory criteria for a probable case:
- A.
- B.
- C.
- 3.47. Clinical Criteria
- A.
- B.
- C.
- 3.48. Clinical Criteria
- A.
- B.
- C.
- 3.49. Clinical Criteria
- Laboratory criteria for case confirmation
- Laboratory criteria for a probable case
- A.
- B.
- C.
- 3.50. Clinical Criteria
- A.
- B.
- C.
- 3.51. Clinical Criteria
- A.
- B.
- C.
- 3.52. Clinical Criteria
- A.
- B.
- C.
- 3.53. Clinical Criteria
- Laboratory test for case confirmation
- Laboratory test for a probable case
- A.
- B.
- C.
- 3.54. Clinical Criteria
- A.
- B.
- C.
- 3.55. Clinical Criteria
- A.
- B.
- C.
- 3.56. Laboratory Criteria
- A.
- B.
- C.
- 3.57. Laboratory Criteria
- A.
- B.
- 4.
- 4.1.
- 4.1.1. BJ-BONE: Osteomyelitis Note reporting instruction
- 4.1.2. BSI: Laboratory-confirmed bloodstream infection
- 4.1.3. CNS-IC: Intracranial infection (brain abscess, subdural or epidural infection, encephalitis) Note reporting instruction
- 4.1.4.
- CRI3-CVC: microbiologically confirmed CVC-related bloodstream infection
- CRI3-PVC: microbiologically confirmed PVC-related bloodstream infection
- 4.1.5. CVS-VASC: Arterial or venous infection Note reporting instructions
- 4.1.6. EENT-CONJ: Conjunctivitis Note reporting instructions
- 4.1.7. GI-CDI: Clostridium difficile infection
- 4.1.8. LRI-BRON: Bronchitis, tracheobronchitis, bronchiolitis, tracheitis, without evidence of pneumonia Note reporting instruction
- 4.1.9. NEO-CSEP: Clinical Sepsis
- 4.1.10. Notes:
- 4.1.10.
- 4.1.11. REPR-EMET: Endometritis Note reporting instruction
- 4.1.12. Superficial incisional (SSI-S)
- 4.1.13. SST-SKIN: Skin infection Note reporting instructions
- 4.1.14. SYS-DI: Disseminated infection Note reporting instructions
- 4.1.15. UTI-A: microbiologically confirmed symptomatic UTI
- 4.2. Clinical criteria
- A.
- B.
- C.
- 4.3. Clinical resistance to antimicrobial agents
- Definition
- Classification Clinically Resistant (R)
- Phenotypic definition
- Phenotypic classification Non-wild-type (NWT) phenotype
- Identification of an acquired antimicrobial resistance mechanism (for example, drug inactivating enzyme, modification of drug target protein type, efflux pump)
- Genotypic definition
- Genotypic classification
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC, and in particular Article 6(5)(a) and (b) thereof,
Whereas:
(1) Pursuant to Decision No 2119/98/EC of the European Parliament and of the Council, Commission Decision 2000/96/EC established a list of communicable diseases and special health issues to be covered by epidemiological surveillance in the Community network.
(2) Commission Decision 2002/253/EC laid down case definitions for reporting communicable diseases listed in Decision 2000/96/EC to the Community network.
(3) The Annex to Decision No 1082/2013/EU sets out the criteria for selecting the communicable diseases and related special health issues to be covered by epidemiological surveillance within the network.
(4) The list of diseases and related special health issues established by Decision 2000/96/EC should be updated to reflect changes in disease incidence and prevalence, the needs of the European Union and its Member States, as well as to ensure compliance with the criteria provided in the Annex to Decision No 1082/2013/EU.
(5) The list of case definitions should be updated in the light of new scientific information and evolving laboratory diagnostic criteria and practices.
(6) Both the list of diseases and the list of case definitions are brought into line with the World Health Organisation nomenclature according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10).
(7) The updated list of diseases should cover the following communicable diseases threatening public health that have emerged or re-emerged more recently in accordance with the criteria provided in the Annex to Decision No 1082/2013/EU for selection of communicable diseases and related special health issues to be covered by epidemiological surveillance:
Chikungunya: In view of autochthonous outbreaks of chikungunya virus infections in Italy (2007) and France (2010 and 2014), the widespread presence of competent vectors (Aedes albopictus) in the Mediterranean basin, and the return of travellers from endemic areas, systematic surveillance is necessary to prevent the spread of chikungunya virus in the Union,
Dengue: The large dengue outbreak in Madeira in 2012 and the presence of competent vectors (Aedes mosquitos), in particular in Mediterranean Member States, highlight the need for additional surveillance to help prevent the spread of the dengue virus in the Union,
Zika: The infection of pregnant women with the Zika virus can lead to the birth of children with severe neurological defects. Early detection and surveillance of people returning from affected areas are crucial. Surveillance data is needed to inform public health measures to prevent the introduction and spread of the Zika virus to the Union,
Lyme neuroborreliosis: The transmission of Lyme neuroborreliosis, a complication of Lyme disease which is caused by the bacterium Borrelia burgdorferi and transmitted to humans through the bite of infected ticks, is a concern for the Union. Systematic surveillance is needed to monitor its epidemiology in order to support measures to prevent and control the disease and its complications.
(8) Pursuant to Article 9 of Regulation (EC) No 851/2004 of the European Parliament and of the Council, the European Centre for Disease Prevention and Control (ECDC) has, at the Commission's request, provided scientific assistance on the establishment of case definitions for Chikungunya, Dengue, Lyme neuroborreliosis and Zika infections on the revision of case definitions for a number of other diseases, as well as on the revision of case definitions related to certain healthcare associated infections and to antimicrobial resistance. The case definitions should therefore be amended accordingly.
(9) The measures provided for in this Decision are in accordance with the opinion of the Committee on serious cross-border threats to health established under Article 18 of Decision No 1082/2013/EU.
(10) Accordingly, Decisions 2000/96/EC and 2002/253/EC should be replaced by this Decision,
HAS ADOPTED THIS DECISION:
Article 1
The communicable diseases and related special health issues to be covered by the epidemiological surveillance network are listed in Annex I.
Article 2
For the purposes of submitting data for the epidemiological surveillance of the communicable diseases and related special health issues listed in Annex I, Member States shall apply the case definitions specified in Annex II.
Article 3
Decisions 2000/96/EC and 2002/253/EC are hereby repealed. References to those Decisions shall be construed as references to this Decision.
Article 4
This Decision shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
Done at Brussels, 22 June 2018. For the Commission The President Jean-Claude Juncker
ANNEX
ANNEX I Communicable diseases and related special health issues to be covered by the epidemiological surveillance network
2.
ANNEX II
1. EXPLANATION OF THE SECTIONS USED IN THE DEFINITION AND CLASSIFICATION OF CASES
1. CLINICAL CRITERIA
Clinical criteria include common and relevant signs and symptoms of the disease which either individually or in combination constitutes a clear or indicative clinical picture of the disease. They give the general outline of the disease and do not necessarily indicate all the features needed for individual clinical diagnosis.
LABORATORY CRITERIA
Laboratory criteria are a list of laboratory methods that are used to confirm a case. Usually only one of the listed tests will be enough to confirm the case. If a combination of methods is needed to meet the laboratory confirmation, this is specified. The type of specimen to be collected for the laboratory tests is only specified when only certain specimen types are considered relevant for the confirmation of a diagnosis. Laboratory criteria for a probable case are included for some agreed exceptional cases. Those laboratory criteria consist of a list of laboratory methods which can be used to support the diagnosis of a case but which are not confirmatory.
EPIDEMIOLOGICAL CRITERIA AND EPIDEMIOLOGICAL LINK
Epidemiological criteria are deemed to have been met when an epidemiological link can be established. Epidemiological link, during the incubation period, means one of the following six: — Human to human transmission the fact that a person has had contact with a laboratory confirmed human case in such a way as to have had the opportunity to acquire the infection; — Animal to human transmission the fact that a person has had contact with an animal with a laboratory confirmed infection/colonization in such a way as to have had the opportunity to acquire the infection; — Exposure to a common source the fact that a person has been exposed to the same common source or vehicle of infection, as a confirmed human case; — Exposure to contaminated food/drinking water the fact that a person has consumed food or drinking water with a laboratory confirmed contamination or has consumed potentially contaminated products from an animal with a laboratory confirmed infection/colonization; — Environmental exposure the fact that a person has bathed in water or has had contact with a contaminated environmental source that has been laboratory confirmed; — Laboratory exposure the fact that a person has worked in a laboratory where there is a potential for exposure. A person may be considered epidemiologically linked to a confirmed case if at least one case in the chain of transmission is laboratory confirmed. In case of an outbreak of faeco-oral or airborne transmitted infections, the chain of transmission does not necessarily need to be established to consider a case epidemiologically linked. Transmission may occur by one or more of the following routes:
Airborne: by projection of aerosol from an infected person onto the mucous membranes while coughing, spitting, singing or talking, or when microbial aerosols dispersed into the atmosphere are inhaled by others;
Contact: direct contact with an infected person (faecal-oral, respiratory droplets, skin or sexual exposure) or animal (for example, biting, touching) or indirect contact to infected materials or objects (infected fomites, body fluids, blood);
Vertical: from mother to child, often in utero, or as a result of the incidental exchange of body fluids usually during the perinatal period;
Vector transmission: transmission by infected mosquitoes, ticks, mites, flies and other insects which transmit disease to humans through their bites;
Food or water: consumption of potentially contaminated food or drinking water.
CASE CLASSIFICATION
Cases are classified as possible, probable and confirmed. The incubation periods for diseases are given in the additional information to facilitate the assessment of the epidemiological link.
POSSIBLE CASE
A possible case means a case classified as possible for reporting purposes. It is usually a case meeting the clinical criteria as described in the case definition without epidemiological or laboratory evidence of the disease in question. The definition of a case as possible has high sensitivity and low specificity. It allows for detection of most cases but some false positives cases will be included into this category.
PROBABLE CASE
A probable case means a case classified as probable for reporting purposes. It is usually a case with clinical criteria and an epidemiological link as described in the case definition. Laboratory tests for probable cases are specified only for some diseases.
CONFIRMED CASE
A confirmed case means a case classified as confirmed for reporting purposes. Confirmed cases are laboratory confirmed and may or may not fulfil the clinical criteria as described in the case definition. The definition of a case as confirmed is highly specific and less sensitive; therefore most of the collected cases will be true cases although some will be missed. The clinical criteria of some diseases do not allude to the fact that many acute cases are asymptomatic (for example, hepatitis A, B and C, campylobacteriosis, salmonellosis) although these cases may still be important from a public health perspective on national level. Confirmed cases fall in one of the three subcategories listed below. They will be assigned to one of those subcategories during the analysis of data using the variables collected within the context of the case information.
LABORATORY-CONFIRMED CASE WITH CLINICAL CRITERIA
The case meets the laboratory criteria for case confirmation and the clinical criteria included in the case definition.
LABORATORY-CONFIRMED CASE WITH UNKNOWN CLINICAL CRITERIA
The case meets the laboratory criteria for case confirmation but there is no information available regarding the clinical criteria (for example,only laboratory report).
LABORATORY-CONFIRMED CASE WITHOUT CLINICAL CRITERIA
The case meets the laboratory criteria for case confirmation but doesn't meet the clinical criteria in the case definition or is asymptomatic. Note: For some of the conditions under surveillance the structure of the case definitions does not follow the typical structure of the case definition such as in the cases of Creutzfeldt-Jakob disease (CJD), healthcare associated infections and antimicrobial resistance.
2. ABBREVIATION LIST 1. AFP acute flaccid paralysis 2. AIDS acquired immune deficiency syndrome 3. AMR antimicrobial resistance 4. Anti-HBc hepatitis B core antibody 5. anti-HCV hepatitis C virus specific antibody 6. ARI acute respiratory infection 7. BAL broncho-alveolar lavage 8. BCG Bacille de Calmette et Guérin 9. BJ bone and joint infection 10. BJ-BONE osteomyelitis 11. BJ-DISC disc space infection 12. BJ-JNT joint or bursa infection 13. BoNT botulinum neurotoxin 14. BSI bloodstream infection 15. C-CVC catheter-related — central venous catheter 16. CDAD Clostridium difficile associated diarrhoea 17. CFU colony-forming unit 18. CJD Creutzfeldt-Jakob disease 19. CMV cytomegalovirus 20. CNRL EU Community Network of Reference Laboratories for human influenza 21. CNS central nervous system 22. CNS-IC central nervous system infection — intracranial infection 23. CNS-MEN central nervous system infection — meningitis or ventriculitis 24. CNS-SA central nervous system infection — spinal abscess without meningitis 25. C-PVC catheter-related — peripheral venous catheter 26. CRI catheter-related infection 27. CRS Congenital rubella syndrome 28. CRT capillary refilling time 29. CSF Cerebrospinal fluid 30. CT scan computed tomography scan 31. CVS cardiovascular system infection 32. CVS-CARD cardiovascular system infection — myocarditis or pericarditis 33. CVS-ENDO cardiovascular system infection — endocarditis 34. CVS-MED cardiovascular system infection — mediastinitis 35. CVS-VASC cardiovascular system infection — arterial or venous infection 36. DFA direct fluorescent antibody 37. DFA-TP direct fluorescent antibody test for Treponema pallidum 38. DNA deoxyribonucleic acid 39. DPA distal protected aspirate 40. EARS-Net European Antimicrobial Resistance Surveillance Network 41. ECDC European Centre for Disease Prevention and Control 42. ECOFFs epidemiological cut-off values 43. EEG electroencephalography 44. EENT eye, ear, nose, throat, or mouth infection 45. EENT-CONJ eye, ear, nose, throat, or mouth infection — conjunctivitis 46. EENT-EAR eye, ear, nose, throat, or mouth infection — ear mastoid 47. EENT-EYE eye, ear, nose, throat, or mouth infection — eye, other than conjunctivitis 48. EENT-ORAL eye, ear, nose, throat, or mouth infection — oral cavity (mouth, tongue, or gums) 49. EENT-SINU eye, ear, nose, throat, or mouth infection — sinusitis 50. EENT-UR eye, ear, nose, throat, or mouth infection — upper respiratory tract, pharyngitis, laryngitis, epiglottitis 51. EFNS European Federation of Neurological Societies 52. EIA enzyme immunoassay 53. ELISA enzyme-linked immunosorbent assay 54. EM electron microscopy 55. EUCAST European Committee on Antimicrobial Susceptibility Testing 56. FAMA fluorescent antibody to membrane antigen 57. FTA-abs fluorescent treponemal antibody absorption 58. FUO fever of unknown origin 59. GI gastrointestinal system infection 60. GI-CDI gastrointestinal system infection — Clostridium difficile infection 61. GI-GE gastrointestinal system infection — gastroenteritis (excl. CDI) 62. GI-GIT gastrointestinal system infection — gastrointestinal tract (esophagus, stomach, small and large bowel, and rectum) excluding gastroenteritis and appendicitis 63. GI-HEP gastrointestinal system infection — hepatitis 64. GI-IAB gastrointestinal system infection — intraabdominal, not specified elsewhere including gallbladder, bile ducts, liver (excluding viral hepatitis), spleen, pancreas, peritoneum, subphrenic or subdiaphragmatic space, or other intraabdominal tissue or area not specified elsewhere 65. HAI healthcare-associated infections 66. HbeAg hepatitis B e antigen 67. HbsAg hepatitis B surface antigen 68. HBV-DNA hepatitis B nucleic acid 69. HCV-core hepatitis C virus core antigen 70. HCV-RNA hepatitis C virus nucleic acid 71. HIV human immunodeficiency virus 72. HUS haemolytic-uraemic syndrome 73. IAP intubation-associated pneumonia 74. IFA indirect fluorescent antibody 75. IgG immunoglobulin G 76. IgM immunoglobulin M 77. ILI influenza-like illness 78. LGV lymphogranuloma (venereum) 79. LPS lipopolysaccharides 80. LRI lower respiratory tract infection, other than pneumonia 81. LRI-BRON lower respiratory tract infection — bronchitis, tracheobronchitis, bronchiolitis, tracheitis, without evidence of pneumonia 82. TBE Tick-borne encephalitis
3. CASE DEFINITIONS OF COMMUNICABLE DISEASES
3.
3.1. ANTHRAX
3.1. Clinical Criteria
Any person with at least one of the following clinical forms:
Cutaneous anthrax At least one the following two:
Papular or vesicular lesion;
Depressed black eschar with surrounding oedema.
Gastrointestinal anthrax AND at least one of the following two:
Fever or feverishness;
Severe abdominal pain;
Diarrhoea.
Inhalational anthrax AND at least one of the following two:
Fever or feverishness;
Acute respiratory distress;
Radiological evidence of mediastinal widening.
Meningeal/meningoencephalitic anthrax AND at least one of the following three:
Fever;
Convulsions;
Loss of consciousness;
Meningeal signs.
Anthrax septicaemia
Laboratory Criteria
At least one of the following two: Positive nasal swab without clinical symptoms does not contribute to a confirmed diagnosis of a case.
Isolation of Bacillus anthracis from a clinical specimen
Detection of Bacillus anthracis nucleic acid in a clinical specimen
Epidemiological Criteria
At least one of the following three epidemiological links:
Animal to human transmission;
Exposure to a common source;
Exposure to contaminated food/drinking water.
Case Classification
Note: If the national surveillance system is not capturing clinical symptoms, all laboratory-confirmed individuals should be reported as confirmed cases.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
3.2. BOTULISM
3.2. Clinical Criteria
Any person with at least one of the following clinical forms: The type of botulism usually encountered in infants (< 12 months of age) can affect children also over 12 months of age and occasionally adults, with altered gastrointestinal anatomy and microflora
Food-borne and wound botulism At least one of the following two:
Bilateral cranial nerve impairment (for example, diplopia, blurred vision, dysphagia, bulbar weakness);
Peripheral symmetric paralysis.
Infant botulism Any infant with at least one of the following six:
Constipation;
Lethargy;
Difficulty in sucking or feeding;
Ptosis;
Dysphagia;
General muscle weakness.
Laboratory Criteria
At least one of the following three:
Isolation of BoNT-producing clostridia (for example, Clostridium botulinum, C. baratii, C. butyricum) for infant botulism (stool) or wound botulism (wound);
Detection of botulinum neurotoxins in a clinical specimen;
Detection of genes encoding for botulinum neurotoxins in a clinical specimen.
Epidemiological Criteria
At least one of the following two epidemiological links:
Exposure to a common source (for example, food, sharing of needles or other devices);
Exposure to contaminated food/drinking water
Case Classification
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
3.3. BRUCELLOSIS
3.3. Clinical Criteria
Any person with fever And at least one of the following seven:
Sweating (profuse, malodorous, specially nocturnal);
Chills;
Arthralgia;
Weakness;
Depression;
Headache;
Anorexia.
Laboratory Criteria
At least one of the following three:
Isolation of human pathogenic Brucella spp. from a clinical specimen;
Human pathogenic Brucella specific antibody response (Standard Agglutination Test, Complement Fixation, ELISA);
Detection of human pathogenic Brucella spp. nucleic acid in a clinical specimen.
Epidemiological Criteria
At least one of the following five epidemiological links:
Exposure to contaminated food/drinking water;
Exposure to products from a contaminated animal (milk or milk products);
Animal to human transmission (contaminated secretions or organs for example, vaginal discharge, placenta);
Exposure to a common source;
Laboratory exposure.
Case Classification
Note: If the national surveillance system is not capturing clinical symptoms, all laboratory-confirmed individuals should be reported as confirmed cases.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
3.4. CAMPYLOBACTER ENTERITIS
3.4. Clinical Criteria
Any person with at least one of the following three:
Diarrhoea;
Abdominal pain;
Fever.
Laboratory Criteria
At least one of the following two: Note: Antimicrobial susceptibility testing of Campylobacter spp. should be performed on a representative subset of isolates
Isolation of human pathogenic Campylobacter spp. from a clinical specimen;
Detection of Campylobacter spp. nucleic acid in a clinical specimen.
Epidemiological Criteria
At least one of the following five epidemiological links:
Animal to human transmission;
Human to human transmission;
Exposure to a common source;
Exposure to contaminated food/drinking water;
Environmental exposure.
Case Classification
Note: If the national surveillance system is not capturing clinical symptoms, all laboratory-confirmed individuals should be reported as confirmed cases.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
Antimicrobial resistance
The results of antimicrobial susceptibility tests must be reported according to the methods and criteria agreed between ECDC and Member States as specified in the EU protocol for harmonised monitoring of antimicrobial resistance in human Salmonella and Campylobacter isolates.
3.5. CHIKUNGUNYA VIRUS DISEASE
Fever
3.5. Laboratory Criteria
A.
Probable case
Detection of chikungunya specific IgM antibodies in a single serum sample.
B.
Confirmed case At least one of the following four:
Isolation of chikungunya virus from a clinical specimen;
Detection of chikungunya viral nucleic acid from a clinical specimen;
Detection of chikungunya specific IgM antibodies in a single serum sample AND confirmation by neutralisation;
Seroconversion or four-fold antibody titre increase of chikungunya specific antibodies in paired serum samples.
Epidemiological Criteria
History of travel to, or residence in an area with documented on-going transmission of chikungunya, within the two-week period prior to the onset of symptoms
Case Classification
Note: Serological results should be interpreted according to previous exposure to other flaviviral infections and the flavivirus vaccination status. Confirmed cases in such situations should be validated by serum neutralization assay or other equivalent assays.
A.
Possible case NA
B.
Probable case Any person meeting the clinical and the epidemiological criteria, and the laboratory criteria for a probable case
C.
Confirmed case Any person meeting the laboratory criteria for a confirmed case
3.6. CHLAMYDIAL INFECTION, INCLUDING CHLAMYDIAL LYMPHOGRANULOMA (VENEREUM) (LGV)
3.6. Clinical Criteria
Any person with at least one of the following clinical forms:
Chlamydial infection non-LGV
At least one of the following six:
Urethritis;
Epididymitis;
Acute salpingitis;
Acute endometritis;
Cervicitis;
Proctitis.
In newborn children at least one of the following two:
Conjunctivitis;
Pneumonia.
LGV At least one of the following five:
Urethritis;
Genital ulcer;
Inguinal lymphadenopathy;
Cervicitis;
Proctitis.
Laboratory Criteria
Chlamydial infection non-LGV
At least one of the following three:
Isolation of Chlamydia trachomatis from a specimen of the ano-genital tract or from the conjunctiva;
Demonstration of Chlamydia trachomatis by DFA test in a clinical specimen;
Detection of Chlamydia trachomatis nucleic acid in a clinical specimen.
LGV
At least one of the following two:
Isolation of Chlamydia trachomatis from a specimen of the ano-genital tract or from the conjunctiva;
Detection of Chlamydia trachomatis nucleic acid in a clinical specimen. AND
Identification of serovar (genovar) L1, L2 or L3
Epidemiological Criteria
An epidemiological link by human to human transmission (sexual contact or vertical transmission)
Case Classification
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the laboratory criteria
3.7. CHOLERA
3.7. Clinical Criteria
Any person with at least one of the following two:
Diarrhoea;
Vomiting.
Isolation of Vibrio cholerae from a clinical specimen AND
Demonstration of O1 or O139 antigen in the isolate AND
Demonstration of cholera-enterotoxin or the cholera-enterotoxin gene in the isolate
Epidemiological Criteria
At least one of the following four epidemiological links:
Exposure to a common source;
Human to human transmission;
Exposure to contaminated food/drinking water;
Environmental exposure.
Case Classification
Note: If the national surveillance system is not capturing clinical symptoms, all laboratory-confirmed individuals should be reported as confirmed cases.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria;
3.8. CREUTZFELDT-JAKOB DISEASE (CJD)
Any person with a progressive neuropsychiatric disorder with a duration of illness of at least 6 months
Routine investigations do not suggest an alternative diagnosis
No history of exposure to human pituitary hormones or human dura mater graft
No evidence of a genetic form of transmissible spongiform encephalopathy
3.8. Clinical Criteria
Any person with at least four of the following five:
Early psychiatric symptoms;
Persistent painful sensory symptoms;
Ataxia;
Myoclonus or chorea or dystonia;
Dementia.
Neuropathological confirmation: spongiform change and extensive prion protein deposition with florid plaques throughout the cerebrum and cerebellum
EEG does not show the typical appearance of sporadic CJD in the early stages of the illness;
Bilateral pulvinar high signal on MRI brain scan;
A positive tonsil biopsy.
Epidemiological Criteria
An epidemiological link by human to human transmission (for example, blood transfusion)
Case Classification
A.
Possible case Any person fulfilling the preconditions AND
meeting the clinical criteria AND
a negative EEG for sporadic CJD
B.
Probable case Any person fulfilling the preconditions AND
meeting the clinical criteria AND
a negative EEG for sporadic CJD AND
a positive MRI brain scan OR
Any person fulfilling the preconditions AND
a positive tonsil biopsy
C.
Confirmed case Any person fulfilling the preconditions AND meeting the diagnostic criteria for case confirmation
3.9. CRYPTOSPORIDIOSIS
3.9. Clinical Criteria
Any person with at least one of the following two:
Diarrhoea;
Abdominal pain.
Laboratory Criteria
At least one of the following four:
Demonstration of Cryptosporidium oocysts in stool;
Demonstration of Cryptosporidium in intestinal fluid or small-bowel biopsy specimens;
Detection of Cryptosporidium nucleic acid in stool;
Detection of Cryptosporidium antigen in stool.
Epidemiological Criteria
One of the following five epidemiological links:
Human to human transmission
Exposure to a common source
Animal to human transmission
Exposure to contaminated food/drinking water
Environmental exposure
Case Classification
Note: If the national surveillance system is not capturing clinical symptoms, all laboratory-confirmed individuals should be reported as confirmed cases.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
3.10. DENGUE
Fever
3.10. Laboratory Criteria
A.
Probable case
Detection of dengue specific IgM antibodies in a single serum sample
B.
Confirmed case At least one of the following five:
Isolation of a dengue virus from a clinical specimen;
Detection of dengue viral nucleic acid from a clinical specimen;
Detection of dengue viral antigen from a clinical specimen;
Detection of dengue specific IgM antibodies in a single serum sample AND confirmation by neutralization;
Seroconversion or four-fold antibody titre increase of dengue specific antibodies in paired serum samples
Epidemiological Criteria
History of travel to, or residence in an area with documented on-going transmission of dengue, within the two-week period prior to the onset of symptoms
Case Classification
A.
Possible case NA
B.
Probable case Any person meeting the clinical and the epidemiological criteria, and the laboratory criteria for a probable case
C.
Confirmed case Any person meeting the laboratory criteria for a confirmed case.
3.11. DIPHTHERIA
3.11. Clinical Criteria
Any person with at least one of the following clinical forms:
Classic Respiratory Diphtheria: An upper respiratory tract illness with laryngitis or nasopharyngitis or tonsillitis AND an adherent membrane/pseudomembrane
Mild Respiratory Diphtheria: An upper respiratory tract illness with laryngitis or nasopharyngitis or tonsillitis WITHOUT an adherent membrane/pseudomembrane.
Cutaneous Diphtheria: Skin lesion
Diphtheria of other sites: Lesion of conjunctiva or mucous membranes
Laboratory Criteria
Isolation of toxin-producing Corynebacterium diphtheriae, Corynebacterium ulcerans or Corynebacterium pseudotuberculosis from a clinical specimen.
Epidemiological Criteria
At least one of the following epidemiological links:
Human to human transmission
Animal to human transmission
Case Classification
A.
Possible case Any person meeting the clinical criteria for classical respiratory diphtheria
B.
Probable case Any person meeting the clinical criteria for diphtheria (Classic Respiratory Diphtheria, Mild Respiratory Diphtheria, Cutaneous Diphtheria, Diphtheria of other sites) with an epidemiological link to a human confirmed case or with an epidemiological link to animal to human transmission
C.
Confirmed case Any person meeting the laboratory criteria AND at least one of the clinical forms
3.12. ECHINOCOCCOSIS Epidemiological Criteria NA
3.12. Clinical Criteria
Not relevant for surveillance purposes
Diagnostic Criteria
At least one of the following five:
Histopathology or parasitology compatible with Echinococcus multilocularis or granulosus (for example, direct visualization of the protoscolex in cyst fluid)
Detection of Echinoccocus granulosus pathognomonic macroscopic morphology of cyst(s) in surgical specimens
Typical organ lesions detected by imaging techniques (for example, computerized tomography, sonography, MRI) AND confirmed by a serological test
Echinococcus spp. specific serum antibodies by high-sensitivity serological test AND confirmed by a high specificity serological test
Detection of Echinococcus multilocularis or granulosus nucleic acid in a clinical specimen
Case Classification
A.
Possible case NA
B.
Probable case NA
C.
Confirmed case Any person meeting the diagnostic criteria
3.13. GIARDIASIS (LAMBLIASIS)
3.13. Clinical Criteria
Any person with at least one of the following four:
Diarrhoea
Abdominal pain
Bloating
Signs of malabsorption (for example, steatorrhoea, weight loss)
Laboratory Criteria
At least one of the following three:
Demonstration of Giardia lamblia cysts or trophozoites in stool, duodenal fluid or small-bowel biopsy
Demonstration of Giardia lamblia antigen in stool, duodenal fluid or small-bowel biopsy
Detection of Giardia lamblia nucleic acid in stool, duodenal fluid or small-bowel biopsy
Epidemiological Criteria
At least one of the following four epidemiological links:
Exposure to contaminated food/drinking water
Human to human transmission
Exposure to a common source
Environmental exposure
Case Classification
Note: If the national surveillance system is not capturing clinical symptoms, all laboratory-confirmed individuals should be reported as confirmed cases.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
3.14. GONOCOCCAL INFECTION
3.14. Clinical Criteria
Any person with at least one of the following eight: OR Any newborn child with conjunctivitis
Urethritis
Acute salpingitis
Pelvic inflammatory disease
Cervicitis
Epididymitis
Proctitis
Pharyngitis
Arthritis
Laboratory Criteria
At least one of the following four:
Isolation of Neisseria gonorrhoeae from a clinical specimen
Detection of Neisseria gonorrhoeae nucleic acid in a clinical specimen
Demonstration of Neisseria gonorrhoeae by a non-amplified nucleic acid probe test in a clinical specimen
Microscopic detection of intracellular Gram-negative diploccocci in an urethral male specimen
Epidemiological Criteria
An epidemiological link by human to human transmission (sexual contact or vertical transmission)
Case Classification
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the laboratory criteria
Antimicrobial resistance
For cases ascertained by culture, the results of antimicrobial susceptibility tests must be reported according to the methods and criteria agreed between ECDC and Member States as specified in the ECDC standard protocol for gonococcal antimicrobial resistance surveillance.
3.15. HAEMOPHILUS INFLUENZAE INFECTION, INVASIVE DISEASE Epidemiological Criteria NA
3.15. Clinical Criteria
Not relevant for surveillance purposes
Laboratory Criteria
At least one of the following two:
Isolation of Haemophilus influenzae from a normally sterile site
Detection of Haemophilus influenzae nucleic acid from a normally sterile site
Case Classification
A.
Possible case NA
B.
Probable case NA
C.
Confirmed case Any person meeting the laboratory criteria
3.16. ACUTE HEPATITIS A
3.16. Clinical Criteria
Any person with a discrete onset of symptoms (for example, fatigue, abdominal pain, loss of appetite, intermittent nausea and vomiting) AND At least one of the following three:
Fever
Jaundice
Elevated serum aminotransferase levels
Laboratory Criteria
At least one of the following three:
Detection of hepatitis A virus nucleic acid in serum or stool
Hepatitis A virus specific antibody response
Detection of hepatitis A virus antigen in stool
Epidemiological Criteria
At least one of the following four:
Human to human transmission
Exposure to a common source
Exposure to contaminated food/drinking water
Environmental exposure
Case Classification
Note: If the national surveillance system is not capturing clinical symptoms, all laboratory-confirmed individuals should be reported as confirmed cases.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
3.17. HEPATITIS B
3.17. Clinical Criteria
Not relevant for surveillance purposes
Laboratory Criteria
Positive results of at least one or more of the following tests or combination of tests:
IgM hepatitis B core antibody (anti-HBc IgM)
Hepatitis B surface antigen (HBsAg)
Hepatitis B e antigen (HBeAg)
Hepatitis B nucleic acid (HBV-DNA)
Epidemiological Criteria
Not relevant for surveillance purposes
Case Classification
A.
Possible case NA
B.
Probable case NA
C.
Confirmed case Any person meeting the laboratory criteria
3.18. HEPATITIS C Epidemiological Criteria NA
3.18. Clinical Criteria
Not relevant for surveillance purposes
Laboratory Criteria
At least one of the following three:
Detection of hepatitis C virus nucleic acid (HCV RNA)
Detection of hepatitis C virus core antigen (HCV-core)
Hepatitis C virus specific antibody (anti-HCV) response confirmed by a confirmatory (for example, immunoblot) antibody test in persons older than 18 months without evidence of resolved infection)
Case Classification
A.
Possible case NA
B.
Probable case NA
C.
Confirmed case Any person meeting the laboratory criteria
3.19. HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION AND ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) Epidemiological Criteria NA
3.19. Clinical Criteria (AIDS)
Any person who has any of the clinical conditions as defined in the European AIDS case definition for:
Adults and adolescents ≥ 15 years
Children < 15 years of age
Adults, adolescents and children aged ≥ 18 months At least one of the following three:
Positive result of a HIV screening antibody test or a combined screening test (HIV antibody and HIV p24 antigen) confirmed by a more specific antibody test (for example, Western blot);
Positive result of 2 EIA antibody test confirmed by a positive result of a further EIA test;
Positive results on two separate specimens from at least one of the following three:
Detection of HIV nucleic acid (HIV-RNA, HIV-DNA);
Demonstration of HIV by HIV p24 antigen test, including neutralisation assay;
Isolation of HIV.
Children aged < 18 months Positive results on two separate specimens (excluding cord blood) from at least one of the following three:
Isolation of HIV;
Detection of HIV nucleic acid (HIV-RNA, HIV-DNA);
Demonstration of HIV by HIV p24 antigen test, including neutralisation assay in a child ≥ 1 month of age.
Case Classification
A.
Possible case NA
B.
Probable case NA
C.
Confirmed case
HIV infection: Any person meeting the laboratory criteria for HIV infection.
AIDS: Any person meeting the clinical criteria for AIDS and the laboratory criteria for HIV infection.
3.20. INFLUENZA
3.20. Clinical Criteria
Any person with at least one of the following clinical forms:
Influenza-like illness (ILI)
Sudden onset of symptoms AND
at least one of the following four systemic symptoms:
Fever or feverishness
Malaise
Headache
Myalgia AND
At least one of the following three respiratory symptoms:
Cough
Sore throat
Shortness of breath
Acute respiratory infection (ARI)
Sudden onset of symptoms AND
At least one of the following four respiratory symptoms: AND
Cough
Sore throat
Shortness of breath
Coryza
A clinician's judgement that the illness is due to an infection
Laboratory Criteria
At least one the following four: Sub typing of the influenza isolate should be performed, if possible
Isolation of influenza virus from a clinical specimen
Detection of influenza virus nucleic acid in a clinical specimen
Identification of influenza virus antigen by DFA test in a clinical specimen
Influenza specific antibody response
Epidemiological Criteria
An epidemiological link by human to human transmission
Case Classification
A.
Possible case Any person meeting the clinical criteria (ILI or ARI)
B.
Probable case Any person meeting the clinical criteria (ILI or ARI) with an epidemiological link
C.
Confirmed case Any person meeting the clinical (ILI or ARI) and the laboratory criteria
3.21. INFLUENZA A/H5N1
3.21. Clinical Criteria
Any person with one of the following two:
Fever AND signs and symptoms of acute respiratory infection;
Death from an unexplained acute respiratory illness.
Laboratory Criteria
At least one of the following three:
Isolation of influenza A/H5N1 from a clinical specimen;
Detection of influenza A/H5 nucleic acid in a clinical specimen;
Influenza A/H5 specific antibody response (four-fold or greater rise or single high titre).
Epidemiological Criteria
At least one of the following four:
Human to human transmission by having been in close contact (within 1 metre) to a person reported as probable or confirmed case;
Laboratory exposure: where there is a potential exposure to influenza A/H5N1;
Close contact (within 1 metre) with an animal with confirmed A/H5N1 infection other than poultry or wild birds (for example, cat or pig);
Reside in or have visited an area where influenza A/H5N1 is currently suspected or confirmed AND at least one of the following two:
Having been in close contact (within 1 metre) with sick or dead domestic poultry or wild birds in the affected area;
Having been in a home or a farm where sick or dead domestic poultry have been reported in the previous month in the affected area.
Case Classification
A.
Possible case Any person meeting the clinical and the epidemiological criteria
B.
Probable case Any person with a positive test for influenza A/H5 or A/H5N1 performed by a laboratory which is not a National Reference Laboratory participating in the EU Community Network of Reference Laboratories for human influenza (CNRL)
C.
Nationally confirmed case Any person with a positive test for influenza A/H5 or A/H5N1 performed by a National Reference Laboratory participating in the EU Community Network of Reference Laboratories for human influenza (CNRL)
D.
WHO confirmed case Any person with a laboratory confirmation by a WHO Collaborating Centre for H5
3.22. LEGIONNAIRES' DISEASE Epidemiological Criteria NA
3.22. Clinical Criteria
Any person with pneumonia
Laboratory Criteria
Laboratory criteria for case confirmation
At least one of the following three:
Isolation of Legionella spp. from respiratory secretions or any normally sterile site
Detection of Legionella pneumophila antigen in urine
Significant rise in specific antibody level to Legionella pneumophila serogroup 1 in paired serum samples
Laboratory criteria for a probable case
At least one of the following four:
Detection of Legionella pneumophila antigen in respiratory secretions or lung tissue for example, by DFA staining using monoclonal-antibody derived reagents
Detection of Legionella spp. nucleic acid in respiratory secretions, lung tissue or any normally sterile site
Significant rise in specific antibody level to Legionella pneumophila other than serogroup 1 or other Legionella spp. in paired serum samples
Single high level of specific antibody to Legionella pneumophila serogroup 1 in serum
Case Classification
A.
Possible case NA
B.
Probable case Any person meeting the clinical criterion AND at least one laboratory criterion for a probable case
C.
Confirmed case Any person meeting the clinical criterion AND at least one laboratory criterion for a confirmed case
3.23. LEPTOSPIROSIS
3.23. Clinical Criteria
Any person with OR At least two of the following eleven:
Fever
Chills
Headache
Myalgia
Conjunctival suffusion
Haemorrhages into skin and mucous membranes
Rash
Jaundice
Myocarditis
Meningitis
Renal impairment
Respiratory symptoms such as haemoptysis
Laboratory Criteria
At least one of the following four:
Isolation of Leptospira interrogans or any other pathogenic Leptospira spp. from a clinical specimen
Detection of Leptospira interrogans or any other pathogenic Leptospira spp. nucleic acid in a clinical specimen
Demonstration of Leptospira interrogans or any other pathogenic Leptospira spp. by immunofluorescence in a clinical specimen
Leptospira interrogans or any other pathogenic Leptospira spp. specific antibody response
Epidemiological Criteria
At least one of the following three epidemiological links:
Animal to human transmission
Environmental exposure
Exposure to a common source
Case Classification
Note: If the national surveillance system is not capturing clinical symptoms, all laboratory-confirmed individuals should be reported as confirmed cases.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
3.24. LISTERIOSIS
3.24. Clinical Criteria
Any person with at least one of the following five:
Fever
Meningitis, meningoencephalitis, or encephalitis
Influenza-like symptoms
Septicaemia
Localized infections such as arthritis, endocarditis, endophthalmitis, and abscesses
Listeriosis in pregnancy:
OR At least one of the following five in the first month of life (neonatal listeriosis):
Pregnancy-related consequences of Listeria infection defined as: miscarriage, stillbirth or premature birth during the pregnancy
Listeriosis of newborns defined as one of the following
Stillbirth (fetal death after 20 weeks of gestation)
Premature birth (before 37 gestational weeks)
Meningitis or meningoencephalitis
Septicaemia
Dyspnoea
Granulomatosis infantiseptica
Lesions on skin, mucosal membranes or conjunctivae
Laboratory Criteria
At least one of the following two:
Isolation of Listeria monocytogenes or detection of nucleic acid of Listeria monocytogenes from a normally sterile site
In a pregnancy-associated case also: Isolation of Listeria monocytogenes or detection of nucleic acid from Listeria monocytogenes in a normally non-sterile site (for example, placental tissue, amniotic fluid, meconium, vaginal swab) or from a foetus, stillborn, newborn or the mother
Epidemiological Criteria
At least one of the following four epidemiological links:
Exposure to a common source
Human to human transmission (vertical transmission)
Exposure to contaminated food
Animal to human transmission
Case Classification
Note: If the national surveillance system is not capturing clinical symptoms, all laboratory-confirmed individuals should be reported as confirmed cases.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the laboratory criteria for a normal sterile site OR In a pregnancy-associated case (mother or newborn in the first month of life) meeting the laboratory criteria, only the mother is to be reported as a case.
3.25. LYME NEUROBORRELIOSIS
Neurological symptoms according to European Federation of Neurological Societies (EFNS) suggested case definition, without other obvious reasons
3.25. Laboratory Criteria
A.
Confirmed case
Pleocytosis in cerebrospinal fluid, AND OR
Evidence of intrathecal production of Lyme borreliosis antibodies, OR
Borrelia burdgorferi s.l. isolation, OR
nucleic acid detection in cerebrospinal fluid
Detection of IgG Lyme borreliosis antibodies in blood specimen only for children (age under 18) with facial palsy or other cranial neuritis and a recent (< 2 months) history of erythema migrans
B.
Probable case
Pleocytosis in cerebrospinal fluid AND positive Lyme borreliosis serology in cerebrospinal fluid OR
Specific intrathecal Lyme borreliosis antibody production
Epidemiological Criteria
Not applicable
Case Classification
A.
Possible case Not applicable
B.
Probable case Any person meeting the clinical criteria and at least one of the laboratory criteria for probable cases
C.
Confirmed case Any person meeting the clinical criteria and at least one of the laboratory criteria for confirmed cases
3.26. MALARIA Epidemiological Criteria NA
3.26. Clinical Criteria
Any person with fever OR a history of fever
Laboratory Criteria
At least one of the following three: Differentiation of Plasmodium spp. should be performed if possible
Demonstration of malaria parasites by light microscopy in blood films
Detection of Plasmodium nucleic acid in blood
Detection of Plasmodium antigen
Case Classification
Note: If the national surveillance system is not capturing clinical symptoms, all laboratory-confirmed individuals should be reported as confirmed cases.
A.
Possible case NA
B.
Probable case NA
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
3.27. MEASLES
3.27. Clinical Criteria
Any person with fever AND AND at least one of the following three:
Maculo-papular rash
Cough
Coryza
Conjunctivitis
Laboratory Criteria
At least one of the following four: Laboratory results need to be interpreted according to the vaccination status. If recently vaccinated, investigate for wild virus
Isolation of measles virus from a clinical specimen
Detection of measles virus nucleic acid in a clinical specimen
Measles virus specific antibody response characteristic for acute infection in serum or saliva
Detection of measles virus antigen by DFA in a clinical specimen using measles specific monoclonal antibodies
Epidemiological criteria
An epidemiological link by human to human transmission
Case Classification
A.
Possible case Any person meeting the clinical criteria
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person not recently vaccinated and meeting the clinical and the laboratory criteria
3.28. MENINGOCOCCAL INFECTION, INVASIVE DISEASE
3.28. Clinical Criteria
Any person with at least one of the following symptoms:
Meningeal signs
Haemorrhagic rash
Septic shock
Septic arthritis
Laboratory Criteria
At least one of the following four:
Isolation of Neisseria meningitidis from a normally sterile site, or from purpuric skin lesions
Detection of Neisseria meningitidis nucleic acid from a normally sterile site, or from purpuric skin lesions
Detection of Neisseria meningitidis antigen in CSF
Detection of Gram-negative stained diplococcus in CSF
Epidemiological Criteria
An epidemiological link by human to human transmission
Case Classification
A.
Possible case Any person meeting the clinical criteria
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the laboratory criteria
3.29. MUMPS
3.29. Clinical Criteria
Any person with AND At least one of the following three:
Fever
Sudden onset of unilateral or bilateral tender swelling of the parotid or other salivary glands without other apparent cause
Orchitis
Meningitis
Laboratory Criteria
At least one of the following three: Laboratory results need to be interpreted according to the vaccination status
Isolation of mumps virus from a clinical specimen
Detection of mumps virus nucleic acid
Mumps virus specific antibody response characteristic for acute infection in serum or Saliva
Epidemiological Criteria
An epidemiological link by human to human transmission
Case Classification
A.
Possible case Any person meeting the clinical criteria
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person not recently vaccinated and meeting the laboratory criteria In case of recent vaccination: any person with detection of wild-type mumps virus strain
3.30. PERTUSSIS
3.30. Clinical Criteria Notes:
Any person with a cough lasting at least two weeks AND OR Any person diagnosed as pertussis by a physician OR Apnoeic episodes in infants All individuals including adults, adolescents or vaccinated children can present with atypical symptoms. Characteristics of cough should be investigated, particularly whether the cough is paroxysmal in nature, increases during the night and occurs in the absence of fever.
at least one of the following three:
Paroxysms of coughing
Inspiratory whooping
Post-tussive vomiting
Laboratory Criteria
At least one of the following three: Direct diagnosis (i)-(ii): Bordetella pertussis and its nucleic acid are best isolated/detected from nasopharyngeal samples. Indirect diagnosis (iii): if possible ELISA should be performed using highly purified Pertussis Toxin and WHO reference sera as a standard. Results need to interpreted according to pertussis vaccination status. If vaccinated within the last few years before specimen collection, the titre of specific antibodies against Bordetella pertussis toxin may be a consequence of, or modified by, previous vaccination.
(i) Isolation of Bordetella pertussis from a clinical specimen
(ii) Detection of Bordetella pertussis nucleic acid in a clinical specimen
(iii) Bordetella pertussis specific antibody response
Epidemiological Criteria
An epidemiological link by human to human transmission
Case Classification
A.
Possible case Any person meeting the clinical criteria
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
3.31. PLAGUE
3.31. Clinical Criteria
Any person with at least one of the following clinical forms:
Bubonic plague:
Fever AND
Sudden onset of painful lymphadenitis
Septicaemic plague:
Fever
Pneumonic plague: AND At least one of the following three:
Fever
Cough
Chest pain
Haemoptysis
Laboratory Criteria
At least one of the following three:
Isolation of Yersinia pestis from a clinical specimen
Detection of Yersinia pestis nucleic acid from a clinical specimen
Yersinia pestis anti-F1 antigen specific antibody response
Epidemiological Criteria
At least one of the following four epidemiological links:
Human to human transmission
Animal to human transmission
Laboratory exposure (where there is a potential exposure to plague)
Exposure to a common source
Case Classification
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the laboratory criteria
3.32. STREPTOCOCCUS PNEUMONIAE INFECTION, INVASIVE DISEASE Epidemiological Criteria NA
3.32. Clinical Criteria
Not relevant for surveillance purposes
Laboratory Criteria
At least one of the following three:
Isolation of Streptococcus pneumoniae from a normally sterile site
Detection of Streptococcus pneumoniae nucleic acid from a normally sterile site
Detection of Streptococcus pneumoniae antigen from a normally sterile site
Case Classification
A.
Possible case NA
B.
Probable case NA
C.
Confirmed case Any person meeting the laboratory criteria
Antimicrobial resistance:
The results of antimicrobial susceptibility tests must be reported according to the methods and criteria agreed between ECDC and Member States as specified by ECDC's European Antimicrobial Resistance Surveillance Network (EARS-Net).
3.33. ACUTE POLIOMYELITIS
3.33. Clinical Criteria
Any person < 15 years of age with Acute flaccid paralysis (AFP) OR Any person in whom polio is suspected by a physician
Laboratory Criteria
At least one of the following three:
Isolation of a polio virus and intratypic differentiation — Wild polio virus (WPV)
Vaccine derived poliovirus (VDPV) (for the VDPV at least 85 % similarity with vaccine virus in the nucleotide sequences in the VP1 section)
Sabin-like poliovirus: intratypic differentiation performed by a WHO-accredited polio laboratory (for the VDPV a > 1 % up to 15 % VP1 sequence difference compared with vaccine virus of the same serotype)
Epidemiological Criteria
At least one of the following two epidemiological links:
Human to human transmission
An history of travel to a polio-endemic area or an area with suspected or confirmed circulation of poliovirus
Case Classification
A.
Possible case Any person meeting the clinical criteria
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
3.34. Q FEVER
3.34. Clinical Criteria
Any person with at least one of the following three:
Fever
Pneumonia
Hepatitis
Laboratory Criteria
At least one of the following three:
Isolation of Coxiella burnetii from a clinical specimen
Detection of Coxiella burnetii nucleic acid in a clinical specimen
Coxiella burnetii specific antibody response (IgG or IgM phase II)
Epidemiological Criteria
At least one of the following two epidemiological links:
Exposure to a common source
Animal to human transmission
Case Classification
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
3.35. RABIES
3.35. Clinical Criteria
Any person with an acute encephalomyelitis AND At least two of the following seven:
Sensory changes referred to the site of a preceding animal bite
Paresis or paralysis
Spasms of swallowing muscles
Hydrophobia
Delirium
Convulsions
Anxiety
Laboratory Criteria
At least one of the following four: Laboratory results need to be interpreted according to the vaccination or immunization status
Isolation of Lyssa virus from a clinical specimen
Detection of Lyssa virus nucleic acid in a clinical specimen (for example, saliva or brain tissue)
Detection of viral antigens by a DFA in a clinical specimen
Lyssa virus specific antibody response by virus neutralization assay in serum or CSF
Epidemiological Criteria
At least one of the following three epidemiological links:
Animal to human transmission (animal with suspected or confirmed infection)
Exposure to a common source (same animal)
Human to human transmission (for example, transplantation of organs)
Case Classification
A.
Possible case Any person meeting the clinical criteria
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
3.36. RUBELLA
3.36. Clinical Criteria
Any person with sudden onset of generalised maculo-papular rash AND At least one of the following five:
Cervical adenopathy
Sub-occipital adenopathy
Post-auricular adenopathy
Arthralgia
Arthritis
Laboratory Criteria
At least one of the following four: Laboratory results need to be interpreted according to the vaccination status (possible persistence of IgM antibodies upon vaccination).
Isolation of rubella virus from a clinical specimen
Detection of rubella virus nucleic acid in a clinical specimen
Rubella IgM antibody detection
Rubella IgG seroconversion or significant rise in rubella IgG antibody titre in paired specimens tested in parallel.
Epidemiological Criteria
An epidemiological link to a confirmed case
Case Classification
Note: When rubella in pregnancy is suspected, further confirmation of a positive rubella IgM results is required for case management (for example, a rubella specific IgG avidity test, rubella IgM and comparison of rubella IgG levels on paired sera conducted in a reference laboratory).
A.
Possible case Any person meeting the clinical criteria
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria who has not been recently vaccinated. In case of recent vaccination, a person meeting the clinical criteria with detection of wild-type rubella virus strain is considered as a confirmed case.
3.37. CONGENITAL RUBELLA SYNDROME
3.37. Clinical Criteria
Congenital rubella infection (CRI)
No clinical criteria can be defined for CRI
Congenital rubella syndrome (CRS)
Any infant < 1 year of age or any stillborn with: At least two of the conditions listed in (A) OR One in category (A) and one in category (B) (A) (B)
Cataract(s)
Congenital glaucoma
Congenital heart disease
Loss of hearing
Pigmentary retinopathy
Purpura
Splenomegaly
Microcephaly
Developmental delay
Meningo-encephalitis
Radiolucent bone disease
Jaundice that begins within 24 hours after birth
Laboratory Criteria
At least one of the following four: Laboratory results need to be interpreted according to the vaccination status
Isolation of rubella virus from a clinical specimen
Detection of Rubella virus nucleic acid
Rubella virus specific antibody response (IgM)
Persistence of rubella IgG between 6 and 12 months of age (at least two samples with similar concentration of rubella IgG)
Epidemiological Criteria
Any infant or any stillborn born to a woman with a laboratory confirmed rubella infection during pregnancy by human to human transmission vertical transmission)
Case Classification Congenital Rubella
A.
Possible case NA
B.
Probable case Any stillborn or infant either not tested OR with negative laboratory results with at least one of the following two:
An epidemiological link AND at least one of the conditions listed in the category A CRS clinical criteria
Meeting the clinical criteria for CRS
C.
Confirmed case Any stillborn meeting the laboratory criteria OR Any infant meeting the laboratory criteria AND at least one of the following two:
An epidemiological link
At least one of the conditions listed in the category A CRS clinical criteria
3.38. SALMONELLA ENTERITIS
3.38. Clinical Criteria
Any person with at least one of the following four:
Diarrhoea
Fever
Abdominal pain
Vomiting
Laboratory Criteria
At least one of the following two: Note: Antimicrobial susceptibility testing of Salmonella enterica should be performed on a representative subset of isolates
Isolation of Salmonella (other than S. Typhi or S. Paratyphi) in a clinical specimen
Detection of nucleic acid from Salmonella (other than S. Typhi or S. Paratyphi) in a clinical specimen
Epidemiological Criteria
At least one of the following five epidemiological links:
Human to human transmission
Exposure to a common source
Animal to human transmission
Exposure to contaminated food/drinking water
Environmental exposure
Case Classification
Note: If the national surveillance system is not capturing clinical symptoms, all laboratory-confirmed individuals should be reported as confirmed cases.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
Antimicrobial resistance
The results of antimicrobial susceptibility tests must be reported according to the methods and criteria agreed between ECDC and Member States as specified in the EU protocol for harmonised monitoring of antimicrobial resistance in human Salmonella and Campylobacter isolates.
3.39. SEVERE ACUTE RESPIRATORY SYNDROME (SARS)
3.39. Clinical Criteria
Any person with fever or a history of fever AND At least one of the following three: AND At least one of the following four: AND No alternative diagnosis which can fully explain the illness
Cough
Difficulty in breathing
Shortness of breath
Radiographic evidence of pneumonia
Radiographic evidence of acute respiratory distress syndrome
Autopsy findings of pneumonia
Autopsy findings of acute respiratory distress syndrome
Laboratory Criteria
Laboratory criteria for case confirmation
At least one of the following three:
Isolation of virus in cell culture from any clinical specimen and identification of SARS-CoV using method such as RT-PCR
Detection SARS-CoV nucleic acid in at least one of the following three:
At least two different clinical specimens (for example, nasopharyngeal swab and stool)
The same clinical specimen collected on two or more occasions during the course of the illness (for example, sequential nasopharyngeal aspirates)
Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing
SARS-CoV specific antibody response by one of the following two:
Seroconversion by ELISA or IFA in acute and convalescent phase serum tested in parallel
Four-fold or greater rise in antibody titre between acute and convalescent phase sera tested in parallel
Laboratory criteria for a probable case
At least one of the following two:
A single positive antibody test for SARS-CoV
A positive PCR result for SARS-CoV on a single clinical specimen and assay
Epidemiological Criteria
At least one of the following three:
Any person with at least one of the following three:
Employed in an occupation associated with an increased risk of SARS-CoV exposure (for example, staff in a laboratory working with live SARS-CoV/SARS-CoV-like viruses or storing clinical specimens infected with SARS-CoV; persons with exposure to wildlife or other animals considered a reservoir of SARS-CoV, their excretions or secretions, etc.)
Close contact of one or more persons with confirmed SARS or under investigation for SARS
History of travel to, or residence in, an area experiencing an outbreak of SARS
Two or more health-care workers with clinical evidence of SARS in the same health-care unit with onset of illness in the same 10-day period
Three or more persons (health-care workers and/or patients and/or visitors) with clinical evidence of SARS with onset of illness in the same 10-day period and epidemiologically linked to a healthcare facility
Case Classification for the inter-epidemic period
Also applies during an outbreak in a non-affected country or area
A.
Possible case Any person meeting the clinical criteria with an epidemiological link
B.
Probable case Any person meeting the clinical criteria with an epidemiological link and meeting the laboratory criteria for a probable case
C.
Nationally confirmed case Any person meeting the clinical and the laboratory criteria for case confirmation where the testing has been performed at a national reference laboratory
D.
Confirmed case Any person meeting the clinical and the laboratory criteria for case confirmation where the testing has been performed at a WHO SARS verification and reference laboratory
Case Classification during an outbreak
Applies during an outbreak in a country/area where at least one person has been laboratory confirmed by a WHO SARS verification and reference laboratory
A.
Possible case Any person meeting the clinical criteria
B.
Probable case Any person meeting the clinical criteria with an epidemiological link to a nationally confirmed or a confirmed case
C.
Nationally confirmed case Any person meeting the clinical and the laboratory criteria for case confirmation where the testing has been performed at a national reference laboratory
D.
Confirmed case One of the following three:
Any person meeting the clinical and the laboratory criteria for case confirmation where the testing has been performed at a WHO SARS verification and reference laboratory
Any nationally confirmed case with an epidemiological link to a chain of transmission where at least one case has been independently verified by a WHO SARS Reference and Verification Laboratory
Any person meeting the clinical criteria and with laboratory criteria for probable case with an epidemiological link to a chain of transmission where at least one case has been independently verified by a WHO SARS Reference and Verification Laboratory
3.40. SHIGA TOXIN/VEROCYTOTOXIN-PRODUCING E. COLI INFECTION (STEC/VTEC), INCLUDING HAEMOLYTIC-URAEMIC SYNDROME (HUS)
3.40. Clinical Criteria
STEC/VTEC diarrhoea
Any person with at least one of the following two:
Diarrhoea
Abdominal pain
HUS
Any person with acute renal failure and at least one of the following two:
Microangiopatic haemolytic anaemia
Thrombocytopenia
Laboratory Criteria
At least one of the following four: Only for HUS the following can be used as a laboratory criterion to confirm STEC/VTEC:
Isolation/cultivation of Escherichia coli that produces Shiga toxin/verocytotoxin or harbours stx1/vtx1 or stx2/vtx2 gene(s)
Isolation of non-sorbitol-fermenting (NSF) Escherichia coli O157 (without testing for the toxin or toxin-producing genes)
Direct detection of stx1/vtx1 or stx2/vtx2 gene(s) nucleic acid
Direct detection of free Shiga toxin/verocytotoxin in faeces
Escherichia coli serogroup-specific (LPS) antibody response
Epidemiological Criteria
At least one of the following five epidemiological links:
Human to human transmission
Exposure to a common source
Animal to human transmission
Exposure to contaminated food/drinking water
Environmental exposure
Case Classification
Note: If the national surveillance system is not capturing clinical symptoms, all laboratory-confirmed individuals should be reported as confirmed cases.
A.
Possible case of STEC-associated HUS Any person meeting the clinical criteria for HUS
B.
Probable case of STEC/VTEC Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case of STEC/VTEC Any person meeting the clinical and the laboratory criteria
3.41. SHIGELLOSIS
3.41. Clinical Criteria
Any person with at least one of the following four:
Diarrhoea
Fever
Vomiting
Abdominal pain
Laboratory Criteria
For a confirmed case: For a probable case: Note: Antimicrobial susceptibility testing of Shigella should be performed, if possible
Isolation of Shigella spp. from a clinical specimen
Detection of Shigella spp. nucleic acid in a clinical specimen
Epidemiological Criteria
At least one of the following four epidemiological links:
Human to human transmission
Exposure to a common source
Exposure to contaminated food/drinking water
Environmental exposure
Case Classification
Note: If the national surveillance system is not capturing clinical symptoms, all laboratory-confirmed individuals should be reported as confirmed cases.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link OR Any person meeting the clinical criteria and laboratory criteria for a probable case
C.
Confirmed case Any person meeting the clinical and the laboratory criteria for a confirmed case
Antimicrobial resistance
The results of antimicrobial susceptibility tests must be reported according to the methods and criteria agreed between ECDC and Member States.
3.42. SMALLPOX
3.42. Clinical Criteria
Any person with at least one of the following two: AND Vesicles or firm pustules rash at the same stage of development with a centrifugal distribution
Fever
Atypical presentations defined as at least one of the following four:
Haemorrhagic lesions
Flat velvety lesions not progressing to vesicles
Variola sine eruptione
Milder type
Laboratory Criteria
Laboratory criteria for case confirmation
At least one of the following two laboratory tests: Laboratory results need to be interpreted according to the vaccination status
Isolation of smallpox (Variola virus) from a clinical specimen followed by sequencing (designated P4 laboratories only)
Detection of Variola virus nucleic acid in a clinical specimen followed by sequencing
Identification of orthopox virus particles by EM
Epidemiological Criteria
At least one of the following two epidemiological links:
Human to human transmission
Laboratory exposure (where there is a potential exposure to Variola virus)
Case Classification
A.
Possible case Any person meeting the clinical criteria
B.
Probable case Any person meeting the clinical criteria and with at least one of the following two:
An epidemiological link to a confirmed human case by human to human transmission
Meeting the laboratory criteria for a probable case
C.
Confirmed case Any person meeting the laboratory criteria for case confirmation During an outbreak: any person meeting the clinical criteria with an epidemiological link
3.43. SYPHILIS
3.43. Clinical Criteria
Note that ocular and neurological manifestations may occur at any stage of syphilis. Note that cases of late latent syphilis (> 1 year) are not under EU/EEA surveillance.
Primary syphilis
Any person with one or several (usually painless) chancres in the genital, perineal, anal area or mouth or pharyngeal mucosa or elsewhere extragenitally
Secondary syphilis
Any person with at least one of the following five:
Diffuse maculo-papular rash often involving palms and soles
Generalized lymphadenopathy
Condyloma lata
Enanthema
Diffuse alopecia
Early latent syphilis (< 1 year)
No symptoms and a history of symptoms compatible with those of the earlier stages of syphilis within the previous 12 months
Laboratory Criteria
At least one of the following:
Demonstration of Treponema pallidum in lesion exudates or tissues by dark-field microscopic examination
Demonstration of Treponema pallidum in lesion exudates or tissues by DFA test
Demonstration of Treponema in lesion exudates or tissues by nuclear acid amplification techniques (NAAT)
Detection of Treponema pallidum antibodies by screening test (TPHA, TPPA or EIA) AND additionally detection of either TP-IgM antibodies (for example, IgM-ELISA or immunoblot or 19S-IgM-FTA-abs) OR non-TP antibodies (for example, RPR, VDRL).
Epidemiological Criteria
Primary/secondary syphilis
An epidemiological link by human to human (sexual contact)
Early latent syphilis
An epidemiological link by human to human (sexual contact) within the 12 previous months
Case Classification
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the laboratory criteria for case confirmation
3.44. CONGENITAL SYPHILIS
3.44. Clinical Criteria
Any infant < 2 years of age with at least one of the following ten:
Hepatospenomegaly
Mucocutaneous lesions
Condyloma lata
Persistent rhinitis
Jaundice
Pseudoparalysis (due to periostitis and osteochondritis)
Central nervous involvement
Anaemia
Nephrotic syndrome
Malnutrition
Laboratory Criteria
Laboratory criteria for case confirmation
At least one of the following three: AND a reactive non-treponemal test (VDRL, RPR) in the child's serum
Demonstration of Treponema pallidum by dark field microscopy in the umbilical cord, the placenta, a nasal discharge or skin lesion material
Demonstration of Treponema pallidum by DFA-TP in the umbilical cord, the placenta, a nasal discharge or skin lesion material
Detection of Treponema pallidum-specific IgM (FTA-abs, EIA)
Laboratory criteria for a probable case
At least one of the following three:
Reactive VDRL-CSF test result
Reactive non-treponemal and treponemal serologic tests in the mother's serum
Infant's non-treponemal antibody titre is four-fold or greater than the antibody titre in the mother's serum
Epidemiological Criteria
Any infant with an epidemiological link by human to human transmission (vertical transmission)
Case Classification
A.
Possible case NA
B.
Probable case Any infant or child meeting the clinical criteria and with at least one of the following two:
An epidemiological link
Meeting the laboratory criteria for a probable case
C.
Confirmed case Any infant meeting the laboratory criteria for case confirmation
3.45. TETANUS Laboratory Criteria NA Epidemiological Criteria NA
3.45. Clinical Criteria
Any person with acute onset of at least two of the following three:
Painful muscular contractions primarily of the masseter and neck muscles leading to facial spasms known as trismus and risus sardonicus
Painful muscular contractions of trunk muscles
Generalized spasms, frequently position of opisthotonus
Case Classification
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria in the absense of a more likely diagnosis
C.
Confirmed case NA
3.46. TICK-BORNE VIRAL ENCEPHALITIS
3.46. Clinical Criteria
Any person with symptoms of inflammation of the CNS (for example, meningitis, meningo-encephalitis, encephalomyelitis, encephaloradiculitis)
Laboratory Criteria
Laboratory criteria for case confirmation:
At least one of the following five:
TBE specific IgM AND IgG antibodies in blood
TBE specific IgM antibodies in CSF
Seroconversion or four-fold increase of TBE-specific antibodies in paired serum samples
Detection of TBE viral nucleic acid in a clinical specimen,
Isolation of TBE virus from clinical specimen
Laboratory criteria for a probable case:
Detection of TBE-specific IgM-antibodies in a unique serum sample
Epidemiological Criteria
Exposure to a common source (unpasteurised dairy products)
Case Classification
Note: Serological results should be interpreted according to previous exposure to other flaviviral infections and the flavivirus vaccination status. Confirmed cases in such situations should be validated by serum neutralization assay or other equivalent assays.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria and the laboratory criteria for a probable case, OR Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and laboratory criteria for case confirmation
3.47. CONGENITAL TOXOPLASMOSIS Epidemiological Criteria NA
3.47. Clinical Criteria
Not relevant for surveillance purposes
Laboratory Criteria
At least one of the following four:
Demonstration of Toxoplasma gondii in body tissues or fluids
Detection of Toxoplasma gondii nucleic acid in a clinical specimen
Toxoplasma gondii specific antibody response (IgM, IgG, IgA) in a newborn
Persistently stable IgG Toxoplasma gondii titres in an infant (< 12 months of age)
Case Classification
A.
Possible case NA
B.
Probable case NA
C.
Confirmed case Any infant meeting the laboratory criteria
3.48. TRICHINELLOSIS
3.48. Clinical Criteria
Any person with at least three of the following six:
Fever
Muscle soreness and pain
Diarrhoea
Facial oedema
Eosinophilia
Subconjunctival, subungual and retinal haemorrhages
Laboratory Criteria
At least one of the following two:
Demonstration of Trichinella larvae in tissue obtained by muscle biopsy
Trichinella specific antibody response (IFA test, ELISA or Western Blot)
Epidemiological Criteria
At least one of the following two epidemiological links:
Exposure to contaminated food (meat)
Exposure to a common source
Case Classification
Note: If the national surveillance system is not capturing clinical symptoms, all laboratory-confirmed individuals should be reported as confirmed cases.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical criteria and the laboratory criteria
3.49. TUBERCULOSIS Epidemiological Criteria NA
3.49. Clinical Criteria
Any person with the following two: OR A case discovered post-mortem with pathological findings consistent with active tuberculosis that would have indicated anti-tuberculosis antibiotic treatment had the patient been diagnosed before dying
Signs, symptoms and/or radiological findings consistent with active tuberculosis in any site AND
A clinician's decision to treat the person with a full course of anti-tuberculosis therapy
Laboratory Criteria
Laboratory criteria for case confirmation
At least one of the following two:
Isolation of Mycobacterium tuberculosis complex (excluding Mycobacterium bovis-BCG) from a clinical specimen
Detection of Mycobacterium tuberculosis complex nucleic acid in a clinical specimen AND positive microscopy for acid-fast bacilli or equivalent fluorescent staining bacilli on light microscopy
Laboratory criteria for a probable case
At least one of the following three:
Microscopy for acid-fast bacilli or equivalent fluorescent staining bacilli on light microscopy
Detection of Mycobacterium tuberculosis complex nucleic acid in a clinical specimen
Histological appearance of granulomata
Case Classification
A.
Possible case Any person meeting the clinical criteria
B.
Probable case Any person meeting the clinical criteria and the laboratory criteria for a probable case
C.
Confirmed case Any person meeting the clinical and the laboratory criteria for case confirmation
Antimicrobial resistance
The results of antimicrobial susceptibility tests must be reported according to the methods and criteria agreed between ECDC and Member States as specified by the European Reference Laboratory Network for Tuberculosis and the European Tuberculosis Surveillance Network.
3.50. TULARAEMIA
3.50. Clinical Criteria
Any person with at least one of the following clinical forms:
Ulceroglandular tularaemia
Cutaneous ulcer AND
Regional lymphadenopathy
Glandular tularaemia
Enlarged and painful lymph nodes without apparent ulcer
Oculoglandular tularaemia
Conjunctivitis AND
Regional lymphadenopathy
Oropharyngeal tularaemia AND at least one of the following three:
Cervical lymphadenopathy
Stomatitis
Pharyngitis
Tonsillitis
Intestinal tularaemia At least one of the following three:
Abdominal pain
Vomiting
Diarrhoea
Pneumonic tularaemia
Pneumonia
Typhoidal tularaemia At least one of the following two:
Fever without early localising signs and symptoms
Septicaemia
Laboratory Criteria
At least one of the following three:
Isolation of Francisella tularensis from a clinical specimen
Detection of Francisella tularensis nucleic acid in a clinical specimen
Francisella tularensis specific antibody response
Epidemiological Criteria
At least one of the following three epidemiological links:
Exposure to a common source
Animal to human transmission
Exposure to contaminated food/drinking water
Case Classification
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
3.51. TYPHOID AND PARATYPHOID FEVERS
3.51. Clinical Criteria
Any person with at least one of the following two:
Onset of sustained fever OR
At least two of the following four:
Headache
Relative bradycardia
Non-productive cough
Diarrhoea, constipation, malaise or abdominal pain
Laboratory Criteria
At least one of the following two:
Isolation of Salmonella Typhi or Paratyphi from a clinical specimen
Detection of Salmonella Typhi or Paratyphi nucleic acid in a clinical specimen
Epidemiological Criteria
At least one of the following three epidemiological links:
Exposure to a common source
Human to human transmission
Exposure to contaminated food/drinking water
Case Classification
Note: If the national surveillance system is not capturing clinical symptoms, all laboratory-confirmed individuals should be reported as confirmed cases.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
3.52. VIRAL HAEMORRHAGIC FEVERS (VHF)
3.52. Clinical Criteria
Any person with at least one of the following two:
Fever
Haemorrhagic manifestations in various forms that may lead to multi-organ failure
Laboratory Criteria
At least one of the following two:
Isolation of specific virus from a clinical specimen
Detection of specific virus nucleic acid in a clinical specimen and genotyping
Epidemiological Criteria
At least one of the following:
Travel in the last 21 days to a region where VHF cases are known or believed to have occurred
Exposure within the last 21 days to a probable or confirmed case of a VHF whose onset of illness was within the last 6 months
Case Classification
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
3.53. WEST NILE VIRUS INFECTION (WNV)
3.53. Clinical Criteria
At least one of the following three:
Any person with fever
Encephalitis
Meningitis
Laboratory Criteria
Laboratory test for case confirmation
At least one of the following four:
Isolation of WNV from blood or CSF
Detection of WNV nucleic acid in blood or CSF
WNV specific antibody response (IgM) in CSF
WNV IgM high titre AND detection of WNV IgG, AND confirmation by neutralisation
Laboratory test for a probable case
WNV specific antibody response in serum Laboratory results need to be interpreted according to flavivirus vaccination status
Epidemiological Criteria
At least one of the following two epidemiological links:
Animal to human transmission (residing, having visited or having been exposed to mosquito bites in an area where WNV is endemic in horses or birds)
Human to human transmission (vertical transmission, blood transfusion, transplants)
Case Classification
Note: Serological results should be interpreted according to previous exposure to other flaviviral infections and the flavivirus vaccination status. Confirmed cases in such situations should be validated by serum neutralization assay or other equivalent assays.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria AND with at least one of the following two:
an epidemiological link
a laboratory test for a probable case
C.
Confirmed case Any person meeting the laboratory criteria for case confirmation
3.54. YELLOW FEVER
3.54. Clinical Criteria
Any person with fever AND At least one of the following two:
Jaundice
Generalised haemorrhage
Laboratory Criteria
At least one of the following five:
Isolation of yellow fever virus from a clinical specimen
Detection of yellow fever virus nucleic acid
Detection of yellow fever antigen
Yellow fever specific antibody response
Demonstration of typical lesions in post mortem liver histopathology
Epidemiological Criteria
Travel in the last 1 week to a region where yellow fever cases are known or believed to have occurred
Case Classification
Note: Serological results should be interpreted according to previous exposure to other flaviviral infections and the flavivirus vaccination status. Confirmed cases in such situations should be validated by serum neutralization assay or other equivalent assays.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person not recently vaccinated meeting the clinical and the laboratory criteria In case of recent vaccination, a person with detection of wild-type yellow fever virus strain
3.55. ENTERITIS DUE TO YERSINIA ENTEROCOLITICA OR YERSINIA PSEUDOTUBERCULOSIS
3.55. Clinical Criteria
Any person with at least one of the following five:
Fever
Diarrhoea
Vomiting
Abdominal pain (pseudoappendicitis)
Rectal tenesmus
Laboratory Criteria
At least one of the following two:
Isolation of human pathogenic Yersinia enterocolitica or Yersinia pseudotuberculosis from a clinical specimen
Detection of Y. enterocolitica or Y. pseudotuberculosis virulence genes in a clinical specimen
Epidemiological Criteria
At least one of the following four epidemiological links:
Human to human transmission
Exposure to a common source
Animal to human transmission
Exposure to contaminated food
Case Classification
Note: If the national surveillance system is not capturing clinical symptoms, all laboratory-confirmed individuals should be reported as confirmed cases.
A.
Possible case NA
B.
Probable case Any person meeting the clinical criteria with an epidemiological link
C.
Confirmed case Any person meeting the clinical and the laboratory criteria
3.56. ZIKA VIRUS DISEASE
A person presenting with a rash
3.56. Laboratory Criteria
A.
Confirmed case At least one of the following:
Detection of Zika virus nucleic acid in a clinical specimen;
Detection of Zika virus antigen in a clinical specimen;
Isolation of Zika virus from a clinical specimen;
Detection of Zika virus specific IgM antibodies in serum sample(s) AND confirmation by neutralization test;
Seroconversion or four-fold increase in the titre of Zika specific antibodies in paired serum samples.
B.
Probable case
Detection of Zika specific IgM antibodies in a serum sample.
Epidemiological Criteria
History of travel to, or residence in an area with documented on-going transmission of Zika virus, within the two-week period prior to the onset of symptoms OR Sexual contact with a person recently exposed to or confirmed with Zika virus infection
Case Classification
Note: Serological results should be interpreted according to previous exposure to other flaviviral infections and the flavivirus vaccination status. Confirmed cases in such situations should be validated by serum neutralization assay or other equivalent assays.
A.
Possible case NA
B.
Probable case A person meeting the clinical and the epidemiological criteria, and the laboratory criteria for a probable case.
C.
Confirmed case A person meeting the laboratory criteria for a confirmed case.
3.57. CONGENITAL ZIKA VIRUS DISEASE
An infant or foetus with microcephaly or intracranial calcifications or other central nervous system abnormalities.
3.57. Laboratory Criteria
A.
Confirmed case
Detection of Zika virus nucleic acid in a clinical specimen;
Detection of Zika virus antigen in a clinical specimen;
Isolation of Zika virus from a clinical specimen;
Detection of Zika specific IgM antibodies in serum, cerebrospinal fluid (CSF) or amniotic fluid.
Epidemiological Criteria
Mother having had confirmed Zika virus infection during pregnancy.
Case Classification
A.
Probable case An infant or foetus that meets the clinical criteria with an epidemiological link.
B.
Confirmed case An infant or foetus that meets the clinical criteria and the laboratory criteria.
4. CASE DEFINITIONS OF SPECIAL HEALTH ISSUES
4.
4.1. GENERAL CASE DEFINITION OF NOSOCOMIAL INFECTION (OR HEALTHCARE-ASSOCIATED INFECTION (HAI)) A nosocomial infection associated to the current hospital stay is defined as infection that matches one of the case definitions AND A nosocomial infection associated to a previous hospital stay is defined as an infection that matches one of the case definitions AND Note: For the purpose of point prevalence surveys, an active nosocomial infection present on the day of the survey is defined as an infection for which signs and symptoms of the infection are present on the survey date or signs and symptoms were present in the past and the patient is (still) receiving treatment for that infection on the survey date. The presence of symptoms and signs should be verified until the start of the treatment in order to determine whether the treated infection matches one of the case definitions of nosocomial infection
the onset of symptoms was on day 3 or later (day of admission = day 1) of the current hospital admission OR
the patient underwent surgery on day 1 or day 2 and develops symptoms of a Surgical Site Infection before day 3 OR
an invasive device was placed on day 1 or day 2 resulting in an HAI before day 3
the patient presents with an infection but has been readmitted less than 48 hours after a previous admission to an acute care hospital OR
the patient has been admitted with an infection that meets the case definition of a Surgical Site Infection i.e. the SSI occurred within 30 days of the operation (or in the case of surgery involving an implant was a deep or organ/space SSI that developed within 90 days of the operation) and the patient either has symptoms that meet the case definition and/or is on antimicrobial treatment for that infection OR
the patient has been admitted (or develops symptoms within 2 days) with Clostridium difficile infection less than 28 days from a previous discharge from an acute care hospital.
4.1.
4.1.1. BJ: Bone and joint infection
4.1.1. BJ-BONE: Osteomyelitis Note reporting instruction
Osteomyelitis must meet at least one of the following criteria: Report mediastinitis following cardiac surgery that is accompanied by osteomyelitis as surgical site infection-organ/space (SSI-O).
Patient has organisms cultured from bone
Patient has evidence of osteomyelitis on direct examination of the bone during a surgical operation or histopathologic examination
Patient has at least 2 of the following signs or symptoms with no other recognized cause: fever (> 38 °C), localized swelling, tenderness, heat, or drainage at suspected site of bone infection AND at least 1 of the following:
organisms cultured from blood
positive blood antigen test (for example, Haemophilus influenzae, Streptococcus pneumoniae)
radiographic evidence of infection (for example, abnormal findings on X-ray, CT scan, MRI, radiolabel scan (gallium, technetium, etc.)).
BJ-JNT: Joint or bursa
Joint or bursa infections must meet at least one of the following criteria:
Patient has organisms cultured from joint fluid or synovial biopsy
Patient has evidence of joint or bursa infection seen during a surgical operation or histopathologic examination
Patient has at least two of the following signs or symptoms with no other recognized cause: joint pain, swelling, tenderness, heat, evidence of effusion or limitation of motion AND at least one of the following:
organisms and white blood cells seen on Gram's stain of joint fluid
positive antigen test on blood, urine, or joint fluid
cellular profile and chemistries of joint fluid compatible with infection and not explained by an underlying rheumatologic disorder
radiographic evidence of infection (for example, abnormal findings on X-ray, CT scan, MRI, radiolabel scan (gallium, technetium, etc.))
BJ-DISC: Disc space infection
Vertebral disc space infection must meet at least one of the following criteria:
Patient has organisms cultured from vertebral disc space tissue obtained during a surgical operation or needle aspiration
Patient has evidence of vertebral disc space infection seen during a surgical operation or histopathologic examination
Patient has fever (> 38 °C) with no other recognized cause or pain at the involved vertebral disc space AND radiographic evidence of infection (for example, abnormal findings on X-ray, CT scan, MRI, radiolabel scan (gallium, technetium, etc.)).
Patient has fever (> 38 °C) with no other recognized cause and pain at the involved vertebral disc space AND positive antigen test on blood or urine (for example, Haemophilus influenzae, Streptococcus pneumoniae, Neisseria meningitidis, or Group B Streptococcus).
4.1.2. BSI: Bloodstream infection
4.1.2. BSI: Laboratory-confirmed bloodstream infection
One positive blood culture for a recognised pathogen OR Patient has at least one of the following signs or symptoms: fever (> 38 °C), chills, or hypotension AND Two positive blood cultures for a common skin contaminant (from 2 separate blood samples, usually within 48 hours) Skin contaminants = coagulase-negative staphylococci, Micrococcus spp., Propionibacterium acnes, Bacillus spp., Corynebacterium spp. Source of bloodstream infection:
Catheter-related: the same micro-organism was cultured from the catheter or symptoms improve within 48 hours after removal of the catheter (C-PVC: peripheral catheter, C-CVC: central venous catheter (Note: report C-CVC or C-PVC BSI as CRI3-CVC or CRI3-PVC respectively if microbiologically confirmed, see CRI3 definition)).
Secondary to another infection: the same micro-organism was isolated from another infection site or strong clinical evidence exists that bloodstream infection was secondary to another infection site, invasive diagnostic procedure or foreign body
Pulmonary (S-PUL)
Urinary tract infection (S-UTI)
Digestive tract infection (S-DIG)
SSI (S-SSI): surgical site infection
Skin and soft tissue (S-SST)
Other (S-OTH)
Unknown origin (UO): None of the above, bloodstream infection of unknown origin (verified during survey and no source found)
Unknown (UNK): No information available about the source of the bloodstream infection or information missing
4.1.3. CNS: Central nervous system infection
4.1.3. CNS-IC: Intracranial infection (brain abscess, subdural or epidural infection, encephalitis) Note reporting instruction
Intracranial infection must meet at least one of the following criteria: If meningitis and a brain abscess are present together, report the infection as IC
Patient has organisms cultured from brain tissue or dura
Patient has an abscess or evidence of intracranial infection seen during a surgical operation or histopathologic examination
Patient has at least 2 of the following signs or symptoms with no other recognized cause: headache, dizziness, fever (> 38 °C), localizing neurologic signs, changing level of consciousness, or confusion AND at least 1 of the following: AND if diagnosis is made antemortem, physician institutes appropriate antimicrobial therapy.
organisms seen on microscopic examination of brain or abscess tissue obtained by needle aspiration or by biopsy during a surgical operation or autopsy
positive antigen test on blood or urine
radiographic evidence of infection (for example, abnormal findings on ultrasound, CT scan, MRI, radionuclide brain scan, or arteriogram)
diagnostic single antibody titre (IgM) or 4-fold increase in paired sera (IgG) for pathogen
CNS-MEN: Meningitis or ventriculitis Note reporting instructions
Meningitis or ventriculitis must meet at least one of the following criteria:
Patient has organisms cultured from cerebrospinal fluid (CSF)
Patient has at least 1 of the following signs or symptoms with no other recognized cause: fever (> 38 °C), headache, stiff neck, meningeal signs, cranial nerve signs, or irritability AND at least one of the following: AND if diagnosis is made antemortem, physician institutes appropriate antimicrobial therapy.
increased white cells, elevated protein, and/or decreased glucose in CSF
organisms seen on Gram's stain of CSF
organisms cultured from blood
positive antigen test of CSF, blood, or urine
diagnostic single antibody titre (IgM) or 4-fold increase in paired sera (IgG) for pathogen
Report CSF shunt infection as SSI if it occurs <=90 days of placement; if > 90 days or after manipulation/access of the shunt, report as CNS-MEN if the infection meets the general case definition of HAI
Report meningoencephalitis as MEN
Report spinal abscess with meningitis as MEN
CNS-SA: Spinal abscess without meningitis Note reporting instruction
An abscess of the spinal epidural or subdural space, without involvement of the cerebrospinal fluid or adjacent bone structures, must meet at least one of the following criteria: Report spinal abscess with meningitis as meningitis (CNS-MEN)
Patient has organisms cultured from abscess in the spinal epidural or subdural space
Patient has an abscess in the spinal epidural or subdural space seen during a surgical operation or at autopsy or evidence of an abscess seen during a histopathologic examination
Patient has at least 1 of the following signs or symptoms with no other recognized cause: fever (> 38 °C), back pain, focal tenderness, radiculitis, paraparesis, or paraplegia AND at least 1 of the following: AND if diagnosis is made antemortem, physician institutes appropriate antimicrobial therapy
organisms cultured from blood
radiographic evidence of a spinal abscess (for example, abnormal findings on myelography, ultrasound, CT scan, MRI, or other scans (gallium, technetium, etc.))
4.1.4. CRI: Catheter-related infection
4.1.4.
CRI3-CVC: microbiologically confirmed CVC-related bloodstream infection
AND positive culture with the same micro-organism of either:
CRI3-PVC: microbiologically confirmed PVC-related bloodstream infection
BSI occurring 48 hours before or after catheter removal (if any) AND positive culture with the same micro-organism of either:
4.1.5. CVS: Cardiovascular system infection
4.1.5. CVS-VASC: Arterial or venous infection Note reporting instructions
Arterial or venous infection must meet at least one of the following criteria: Report infections of an arteriovenous graft, shunt, or fistula or intravascular cannulation site without organisms cultured from blood as CVS-VASC. Report CVS-VASC matching the third criterion as CRI1 or CRI2, as appropriate.
Patient has organisms cultured from arteries or veins removed during a surgical operation AND blood culture not done or no organisms cultured from blood
Patient has evidence of arterial or venous infection seen during a surgical operation or histopathologic examination
Patient has at least 1 of the following signs or symptoms with no other recognized cause: fever (> 38 °C), pain, erythema, or heat at involved vascular site AND more than 15 colonies cultured from intravascular cannula tip using semiquantitative culture method AND blood culture not done or no organisms cultured from blood
Patient has purulent drainage at involved vascular site AND blood culture not done or no organisms cultured from blood
CVS-ENDO: Endocarditis
Endocarditis of a natural or prosthetic heart valve must meet at least one of the following criteria:
Patient has organisms cultured from valve or vegetation
Patient has two or more of the following signs or symptoms with no other recognized cause: fever (> 38 °C), new or changing murmur, embolic phenomena, skin manifestations (for example, petechiae, splinter hemorrhages, painful subcutaneous nodules), congestive heart failure, or cardiac conduction abnormality AND at least one of the following: AND if diagnosis is made antemortem, physician institutes appropriate antimicrobial therapy
organisms cultured from two or more blood cultures
organisms seen on Gram's stain of valve when culture is negative or not done
valvular vegetation seen during a surgical operation or autopsy
positive antigen test on blood or urine (for example, Haemophilus influenzae, Streptococcus pneumoniae, Neisseria meningitidis, or Group B Streptococcus)
evidence of new vegetation seen on echocardiogram
CVS-CARD: Myocarditis or pericarditis
Myocarditis or pericarditis must meet at least one of the following criteria:
Patient has organisms cultured from pericardial tissue or fluid obtained by needle aspiration or during a surgical operation
Patient has at least two of the following signs or symptoms with no other recognized cause: fever (> 38 °C), chest pain, paradoxical pulse, or increased heart size AND at least one of the following:
abnormal EKG consistent with myocarditis or pericarditis
positive antigen test on blood (for example, Haemophilus influenzae, Streptococcus pneumoniae)
evidence of myocarditis or pericarditis on histologic examination of heart tissue
4-fold rise in type-specific antibody with or without isolation of virus from pharynx or feces
pericardial effusion identified by echocardiogram, CT scan, MRI, or angiography
CVS-MED: Mediastinitis Note reporting instruction
Mediastinitis must meet at least one of the following criteria: Report mediastinitis following cardiac surgery that is accompanied by osteomyelitis as SSI-O
Patient has organisms cultured from mediastinal tissue or fluid obtained during a surgical operation or needle aspiration
Patient has evidence of mediastinitis seen during a surgical operation or histopathologic examination
Patient has at least one of the following signs or symptoms with no other recognized cause: fever (> 38 °C), chest pain, or sternal instability AND at least 1 of the following:
purulent discharge from mediastinal area
organisms cultured from blood or discharge from mediastinal area
mediastinal widening on X-ray
4.1.6. EENT: Eye, ear, nose, throat, or mouth infection
4.1.6. EENT-CONJ: Conjunctivitis Note reporting instructions
Conjunctivitis must meet at least one of the following criteria:
Patient has pathogens cultured from purulent exudate obtained from the conjunctiva or contiguous tissues, such as eyelid, cornea, meibomian glands, or lacrimal glands
Patient has pain or redness of conjunctiva or around eye AND at least 1 of the following:
WBCs and organisms seen on Gram's stain of exudates
purulent exudates
positive antigen test (for example, ELISA or IF for Chlamydia trachomatis, herpes simplex virus, adenovirus) on exudate or conjunctival scraping
multinucleated giant cells seen on microscopic examination of conjunctival exudate or scrapings
positive viral culture
diagnostic single antibody titre (IgM) or 4-fold increase in paired sera (IgG) for pathogen
Report other infections of the eye as EYE
Do not report chemical conjunctivitis caused by silver nitrate (AgNO3) as a health care-associated infection
Do not report conjunctivitis that occurs as a part of a more widely disseminated viral illness (such as measles, chickenpox, or a URI)
EENT-EYE: Eye, other than conjunctivitis
An infection of the eye, other than conjunctivitis, must meet at least one of the following criteria:
Patient has organisms cultured from anterior or posterior chamber or vitreous fluid
Patient has at least 2 of the following signs or symptoms with no other recognized cause: eye pain, visual disturbance, or hypopyon AND at least 1 of the following:
physician diagnosis of an eye infection
positive antigen test on blood (for example, Haemophilus influenzae, Streptococcus pneumoniae)
organisms cultured from blood
EENT-EAR: Ear mastoid
Ear and mastoid infections must meet at least one of the following criteria:
Otitis externa must meet at least one of the following criteria:
Patient has pathogens cultured from purulent drainage from ear canal
Patient has at least one of the following signs or symptoms with no other recognized cause: fever (> 38 °C), pain, redness, or drainage from ear canal
and organisms seen on Gram's stain of purulent drainage
Otitis media must meet at least one of the following criteria:
Patient has organisms cultured from fluid from middle ear obtained by tympanocentesis or at surgical operation
Patient has at least two of the following signs or symptoms with no other recognized cause: fever (> 38 °C), pain in the eardrum, inflammation, retraction or decreased mobility of eardrum, or fluid behind eardrum
Otitis interna must meet at least one of the following criteria:
Patient has organisms cultured from fluid from inner ear obtained at surgical operation
Patient has a physician diagnosis of inner ear infection
Mastoiditis must meet at least one of the following criteria:
Patient has organisms cultured from purulent drainage from mastoid
Patient has at least two of the following signs or symptoms with no other recognized cause: fever (> 38 °C), pain, tenderness, erythema, headache, or facial paralysis AND at least 1 of the following:
organisms seen on Gram's stain of purulent material from mastoid
positive antigen test on blood
EENT-ORAL: Oral cavity (mouth, tongue, or gums) Note reporting instruction
Oral cavity infections must meet at least one of the following criteria: Report health care-associated primary herpes simplex infections of the oral cavity as ORAL; recurrent herpes infections are not healthcare-associated
Patient has organisms cultured from purulent material from tissues of oral cavity
Patient has an abscess or other evidence of oral cavity infection seen on direct examination, during a surgical operation, or during a histopathologic examination
Patient has at least 1 of the following signs or symptoms with no other recognized cause: abscess, ulceration, or raised white patches on inflamed mucosa, or plaques on oral mucosa AND at least one of the following:
organisms seen on Gram's stain
positive KOH (potassium hydroxide) stain
multinucleated giant cells seen on microscopic examination of mucosal scrapings
positive antigen test on oral secretions
diagnostic single antibody titre (IgM) or 4-fold increase in paired sera (IgG) for pathogen
physician diagnosis of infection and treatment with topical or oral antifungal therapy
EENT-SINU: Sinusitis
Sinusitis must meet at least 1 of the following criteria:
Patient has organisms cultured from purulent material obtained from sinus cavity
Patient has at least 1 of the following signs or symptoms with no other recognized cause: fever (> 38 °C), pain or tenderness over the involved sinus, headache, purulent exudate, or nasal obstruction AND at least 1 of the following:
positive transillumination
positive radiographic examination (including CT scan)
EENT-UR: Upper respiratory tract, pharyngitis, laryngitis, epiglottitis
Upper respiratory tract infections must meet at least 1 of the following criteria:
Patient has at least two of the following signs or symptoms with no other recognized cause: fever (> 38 °C), erythema of pharynx, sore throat, cough, hoarseness, or purulent exudate in throat AND at least 1 of the following:
organisms cultured from the specific site
organisms cultured from blood
positive antigen test on blood or respiratory secretions
diagnostic single antibody titre (IgM) or 4-fold increase in paired sera (IgG) for pathogen
physician diagnosis of an upper respiratory infection
Patient has an abscess seen on direct examination, during a surgical operation, or during a histopathologic examination
4.1.7. GI: Gastrointestinal system infection
4.1.7. GI-CDI: Clostridium difficile infection
A Clostridium difficile infection (previously also referred to as Clostridium difficile associated diarrhoea or CDAD) must meet at least one of the following criteria:
Diarrhoeal stools or toxic megacolon, AND a positive laboratory assay for Clostridium difficile toxin A and/or B in stools or a toxin-producing C. difficile organism detected in stool via culture or other means for example, a positive PCR result;
Pseudomembranous colitis revealed by lower gastro-intestinal endoscopy
Colonic histopathology characteristic of Clostridium difficile infection (with or without diarrhoea) on a specimen obtained during endoscopy, colectomy or autopsy
GI-GE: Gastroenteritis (excl. CDI)
Gastroenteritis must meet at least one of the following criteria:
Patient has an acute onset of diarrhea (liquid stools for more than 12 hours) with or without vomiting or fever (> 38 °C) and no likely noninfectious cause (for example, diagnostic tests, therapeutic regimen other than antimicrobial agents, acute exacerbation of a chronic condition, or psychologic stress)
Patient has at least 2 of the following signs or symptoms with no other recognized cause: nausea, vomiting, abdominal pain, fever (> 38 °C), or headache AND at least 1 of the following:
an enteric pathogen is cultured from stool or rectal swab
an enteric pathogen is detected by routine or electron microscopy
an enteric pathogen is detected by antigen or antibody assay on blood or feces
evidence of an enteric pathogen is detected by cytopathic changes in tissue culture (toxin assay)
diagnostic single antibody titre (IgM) or 4-fold increase in paired sera (IgG) for pathogen
GI-GIT: Gastrointestinal tract (esophagus, stomach, small and large bowel, and rectum) excluding gastroenteritis and appendicitis
Gastrointestinal tract infections, excluding gastroenteritis and appendicitis, must meet at least 1 of the following criteria:
Patient has an abscess or other evidence of infection seen during a surgical operation or histopathologic examination
Patient has at least 2 of the following signs or symptoms with no other recognized cause and compatible with infection of the organ or tissue involved: fever (> 38 °C), nausea, vomiting, abdominal pain, or tenderness AND at least 1 of the following:
organisms cultured from drainage or tissue obtained during a surgical operation or endoscopy or from a surgically placed drain
organisms seen on Gram's or KOH stain or multinucleated giant cells seen on microscopic examination of drainage or tissue obtained during a surgical operation or endoscopy or from a surgically placed drain
organisms cultured from blood
evidence of pathologic findings on radiographic examination
evidence of pathologic findings on endoscopic examination (for example, Candida spp. esophagitis or proctitis)
GI-HEP: Hepatitis Note reporting instructions
Hepatitis must meet the following criterion: Patient has at least 2 of the following signs or symptoms with no other recognized cause: fever (> 38 °C), anorexia, nausea, vomiting, abdominal pain, jaundice, or history of transfusion within the previous 3 months AND at least 1 of the following:
positive antigen or antibody test for hepatitis A, hepatitis B, hepatitis C, or delta hepatitis
abnormal liver function tests (for example, elevated ALT/AST, bilirubin)
cytomegalovirus (CMV) detected in urine or oropharyngeal secretions
Do not report hepatitis or jaundice of non-infectious origin (alpha-1 antitrypsin deficiency, etc.)
Do not report hepatitis or jaundice that results from exposure to hepatotoxins (alcoholic or acetaminophen-induced hepatitis, etc.)
Do not report hepatitis or jaundice that results from biliary obstruction (cholecystitis)
GI-IAB: Intraabdominal, not specified elsewhere including gallbladder, bile ducts, liver (excluding viral hepatitis), spleen, pancreas, peritoneum, subphrenic or subdiaphragmatic space, or other intraabdominal tissue or area not specified elsewhere Note reporting instruction
4.1.8. LRI: Lower respiratory tract infection, other than pneumonia
4.1.8. LRI-BRON: Bronchitis, tracheobronchitis, bronchiolitis, tracheitis, without evidence of pneumonia Note reporting instruction
Patient has no clinical or radiographic evidence of pneumonia AND patient has at least two of the following signs or symptoms with no other recognized cause: fever (> 38 °C), cough, new or increased sputum production, rhonchi, wheezing AND at least one of the following: Do not report chronic bronchitis in a patient with chronic lung disease as an infection unless there is evidence of an acute secondary infection, manifested by change in organism
positive culture obtained by deep tracheal aspirate or bronchoscopy
positive antigen test on respiratory secretions
LRI-LUNG: Other infections of the lower respiratory tract Note reporting instruction
Other infections of the lower respiratory tract must meet at least one of the following criteria: Report lung abscess or empyema without pneumonia as LUNG
Patient has organisms seen on smear or cultured from lung tissue or fluid, including pleural fluid
Patient has a lung abscess or empyema seen during a surgical operation or histopathologic examination
Patient has an abscess cavity seen on radiographic examination of lung
4.1.9. NEO: Specific neonatal case definitions
4.1.9. NEO-CSEP: Clinical Sepsis
ALL of the three following criteria: AND 2 of the following criteria (without other apparent cause):
Supervising physician started appropriate antimicrobial therapy for sepsis for at least 5 days
No detection of pathogens in blood culture or not tested
No obvious infection at another site
Fever (> 38 °C) or temperature instability (frequent post-set of the incubator) or hypothermia (< 36,5 °C)
Tachycardia (> 200/min) or new/increased bradycardia (< 80/min)
Capillary refilling time (CRT) > 2s
New or increased apnoea (s) (> 20s)
Unexplained metabolic acidosis
New-onset hyperglycemia (> 140 mg/dl)
Another sign of sepsis (skin colour (only if the CRT is not used), laboratory signs (CRP, interleukin), increased oxygen requirement (intubation), unstable general condition of the patient, apathy)
NEO-LCBI: Laboratory-confirmed BSI Note reporting instructions
at least two of: temperature > 38 °C or < 36,5 °C or temperature instability, tachycardia or bradycardia, apnoea, extended capillary refilling time (CRT), metabolic acidosis, hyperglycaemia, other sign of BSI such as apathy AND a recognised pathogen other than coagulase-negative staphylococci cultured from blood or cerebrospinal fluid (CSF; this is included because meningitis in this age group is usually haematogenous, so positive CSF can be regarded as evidence of BSI even if blood cultures are negative or were not taken)
in order to be consistent with BSI reporting in adults (including secondary BSI), the criterion the organism is not related to an infection at another site was removed from the Neo-KISS definition for the purposes of the EU PPS
report the origin of the neonatal BSI in the field BSI origin
if both the case definitions for NEO-LCBI and NEO-CNSB are matched, report NEO-LCBI
at least two of: temperature > 38 °C or < 36,5 °C or temperature instability, tachycardia or bradycardia, apnoea, extended recapillarisation time, metabolic acidosis, hyperglycaemia, other sign of BSI such as apathy
AND coagulase-negative staphylococci is cultured from blood or catheter tip
AND patient has one of: C-reactive protein > 2,0 mg/dL, immature/total neutrophil ratio (I/T ratio) > 0,2, leukocytes < 5/nL, platelets < 100/nL
in order to be consistent with BSI reporting in adults (including secondary BSI), the criterion the organism is not related to an infection at another site was removed from the Neo-KISS definition for the purposes of the EU PPS
report the origin of the neonatal BSI in the field BSI origin
if both the case definitions for NEO-LCBI and NEO-CNSB are matched, report NEO-LCBI
respiratory compromise
AND new infiltrate, consolidation or pleural effusion on chest X ray
AND at least four of: temperature > 38 °C or < 36,5 °C or temperature instability, tachycardia or bradycardia, tachypnoea or apnoea, dyspnoea, increased respiratory secretions, new onset of purulent sputum, isolation of a pathogen from respiratory secretions, C-reactive protein > 2,0 mg/dL, I/T ratio > 0,2
NEO-NEC: Necrotising enterocolitis
Histopathological evidence of necrotising enterocolitis OR at least one characteristic radiographic abnormality (pneumoperitoneum, pneumatosis intestinalis, unchanging rigid loops of small bowel) plus at least two of the following without other explanation: vomiting, abdominal distention, prefeeding residuals, persistent microscopic or gross blood in stools
4.1.10. Notes:
PN: Pneumonia Two or more serial chest X-rays or CT-scans with a suggestive image of pneumonia for patients with underlying cardiac or pulmonary disease. In patients without underlying cardiac or pulmonary disease one definitive chest X-ray or CT-scan is sufficient AND at least one of the following symptoms AND at least one of the following (or at least two if clinical pneumonia only = PN 4 and PN 5) and according to the used diagnostic method
Fever > 38 °C with no other cause
Leukopenia (< 4000 WBC/mm3) or leucocytosis (≥ 12000 WBC/mm3)
New onset of purulent sputum, or change in character of sputum (colour, odour, quantity, consistency)
Cough or dyspnea or tachypnea
Suggestive auscultation (rales or bronchial breath sounds), ronchi, wheezing
Worsening gas exchange (for example, O2 desaturation or increased oxygen requirements or increased ventilation demand)
4.1.10.
(a) Bacteriologic diagnostic performed by:
Broncho-alveolar lavage (BAL) with a threshold of ≥ 104 CFU/ml or ≥ 5 % of BAL obtained cells contains intracellular bacteria on direct microscopic exam (classified on the diagnostic category BAL)
Protected brush (PB Wimberley) with a threshold of ≥ 103 CFU/ml
Distal protected aspirate (DPA) with a threshold of ≥ 103 CFU/ml
Quantitative culture of LRT specimen (for example, endotracheal aspirate) with a threshold of 106 CFU/ml
(b) Alternative microbiology methods (PN 3)
Positive blood culture not related to another source of infection
Positive growth in culture of pleural fluid
Pleural or pulmonary abscess with positive needle aspiration
Histologic pulmonary exam shows evidence of pneumonia
Positive exams for pneumonia with virus or particular germs (for example, Legionella, Aspergillus, mycobacteria, mycoplasma, Pneumocystis jirovecii):
Positive detection of viral antigen or antibody from respiratory secretions (for example, EIA, FAMA, shell vial assay, PCR)
Positive direct exam or positive culture from bronchial secretions or tissue
Seroconversion (for example, influenza viruses, Legionella, Chlamydia)
Detection of antigens in urine (Legionella)
(c) Others
Positive sputum culture or non-quantitative LRT specimen culture (PN 4)
No positive microbiology (PN 5)
One definitive chest X-ray or CT-scan for the current pneumonia episode may be sufficient in patients with underlying cardiac or pulmonary disease if comparison with previous X-rays is possible.
PN 1 and PN 2 criteria were validated without previous antimicrobial therapy. However, this does not exclude the diagnosis of PN 1 or PN 2 in case of previous antimicrobial use.
4.1.10. Notes: Intubation-associated pneumonia (IAP)
A pneumonia is defined as intubation-associated (IAP) if an invasive respiratory device was present (even intermittently) in the 48 hours preceding the onset of infection Note: Pneumonia for which intubation was started on the day of onset without additional information on the sequence of the events is not considered as IAP
4.1.11. REPR: Reproductive tract infection
4.1.11. REPR-EMET: Endometritis Note reporting instruction
Endometritis must meet at least 1 of the following criteria: Report postpartum endometritis as a health care-associated infection unless the amniotic fluid is infected at the time of admission or the patient was admitted 48 hours after rupture of the membrane
Patient has organisms cultured from fluid or tissue from endometrium obtained during surgical operation, by needle aspiration, or by brush biopsy
Patient has at least 2 of the following signs or symptoms with no other recognized cause: fever (> 38 °C), abdominal pain, uterine tenderness, or purulent drainage from uterus
REPR-EPIS: Episiotomy
Episiotomy infections must meet at least 1 of the following criteria:
Postvaginal delivery patient has purulent drainage from the episiotomy
Postvaginal delivery patient has an episiotomy abscess
REPR-VCUF: Vaginal cuff Note reporting instruction
Vaginal cuff infections must meet at least 1 of the following criteria: Report vaginal cuff infections as SSI-O if other SSI criteria are met (within 30 days following hysterectomy).
Posthysterectomy patient has purulent drainage from the vaginal cuff
Posthysterectomy patient has an abscess at the vaginal cuff
Posthysterectomy patient has pathogens cultured from fluid or tissue obtained from the vaginal cuff
REPR-OREP: Other infections of the male or female reproductive tract (epididymis, testes, prostate, vagina, ovaries, uterus, or other deep pelvic tissues, excluding endometritis or vaginal cuff infections) Note reporting instructions
Other infections of the male or female reproductive tract must meet at least 1 of the following criteria:
Patient has organisms cultured from tissue or fluid from affected site
Patient has an abscess or other evidence of infection of affected site seen during a surgical operation or histopathologic examination
Patient has 2 of the following signs or symptoms with no other recognized cause: fever (> 38 °C), nausea, vomiting, pain, tenderness, or dysuria AND at least 1 of the following:
organisms cultured from blood
physician diagnosis
Report endometritis as EMET
Report vaginal cuff infections as VCUF
4.1.12. SSI: Surgical site infection Note: All definitions are to be assumed to be confirmed for the purposes of surveillance reporting.
4.1.12. Superficial incisional (SSI-S)
Infection occurs within 30 days after the operation AND infection involves only skin and subcutaneous tissue of the incision AND at least one of the following:
Purulent drainage with or without laboratory confirmation, from the superficial incision
Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision
At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat AND superficial incision is deliberately opened by surgeon, unless incision is culture-negative
Diagnosis of superficial incisional SSI made by a surgeon or attending physician
Deep incisional (SSI-D)
Infection occurs within 30 days after the operation if no implant is left in place or within 90 days if implant is in place AND the infection appears to be related to the operation AND infection involves deep soft tissue (for example, fascia, muscle) of the incision AND at least one of the following:
Purulent drainage from the deep incision but not from the organ/space component of the surgical site
A deep incision spontaneously dehisces or is deliberately opened by a surgeon when the patient has at least one of the following signs or symptoms: fever (> 38 °C), localized pain or tenderness, unless incision is culture-negative
An abscess or other evidence of infection involving the deep incision is found on direct examination, during reoperation, or by histopathologic or radiologic examination
Diagnosis of deep incisional SSI made by a surgeon or attending physician
Organ/Space (SSI-O)
Infection occurs within 30 days after the operation if no implant is left in place or within 90 days if implant is in place AND the infection appears to be related to the operation AND infection involves any part of the anatomy (for example, organs and spaces) other than the incision which was opened or manipulated during an operation AND at least one of the following:
Purulent drainage from a drain that is placed through a stab wound into the organ/space
Organisms isolated from an aseptically obtained culture of fluid or tissue in the organ/space
An abscess or other evidence of infection involving the organ/space that is found on direct examination, during reoperation, or by histopathologic or radiologic examination
Diagnosis of organ/space SSI made by a surgeon or attending physician
4.1.13. SST: Skin and soft tissue infection
4.1.13. SST-SKIN: Skin infection Note reporting instructions
Skin infections must meet at least one of the following criteria:
Patient has purulent drainage, pustules, vesicles, or boils
Patient has at least two of the following signs or symptoms with no other recognized cause: pain or tenderness, localized swelling, redness, or heat AND at least one of the following:
organisms cultured from aspirate or drainage from affected site; if organisms are normal skin flora (for example, diphtheroids (Corynebacterium spp.), Bacillus (not B. anthracis) spp., Propionibacterium spp., coagulase-negative staphylococci (including Staphylococcus epidermidis), viridans group streptococci, Aerococcus spp., Micrococcus spp.), they must be a pure culture
organisms cultured from blood
positive antigen test performed on infected tissue or blood
multinucleated giant cells seen on microscopic examination of affected tissue
diagnostic single antibody titre (IgM) or 4-fold increase in paired sera (IgG) for pathogen
Report infected decubitus ulcers as DECU
Report infected burns as BURN
Report breast abscesses or mastitis as BRST
SST-ST: Soft tissue (necrotizing fascitis, infectious gangrene, necrotizing cellulitis, infectious myositis, lymphadenitis, or lymphangitis) Note reporting instructions
Soft tissue infections must meet at least 1 of the following criteria:
Patient has organisms cultured from tissue or drainage from affected site
Patient has purulent drainage at affected site
Patient has an abscess or other evidence of infection seen during a surgical operation or histopathologic examination
Patient has at least 2 of the following signs or symptoms at the affected site with no other recognized cause: localized pain or tenderness, redness, swelling, or heat AND at least 1 of the following:
organisms cultured from blood
positive antigen test performed on blood or urine (for example, Haemophilus influenzae, Streptococcus pneumoniae, Neisseria meningitidis, Group B Streptococcus, Candida spp.)
diagnostic single antibody titre (IgM) or 4-fold increase in paired sera (IgG) for pathogen
Report infected decubitus ulcers as DECU
Report infection of deep pelvic tissues as OREP
SST-DECU: Decubitus ulcer, including both superficial and deep infections
Decubitus ulcer infections must meet the following criterion:
Patient has at least 2 of the following signs or symptoms with no other recognized cause: redness, tenderness, or swelling of decubitus wound edges AND at least one of the following:
organisms cultured from properly collected fluid or tissue
organisms cultured from blood
SST-BURN: Burn
Burn infections must meet at least 1 of the following criteria:
Patient has a change in burn wound appearance or character, such as rapid eschar separation, or dark brown, black, or violaceous discoloration of the eschar, or edema at wound margin
and histologic examination of burn biopsy shows invasion of organisms into adjacent viable tissue
Patient has a change in burn wound appearance or character, such as rapid eschar separation, or dark brown, black, or violaceous discoloration of the eschar, or edema at wound margin AND at least one of the following:
organisms cultured from blood in the absence of other identifiable infection
isolation of herpes simplex virus, histologic identification of inclusions by light or electron microscopy, or visualization of viral particles by electron microscopy in biopsies or lesion scrapings
Patient with a burn has at least two of the following signs or symptoms with no other recognized cause: fever (> 38 °C) or hypothermia (< 36 °C), hypotension, oliguria (< 20 cc/hr), hyperglycemia at previously tolerated level of dietary carbohydrate, or mental confusion AND at least one of the following:
histologic examination of burn biopsy shows invasion of organisms into adjacent viable tissue
organisms cultured from blood
isolation of herpes simplex virus, histologic identification of inclusions by light or electron microscopy, or visualization of viral particles by electron microscopy in biopsies or lesion scrapings
SST-BRST: Breast abscess or mastitis
A breast abscess or mastitis must meet at least one of the following criteria: AND physician diagnosis of breast abscess
Patient has a positive culture of affected breast tissue or fluid obtained by incision and drainage or needle aspiration
Patient has a breast abscess or other evidence of infection seen during a surgical operation or histopathologic examination
Patient has fever (> 38 °C) and local inflammation of the breast
4.1.14. SYS: Systemic infection
4.1.14. SYS-DI: Disseminated infection Note reporting instructions
Disseminated infection is infection involving multiple organs or systems, without an apparent single site of infection, usually of viral origin, and with signs or symptoms with no other recognized cause and compatible with infectious involvement of multiple organs or systems
Use this code for viral infections involving multiple organ systems (for example, measles, mumps, rubella, varicella, erythema infectiosum). These infections often can be identified by clinical criteria alone.
Do not use this code for healthcare-associated infections with multiple metastatic sites, such as with bacterial endocarditis; only the primary site of these infections should be reported
Do not report fever of unknown origin (FUO) as DI
Report viral exanthems or rash illness as DI
SYS-CSEP: treated unidentified severe infection Note reporting instructions
Patient has at least one of the following And blood culture not done or no organisms or antigen detected in blood And no apparent infection at another site And physician institutes treatment for sepsis Do not use this code unless absolutely needed For CSEP in neonates, use NEO-CSEP case definition (see below)
clinical signs or symptoms with no other recognized cause
fever (> 38 °C)
hypotension (systolic pressure < 90 mm/Hg)
or oliguria (20 cm3 (ml)/hr)
4.1.15. UTI: Urinary tract infection
4.1.15. UTI-A: microbiologically confirmed symptomatic UTI
Patient has at least one of the following signs or symptoms with no other recognized cause: fever (> 38 °C), urgency, frequency, dysuria, or suprapubic tenderness AND patient has a positive urine culture, that is, ≥ 105 microorganisms per ml of urine with no more than two species of microorganisms.
UTI-B: not microbiologically confirmed symptomatic UTI
Patient has at least two of the following with no other recognized cause: fever (> 38 °C), urgency, frequency, dysuria, or suprapubic tenderness AND at least one of the following: Asymptomatic bacteriuria should not be reported, but bloodstream infections secondary to asymptomatic bacteriuria are reported as BSI with source (origin) S-UTI A urinary tract infection is defined as catheter-associated if an indwelling urinary catheter was present (even intermittently) in the 7 days preceding the onset of infection
Positive dipstick for leukocyte esterase and/or nitrate
Pyuria urine specimen with ≥ 104 WBC/ml or ≥ 3 WBC/high-power field of unspun urine
Organisms seen on Gram stain of unspun urine
At least two urine cultures with repeated isolation of the same uropathogen (Gram-negative bacteria or Staphylococcus saprophyticus) with ≥ 102 colonies/ml urine in nonvoided specimens
≤ 105 colonies/ml of a single uropathogen (Gram-negative bacteria or Staphylococcus saprophyticus) in a patient being treated with effective antimicrobial agent for a urinary infection
Physician diagnosis of a urinary tract infection
Physician institutes appropriate therapy for a urinary infection
4.2. GENERAL CASE DEFINITION OF BLOOD STREAM INFECTION DUE TO SPECIFIC PATHOGENS
4.2. Clinical criteria
Not relevant for surveillance purposes
Laboratory criteria
At least one blood culture positive for Staphylococcus aureus or Klebsiella pneumoniae or Escherichia coli or Enterococcus faecium or Enterococcus faecalis or Pseudomonas aeruginosa or Acinetobacter species or Streptococcus pneumoniae.
Epidemiological criteria
Not relevant for surveillance purposes
Case classification
A.
Possible case NA
B.
Probable case NA
C.
Confirmed case
Antimicrobial resistance
The results of antimicrobial susceptibility tests must be reported according to the methods and criteria agreed between ECDC and Member States as specified by ECDC's European Antimicrobial Resistance Surveillance Network (EARS-Net), and in particular:
for Staphylococcus aureus: susceptibility to meticillin and other anti-staphylococcal beta-lactams;
for Enterococcus faecium and Enterococcus faecalis: susceptibility to glycopeptides;
for Klebsiella pneumoniae and Escherichia coli: susceptibility to carbapenems, and susceptibility to colistin in carbapenem-resistant isolates;
for Pseudomonas aeruginosa and Acinetobacter species: susceptibility to carbapenems.
4.3. GENERIC CASE DEFINITION AND CLASSIFICATION OF ANTIMICROBIAL REISTANCE TO ANTIMICROBIAL AGENTS
4.3. Clinical resistance to antimicrobial agents
Definition
A micro-organism is classified as clinically susceptible, clinically intermediate, or clinically resistant to an antimicrobial agent by applying the appropriate EUCAST clinical breakpoints in a standardized methodology (or a methodology calibrated to a standardized methodology), i.e. clinical minimum inhibitory concentration (MIC) breakpoints and their inhibition zone diameter correlates. Breakpoints may be altered with legitimate changes in circumstances.
a micro-organism is defined as susceptible (S) by a level of antimicrobial exposure associated with a high likelihood of therapeutic success.
a micro-organism is defined as intermediate (I) by a level of antimicrobial agent activity associated with uncertain therapeutic effect. It implies that an infection due to the isolate may be appropriately treated in body sites where the drugs are physically concentrated or when a dosage regimen of drug producing higher exposure can be used; it also indicates a buffer zone that should prevent small, uncontrolled, technical factors from causing major discrepancies in interpretations.
Classification Clinically Resistant (R)
Clinical breakpoints are presented as:
a micro-organism is defined as resistant (R) by a level of antimicrobial exposure associated with a high likelihood of therapeutic failure.
S: MIC ≤ x mg/L; disk diffusion zone diameter ≥ σ mm
I: MIC > x, ≤ y mg/L; disk diffusion zone diameter ≥ ρ mm, < σ mm
R: MIC > y mg/L; disk diffusion zone diameter < ρ mm
for Staphylococcus aureus, Enterococcus species, Enterobacteriaceae including Klebsiella pneumoniae and Escherichia coli, Pseudomonas aeruginosa and Acinetobacter species, an isolate is defined as pandrug-resistant (PDR) based on the fact that it is resistant to all antimicrobial agents, as in the international expert proposal for interim standard definitions for acquired resistance
an isolate is defined as confirmed PDR when it is non-susceptible (i.e. intermediate — I, or resistant — R) to all agents in all antimicrobial categories, confirmed by a reference or other clinical microbiology laboratory testing a supplemental panel of antimicrobial agents beyond those routinely tested, in accordance with the definitions by microorganism in the international expert proposal for interim standard definitions for acquired resistance
an isolate is defined as possibly PDR when it is non-susceptible (i.e. intermediate — I, or resistant — R) to all the antimicrobial agents tested in the laboratory
an isolate is defined as not PDR when it is susceptible to at least one of the tested antimicrobial agents
Microbiological resistance to antimicrobial agents
Phenotypic definition
A microorganism is classified as having a wild-type phenotype or a non-wild-type phenotype for a species according to the EUCAST epidemiological cut-off concentrations (ECOFFs) in a standardized methodology (or a methodology calibrated to a standardized methodology) based on species-specific MIC distributions and their inhibition zone diameter correlates.
a micro-organism is defined as wild-type (WT) for a species or species complex when it is devoid of phenotypically-detectable acquired resistance mechanism
Phenotypic classification Non-wild-type (NWT) phenotype
ECOFFs are presented as
a micro-organism is defined as non-wild-type (NWT) for a species when it expresses at least one phenotypically-detectable acquired resistance mechanism
WT: ECOFF ≤ x mg/L; disk diffusion zone diameter ≥ σ mm
NWT: ECOFF > x mg/L; disk diffusion diameter < σ mm
Identification of an acquired antimicrobial resistance mechanism (for example, drug inactivating enzyme, modification of drug target protein type, efflux pump)
Expression of an acquired antimicrobial resistance mechanism by a micro-organism can be determined in vitro and the type of mechanism identified using standardized methodology according to the EUCAST guidelines for detection of resistance mechanisms and specific resistances of clinical and/or epidemiological importance
Genotypic definition
A microorganism is classified as harbouring or lacking a genetic determinant or combination of determinants conferring to it a non-wild type susceptibility phenotype in relation to antimicrobial agent (transferable gene or core gene mutation). The presence of a genetic determinant or combination of determinants conferring to it a non-wild type susceptibility phenotype in relation to one or several antimicrobial agents can be shown by detecting and identifying the corresponding nucleic acid sequence(s) in a bacterial genome.
Genotypic classification
Genotypes are reported as:
Positive: presence of [name of resistance gene or core gene mutation]
Negative: absence of [name of resistance gene] or wild-type core gene sequence
Versions
Cited by
- Commission Implementing Regulation (EU) 2026/2097 of 18 September 2026 on the communicable diseases and related special health issues subject to epidemiological surveillance and the corresponding case definitions, and repealing Implementing Decision (EU) 2018/945 (Text with EEA relevance) Regulation · Grade B
Commission Implementing Decision (EU) 2018/945 establishes a list of communicable diseases and related special health issues to be covered by epidemiological surveillance. In addition, it sets out the case definitions for the purposes of submitting data for the epidemiological surveillance of those communicable diseases. That Implementing Decision was adopted on the basis of Decision No 1082/2013/EU of the European Parliament and of the Council, which has now been repealed by Regulation (EU) 2022/2371.
- Commission Implementing Regulation (EU) 2026/2097 of 18 September 2026 on the communicable diseases and related special health issues subject to epidemiological surveillance and the corresponding case definitions, and repealing Implementing Decision (EU) 2018/945 (Text with EEA relevance) Regulation · Grade B
The list of communicable diseases and related special health issues established by Implementing Decision (EU) 2018/945 should be updated to reflect changes in disease epidemiology and the public health needs and priorities of the Union and the Member States. The updated list should cover certain communicable diseases and related special health issues in accordance with the criteria for the selection of communicable diseases and related special health issues for epidemiological surveillance set out in Section 1 of Annex I to Regulation (EU) 2022/2371.
- Commission Implementing Regulation (EU) 2026/2097 of 18 September 2026 on the communicable diseases and related special health issues subject to epidemiological surveillance and the corresponding case definitions, and repealing Implementing Decision (EU) 2018/945 (Text with EEA relevance) Regulation · Grade B
In addition, the list of case definitions, currently set out in Implementing Decision (EU) 2018/945, should be updated in the light of new scientific information and evolving laboratory diagnostic criteria and practices.
- Commission Implementing Regulation (EU) 2026/2097 of 18 September 2026 on the communicable diseases and related special health issues subject to epidemiological surveillance and the corresponding case definitions, and repealing Implementing Decision (EU) 2018/945 (Text with EEA relevance) Regulation · Grade B
Any zoonotic influenza virus (an animal-hosted type A influenza virus that crosses the species barrier to infect humans) may cause a pandemic in the future, hence any human infection with such a virus should be subject to epidemiological surveillance at Union level. In Annex I to this Regulation, Zoonotic influenza should therefore replace the influenza A/H5N1 as currently listed in Implementing Decision (EU) 2018/945.
- Commission Implementing Regulation (EU) 2026/2097 of 18 September 2026 on the communicable diseases and related special health issues subject to epidemiological surveillance and the corresponding case definitions, and repealing Implementing Decision (EU) 2018/945 (Text with EEA relevance) Regulation · Grade B
Rabies virus and other lyssaviruses can cause central nervous disease in humans. It is therefore appropriate to expand rabies, as currently listed in Implementing Decision (EU) 2018/945, to rabies and other lyssavirus infections in Annex I to this Regulation.
- Commission Implementing Regulation (EU) 2026/2097 of 18 September 2026 on the communicable diseases and related special health issues subject to epidemiological surveillance and the corresponding case definitions, and repealing Implementing Decision (EU) 2018/945 (Text with EEA relevance) Regulation · Grade B
This Regulation replaces Implementing Decision (EU) 2018/945 which should be repealed.
- Commission Implementing Regulation (EU) 2026/2097 of 18 September 2026 on the communicable diseases and related special health issues subject to epidemiological surveillance and the corresponding case definitions, and repealing Implementing Decision (EU) 2018/945 (Text with EEA relevance) Regulation · Grade B
Implementing Decision (EU) 2018/945 is repealed.
- P8_TA(2018)0465 Lyme disease (Borreliosis) European Parliament resolution of 15 November 2018 on Lyme disease (Borreliosis) (2018/2774(RSP)) 2020/C 363/13 Notice · Grade B
Expresses its concern at the alarming proportions of the spread of Lyme disease in the European population, with around 1 million citizens suffering from the disease according to the census methods used; Recalls that all Member States, to varying degrees, are experiencing an upsurge in Lyme borreliosis, making it a European health problem; Welcomes the funding allocated to date by the Union for research into the early detection and future treatment of Lyme borreliosis (some EUR 16 million through projects such as ANTIDotE, ID-LYME and LYMEDIADEX); Calls for additional funding of the methods fo