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  1. Case Definitions/

Zika Virus Disease (ECDC/EU Case Definition)

Authors: European Centre for Disease Prevention and Control (ECDC)

Location: European Union

Purpose #

EU/ECDC case definition for Zika virus disease surveillance, per Commission Implementing Decision (EU) 2018/945: clinical criteria (rash), laboratory criteria for confirmed and probable cases, and epidemiological criteria (travel/residence in a transmission area or sexual contact with an exposed/confirmed person).

The definition #

Clinical criteria: A person presenting with a rash.

Laboratory criteria for confirmed case (at least one of the following):

  • Detection of Zika virus nucleic acid in a clinical specimen
  • Detection of Zika virus antigen in a clinical specimen
  • Isolation of Zika virus from a clinical specimen
  • Detection of Zika virus specific IgM antibodies in serum sample(s) AND confirmation by neutralisation test
  • Seroconversion or four-fold increase in the titre of Zika specific antibodies in paired serum samples

Laboratory criteria for probable case: Detection of Zika specific IgM antibodies in a serum sample.

Epidemiological criteria (at least one of the following):

  • History of travel to, or residence in an area with documented on-going transmission of Zika virus, within the two-week period prior to the onset of symptoms
  • Sexual contact with a person recently exposed to or confirmed with Zika virus infection

Case classification: A. Possible case: not applicable B. Probable case: a person meeting the clinical and epidemiological criteria, with a probable-level laboratory result C. Confirmed case: a person meeting the laboratory criteria for case confirmation

Machine-readable definition #

The definition is available in JSON format following the Open Syndrome v1.0 specification:

{
   "$schema": "https://w3id.org/opensyndrome/v1/schema.json",
   "@context": "https://opensyndrome.org/schema/v1/context.jsonld",
   "authors": [],
   "category": "probable",
   "definition_type": "case_definition",
   "description": "EU/ECDC case definition for Zika virus disease surveillance, per Commission Implementing Decision (EU) 2018/945: clinical criteria (rash), laboratory criteria for confirmed and probable cases, and epidemiological criteria (travel/residence in a transmission area or sexual contact with an exposed/confirmed person).",
   "human_readable_definition": "Clinical criteria:\nA person presenting with a rash.\n\nLaboratory criteria for confirmed case (at least one of the following):\n- Detection of Zika virus nucleic acid in a clinical specimen\n- Detection of Zika virus antigen in a clinical specimen\n- Isolation of Zika virus from a clinical specimen\n- Detection of Zika virus specific IgM antibodies in serum sample(s) AND confirmation by neutralisation test\n- Seroconversion or four-fold increase in the titre of Zika specific antibodies in paired serum samples\n\nLaboratory criteria for probable case:\nDetection of Zika specific IgM antibodies in a serum sample.\n\nEpidemiological criteria (at least one of the following):\n- History of travel to, or residence in an area with documented on-going transmission of Zika virus, within the two-week period prior to the onset of symptoms\n- Sexual contact with a person recently exposed to or confirmed with Zika virus infection\n\nCase classification:\nA. Possible case: not applicable\nB. Probable case: a person meeting the clinical and epidemiological criteria, with a probable-level laboratory result\nC. Confirmed case: a person meeting the laboratory criteria for case confirmation",
   "inclusion_criteria": [
     {
       "logical_operator": "OR",
       "name": "Zika virus disease case classification (probable or confirmed)",
       "type": "criterion",
       "values": [
         {
           "logical_operator": "AND",
           "name": "Confirmed case (laboratory criteria for case confirmation)",
           "type": "criterion",
           "values": [
             {
               "logical_operator": "OR",
               "name": "Laboratory criteria for confirmed case",
               "type": "criterion",
               "values": [
                 {
                   "name": "Detection of Zika virus nucleic acid in a clinical specimen",
                   "type": "diagnostic_test"
                 },
                 {
                   "name": "Detection of Zika virus antigen in a clinical specimen",
                   "type": "diagnostic_test"
                 },
                 {
                   "name": "Isolation of Zika virus from a clinical specimen",
                   "type": "diagnostic_test"
                 },
                 {
                   "logical_operator": "AND",
                   "name": "Zika-specific IgM antibodies detected, confirmed by neutralisation test",
                   "type": "criterion",
                   "values": [
                     {
                       "name": "Zika virus specific IgM antibodies detected in serum sample(s)",
                       "type": "diagnostic_test"
                     },
                     {
                       "name": "Confirmation by neutralisation test",
                       "type": "diagnostic_test"
                     }
                   ]
                 },
                 {
                   "name": "Seroconversion or four-fold increase in the titre of Zika specific antibodies in paired serum samples",
                   "type": "diagnostic_test"
                 }
               ]
             }
           ]
         },
         {
           "logical_operator": "AND",
           "name": "Probable case (clinical, epidemiological and probable-level laboratory criteria)",
           "type": "criterion",
           "values": [
             {
               "name": "Rash",
               "type": "symptom"
             },
             {
               "logical_operator": "OR",
               "name": "Epidemiological criteria",
               "type": "criterion",
               "values": [
                 {
                   "description": "History of travel to, or residence in an area with documented on-going transmission of Zika virus, within the two-week period prior to the onset of symptoms",
                   "name": "Travel or residence in transmission area",
                   "type": "epidemiological_history"
                 },
                 {
                   "description": "Sexual contact with a person recently exposed to or confirmed with Zika virus infection",
                   "name": "Sexual contact with exposed or confirmed person",
                   "type": "epidemiological_history"
                 }
               ]
             },
             {
               "description": "Probable-level laboratory criterion (does not require confirmation by neutralisation test)",
               "name": "Zika specific IgM antibodies detected in a serum sample",
               "type": "diagnostic_test"
             }
           ]
         }
       ]
     }
   ],
   "keywords": [
     "Zika",
     "arbovirus",
     "flavivirus",
     "ECDC",
     "European Union",
     "case definition"
   ],
   "language": "English",
   "location": "European Union",
   "notes": [],
   "open_syndrome_version": "1.0.0",
   "organization": "European Centre for Disease Prevention and Control (ECDC)",
   "published_at": "2026-09-09T14:00:00Z",
   "published_by": [
     "Open Syndrome Initiative"
   ],
   "published_in": "https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018D0945\u0026from=EN#page=53",
   "references": [
     {
       "citation": "Commission Implementing Decision (EU) 2018/945 of 22 June 2018 on the communicable diseases and related special health issues to be covered by epidemiological surveillance as well as relevant case definitions, Annex II.",
       "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018D0945\u0026from=EN#page=53"
     },
     {
       "citation": "European Centre for Disease Prevention and Control (ECDC). Case definition for surveillance of Zika virus infection.",
       "url": "https://www.ecdc.europa.eu/en/zika-virus-infection/surveillance-and-disease-data/case-definition"
     }
   ],
   "scope": "specific",
   "status": "draft",
   "surveillance_system_type": "EU epidemiological surveillance under Commission Implementing Decision (EU) 2018/945",
   "target_public_health_threats": [
     "Zika virus disease",
     "Zika virus infection"
   ],
   "title": "Zika Virus Disease (ECDC/EU Case Definition)",
   "version": "1.0.0"
 }

Using the Definition #

Healthcare organizations can implement this definition through:

  • Direct integration with surveillance systems
  • API endpoints for real-time validation
  • Manual case verification processes

Next Steps #

We encourage:

  • Clinical feedback on the definition criteria
  • Technical feedback on the implementation format
  • Suggestions for additional symptoms or signs
  • Reports of implementation experiences

Get Involved #

We welcome contributions and feedback from the community.