2002D0253 — EN — 23.07.2003 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSIONDECISION
of19March2002
laying down case definitions for reporting communicable diseases to the Community network
underDecisionNo2119/98/ECoftheEuropeanParliament andoftheCouncil
(notified under document number C(2002) 1043)
(2002/253/EC)
(OJ L 86, 3.4.2002, p. 44)
Amended by:
Official Journal
No page date
►M1Commission Decision 2003/534/EC of 17 July 2003 L 184 35 23.7.2003
▼B
COMMISSIONDECISION
of19March2002
laying down case definitions for reporting communicable diseases
to the Community network under Decision No 2119/98/EC of the
EuropeanParliament andoftheCouncil
(notified under document number C(2002) 1043)
(2002/253/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 theepidemiological surveillance and control of communicable diseases in
the Community (
1), and in particular Article 3(c) thereof,
Whereas:
(1)Member States should communicate information on the epide-
miological development and emergence of public health threatsdue to communicable diseases using the Community network ina way which allows comparisons to be made for preventive and
control action to be taken at Community and national level.
(2)For comparability of such information, the setting up of common
case definitions is a prerequisite even where disease-specificsurveillance networks have not yet been put in place. As soon
as this Decision comes into effect these case definitions should
be used for reporting to the Community network, and shouldcomply with regulations on individual data protection.
(3)The case definitions which allow comparable reporting shouldcomprise a tiered system allowing Member States' structures
and/or authorities flexibility in communicating information on
diseases and special health issues. In particular, these case defi-nitions will facilitate reporting on diseases listed in CommissionDecision 2000/96/EC (
2).
(4)Case definitions should be constructed to enable all MemberStates to participate in the reporting to the greatest extentpossible, using data from their existing systems. They shouldallow for different levels of sensitivity and specificity accordingto the different goals of information collection and they shouldbe easy to amend.
(5)The measures provided for in this Decision are in accordancewith the opinion of the Committee set up by Decision No 2119/98/EC,
HAS ADOPTED THIS DECISION:
Article 1
For the purposes of submitting data for the epidemiological surveil-
lance and control of communicable diseases under the provisions ofDecision No 2119/98/EC, and in particular Article 4 thereof, MemberStates shall apply the case definitions specified in the Annex.
Article 2
This Decision will be adapted to the extent necessary on the basis of
the latest scientific data.2002D0253 — EN — 23.07.2003 — 001.001 — 2
(1) OJ L 268, 3.10.1998, p. 1.
(2) OJ L 28, 3.2.2000, p. 50.
▼B
Article 3
This Decision shall apply as of 1 January 2003.
Article 4
This Decision is addressed to the Member States.2002D0253 — EN — 23.07.2003 — 001.001 — 3
▼B
ANNEX
CASE DEFINITIONS FOR COMMUNICABLE DISEASES LISTED IN
DECISION2000/96/EC
GENERAL PRINCIPLES FOR THE APPLICATION OF THESE CASE DEFI-
NITIONS
— Unless specifically stated, only symptomatic cases are to be reported,
however, asymptomatic infections are to be regarded as cases, if the infec-
tion has therapeutic or public health implications.
— A ‘case with an epidemiological link’ is a case that has either been exposed
to a confirmed case, or has had the same exposure as a confirmed case (e.g.
eaten the same food, stayed in the same hotel, etc.).
— A three-tiered system with following levels is to be used:
— confirmed case: verified by laboratory analysis,
— probable case: clear clinical picture, or linked epidemiologically to a
confirmed case,
— possible case: indicative clinical picture without being a confirmed or
probable case.
The classification on these different levels might vary according to the
epidemiology of the individual diseases.
— Clinical symptoms listed are only given as indicative examples and not
exhaustive.
— For most diseases, several ‘criteria for laboratory diagnosis’ are listed.
Unless otherwise stated, only one of these is needed to confirm a case.
— N.A. in the case definition list means ‘not applicable’.
INTRODUCTORY NOTES
1. The information reported in this document is intended only for uniform
reporting/comparability of data within the Community network. The clinical
description gives a general outline of the disease and does not necessarily
indicate all the features needed for clinical diagnosis of the disease.
2. The laboratory criteria for diagnosis reported here may be fulfilled with
different testing methods. However, when specific techniques are indicated,
their use is recommended.
CASEDEFINITIONS
ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HIV INFEC-
TION
1.Aids
Clinical description
Includes all human immunodeficiency virus (HIV)-infected individuals who
have any of the 28 clinical conditions listed in the European AIDS surveillance
case definition.
Criteria fordiagnosis
I.Adults and adolescents : 1993 European AIDS surveillance case definition
(see Annex II).
II.Children aged <13 years : 1995 revision of the European case definition for
AIDS surveillance in children (see Annex III).
CaseclassificationPossible: N.A.
Probable: N.A.
Confirmed: A case meeting the European AIDS case definition.2002D0253 — EN — 23.07.2003 — 001.001 — 4
▼B
2.HIV infection
Clinical description
The diagnosis is based on laboratory criteria of HIV infection or a diagnosis of
AIDS.
Laboratorycriteria fordiagnosisI.Adults, adolescents and children aged ≥18 months
— Positive result on a screening HIV antibody test confirmed by a different
HIV antibody test
— Detection of HIV nucleic acid (RNA or DNA)— Detection of HIV by HIV p24 antigen test, including neutralisation assay
— HIV isolation (viral culture)
II.Children <18 months
— Positive results on two separate determinations (excluding cord blood)
from one or more of the following HIV detection tests:
— HIV nucleic acid (RNA or DNA) detection
— HIV p24 antigen test, including neutralisation assay, in a child ≥1
month of age
— HIV isolation (viral culture).
Caseclassification
Possible: N.A.
Probable: N.A.
Confirmed: A case that is laboratory confirmed or meets the European
AIDS case definition.
ANTHRAX
Clinical descriptionInhalational anthrax
After inhalation of Bacillusanthracis and a brief prodrome acute febrile respira-
tory failure develops with hypoxia, dyspnoa and radiological evidence of
mediastinal widening.
Cutaneous anthrax
A skin lesion evolving from a papule, through a vesicular stage to a depressed
black eschar with surrounding oedema. The lesion is usually painless but there
may be constitutional disturbance (fever and malaise).
Gastointestinal anthrax
Following consumption of raw contaminated food a syndrome of severe abdom-
inal pain, diarrhoea, fever and septicaemia.
Laboratorycriteria fordiagnosis
— Isolation and confirmation of B. anthracis from specimens collected from a
normally sterile site (e.g. blood or CSF) or lesion of other affected tissue
(skin, lung or gut);
— both of the following:
— evidence of B. anthracis DNA (e.g. by PCR) from specimens collected
from a normally sterile site (e.g. blood or CSF) or lesion of other
affected tissue (skin, lung or gut),
— demonstration of B. anthracis in a clinical specimen by immunohisto-
chemical staining of affected tissue (skin, lung or gut).
Nasal swab without indication of disease does not contribute to diagnosis of a
case.2002D0253 — EN — 23.07.2003 — 001.001 — 5
▼B
Caseclassification
Possible: N.A.
Probable: A probable case is defined as:
— a clinically compatible case of illness without isolation
ofB. anthracis and no alternative diagnosis, but with
laboratory evidence of B. anthracis by one supportive
laboratory test,
— a clinically compatible case of anthrax epidemiologi-
cally linked to a confirmed environmental exposure,
but without corroborative laboratory evidence of B.
anthracis infection.
Confirmed: A clinically compatible case that is laboratory confirmed.
BOTULISM
Clinical description
Clinical picture compatible with botulism, e.g. symptoms such as diplopia,
blurred vision and bulbar weakness. Symmetric paralysis may progress rapidly.
Laboratorycriteria fordiagnosis
— Detection of botulinum toxin in serum, stool, stomach content or patient's
food
— Isolation of Clostridium botulinum from stool.
Caseclassification
Possible: N.A.
Probable: A clinically compatible case with an epidemiological linkConfirmed: A clinically compatible case that is laboratory confirmed.
BRUCELLOSIS
Clinical description
Clinical picture compatible with brucellosis, e.g. acute or insidious onset of
fever, night sweats, undue fatigue, anorexia, weight loss, headache and
arthralgia.
Laboratorycriteria fordiagnosis
— Demonstration of a specific antibody response
— Demonstration by immunofluorescence of Brucellasp . in a clinical specimen
— Isolation of Brucella sp . from a clinical specimen
For probable case:
— A single high titre.
Caseclassification
Possible: N.A.
Probable: A clinically compatible case with an epidemiological link,
or a case with an isolated high titre
Confirmed: A clinically compatible case that is laboratory confirmed.
CAMPYLOBACTER INFECTION
Clinical description
Clinical picture compatible with campylobacteriosis, e.g. diarrhoeal illness of
variable severity.2002D0253 — EN — 23.07.2003 — 001.001 — 6
▼M1
▼B
▼B
Laboratorycriteria fordiagnosis
— Isolation of Campylobacter sp . from any clinical specimen.
CaseclassificationPossible: N.A.
Probable: A clinically compatible case with an epidemiological link
Confirmed: A clinically compatible case that is laboratory confirmed.
CHLAMYDIA TRACHOMATIS, GENITAL INFECTION
Clinical description
Clinical picture compatible with Chlamydiatrachomatis infection, e.g. urethritis,
epididymitis, cervicitis, acute salpingitis or other syndromes when sexually
transmitted.
Laboratorycriteria fordiagnosis
— Isolation of C.trachomatis by culture from specimen of the uro-genital tract
— Demonstration of C. trachomatis in a clinical specimen from the uro-genital
tract by detection of antigen or nucleic acid.
CaseclassificationPossible: N.A.
Probable: N.A.
Confirmed: A case that is laboratory confirmed.
CHOLERA
Clinical description
Clinical picture compatible with cholera, e.g. watery diarrhoea and/or vomiting.
Severity is variable.
Laboratorycriteria fordiagnosis
— Isolation of toxigenic (i.e. cholera toxin-producing) Vibrio cholerae O1 or
O139 from stool or vomitus
— Demonstration of a specific anti-toxin and vibrocidal antibody response.
CaseclassificationPossible: N.A.
Probable: A clinically compatible case with an epidemiological link
Confirmed: A clinically compatible case that is laboratory confirmed.
CRYPTOSPORIDIOSIS
Clinical description
Clinical picture compatible with cryptosporidiosis, characterised by diarrhoea,
abdominal cramps, loss of appetite, nausea and vomiting.
Laboratorycriteria fordiagnosis
— Demonstration of Cryptosporidium oocysts in stool
— Demonstration of Cryptosporidium in intestinal fluid or small-bowel biopsy
specimens
— Demonstration of Cryptosporidium antigen in stool.2002D0253 — EN — 23.07.2003 — 001.001 — 7
▼B
Caseclassification
Possible: N.A.
Probable: A clinically compatible case with an epidemiological link
Confirmed: A case that is laboratory confirmed.
DIPHTHERIA
Clinical description
Clinical picture compatible with either respiratory diphtheria, i.e. an upper
respiratory tract illness characterised by an adherent membrane of the tonsils,
pharynx or nose, in combination with sore throat and low grade fever, or non-
respiratory diphtheria; i.e. an illness characterised by cutaneous, conjunctival,
otic, genital or other types of ulcers.
Laboratorycriteria fordiagnosis
Isolation of diphtheria toxin-producing corynebacteria (typically Corynebac-
terium diphtheriae orC. ulcerans ) from a clinical specimen.
Caseclassification
Possible: N.A.
Probable: a clinically compatible case.
Asymptomatic
carriers:asymptomatic carriers with toxigenic strains.
Confirmed: a clinically compatible case that is laboratory confirmed
with the isolation of a toxigenic strain of corynebacteria,
or a clinically compatible case with an epidemiological
link to a laboratory confirmed case.
It is to be noted that both respiratory and non-respiratory diphtheria cases with
isolation of toxigenic strains should be reported, as should asymptomatic carriers
with toxigenic strains, if they are detected. Cases with non-toxigenic C.
diphtheriae orC. ulcerans should not be reported.
ECHINOCOCCOSIS
Clinical description
Clinical picture compatible with echinococcosis, which may produce any of
several clinical syndromes, varying with cyst size and location.
Laboratorycriteria fordiagnosis
Diagnosis by:
— Histopathology
— A combination of imaging techniques and serological tests (e.g. indirect
haemagglutination, immunodiffusion, immunoblot assay).
CaseclassificationPossible: N.A.
Probable: N.A.
Confirmed: A clinically compatible case that is laboratory confirmed.2002D0253 — EN — 23.07.2003 — 001.001 — 8
▼M1
▼B
▼B
EHEC (infection with entero-haemorrhagic Escherichia coli )
Clinical description
Clinical picture compatible with EHEC infection, e.g. diarrhoea (often bloody)
and abdominal cramps. Illness may be complicated by haemolytic uraemic
syndrome (HUS) or thrombotic thrombocytopenic purpura (TTP).
Laboratorycriteria fordiagnosis
— Isolation of E.colibelonging to a sero-groupknown to cause enterohaemor-
rhagic disease
— Serological confirmation in patients with HUS or TTP
— For probable cases: detection of genes coding for St×1/St×2 production.
CaseclassificationPossible: N.A.
Probable: A laboratory confirmed isolate without clinical informa-
tion or a case with clinical symptoms that has an epide-
miological link
Confirmed: A clinically compatible case that is laboratory confirmed.
GIARDIASIS
Clinical description
Clinical picture compatible with infection with Giardia lamblia , characterised
by diarrhoea, abdominal cramps, bloating, weight loss, or malabsorption.
Laboratorycriteria fordiagnosis
— Demonstration of G. lamblia cysts in stool
— Demonstration of G. lamblia trophozoites in stool, duodenal fluid, or small-
bowel biopsy
— Demonstration of G. lamblia antigen in stool.
Caseclassification
Possible: N.A.
Probable: A clinically compatible case that has an epidemiological
link
Confirmed: A case that is laboratory confirmed.
GONORRHOEA
Clinical description
Clinical picture compatible with gonorrhoea, e.g. urethritis, cervicitis, or salpin-
gitis.
Laboratorycriteria fordiagnosis
— Isolation of Neisseria gonorrhoeae from a clinical specimen
— Detection of N. gonorrhoeae antigen or nucleic acid
— Demonstration of gram-negative intracellular diplococci in an urethral smear
from a male.
CaseclassificationPossible: N.A.
Probable: N.A.
Confirmed: A case that is laboratory confirmed.2002D0253 — EN — 23.07.2003 — 001.001 — 9
▼B
HAEMOPHILUS INFLUENZAE TYPE B, INVASIVE
Clinical description
Clinical picture compatible with invasive disease, e.g. bacteremia, meningitis,
arthritis, epiglottitis, osteomyelitis or cellulitis.
Laboratorycriteria fordiagnosis
— Isolation of Haemophilus influenzae type B from normally sterile site
— Detection of H. influenzae nucleic acid from normally sterile site
For probable case:
— Detection of H. influenzae antigen from normally sterile site.
Caseclassification
Possible: A case with clinical epiglottitis without any laboratory
confirmation or with identification only from non-sterile
site
Probable: A clinically compatible case with antigen detection as
above
Confirmed: A clinically compatible case that is laboratory confirmed.
HEPATITIS, VIRAL
Clinical description
In symptomatic cases clinical picture compatible with hepatitis, e.g. discrete
onset of symptoms and jaundice or elevated serum aminotransferase levels.
Hepatitis A, acute
Laboratorycriteria fordiagnosis
— IgM antibody to hepatitis A virus (anti-HAV) positive
— Detection of antigen in stool
— Detection of nucleic acid in serum.
Caseclassification
Possible: N.A.
Probable: A case that meets the clinical case definition and has an
epidemiological link
Confirmed: A case that meets the clinical case definition and is
laboratory confirmed.
Hepatitis B, acute
Laboratorycriteria fordiagnosis
— IgM antibody to hepatitis B core antigen (anti-HBc) positive
— Detection of HBV nucleic acid in serum.
Caseclassification
Possible: N.A.
Probable: A case that is HbsAg positive and has a clinical picture
compatible with an acute hepatitis
Confirmed: A case that is laboratory confirmed.
Hepatitis C
Laboratorycriteria fordiagnosis
— Detection of HCV-specific antibodies2002D0253 — EN — 23.07.2003 — 001.001 — 10
▼B
— Detection of HCV nucleic acid from clinical samples.
CaseclassificationPossible: N.A.
Probable: N.A.Confirmed: A symptomatic case that is laboratory confirmed.
HIV INFECTION
(See under Acquired Immunodeficiency Syndrome above).
INFLUENZA
Clinical description
Clinical picture compatible with influenza, e.g. sudden onset of disease, cough,
fever > 38º C, muscular pain and/or headache.
Laboratorycriteria fordiagnosis
— Detection of influenza antigen, or influenza virus specific RNA
— Isolation of influenza virus
— Demonstration of a specific serum antibody response to influenza A or B.
CaseclassificationPossible: A clinically compatible case with an epidemiological link
Probable: N.A.Confirmed: A clinical case that is laboratory confirmed.
LEGIONELLOSIS
Legionnaires' diseaseClinical description
Pneumonia
Pontiac feverClinical description
A self-limiting influenza-like illness characterised by fever, headache, myalgia
and non-productive cough. Patients recover spontaneously without therapy after
2 to 5 days. No signs of pneumonia.
Laboratorycriteria fordiagnosisoflegionellosis
— Isolation of any Legionella organism from respiratory secretion, lung tissue
or blood
— Demonstration of a specific antibody response to Legionella pneumophila
serogroup1 or other serogroup s or other Legionella species by the indirect
immunofluorescent antibody test or by microagglutination
— Detection of specific Legionella antigen in urine using validated reagents
For probable case:
— A single high titre in specific serum antibody to L.pneumophila serogroup1
or other serogroups or other Legionella species
— Detection of specific Legionella antigen in respiratory secretion or direct
fluorescent antibody (DFA) staining of the organism in respiratory secretion
or lung tissue using evaluated monoclonal reagents.2002D0253 — EN — 23.07.2003 — 001.001 — 11
▼B
Caseclassification
Possible: N.A.
Probable: A clinically compatible case that is tested by laboratory as
probable (see above), or a clinically compatible case with
an epidemiological link
Confirmed: A clinically compatible case that is laboratory confirmed.
LEPTOSPIROSIS
Clinical description
Clinical picture compatible with leptospirosis, characterised by fever, headache,
chills, myalgia, conjunctival suffusion, and less frequently by meningitis, rash,
jaundice or renal insufficiency.
Laboratorycriteria fordiagnosis
— Isolation of Leptospira from a clinical specimen
— Demonstration of a specific increase in Leptospira agglutination titre
— Demonstration of Leptospira in a clinical specimen by immunofluorescence
— Detection of Leptospir a IgM antibody in serum.
CaseclassificationPossible: N.A.
Probable: N.A.
Confirmed: A clinically compatible case that is laboratory confirmed.
LISTERIOSIS
Clinical description
Infection caused by Listeria monocytogenes , which may produce any of several
clinical syndromes, including stillbirth, listeriosis of the newborn, meningitis,
bacteremia or localised infections.
Laboratorycriteria fordiagnosis
— Isolation of L. monocytogenes from a normally sterile site (e.g. blood or
cerebrospinal fluid or, less commonly, joint, pleural or pericardial fluid).
Caseclassification
Possible: N.A.
Probable: N.A.
Confirmed: A clinically compatible case that is laboratory confirmed.
MALARIA
Clinical description
Clinical picture compatible with malaria, e.g. fever and common associated
symptoms, which includes headache, back pain, chills, sweats, myalgia, nausea,
vomiting, diarrhoea and cough.
Laboratorycriteria fordiagnosis
— Demonstration of malaria parasites in blood films
— Detection of Plasmodium nucleic acid.2002D0253 — EN — 23.07.2003 — 001.001 — 12
▼B
Caseclassification
Possible: N.A.
Probable: N.A.
Confirmed: An episode of laboratory-confirmed malaria parasitemia in
any person (symptomatic or asymptomatic).
MEASLES
Clinical description
Clinical picture compatible with measles, i.e. a generalised rash lasting >3 days
and a temperature >38,0º C and one or more of the following: cough, coryza,
Koplik's spots, conjunctivitis.
Laboratorycriteria fordiagnosis
— Detection of IgM antibodies against measles in the absence of recent vacci-
nation
— Demonstration of a specific measles antibody response in absence of recent
vaccination
— Detection of measles virus (not vaccine strains) in a clinical specimen.
Caseclassification
Possible: A case diagnosed by a physician as measles
Probable: A clinically compatible case
Confirmed: A case that is laboratory confirmed or a clinically compa-
tible case with an epidemiological link. A laboratory-
confirmed case does not need to meet the clinical case
definition.
MENINGOCOCCAL DISEASE
Clinical description
Clinical picture compatible with meningococcal disease, e.g. meningitis and/or
meningococcemia that may progress rapidly to purpura fulminans, shock and
death. Other manifestations are possible.
Laboratorycriteria fordiagnosis
— Isolation of Neisseriameningitidis from a normally sterile site (e.g. blood or
cerebrospinal fluid (CSF) or, less commonly, joint, pleural or pericardial
fluid)
— Detection of N. meningitidis nucleic acid from normally sterile site
— Detection of N. meningitidis antigen from normally sterile site
— Demonstration of gram-negative diplococci from normally sterile site by
microscopy
For probable case:
— Single high titre of meningococcal antibody in convalescent serum.
CaseclassificationPossible: N.A.
Probable: A clinical picture compatible with invasive meningococcal
disease without any laboratory confirmation, or with N.
meningitidis identification from a non-sterile site, or with
high levels of meningococcal antibody in convalescent
serum
Confirmed: A clinically compatible case that is laboratory confirmed.
Note that asymptomatic carriers should not be reported.2002D0253 — EN — 23.07.2003 — 001.001 — 13
▼B
MUMPS
Clinical description
Clinical picture compatible with mumps, e.g. acute onset of uni- or bilateral
tender, self-limited swelling of the parotid or other salivary gland, lasting >2
days, and without other apparent cause.
Laboratorycriteria fordiagnosis
— Detection of mumps IgM antibody
— Demonstration of specific mumps antibody response in absence of recent
vaccination
— Isolation of mumps virus (not vaccine strains) from clinical specimen— Detection of mumps nucleic acid
CaseclassificationPossible: N.A.
Probable: A case that meets the clinical case definition and is epide-
miologically linked to a confirmed case
Confirmed: A case that is laboratory confirmed.
PERTUSSIS (WHOOPING COUGH)
Clinical description
Clinical picture compatible with pertussis, e.g. a cough illness lasting at least 2
weeks with one of the following: paroxysms of coughing, inspiratory ‘whoop’ or
post-tussive vomiting without other apparent cause.
Laboratorycriteria fordiagnosis
— Demonstration of a specific pertussis antibody response in absence of recent
vaccination
— Detection of nucleic acid— Isolation of Bordetella pertussis from clinical specimen.
CaseclassificationPossible: A case that meets the clinical case definition
Probable: A case that meets the clinical case definition and has an
epidemiological link
Confirmed: A case that is laboratory confirmed.
PLAGUE
Clinical description
The disease is characterized by fever, chills, headache, malaise, prostration and
leukocytosis that manifests in one or more of the following principal clinical
forms:
— regional lymphadenitis (bubonic plague),
— septicaemia without an evident bubo (septicemic plague),— plague pneumonia,— pharyngitis and cervical lymphadenitis.
Laboratorycriteria fordiagnosis
— Isolation of Yersinia pestis from a clinical specimen
— Demonstration of a specific antibody response to Y. pestis F1 antigen.
For probable case:
— Elevated serum antibody titre(s) to Y.pestis fraction 1 (F1) antigen (without
documented specific change) in a patient with no history of plague vaccina-
tion
— Detection of F1 antigen in a clinical specimen by fluorescent assay.2002D0253 — EN — 23.07.2003 — 001.001 — 14
▼B
Caseclassification
Possible: A clinically compatible case
Probable: A clinically compatible case with probable laboratory
results
Confirmed: A clinically compatible case with confirmatory laboratory
results.
POLIOMYELITIS, PARALYTIC
Clinical description
Clinical picture compatible with poliomyelitis, e.g. acute onset of a flaccid
paralysis of one or more limbs with decreased or absent tendon reflexes in the
affected limbs, without other apparent cause and without sensory or cognitive
loss.
Laboratorycriteria fordiagnosis
— Isolation of poliovirus from a clinical specimen
— Detection of polio virus nucleic acid.
Caseclassification
Possible: N.A.
Probable: A case that meets the clinical case definition
Confirmed: A case that meets the clinical case definition and is
laboratory confirmed.
Q-FEVER
Clinical description
A febrile illness accompanied by rigors, myalgia, malaise, and retrobulbar head-
ache. Severe disease can include acute hepatitis, pneumonia,
meningoencephalitis and abortion. Clinical laboratory findings may include
elevated liver enzyme levels and abnormal film findings.
Laboratorycriteria fordiagnosis
— isolation of Coxiella burnetii from a clinical specimen,
— demonstration of a specific antibody response,— demonstration of C. burnetii in a clinical specimen by detection of antigen
or nucleic acid.
For probable cases: a single high titre of specific antibodies.
Caseclassification
Possible: N.A.
Probable: a clinically compatible case that fulfils the laboratory
criteria for a probable case or has an epidemiological link.
Confirmed: a laboratory confirmed case that is clinically compatible
or has an epidemiological link.
RABIES, HUMAN
Clinical description
Rabies is an acute encephalomyelitis that almost always progresses to coma or
death within 10 days after the first symptom.2002D0253 — EN — 23.07.2003 — 001.001 — 15
▼M1
▼B
▼B
Laboratorycriteria fordiagnosis
— Detection by direct fluorescent antibody of viral antigens in a clinical
specimen (preferably the brain or the nerves surrounding hair follicles in
the nape of the neck)
— Detection of rabies nucleic acid in clinical specimen— Isolation (in cell culture or in a laboratory animal) of rabies virus from
saliva, cerebrospinal fluid (CSF), or central nervous system tissue
— Identification of a rabies-neutralising antibody titre (complete neutralization)
in the serum or CSF of an unvaccinated person.
CaseclassificationPossible: A clinical compatible case without laboratory confirma-
tion
Probable: N.A.
Confirmed: A clinically compatible case that is laboratory confirmed
RUBELLA
Clinical description
Clinical picture compatible with rubella, e.g. acute onset of generalized maculo-
papular rash and arthralgia/arthritis, lymphadenopathy, or conjunctivitis.
Laboratorycriteria fordiagnosis
— Detection of rubella IgM antibody in absence of recent vaccination
— Demonstration of a specific rubella antibody response in absence of recent
vaccination
— Isolation of rubella virus in absence of recent vaccination
— Detection of rubella nucleic acid in clinical specimen.
CaseclassificationPossible: A case that meets the clinical case definition
Probable: A clinically compatible case that has an epidemiological
link
Confirmed: A clinically compatible case that is laboratory confirmed.
SALMONELLOSIS (NON-TYPHI, NON-PARATYPHI)
Clinical description
Clinical picture compatible with salmonellosis, e.g. diarrhoea, abdominal pain,
nausea and sometimes vomiting. The organism may cause extraintestinal infec-
tions.
Laboratorycriteria fordiagnosis
— Isolation of Salmonella (non-typhi, non-paratyphi) from a clinical specimen.
CaseclassificationPossible: N.A.
Probable: A laboratory confirmed isolate without clinical informa-
tion or, a case with clinical symptoms that has an epide-
miological link
Confirmed: A clinically compatible case that is laboratory confirmed.
SHIGELLOSIS
Clinical description
An illness of variable severity characterised by diarrhoea, fever, nausea, cramps,
and tenesmus.2002D0253 — EN — 23.07.2003 — 001.001 — 16
▼B
Laboratorycriteria fordiagnosis
— Isolation of Shigella sp . from a clinical specimen.
Caseclassification
Possible: N.A.
Probable: A clinically compatible case with an epidemiological link
Confirmed: A clinically compatible case that is laboratory confirmed.
SMALLPOX
Clinical description
An illness with acute onset of fever over 38 ºC followed by a rash characterised
by vesicles or firm pustules at the same stage of development without other
apparent cause and with a predominantly centrifugal distribution.
Atypical presentations may include:
— haemorrhagic lesions,
— flat velvety lesions not appearing as typical vesicles nor progressing to
pustules.
Laboratorycriteria fordiagnosis
Isolation of smallpox ( Variola) virus from a clinical specimen.
Polymerase chain reaction (PCR) identification of VariolaDNA in a clinical
specimen, followed by sequencing.
Negative-stain Electron microscopy (EM) identification of Variolavirus in a
clinical specimen.
Caseclassification
Possible: a clinically compatible case
A case that has an atypical presentation and has an epide-
miological link to confirmed or probable cases.
Probable: a clinically compatible case with either identification of
orthopox virus by EM or PCR, or an epidemiological
link to other probable or confirmed cases.
Confirmed: for an initial case, a clinically compatible case with
laboratory confirmation by EM and PCR, followed by
sequencing.
During an outbreak, a clinically compatible case with an epidemiological link
and, where possible, laboratory confirmation by either EM or PCR.
STREPTOCOCCUS PNEUMONIAE, INVASIVE DISEASE
Clinical description
Steptococcus pneumoniae causes many clinical syndromes, depending on the
site of infection (e.g. acute otitis media, pneumonia, bacteremia, or meningitis).
Laboratorycriteria fordiagnosis
— Isolation of S. pneumoniae from a normally sterile site (e.g. blood, cere-
brospinal fluid, or, less commonly, joint, pleural or pericardial fluid)
— Detection of S. pneumoniae nucleic acid from a normally sterile site
For probable case:
— Detection of S. pneumoniae antigen from a normally sterile site.2002D0253 — EN — 23.07.2003 — 001.001 — 17
▼M1
▼B
▼B
Caseclassification
Possible: A clinically compatible case without any laboratory
confirmation, or with identification from a non-sterile site
Probable: A clinically compatible case that is antigen positiveConfirmed: A clinically compatible case that is laboratory confirmed.
SYPHILIS
Syphilis, primaryClinical description
A stage of infection with Treponema pallidum characterised by one or more
chancres (ulcers). Chancres might differ considerably in clinical appearance.
Laboratorycriteria fordiagnosis
— Detection of specific IgM by EIA
— Demonstration of T. pallidum in clinical specimens by dark field micro-
scopy, direct fluorescent antibody (DFA-TP) or equivalent methods
For probable case:
— A reactive serologic test (nontreponemal: Venereal Disease Research
Laboratory (VDRL) or rapid plasma reagin (RPR); treponemal: fluorescent
treponemal antibody absorbed (FTA-ABS) or microhemagglutination assay
for antibody to T. pallidum (MHA-T]).
CaseclassificationPossible: N.A.
Probable: A clinically compatible case with one or more ulcers
(chancres) consistent with primary syphilis and any reac-
tive serologic test
Confirmed: A clinically compatible case that is laboratory confirmed.
Syphilis, secondary
Clinical description
A stage of infection caused by T. pallidum and characterised by localised or
diffuse mucocutaneous lesions, often with generalised lymphadenopathy. The
primary chancre may still be present.
Laboratorycriteria fordiagnosis
— Demonstration of T. pallidum in clinical specimens by dark field micro-
scopy, direct fluorescent antibody (DFA-TP) or equivalent methods
For probable case:
— A reactive serologic test (nontreponemal: Venereal Disease Research
Laboratory (VDRL)
— Rapid plasma reagin (RPR); treponemal: fluorescent treponemal antibody
absorbed (FTA-ABS)
— Microhaemagglutination assay for antibody to T. pallidum (MHA-TP).
CaseclassificationPossible: N.A.
Probable: A clinically compatible case with any respective serologic
test
Confirmed: A clinically compatible case that is laboratory confirmed.2002D0253 — EN — 23.07.2003 — 001.001 — 18
▼B
Syphlis, latent
Clinical description
A stage of infection caused by T. pallidum in which organisms persist in the
body of the infected person without causing symptoms or signs.
Laboratorycriteria fordiagnosis
Demonstration of a positive reaction with a specific EIA but negative for labora-
tory test for infectious syphilis (see primary or secondary syphilis).
Caseclassification
Possible: N.A.
Probable: No clinical signs or symptoms of syphilis and a positive
laboratory test as above
Confirmed: N.A.
TETANUS
Clinical description
Clinical picture compatible with tetanus, e.g. acute onset of hypertonia and/or
painful muscular contractions (usually of the muscles of the jaw and neck) and
generalised muscle spasms without other apparent medical cause.
Laboratorycriteria fordiagnosis
— Detection of tetanus toxoid antibody in an unvaccinated and untreated
patient
— Demonstration of a specific tetanus toxoid antibody response.
Caseclassification
Possible: N.A.
Probable: N.A.
Confirmed: A clinically compatible case.
TOXOPLASMOSIS
Clinical description
A protozoan disease, which presents with an acute illness with one or more of
the following: lymphadenopathy, encephalitis, chorioretinitis, disfunction of the
central nervous system. Congenital infections may also occur with hydroce-
phalus, microcephalus, intracerebral calcification, convulsions, cerebral
retardation.
Laboratorycriteria fordiagnosis
— Demonstration of a specific toxoplasma antibody response
— Demonstration of the agent in body tissues or fluids or isolation in animals
or cell culture
— Detection of toxoplasma nucleic acid.
Caseclassification
Possible: N.A.
Probable: N.A.
Confirmed: A clinically compatible case that is laboratory confirmed.2002D0253 — EN — 23.07.2003 — 001.001 — 19
▼B
TRICHINOSIS
Clinical description
A disease caused by ingestion of Trichinella larvae. The disease has variable
clinical manifestations. Common signs and symptoms among symptomatic
persons include eosinophilia, fever, myalgia and periorbital œdema.
Laboratorycriteria fordiagnosis
— Demonstration of Trichinella larvae in tissue obtained by muscle biopsy
— Demonstration of a specific Trichinella antibody response.
Caseclassification
Possible: N.A.
Probable: A clinically compatible case with an epidemiological link
Confirmed: A clinically compatible case that is laboratory confirmed.
TUBERCULOSIS
Clinical criteria
— A clinician's judgement that clinical and/or radiological signs and/or symp-
toms are compatible with tuberculosis
and
— a clinician's decision to treat the patient with a full course of anti-tubercu-
losis therapy.
Laboratorycriteria
— Isolation of Mycobacterium tuberculosis complex (except M. bovis BCG)
from any clinical specimen by culture
— Evidence of acid-fast bacilli (AFB) at microscopic examination of sponta-
neous or induced sputum.
Classificationaccordingtolaboratorycriteria
Definite
A case with isolation of M. tuberculosis complex (except M. bovis BCG) from
any clinical specimen. In countries where culture is not routinely available, a
case with sputum smear examinations positive for AFB is also considered to
be a definite case.
Other than definite
A case that meets the clinical criteria above but does not meet the laboratory
criteria of a definite case.
Classificationaccordingtositeofdisease
Pulmonary tuberculosis
Tuberculosis of the lung parenchyma or the tracheo-bronchial tree.
Extrapulmonary tuberculosis
Tuberculosis affecting any site other than pulmonary as defined above.
Classificationaccordingtopreviousanti-tuberculosistreatmentNever treated
A case which never received a treatment for active tuberculosis in the past or
which received anti-tuberculosis drugs for less than one month.
Previously treated
A case which was diagnosed with active tuberculosis in the past and received
anti-tuberculosis drugs (excluding preventive therapy) for at least one month.2002D0253 — EN — 23.07.2003 — 001.001 — 20
▼M1
TULARAEMIA
Clinical description
Clinical picture compatible with one of the different forms of tularaemia:
— ulceroglandular (cutaneous ulcer with regional lymphadenopathy),
— glandular (regional lymphadenopathy with no ulcer),
— oculoglandular (conjunctivitis with preauricular lymphadenopathy),
— oropharyngeal (stomatitis or pharyngitis or tonsillitis and cervical lymphade-
nopathy),
— intestinal (intestinal pain, vomiting, and diarrhoea),
— pneumonic (primary pneumonic disease),
— typhoidal (febrile illness without early localising signs and symptoms).
Laboratorycriteria fordiagnosis
— Isolation of Francisella tularensis from a clinical specimen,
— demonstration of a specific antibody response.
For probable cases:
— a single high titre,
— detection of F. tularensis in a clinical specimen by fluorescent assay.
Caseclassification
Possible: N.A.
Probable: a clinically compatible case that fulfils the laboratory
criteria for a probable case or has an epidemiological link.
Confirmed: a clinically compatible case that is laboratory confirmed.
TYPHOID/PARATYPHOID FEVER
Clinical description
An illness caused by Salmonella typhi or paratyphii that is often characterised
by insidious onset of sustained fever, headache, malaise, anorexia, relative
bradycardia, constipation or diarrhoea and nonproductive cough. However,
many mild and atypical infections occur.
Laboratorycriteria fordiagnosis
— Isolation of S. typhi or paratyphii from blood, stool or other clinical
specimen.
CaseclassificationPossible: N.A.
Probable: A laboratory confirmed isolate without clinical informa-
tion or, a case with clinical symptoms with an epidemio-
logical link
Confirmed: A clinically compatible case that is laboratory confirmed.
VARIANT CREUTZFELDT–JAKOB'S DISEASE
Clinical description
I.History
— Progressive neuropsychiatric disorder,
— Duration of illness > 6 months,
— Routine investigation do not suggest an alternative diagnosis,
— No history of potential iatrogenic exposure.2002D0253 — EN — 23.07.2003 — 001.001 — 21
▼B
▼B
II.Clinical features
— Early psychiatric symptoms,
— Persistent painful sensory symptoms,— Ataxia,
— Myoclonus or chorea or dystonia,
— Dementia.
Laboratorycriteria fordiagnosis
— EEG does not show typical appearance of classical CJD (or no EEG
performed)
— Bilateral pulvinar high signal on MRI scan
— Characteristic neuropathological and immunopathological findings.
Caseclassification
Possible: N.A.
Probable: I and 4/5 of clinical features and EEG does not show
typical appearance of classical CJD (or no EEG
performed) and Bilateral pulvinar high signal on MRI
scan
I and positive tonsil biopsy
Confirmed: Progressive neuropsychiatric disorder and neuropatholo-
gical confirmation of diagnosis of vCJD.
VIRAL HAEMORRHAGIC FEVERS
Ebola/Marburg fever
Clinical description
Begins with acute fever, diarrhoea that can be bloody and vomiting. Headache,
nausea, and abdominal pain are common. Haemorrhagic manifestations may
follow. Some patients may also show a maculopapular rash on the trunk.
Laboratorycriteria fordiagnosis
— Positive virus isolation
— Positive skin biopsy (immunohistochemistry)— Detection of Ebola/Marburg virus nucleic acid
— Positive serology, which may appear late in the course of the disease.
CaseclassificationPossible: N.A.
Probable: A clinically compatible case with an epidemiological link
Confirmed: A clinically compatible case that is laboratory-confirmed.
Lassa fever
Clinical description
An illness of gradual onset with malaise, fever, headache, sore throat, cough,
nausea, vomiting, diarrhoea, myalgia and chest pain. Haemorrhagic manifesta-
tions may follow.
Laboratorycriteria fordiagnosis
— Virus isolation
— Positive skin biopsy (immunohistochemistry)— Detection of Lassa virus nucleic acid— Positive serology, which may appear late in the course of the disease.2002D0253 — EN — 23.07.2003 — 001.001 — 22
▼B
Caseclassification
Possible: N.A.
Probable: A clinically compatible case with an epidemiological link
Confirmed: A clinically compatible case that is laboratory-confirmed.
Congo-Crimean haemorrhagic fever
Clinical description
An illness of gradual onset with acute high fever, chills, myaliga, nausea, anor-
exia, vomitting, headache and backache. Haemorrhagic manifestations may
follow.
Laboratorycriteria fordiagnosis
— Virus isolation
— Detection of CCHF virus nucleic acid— Positive serology, which may appear late in the course of the disease.
CaseclassificationPossible: N.A.
Probable: A clinically compatible case with an epidemiological linkConfirmed: A clinically compatible case that is laboratory-confirmed.
YELLOW FEVER
Clinical description
An illness characterised by acute onset and constitutional symptoms followed by
a brief remission, a recurrence of fever, hepatitis, albuminuria, and in some
instances, renal failure, shock and generalised hæmorrhages.
Laboratorycriteria fordiagnosis
— Demonstration of a specific yellow fever antibody response in a patient who
has no history of recent yellow fever vaccination and where cross-reactions
to other flaviviruses have been excluded
— Virus isolation
— Detection of yellow fever antigen
— Detection of yellow fever nucleic acid.
CaseclassificationPossible: N.A.
Probable: A clinically compatible case with an epidemiological link
Confirmed: Any clinically compatible case that is laboratory-
confirmed.
YERSINIOSIS
Clinical description
An illness of variable severity characterised by diarrhoea, fever, nausea, cramps
and tenesmus.
Laboratorycriteria fordiagnosis
— Isolation of Yersinia enterocolitica or pseudotubeculosis from a clinical
specimen.2002D0253 — EN — 23.07.2003 — 001.001 — 23
▼B
Caseclassification
Possible: N.A.
Probable: A clinically compatible case with an epidemiological linkConfirmed: A case that is laboratory confirmed.2002D0253 — EN — 23.07.2003 — 001.001 — 24