Commission Decision
of 28 April 2008
amending Decision 2002/253/EC laying down case definitions for reporting communicable diseases to the Community network under Decision No 2119/98/EC of the European Parliament and of the Council
(notified under document number C(2008) 1589)
(Text with EEA relevance)
(2008/426/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community, and in particular Article 3(c) thereof,
OJ L 268, 3.10.1998, p. 1. Decision as last amended by Commission Decision 2007/875/EC (OJ L 344, 28.12.2007, p. 48)
Whereas:
(1) According to Article 2 of Commission Decision 2002/253/EC the case definitions laid down in Annex to that Decision should be updated to the extent necessary on the basis of the latest scientific data.
OJ L 86, 3.4.2002, p. 44. Decision as amended by Decision 2003/534/EC (OJ L 184, 23.7.2003, p. 35)
(2) In accordance with Article 9 of the Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and control (ECDC), the ECDC provided, at the request of the Commission and in agreement with its Advisory Forum, a technical document on case definitions aiding the Commission in the development of intervention strategies in the field of surveillance and response. The technical document has been further published on the web site of the ECDC. The case definitions listed in the Annex to Decision 2002/253/EC should be updated on the basis of this contribution.
OJ L 142, 30.4.2004, p. 1
(3) Those case definitions have the purpose of facilitating the reporting on the diseases and special health issues listed in Annex I to Commission Decision 2000/96/EC of 22 December 1999 on the communicable diseases to be progressively covered by the Community network under Decision No 2119/98/EC of the European Parliament and of the Council. Decision 2002/253/EC however does not entail any reporting obligation.
OJ L 28, 3.2.2000, p. 50. Decision as last amended by Decision 2007/875/EC.
(4) The measures provided for in this Decision are in accordance with the opinion of the Committee set up by Decision No 2119/98/EC,
HAS ADOPTED THIS DECISION:

Article 1 The Annex to Decision 2002/253/EC is replaced by the Annex to this Decision.
Article 2 This Decision is addressed to the Member States.
Done at Brussels, 28 April 2008.
For the Commission
Androulla Vassiliou
Member of the Commission

ANNEX EXPLANATION OF THE SECTIONS USED FOR THE DEFINITION AND CLASSIFICATION OF CASES

Clinical criteria
These should 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. The clinical criteria give the general outline of the disease and do not necessarily indicate all the features needed for individual clinical diagnosis.

Laboratory criteria
Laboratory criteria should be 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. For some agreed exceptions, laboratory criteria for a probable case are included. This is 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, is defined as one of the six following:
human to human transmission: Any person who 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: Any person who has had contact with an animal with a laboratory confirmed infection/colonisation in such a way as to have had the opportunity to acquire the infection,
exposure to a common source: Any person who has been exposed to the same common source or vehicle of infection, as a confirmed human case,
exposure to contaminated food/drinking water: Any person who has consumed food or drinking water with a laboratory confirmed contamination or a person who has consumed potentially contaminated products from an animal with a laboratory confirmed infection/colonisation,
environmental exposure: Any person who has bathed in water or has had contact with a contaminated environmental source that has been laboratory confirmed,
laboratory exposure: Any person working 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 (e.g. 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, indirect transmission by infected mosquitoes, 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 will be 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
Defined as a case that is classified as possible for reporting purposes. It is usually a case with the clinical criteria as described in the case definition without epidemiological or laboratory evidence of the disease in question. The definition of a possible case 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
Defined as a case that is 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
Defined as a case that is classified as confirmed for reporting purposes. Confirmed cases should be laboratory confirmed and may fulfil the clinical criteria or not as described in the case definition. The definition of a confirmed case 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, (e.g. hepatitis A, B and C, campylobacter, salmonellosis) although these cases may still be important from a public health perspective on national level.
Confirmed cases will fall in one of the three subcategories listed below. These subcategories will be created during the analysis of data using the variables collected with 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 (e.g. 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.

ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION

Clinical criteria (AIDS)
Any person who has any of the clinical conditions as defined in the European AIDS case definition for:
Adults and adolescents ≥ 13 years
European Centre for the Epidemiological Monitoring of AIDS. 1993 revision of the European AIDS surveillance case definition. AIDS Surveillance in Europe, Quarterly Report 1993; No 37: 23-28
Children < 13 years of age
European Centre for the Epidemiological Monitoring of AIDS. European case definition for AIDS surveillance in children — revision 1995. HIV/AIDS Surveillance in Europe, Quarterly Report 1995; No 48: 46-53

Laboratory criteria (HIV)
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 (e.g. 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

Epidemiological criteria
NA

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

ANTHRAX (Bacillus anthracis)

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
Fever or feverishness
AND at least one of the following two:
Severe abdominal pain
Diarrhoea

Inhalational anthrax
Fever or feverishness
AND at least one of the following two:
Acute respiratory distress
Radiological evidence of mediastinal widening

Meningeal/meningoencephalitic anthrax
Fever
AND at least one of the following three:
Convulsions
Loss of consciousness
Meningeal signs
Anthrax septicaemia

Laboratory criteria
Isolation of Bacillus anthracis from a clinical specimen
Detection of Bacillus anthracis nucleic acid in a clinical specimen
Positive nasal swab without clinical symptoms does not contribute to a confirmed diagnosis of a case.

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

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

AVIAN INFLUENZA A/H5 OR A/H5N1 IN HUMANS

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 (fourfold 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 one 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 one metre) with an animal with confirmed A/H5N1 infection other than poultry or wild birds (e.g. 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:
See World isOrganisation for Animal Health — OIE — and European Commission (SANCO) Animal Disease Notification System (ADNS), available at: http://www.oie.int/eng/en_index.htm and http://ec.europa.eu/food/animal/diseases/adns/index_en.htm#)
Having been in close contact (within one metre) with sick or dead domestic poultry or wild birds in the affected area
This does not include seemingly well birds that have been killed, for example by hunting.
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

BOTULISM (Clostridium botulinum)

Clinical criteria
Any person with at least one of the following clinical forms:

Food-borne and wound botulism
At least one of the following two:
Bilateral cranial nerve impairment (e.g. diplopia, blurred vision, dysphagia, bulbar weakness)
Peripheral symmetric paralysis

Infant botulism
Any infant with at least one of the following six:
Constipation
Lethargy
Poor feeding
Ptosis
Dysphagia
General muscle weakness
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.

Laboratory criteria
At least one of the following two:
Isolation of C. botulinum for infant botulism (stool) or wound botulism (wound) (isolation of C. botulinum in stool of adults not relevant for the diagnosis of food-borne botulism)
Detection of botulinum toxin in a clinical specimen

Epidemiological criteria
At least one of the following two epidemiological links:
Exposure to a common source (e.g. 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 and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

BRUCELLOSIS (Brucella spp.)

Clinical criteria
Any person with fever
AND at least one of following seven:
Sweating (profuse, malodorous, specially nocturnal)
Chills
Arthralgia
Weakness
Depression
Headache
Anorexia

Laboratory criteria
At least one of the following two:
Isolation of Brucella spp. from a clinical specimen
Brucella specific antibody response (Standard Agglutination Test, Complement Fixation, ELISA)

Epidemiological criteria
At least one of the following four 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 e.g. vaginal discharge, placenta)
Exposure to a common source

Case classification

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

CAMPYLOBACTERIOSIS (Campylobacter spp.)

Clinical criteria
Any person with at least one of the following three:
Diarrhoea
Abdominal pain
Fever

Laboratory criteria
Isolation of Campylobacter spp. from stool or blood
Differentiation of Campylobacter spp. should be performed if possible

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

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

CHLAMYDIAL INFECTION
(Chlamydia trachomatis)
INCLUDING LYMPHOGRANULOMA VENEREUM (LGV)

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 and with an epidemiological link

C. Confirmed case
Any person meeting the laboratory criteria

CHOLERA (Vibrio cholerae)

Clinical criteria
Any person with at least one of the following two:
Diarrhoea
Vomiting

Laboratory criteria
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

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

VARIANT CREUTZFELDT-JAKOB DISEASE (VCJD)

Preconditions
Any person with a progressive neuropsychiatric disorder with a duration of illness of at least six 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

Clinical criteria
Any person with at least four of the following five:
Early psychiatric symptoms
Depression, anxiety, apathy, withdrawal, delusions.
Persistent painful sensory symptoms
This includes both frank pain and/or dysaesthesia.
Ataxia
Myoclonus or chorea or dystonia
Dementia

Diagnostic criteria

Diagnostic criteria for case confirmation:
Neuropathological confirmation: spongiform change and extensive prion protein deposition with florid plaques throughout the cerebrum and cerebellum

Diagnostic criteria for a probable or a possible case:
EEG does not show the typical appearance of sporadic CJD in the early stages of the illness
The typical appearance of the EEG in sporadic CJD consists of generalised periodic complexes at approximately one per second. These may occasionally be seen in the late stages of VCJD.
Bilateral pulvinar high signal on MRI brain scan
A positive tonsil biopsy
Tonsil biopsy is not recommended routinely nor in cases with EEG appearances typical of sporadic CJD, but may be useful in suspect cases in which the clinical features are compatible with VCJD and MRI does not show pulvinar high signal.

Epidemiological criteria
An epidemiological link by human to human transmission (e.g. 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

CRYPTOSPORIDIOSIS (Cryptosporidium spp)

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

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

DIPHTHERIA (Corynebacterium diphtheriae and Corynebacterium ulcerans)

Clinical criteria
Any person with at least one of the following clinical forms:

Respiratory diphtheria:
An upper respiratory tract illness with fever AND one of the following two:
Croup
OR
an adherent membrane in at least one of the following three locations:
Tonsil
Pharynx
Nose

Nasal diphtheria:
Uni- or bilateral nasal discharge initially clear and becoming bloody

Cutaneous diphtheria:
Skin lesion

Diphtheria of other sites:
Lesion of conjunctiva or mucous membranes

Laboratory criteria
Isolation of toxin-producing C. diphtheriae or C. ulcerans from a clinical specimen

Epidemiological criteria
An epidemiological link by human to human transmission

Case classification

A. Possible case
Any person meeting the clinical criteria for respiratory diphtheria

B. Probable case
Any person meeting the clinical criteria for diphtheria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

ECHINOCOCCOSIS (Echinococcus spp)

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 (e.g. direct isvisualisation 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 (e.g.: computerised 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

Epidemiological criteria
NA

Case classification

A. Possible case
NA

B. Probable case
NA

C. Confirmed case
Any person meeting the diagnostic criteria

SHIGA/VERO TOXIN PRODUCING ESCHERICHIA COLI INFECTION (STEC/VTEC)

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 three:
Isolation of Shigatoxin/Verotoxin (STEC/VTEC) producing E. coli
Detection of stx1 or stx2 gene(s) nucleic acid
Detection of free shigatoxins.
Only for HUS the following can be used as laboratory criterion to confirm STEC/VTEC:
E. coli serogroups specific antibody response
Isolation and additional ischaracterisation by serotype, phage type, eae genes, and subtypes of stx1/stx2 should be performed if possible

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

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 and with an epidemiological link or a laboratory confirmed case without clinical criteria

C. Confirmed case of STEC/VTEC
Any person meeting the clinical and the laboratory criteria

GIARDIASIS (Giardia lamblia)

Clinical criteria
Any person with at least one of the following four:
Diarrhoea
Abdominal pain
Bloating
Signs of malabsorption (e.g. steatorrhoea, weight loss)

Laboratory criteria
At least one of the following two:
Demonstration of Giardia lamblia cysts or trophozoites in stool, duodenal fluid or small-bowel biopsy
Demonstration of Giardia lamblia antigen in stool

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

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

GONORRHOEA (Neisseria gonorrhoeae)

Clinical criteria
Any person with at least one of the following eight:
Urethritis
Acute salpingitis
Pelvic inflammatory disease
Cervicitis
Epididymitis
Proctitis
Pharyngitis
Arthritis
OR
Any newborn child with conjunctivitis

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 and with an epidemiological link

C. Confirmed case
Any person meeting the laboratory criteria

HAEMOPHILUS MENINGITIS, INVASIVE DISEASE (Haemophilus influenzae)

Clinical criteria
Not relevant for surveillance purposes

Laboratory criteria
Laboratory criteria for case definition
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
Typing of the isolates should be performed, if possible

Epidemiological link
NA

Case Classification

A. Possible case
NA

B. Probable case
NA

C. Confirmed case
Any person meeting the laboratory criteria for case confirmation

HEPATITIS A (Hepatitis A Virus)

Clinical criteria
Any person with a discrete onset of symptoms (e.g. 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

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

HEPATITIS B, ACUTE (Hepatitis B virus)

Clinical criteria
Any person with a discrete onset of symptoms (e.g. 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
Hepatitis B virus core IgM antigen specific antibody response
Laboratory results need to be interpreted according to the vaccination status

Epidemiological criteria
An epidemiological link by human to human transmission (e.g. sexual contact, vertical transmission or blood transmission)

Case classification

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

HEPATITIS C (Hepatitis C virus)

Clinical criteria
Not relevant for surveillance purposes

Laboratory criteria
At least one of the following two:
Detection of hepatitis C virus nucleic acid in serum
Hepatitis C virus specific antibody response confirmed by a different antibody test

Epidemiological criteria
NA

Case classification

A. Possible case
NA

B. Probable case
NA

C. Confirmed case
Any person meeting the laboratory criteria

INFLUENZA (influenza virus)

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:
Cough
Sore throat
Shortness of breath
Coryza
AND
A clinician's judgement that the illness is due to an infection

Laboratory criteria
At least one the following four:
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
Sub typing of the influenza isolate should be performed, if possible

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) and with an epidemiological link

C. Confirmed case
Any person meeting the clinical (ILI or ARI) and the laboratory criteria

LEGIONNAIRES' DISEASE (Legionella spp.)

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
Legionella pneumophila serogroup 1 specific antibody response
Laboratory criteria for a probable case
At least one of the following four:
Detection of Legionella pneumophila antigen in respiratory secretions or lung tissue e.g. by DFA staining using monoclonal-antibody derived reagents
Detection of Legionella spp. nucleic acid in a clinical specimen
Legionella pneumophila non-serogroup 1 or other Legionella spp. specific antibody response
L. pneumophila serogroup 1, other serogroups or other Legionella species: single high titre in specific serum antibody

Epidemiological criteria
At least one of the following two epidemiological links:
Environmental exposure
Exposure to the same common source

Case classification

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria AND at least one positive laboratory test for a probable case OR an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria for case confirmation

LEPTOSPIROSIS (Leptospira interrogans)

Clinical criteria
Any person with
Fever
OR
At least two of the following eleven:
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 from a clinical specimen
Detection of Leptospira interrogans nucleic acid in a clinical specimen
Demonstration of Leptospira interrogans by immunofluorescence in a clinical specimen
Leptospira interrogans 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

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

LISTERIOSIS (Listeria monocytogenes)

Clinical criteria
Any person with at least one of the following three:
Listeriosis of newborns defined as
Stillbirth
OR
At least one of the following five in the first month of life:
Granulomatosis infantiseptica
Meningitis or meningoencephalitis
Septicaemia
Dyspnoea
Lesions on skin, mucosal membranes or conjunctivae
Listeriosis in pregnancy defined as at least one of the following three:
Abortion, miscarriage, stillbirth or premature birth
Fever
Influenza-like symptoms
Other form of listeriosis defined as at least one of the following four:
Fever
Meningitis or meningoencephalitis
Septicaemia
isLocalised infections such as arthritis, endocarditis, and abscesses

Laboratory criteria
At least one of the following two:
Isolation of Listeria monocytogenes from a normally sterile site
Isolation of Listeria monocytogenes from a normally non-sterile site in a foetus, stillborn, newborn or the mother at or within 24 hours of birth

Epidemiological criteria
At least one of the following three epidemiological links:
Exposure to a common source
Human to human transmission (vertical transmission)
Exposure to contaminated food/drinking water

Additional information
Incubation period 3-70 days, most often 21 days

Case classification

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the laboratory criteria
OR
Any mother with a laboratory confirmed listeriosis infection in her foetus, stillborn or newborn

MALARIA (Plasmodium spp.)

Clinical criteria
Any person with fever OR a history of fever

Laboratory criteria
At least one of the following three:
Demonstration of malaria parasites by light microscopy in blood films
Detection of Plasmodium nucleic acid in blood
Detection of Plasmodium antigen
Differentiation of Plasmodium spp. should be performed if possible

Epidemiological criteria
NA

Case classification

A. Possible case
NA

B. Probable case
NA

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

MEASLES (Measles virus)

Clinical criteria
Any person with fever
AND
Maculo-papular rash
AND at least one of the following three:
Cough
Coryza
Conjunctivitis

Laboratory criteria
At least one of the following four:
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
Laboratory results need to be interpreted according to the vaccination status. If recently vaccinated, investigate for wild virus

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 and with an epidemiological link

C. Confirmed case
Any person not recently vaccinated and meeting the clinical and the laboratory criteria

MENINGOCCOCAL DISEASE, INVASIVE (Neisseria meningitidis)

Clinical criteria
Any person with at least one of the following five:
Fever
Meningeal signs
Petechial rash
Septic shock
Septic arthritis

Laboratory criteria
At least one of the following four:
Isolation of Neisseria meningitidis from a normally sterile site, including purpuric skin lesions
Detection of Neisseria meningitidis nucleic acid from a normally sterile site, including 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 and with an epidemiological link

C. Confirmed case
Any person meeting the laboratory criteria

MUMPS (Mumps virus)

Clinical criteria
Any person with
Fever
AND
At least two of the following three:
Sudden onset of tender swelling of the parotid or other salivary glands
Orchitis
Meningitis

Laboratory criteria
At least one of the following three:
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
Laboratory results need to be interpreted according to the vaccination status

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 and 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

PERTUSSIS (Bordetella pertussis)

Clinical criteria
Any person with a cough lasting at least two weeks
AND
at least one of the following three:
Paroxysms of coughing
Inspiratory ‘whooping’
Post-tussive vomiting
OR
Any person diagnosed as pertussis by a physician
OR
Apnoeic episodes in infants

Laboratory criteria
At least one of the following three:
Isolation of Bordetella pertussis from a clinical specimen
Detection of Bordetella pertussis nucleic acid in a clinical specimen
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 and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

PLAGUE (Yersinia pestis)

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:
Fever
AND
At least one of the following three:
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 (F1 antigen)
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 and with an epidemiological link

C. Confirmed case
Any person meeting the laboratory criteria

PNEUMOCOCCAL INVASIVE DISEASE(S) (Streptococcus pneumoniae)

Clinical criteria
Not relevant for surveillance purposes

Laboratory criteria
At least one of the following three:
Isolation of S. pneumoniae from a normally sterile site
Detection of S. pneumoniae nucleic acid from a normally sterile site
Detection of S. pneumoniae antigen from a normally sterile site

Epidemiological criteria
NA

Case classification

A. Possible case
NA

B. Probable case
NA

C. Confirmed case
Any person meeting the laboratory criteria

POLIOMYELITIS (Polio virus)

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 and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

Q FEVER (Coxiella burnetii)

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 and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

RABIES (Lyssa virus)

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:
Isolation of Lyssa virus from a clinical specimen
Detection of Lyssa virus nucleic acid in a clinical specimen (e.g. saliva or brain tissue)
Detection of viral antigens by a DFA in a clinical specimen
Lyssa virus specific antibody response by virus isneutralisation assay in serum or CSF
Laboratory results need to be interpreted according to the vaccination or immunisation status

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 (e.g. transplantation of organs)

Case classification

A. Possible case
Any person meeting the clinical criteria

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

RUBELLA (Rubella virus)

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
Laboratory criteria for case confirmation
At least one of the following three:
Isolation of rubella virus from a clinical specimen
Detection of rubella virus nucleic acid in a clinical specimen
Rubella virus specific antibody response (IgG) in serum or saliva
Laboratory criteria for probable case
Rubella virus specific antibody response (IgM)
When rubella in pregnancy is suspected, further confirmation of a positive rubella IgM results is required (e.g. a rubella specific IgG avidity test showing a low avidity). In certain situations, such as confirmed rubella outbreaks detection of rubella virus IgM can be considered confirmatory in non-pregnant cases.
Laboratory results need to be interpreted according to the vaccination status

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 and with at least one of the following two:
An epidemiological link
Meeting the laboratory criteria for a probable case

C. Confirmed case
Any person not recently vaccinated and meeting the laboratory criteria for case confirmation
In case of recent vaccination, a person with detection of wild-type rubella virus strain

RUBELLA, CONGENITAL (Including congenital rubella syndrome)

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)
Cataract(s)
Congenital glaucoma
Congenital heart disease
Loss of hearing
Pigmentary retinopathy
(B)
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:
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)
Laboratory results need to be interpreted according to the vaccination status

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 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 category ‘A’ CRS clinical criteria
An infant with positive laboratory criteria only without a history of rubella in the mother during the pregnancy and without ‘A’ clinical criteria will therefore be reported as rubella case.

SALMONELLOSIS (Salmonella spp. other than S. Typhi and S. Paratyphi)

Clinical criteria
Any person with at least one of the following four:
Diarrhoea
Fever
Abdominal pain
Vomiting

Laboratory criteria
Isolation of Salmonella (other than S. Typhi and S. Paratyphi) from stool or blood

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

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

SEVERE ACUTE RESPIRATORY SYNDROME — SARS (SARS-coronavirus, SARS-CoV)

Clinical criteria
Any person with fever or a history of fever
AND
At least one of the following three:
Cough
Difficulty in breathing
Shortness of breath
AND
At least one of the following four:
Radiographic evidence of pneumonia
Radiographic evidence of acute respiratory distress syndrome
Autopsy findings of pneumonia
Autopsy findings of acute respiratory distress syndrome
AND
No alternative diagnosis which can fully explain the illness

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 (e.g. nasopharyngeal swab and stool)
The same clinical specimen collected on two or more occasions during the course of the illness (e.g. 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
Fourfold 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 (e.g. 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
A close contact is a person who has cared for, lived with, or having had direct contact with the respiratory secretions, body fluids and/or excretions (e.g. faeces) of cases of 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 and with onset of illness in the same 10-day period
In this context the term ‘health-care worker’ includes all hospital staff. The definition of the health care unit in which the cluster occurs will depend on the local situation. Unit size may range from an entire health care facility if small, to a single department or ward of a large tertiary hospital.
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 and with an epidemiological link

B. Probable case
Any person meeting the clinical criteria AND 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 and 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

SHIGELLOSIS (Shigella spp.)

Clinical criteria
Any person with at least one of the following four:
Diarrhoea
Fever
Vomiting
Abdominal pain

Laboratory criteria
Isolation of Shigella spp. from 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

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

SMALLPOX (Variola virus)

Clinical criteria
Any person with at least one of the following two:
Fever
AND
Vesicles or firm pustules rash at the same stage of development with a centrifugal distribution
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:
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
Laboratory results need to be interpreted according to the vaccination status
Laboratory criteria for a probable case
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 and with an epidemiological link

SYPHILIS (Treponema pallidum)

Clinical criteria
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 three:
Diffuse maculo-papular rash often involving palms and soles
Generalised lymphadenopathy
Condyloma lata
Enanthema
Allopetia diffusa
Early latent syphilis (< 1 year)
A history of symptoms compatible with those of the earlier stages of syphilis within the previous 12 months
Late latent syphilis (> 1 year)
Any person meeting laboratory criteria (specific serological tests)

Laboratory criteria
At least one of the following four laboratory tests:
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 PCR
Detection of Treponema pallidum antibodies by screening test (TPHA, TPPA or EIA) AND additionally detection of Tp-IgM antibodies (by IgM-ELISA, IgM immunoblot or 19S-IgM-FTA-abs) — confirmed by a second IgM assay

Epidemiological criteria
Primary/secondary syphilis
An epidemiological link by human to human (sexual contact)
Early latent syphilis (< 1 year)
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 and with an epidemiological link

C. Confirmed case
Any person meeting the laboratory criteria for case confirmation

SYPHILIS, CONGENITAL AND NEONATAL (Treponema pallidum)

Clinical criteria
Any infant < 2 years of age with at least one of the following 10:
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:
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)
AND a reactive non treponemal test (VDRL, RPR) in the child's serum
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 fourfold 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

TETANUS (Clostridium tetani)

Clinical criteria
Any person with 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
Generalised spasms, frequently position of opisthotonus

Laboratory criteria
At least one of the following two:
Isolation of Clostridium tetani from an infection site
Detection of tetanus toxin in a serum sample

Epidemiological criteria
NA

Case classification

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

TOXOPLASMOSIS, CONGENITAL (Toxoplasma gondii)

Clinical criteria
Not relevant for surveillance purposes

Laboratory criteria
At least one of the following four:
Demonstration of T. gondii in body tissues or fluids
Detection of T. gondii nucleic acid in a clinical specimen
T. gondii specific antibody response (IgM, IgG, IgA) in a newborn
Persistently stable IgG T. gondii titres in an infant (<12 months of age)

Epidemiological criteria
NA

Case classification

A. Possible case
NA

B. Probable case
NA

C. Confirmed case
Any infant meeting the laboratory criteria

TRICHINELLOSIS (Trichinella spp.)

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

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical criteria and the laboratory criteria

TUBERCULOSIS (Mycobacterium tuberculosis complex)

Clinical criteria
Any person with the following two:
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
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

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

Epidemiological criteria
NA

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

TULARAEMIA (Francisella tularensis)

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
Cervical lymphadenopathy
AND
at least one of the following three:
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 and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

TYPHOID/PARATYPHOID FEVER (Salmonella Typhi/Paratyphi)

Clinical criteria
Any person with at least one of the following two:
Onset of sustained fever
At least two of the following four:
Headache
Relative bradycardia
Non productive cough
Diarrhoea, constipation, malaise or abdominal pain
Paratyphoid fever has the same symptoms as typhoid fever, however usually a milder course.

Laboratory criteria
Isolation of Salmonella Typhi or Paratyphi from 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

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

VIRAL HAEMORRHAGIC FEVERS

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 Viral Hemorrhagic Fever whose onset of illness was within the last six months

Case classification

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria

WEST NILE FEVER (West Nile virus infection, WNV)

Clinical criteria
Any person with fever
OR
At least one of the following two:
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

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

YELLOW FEVER (Yellow fever virus)

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
Laboratory results need to be interpreted according to flavivirus vaccination status

Epidemiological criteria
Travel in the last one week to a region where yellow fever cases are known or believed to have occurred

Case classification

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and 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.

YERSINIOSIS (Yersinia enterocolitica, Yersinia pseudotuberculosis)

Clinical criteria
Any person with at least one of the following five:
Fever
Diarrhoea
Vomiting
Abdominal pain (pseudoappendicitis)
Tenesmus

Laboratory criteria
Isolation of human pathogenic Yersinia enterocolitica or Yersinia pseudotuberculosis from 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

A. Possible case
NA

B. Probable case
Any person meeting the clinical criteria and with an epidemiological link

C. Confirmed case
Any person meeting the clinical and the laboratory criteria