Edastuskiri

E-kiri.eml

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.

To: Operational Contact Points mpox

CC: National Focal points for Emerging and Vector Borne Diseases

National Focal points for HIV/AIDS, STIs and hepatitis B/C

National Focal points for Surveillance

National Coordinators

Dear Colleagues,

This is a reminder that the deadline for the next reporting of mpox cases is November 5^th. As always please report to TESSy through the EpiPulse portal.

If you have Clade I cases, please report these as soon as possible in EpiPulse Events so that we become aware of them as soon as possible, and then to follow up with Tessy reporting.

We are very interested in getting as complete data as possible on all cases in tessy – especially Clade I but also Clade II to use as comparison as we try to understand more about severity, breakthrough infections etc. Please add as much information as you can in Tessy on prior vaccination, prior infection, HIV status, transmission category, clade, travel history, symptoms, hospitalisation, severity and outcome. It is ok to add information later as it becomes available so it is better to report soon and complete/update the record later.

Please find the link to the threat assessment brief published last week: Threat Assessment Brief: Detection of autochthonous transmission of monkeypox virus clade Ib in the EU/EEA

Thank you very much for all your hard work. If you have any questions or need further information, please don't hesitate to contact us at [email protected] (ECDC) or [email protected] (WHO Europe).

Kind regards,

Lina Nerlander

On behalf of ECDC and WHO EURO mpox teams

Lina Nerlander

BMBCh, MPH, PhD

Principal Expert Sexually Transmitted Infections

STI, Blood‑borne Viruses and TB

,

DVD

Phone +46 (0)8 58 60 1080

[email protected]

European Centre for
Disease Prevention and Control (ECDC)

Gustav III:s boulevard 40, 169 73 Solna, Sweden

Phone +46 (0)8 58 60 10 00

www.ecdc.europa.eu

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MPX_Reporting Protocol_v5. 2024_08_20.pdf

Mpox reporting protocol 20 August 2024

TESSy - The European Surveillance System

Mpox (MPX)

Reporting Protocol

Version 5.0, 20 August 2024

Contents

How to use this document .................................................................................................... 4

Finding further information ................................................................................................... 4

Copyright ............................................................................................................................. 4

Introduction .............................................................................................................. 5

Case definition ..................................................................................................................... 5

Aim ..................................................................................................................................... 5

Surveillance Objectives ......................................................................................................... 5

Reporting to TESSy .................................................................................................... 6

Checking metadata ............................................................................................................... 6

Checking your data source profile.......................................................................................... 7

Submitting your data ............................................................................................................ 8

Finalising your submission .................................................................................................... 8

TESSy HelpDesk ................................................................................................................... 8

Changes to mpox (MPX) metadata .............................................................................. 9

Annex 1 – Mpox metadata ........................................................................................ 10

Revisions of MPX metadata set............................................................................................ 10

Current record type versions .......................................................................................... 10

Common TESSy variables ............................................................................................... 10

Epidemiological variables ............................................................................................... 11

Annex 2 – Case definitions ........................................................................................ 23

WHO outbreak case definition for mpox .......................................................................... 23

Page 3 of 24

Summary of changes

20 August 2024 (version 5.0)

− Updated to RecordTypeVersion 5.

− Updated categories to include information on subclades within the clade variable.

− Inclusion of HOUSEABROAD and PLANE categories in the ExposureSetting variable.

− Updated categories to include information on subclades within the PreviousMPXclade variable.

− Redefinition of categories for the Sexual Orientation variable to HETERO, MSM, WSW, O,

BISEXUAL, NA, UNKNOWN, and relabelling the variable as "Sexual behaviour of the Case” Label: SexualBehaviour

10 March 2023 (version 4.0)

- Added variables PreviousMPX, PreviousMPXDate

23 September 2022 (version 3.2)

− Updated description of variable OtherGender. 8 September 2022 (version 3.1)

− Updated case definitions.

− Updated coded value list of CaseDefinition variable with category WHO_Aug2022 to

collect information on the new case definition by WHO from 25 August 2022.

5 August 2022 (version 3.0)

− Updated to RecordTypeVersion 3.

− Removed variables SmallpoxVaccine and DateLastVaccDose.

− Added variables PrEPHIV, SexWorker, NumberSexPartners, OtherGender, VaccPoxPrev,

VaccPoxPrevDate, VaccPoxCurrentStatus, VaccPoxBrand1, VaccPoxBrand2, VaccPoxDate1, VaccPoxDate2, VaccPoxPurpose1, VaccPoxPurpose2, Complications, and

ComplicationsOther.

− Updated coded value list of ClinicalSymptoms variable with category PROCT for reporting of proctitis, category DIARR for reporting of diarrhoea, category LYMPHLOCUNK for

reporting lymphadenopathy where the location is not known, and category GENITEDEM

for reporting of genital soft-tissue oedema/swelling.

− Corrected designation of category SORTHR to SORETHR in the coded value list of ClinicalSymptoms variable.

− Updated coded value list of SpecimenMPX variable with category CSF for reporting of

specimen collection of cerebrospinal fluid.

− Added validation rules.

22 June 2022 (version 2.0 revised)

− Added YUNK (yes for unknown reason) to the coded value list for Hospitalisation.

16 June 2022 (version 2.0)

− Updated to RecordTypeVersion 2.

− Changed coded value list for TravelPlaces to include all places worldwide.

− Added RASHLOCUNK (Skin/mucosal lesions where the location is not known) to the coded

value list for ClinicalSymptoms variable.

Page 4 of 24

How to use this document

This Reporting Protocol provides information for data managers in reporting countries in two main

sections:

• Reporting to TESSy – contains guidelines on how to prepare data for submission to TESSy, deadlines for reporting, subject-specific information (e.g. new changes to metadata), and

links to further information.

• Annex – contains:

o A history of metadata changes for the subject(s) covered by this Reporting Protocol.

o The metadata set for the subject(s) covered by this Reporting Protocol.

Finding further information

Paragraphs denoted by the information icon tell where you can find further information.

Updated links to all the schedules, documentation and training materials mentioned in this Reporting

Protocol are included in the TESSy Technical Guidelines & Tools (see the menu ‘Technical Guidelines

and Tools’ when logged in TESSy), including:

• Metadata sets and history.

• Tutorials for data transformation using respectively Excel and Access.

• TESSy user documentation.

• CSV and XML transport protocols.

Copyright

the source is acknowledged.

Page 5 of 24

Introduction

This reporting protocol is intended for reporting national case-based data for surveillance of mpox

from all the countries and areas of the WHO European Region, including the 27 countries of the

European Union (EU) and the additional three countries of the European Economic Area (EEA), to the

European level.

Data are submitted through the case-based record type MPX to the European Surveillance System

(TESSy) database hosted at ECDC and access through the EpiPulse portal.

Data can be reported to TESSy either manually, for entry of single cases, or through metadata-

standardised CSV or XML files for multiple cases (please see technical annex).

Case definition

Probable and confirmed cases should be reported according to the current WHO case definition for

mpox (Annex 2). Information on the case definition used should be provided in the variable CaseDefinition. If a national case definition is used this information should also be provided in the

variable CaseDefinition.

Aim

To support the timely and complete reporting of key information on mpox epidemiology in the

countries and areas of the WHO European Region, including the 27 countries of the European Union

(EU) and the additional three countries of the European Economic Area (EEA).

Surveillance Objectives

1. Monitor the intensity and geographical spread of the monkeypox virus in the population in time,

place and person; 2. To understand the natural history and epidemiology of the disease including risk factors for

infection in order to assess its impact and prepare accordingly

3. To describe the population at highest risk of infection and severe outcomes in order to target preventive or control measures

4. Assess the impact of any control and prevention measures.

Page 6 of 24

Reporting to TESSy

This section provides both an overview of the TESSy reporting process and tips on where you can find

useful information.

The overall process includes: 1. Familiarising yourself with the data collection deadlines

2. Preparing (exporting and transforming) your data 3. Checking that your data comply with the metadata

4. Checking that your data source profile is up-to-date

5. Submitting your data to TESSy

6. Finalising and approving your submission.

This reporting protocol is supplemented by a technical annex, which contains updated generic

information for data submission.

Please note, if MPXV clade I virus is detected in an mpox case, or if there is an unexpected increase in case numbers, or the emergence of cases in new risk groups, populations, or settings, we kindly

request that these be reported immediately through event-based surveillance mechanisms (EpiPulse,

EWRS, IHR routes). However, ECDC encourages sharing through the following items from EpiPulse: [Mpox due to monkeypox virus clade I – Multi-country – 2024 and Mpox due to clade II - Multi- country (global outbreak) - 2022-2024].

Data collection schedule Case data including retrospective updates to cases already in TESSy should be reported monthly

on the first Thursday of each month, by 10:00AM. Due to potential overlap with holidays, the

following dates for monthly data upload for the next five months are as follows:

• 5 September 2024 • 3 October 2024

• 7 November 2024 • 5 December 2024

Please also note that should there be any significant changes in mpox epidemiology in the coming

months, the reporting frequency through TESSy may increase at short notice to ensure

appropriate surveillance according to the epidemiological situation.

If data is shared through event-based surveillance (EpiPulse, EWRS, IHR), subsequently, or concurrently, upload the relevant data to the TESSy database either or immediately or as of the next

subsequent data call deadline. Please note that all data are collected jointly with the World Health

Organisation – Regional Office for Europe (WHO/Europe) to fulfil Member States reporting

requirements to WHO. Duplicate reporting is therefore not required.

Preparing data Data may be entered directly in TESSy for individual records (‘Manually create a record’). For any

batch reporting by file upload (CSV or XML format) please note that once the data has been exported

from your national database it needs to be in a format that TESSy can accept (see ‘checking metadata’).

Tutorials covering how you can transform your data to the correct TESSy format using Excel or

Access are available on the TESSy documents website. Information on the file formats is available in

the CSV Transport Protocol and XML Transport Protocol.

Checking metadata

The TESSy metadata define the fields and valid data formats for input to TESSy for a given subject.

To ensure data can be saved correctly in TESSy, please check the data are correctly formatted

according to the most recent metadata set.

Page 7 of 24

Changes to the metadata for the subject of this Reporting Protocol are described in:

• Changes to current metadata – changes since the last Reporting Protocol.

• Annex Metadata change history – all preceding changes.

It is especially important to focus on:

• Field formats

Many fields require that data are formatted in a specific way. For example, dates must be in the

YYYY-MM-DD format; dates in the DD/MM/YYYY format will be rejected.

• Coded values

Some fields only permit the use of specific values (coded values). For example, M, F, UNK, or

Other are the coded values for Gender and any other value in a Gender field will be rejected.

• Repeatable fields

For variables where multiple items of the coded value list apply, the field should be repeated as needed to include only one item per field. If not applicable, use N/A.

The metadata file contains all the definitions and rules you need to comply with to format your data

correctly. The file can be downloaded as an Excel file from the TESSy documents website.

By filtering the fields in the file by subject, you can see the fields required for your subject and the

rules applying to these fields.

The Tessy User Guide provides an overview of how you work with the metadata file, and the

TESSy user documentation provides in-depth details on metadata.

Checking your data source profile

Before submitting file(s), please review your data source(s) in EpiPulse (in the menu, go to ‘Report’ ->

‘Surveillance systems descriptors’) and update the information as necessary.

Complete and up-to-date data source information for each subject facilitates surveillance data

interpretation - each surveillance system has different features that need to be considered when

comparing data at international level.

If your data source information is outdated and you do not have access rights to update it, please ask

your National Focal Point for Surveillance or National Coordinator to do so.

In-depth information on the data source variables is available in the TESSy user documentation.

Page 8 of 24

Submitting your data

Data is submitted through the EpiPulse web interface (in the menu, go to Report -> Cases).

The User Guide provides an overview of how to submit files to TESSy and in-depth descriptions of all

the methods for uploading data.

Finalising your submission

The compliance of your data with the validation rules in the metadata is checked automatically during

the data upload process.

The result of your upload – i.e. rejected or validated – is displayed immediately after the check in the

Validation details webpage has completed. Please review the result carefully:

• If your file has been rejected, there will be a message explaining each instance of non-

compliance with the metadata that you need to correct.

• If your file has been validated, there might be warnings and remarks relating to possible data

quality issues or to potential overwriting of existing records that you should consider.

When you file has been validated and you are satisfied that all corrections have been made, please

ensure prompt approval – unapproved uploads can block the approval of other uploads.

• The TESSy user documentation provides information on reviewing validation results and adjusting

reporting periods to avoid overwriting existing records.

• General training and guidance on reporting is available on the TESSy website.

TESSy HelpDesk

Email: [email protected]

Telephone number: +46-(0)8-5860 1601

Availability:

9:00 – 16:00 Stockholm time, Monday to Friday (except ECDC Holidays)

Page 9 of 24

Changes to mpox (MPX) metadata

RecordType: MPX: RecordType Version 5: Review 2024-08-20

− Updated to RecordTypeVersion 5.

− Updated categories to include information on subclades within the clade variable.

− Inclusion of HOUSEABROAD and PLANE categories in the ExposureSetting variable.

− Updated categories to include information on subclades within the PreviousMPXclade variable.

− Redefinition of categories for the Sexual Orientation variable to HETERO, MSM, WSW, O, BISEXUAL, NA, UNKNOWN, and relabelling the variable as "Sexual behaviour of the Case” Label:

SexualBehaviour

Page 10 of 24

Annex 1 – Mpox metadata

Revisions of MPX metadata set

The MPX metadata have been developed in collaboration with WHO.

The TESSy metadata contains all the definitions and rules necessary to format data correctly for every

subject (usually a disease). This can be downloaded as an Excel file from the Technical Guidelines & Tools section of the ‘Documentation and Help’ pages.

By filtering the fields in the file by subject, you can see the fields required for your subject and the rules

applying to these fields.

The User Guide provides an overview of how you work with the metadata file.

Current record type versions

Table 1 shows the record type versions to be used when reporting mpox (Record type: MPX) data to

TESSy.

Table 1: MPX record type versions

Record Type of data Record type version

MPX Case-based 5

Common TESSy variables

Record Identifier (mandatory)

Field: RecordId

Coding: Text (max 80 characters)

The record identifier is provided by the Member State. It must be:

▪ unique within the national MPX reporting system (records with the same ID will be

overwritten)

▪ anonymous.

Record type (mandatory)

Field: RecordType

Coding: MPX

The record type defines the structure and the format of the data reported. The record types are defined by ECDC and are related to the subject. Only valid combinations of subject, record type and

data source are accepted.

Record type version

Field: RecordTypeVersion

Coding: 5

The version of the record type defines the current structure of the data reported. The current version

of the MPX record type is 5.

This variable is not mandatory as TESSy concludes the record type version from the metadataset

indicated by default. However, the variable RecordTypeVersion can override this default.

Page 11 of 24

Subject (mandatory)

Field: Subject

Coding: MPX

The subject describes the disease to be reported.

Data source (mandatory)

Field: DataSource

Coding: To be assigned by each country to an existing data source, or to a newly

created one.

The data source specifies the surveillance system from which the data originates and is generated

and revised/updated by the national focal point in each Member State. The descriptions of the surveillance systems submitted to TESSy (section Data Sources) will be used to assist with data

interpretation. Make sure that the subject "MPX" is associated with this data source.

Reporting country (mandatory)

Field: ReportingCountry

Coding: International organization for standardization (ISO) 3166-1-alpha-2, (two-letter code)

This variable identifies the country reporting the case.

Date used for statistics (mandatory)

Field: DateUsedForStatistics

Coding: yyyy-mm-dd

Date when the case report is notified the first time to the place of notification.

Status (mandatory)

Field: Status

Coding: NEW/UPDATE

DELETE

The field ‘Status’ is used for updating data; the default is ‘New/Update’. By choosing ‘Delete’ the

selected record (or batch of data) will remain in TESSy but be marked as inactive; this data can be

used to reconstruct data for a given date in the past.

Epidemiological variables

In alphabetic order by field.

Accession number

Field: AccessionNumber

Coding: TEXT

Sequence identifier for whole genome or whole or partial gene sequence, based on which the

sequence read data can be retrieved from external database such as GenBank, ENA or other

database.

Age (mandatory)

Field: Age Coding: Numerical (0-120)

UNK = Unknown

Age of patient in years at the time of disease onset.

Page 12 of 24

Age in months

Field: AgeMonth

Coding: Numerical (0-23) NA = Not applicable

UNK = Unknown

Age of patient in months at diagnosis for cases <2 years of age at the time of diagnosis.

Animal contact

Field: AnimalContact

Coding: N = No

PET = Household pets excluding rodents PETRODENTS = Rodent pets

UNK = UNK WILD = Wild animals excluding rodents

WILDRODENTS = Wild rodents

Animal contact in the 21 days before symptom onset or date of diagnosis.

Antiviral treatment

Field: AntiviralTreatment

Coding: TEC = tecovirimat

BRI = brincidofovir CID = cidofovir

UNK = Unknown

YUNK = Yes, but name of antiviral treatment not known N = No antiviral treatment

Information if case has received treatment with antivirals. Note this is a repeatable field.

Brand name of first dose of smallpox/mpox vaccination

Field: VaccPoxBrand1

Coding: SmallpoxVaccine:

ACAM2000 = ACAM2000

APSV = Aventis Pasteur smallpox vaccine)

Imvanex = Imvanex

Imvamune = Imvamune

Jynneos =Jynneos

LC16m8 = LC16m8

O = Other

UNK = Unknown

Brand name of first dose of smallpox/mpox vaccine related to the current mpox event/outbreak.

Brand name of second dose of smallpox/mpox vaccination

Field: VaccPoxBrand2

Coding: SmallpoxVaccine:

ACAM2000 = ACAM2000

APSV = Aventis Pasteur smallpox vaccine)

Imvanex = Imvanex

Imvamune = Imvamune

Jynneos =Jynneos

LC16m8 = LC16m8

Page 13 of 24

O = Other

UNK = Unknown

Brand name of second dose of smallpox/mpox vaccine related to the current mpox event/outbreak.

Case definition used

Field: CaseDefinition

Coding: ECDC = ECDC case definition (prior to 25 August 2022) NAT = National case definition

UNK = Unknown

WHO = WHO case definition (prior to Interim Guidance from 25 August 2022) WHO_Aug2022 = WHO case definition (Interim Guidance from 25 August 2022)

Case definition used for classification of the case (see Annex 2 for the current WHO case definitions). Please refer to Surveillance, case investigation and contact tracing for Monkeypox: Interim guidance

(25 August 2022) for more details on the current WHO mpox case definition.

CD4 cell count Field: CD4Cells

Coding: Numerical (0-6000) NA = Not applicable

UNK = Unknown

CD4 count at time of diagnosis of mpox.

Clade of monkeypox virus

Field: Clade

Coding: Ia = Clade Ia,

Ib= Clade Ib

I= Clade I (for cases where clade is known without subclade identification)

IIa= Clade IIa

IIb= Clade IIb

II= Clade II (for cases where clade is known without subclade identification)

UNK= Unknown

Clade of the genomically characterised monkeypox virus. Please reporting using the option that

provides the most specific data for the case, ie, sub-clade if information is available or clade, if

information on sub-clade is not available).

Classification (mandatory)

Field: Classification

Coding: CONF = Confirmed

PROB = Probable UNK = Unknown

Case classification according to case definition used.

Clinical symptoms of the case (mandatory)

Field: ClinicalSymptoms

Coding: ASY = Asymptomatic RASH = Skin/mucosal lesions excluding oral or anogenital areas

GENITAL = Anogenital dermatological skin/mucosal lesions

GENITEDEM = Genital soft-tissue oedema/swelling RASHLOCUNK = Skin/mucosal lesions where the location is not known

ORAL = Oral dermatological skin/mucosal lesions FEVER = Fever

Page 14 of 24

MUSC = Muscle pain (myalgia)

SORETHR = Sore throat

FATIGUE = Fatigue (defined as a persistent and overwhelming sense of tiredness, weakness, or lack of energy that is not relieved by rest).

WEAK = Weakness (refers to a reduction in the strength of one or more muscles, leading to difficulty or inability to perform normal physical activities)

CHILLS = Chills or sweats HEAD = Headache

CONJ = Conjunctivitis

VOMIT = Vomiting/nausea DIARR = Diarrhoea

COUGH = Cough/respiratory symptoms LYMPH = Generalised lymphadenopathy

LOCALLYMPH = Localised lymphadenopathy

LYMPHLOCUNK = Lymphadenopathy where the location is not known PROCT = Anogenital pain and /or bleeding

O = Other symptoms (specify in ClinicalSymptomsOther) UNK = Unknown

Clinical symptoms including rash/fever/lymphadenopathy at any point during the illness. Note this is a repeatable field.

Clinical symptoms other specified

Field: ClinicalSymptomsOther

Coding: TEXT

Clinical symptoms not captured in the coded values for ClinicalSymptoms variable as indicated by O

response for ClinicalSymptoms variable.

Complications

Field: Complications

Coding: NONE = None

ARDS = Acute respiratory distress syndrome

LRTI = Lower respiratory tract infection (e.g. pneumonia)

ENCEPH = Encephalitis

MENINGENCEPH = Meningoencephalitis

MYOCARD = Myocarditis

KERATITIS = Corneal infection

RETROPHARYNXABSC = Retropharyngeal abscess

SEPSIS = Sepsis

STILLBIRTH = Still birth as pregnancy outcome in a case

SSTI = Skin and/or soft-tissue infection due to secondary bacterial infection

OTHBAC = Other secondary bacterial infection

O = Other (please specify separately)

UNK = Unknown

Complications related to the current mpox event. Note this is a repeatable field and more than one

option can be chosen.

Complications (Other)

Field: ComplicationsMPXOther

Coding: TEXT

Complications not captured in the coded values for Complications variable as indicated by O response

for Complications variable.

Page 15 of 24

Concurrent STI

Field: ConcurrentSTI

Coding: CHLAM = Chlamydia HERP = Genital herpes

LGV = LGV MYCO = Mycoplasma genitalium

N = No concurrent STI SYPH = Infectious syphilis

TRICH = Trichomonas vaginalis

WARTS = Genital warts GONO = Gonorrhoea

UNK = Unknown Concurrent STI at time of diagnosis. Note this is a repeatable field.

Date of death

Field: DateOfDeath

Coding: yyyy-mm-dd

UNK = Unknown

Date for date of death. If not applicable, please use 'UNK'.

Date of diagnosis

Field: DateOfDiagnosis

Coding: yyyy-mm-dd

UNK = Unknown

First date of clinical or laboratory diagnosis. In case the DateofOnset is missing this timestamp is

used.

Date of onset of symptoms (mandatory)

Field: DateOfOnset

Coding: yyyy-mm-dd

UNK = Unknown

Date of onset of symptoms. Not applicable in asymptomatic cases. If not applicable, please use 'UNK'.

Date of first dose smallpox/mpox vaccination

Field: VaccPoxDate1

Coding: yyyy-mm-dd

yyyy-Www

UNK= Unknown

Date of first smallpox/mpox vaccination dose related to current mpox event/outbreak.

Date of second dose smallpox/mpox vaccination

Field: VaccPoxDate2

Coding: yyyy-mm-dd

yyyy-Www

UNK= Unknown

Date of second smallpox/mpox vaccination dose related to current mpox event/outbreak.

Page 16 of 24

Date of previous smallpox vaccination

Field: VaccPoxPrevDate

Coding: yyyy-mm-dd

yyyy-Www

yyyy-mm

yyyy

UNK= Unknown

Date of last vaccination for smallpox vaccine unrelated to the current mpox event/outbreak.

Epidemiological link

Field: EpiLinked

Coding: N = No

UNK = Unknown Y = Yes

Epidemiological link to a confirmed or probable case.

Exposure setting

Field: ExposureSetting

Coding: HOUSE = Household HOUSEABROAD: Household in a country other than the reporting country

WORK = Workplace SCHOOL = School/nursery

HEALTH = Healthcare (including laboratory exposure and transfussion)

PARTY = Sexual contact at night club/private party/sauna or similar setting BAR = Bar/restaurant or other small event where there was no sexual contact

LARGE = Large event with no sexual contact (e.g., festival or sports event) LARGECONTACT = Large event with sexual contact (e.g. PRIDE, ship).

O = Other location (specify in ExposureSettingDetails)

PLANE: Airplane UNK= Unknown

Location of exposure in the 21 days before symptom onset or date of diagnosis. Note this is a repeatable field.

Exposure setting details

Field: ExposureSettingDetails

Coding: TEXT

Details on place of exposure if ExposureSetting "O" or any organised event.

Gender (mandatory)

Field: Gender

Coding: F = Female

M = Male

O = Other

UNK = Unknown/Missing

Gender of the reported case.

Gender (Other)

Field: OtherGender

Coding: TEXT

Please indicate if the case is transgender, regardless of the coded value for Gender.

Page 17 of 24

Genomic characterisation

Field: GenomicCharacterisation

Coding: N = No

UNK = Unknown

Y = Yes

Information if genomic characterisation has been carried out.

Health care worker

Field: HealthCareWorker

Coding: N = No

UNK = Unknown Y = Yes

Information on whether the case is a healthcare worker.

HIV status

Field: HIVStatus

Coding: POS = Positive NEG = Negative

UNK = Unknown

HIV status of the case.

Hospitalisation

Field: Hospitalisation

Coding: N = No

UNK = Unknown YISOL = yes for isolation purposes

YTREAT = yes due to clinical need YUNK= yes for unknown reason

Information if case was admitted to hospital.

Immunocompromised

Field: ImmunoCompromised

Coding: N = No UNK = Unknown

YD = Yes, due to disease

YM = Yes, due to medication YRU = Yes, reason unknown

Information if a case is immunocompromised (if there is immunocompromise related to HIV infection, it should be coded as yes due to disease).

Intensive care

Field: IntensiveCare

Coding: N = No

UNK = Unknown Y = Yes

Information if case was admitted to an intensive care unit or high dependency unit (unit with capabilities for more intensive observation, treatment and nursing care than can be provided on a

regular ward).

Laboratory method

Field: LabMethod

Page 18 of 24

Coding: MPXPCR = Positive monkeypoxvirus-specific PCR

ORTHOPOXPCR = Positive orthopoxvirus PCR

SEQ = Sequencing ISOV = Isolation of virus

EM = Virus detection by electron microscopy SERO = Serology

UNK = Unknown Laboratory method used to diagnose the case. Note this is a repeatable field.

Number of sexual partners

Field: NumberSexPartners

Coding: 0 = No active sexual partner

1 = One sexual partner

2 = Two to four sexual partners

5 = Five to nine sexual partners

10 = Ten or more sexual partners

UNK = Unknown

Information on the number of sexual partners (sequential or concurrent) of a case in the past 3

months from the diagnosis of mpox.

Outcome of the case (mandatory)

Field: Outcome

Coding: A = Alive

D = Died UNK = Unknown

Information on whether the case is alive (still ill, recovered, cured) or deceased. The death should be due to the reported disease.

Place of notification

Field: PlaceOfNotification Coding: NUTS_GAUL

UNK = Unknown

The place of notification should be provided by regions (up to NUTS3 level). Select the most detailed

NUTS level possible. If the place of notification is not an EU/EEA country, then use GAUL

nomenclature.

Pregnant

Field: Pregnant

Coding: PREG = Pregnancy, trimester is unknown

PREG1 = Pregnancy, 1st trim, the 1st trim is from week 1 to the end of week 12 PREG2 = Pregnancy, 2nd trim, the 2nd trim is from week 13 to the end of week 26

PREG3 = Pregnancy, 3rd trim, the 3rd trim is from week 27 to the end of the

pregnancy PREGPOST = Post-partum (<6 weeks)

N = No UNK = Unknown

NA = Not applicable

Information if case is pregnant.

Pre-exposure prophylaxis for HIV

Field: PrEPHIV

Coding: N = No

Page 19 of 24

UNK = Unknown

Y = Yes

Information if the case used pre-exposure prophylaxis for HIV any time in the past year from diagnosis of mpox.

Previous mpox infection

Field: PreviousMPX

Coding: N = No

UNK = Unknown

Y = Yes

Information if case has been previously diagnosed with mpox.

Previous mpox clade infection

Field: PreviousMPXclade

Coding: Ia = Clade Ia,

Ib= Clade Ib

I= Clade I (without subclade identification)

IIa= Clade IIa

IIb= Clade IIb

II= Clade II (without subclade identification)

UNK= Unknown

Clade of the genomically characterised monkeypox virus in a previous infection. Please reporting

using the option that provides the most specific data for the case, ie, sub-clade if information is

available or clade, if information on sub-clade is not available).

Previous mpox infection date

Field: PreviousMPXDate

Coding: yyyy-mm-dd

yyyy-Www

yyyy-mm

yyyy

UNK= Unknown

Date of previous mpox diagnosis. If date of diagnosis is unknown, date of symptom onset or date of

notification of previous mpox infection can be used.

Previous smallpox vaccination

Field: VaccPoxPrev

Coding: N = No

UNK = Unknown

Y = Yes

Information if case has been previously vaccinated with a smallpox vaccine unrelated to the current

mpox event/outbreak.

Purpose for first dose smallpox/mpox vaccination

Field: VaccPoxPurpose1

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Coding: PREEXP = Vaccinated for pre-exposure prophylaxis for current event

POSTEXP = Vaccinated for post-exposure prophylaxis for current event

O = Other

UNK = Unknown

Information on the strategy context for vaccination with first smallpox/mpox vaccination dose related

to current mpox event/outbreak.

Purpose for second dose smallpox/mpox vaccination

Field: VaccPoxPurpose 2

Coding: PREEXP = Vaccinated for pre-exposure prophylaxis for current event

POSTEXP = Vaccinated for post-exposure prophylaxis for current event

O = Other

UNK = Unknown

Information on the strategy context for vaccination with second smallpox/mpox vaccination dose

related to current mpox event/outbreak.

Sexual behaviour of the case

Field: SexualBehaviour

Coding: HETERO = Heterosexual, sex with members of the opposite sex

MSM = Men who have sex with men WSW = Women who have sex with women

BISEXUAL = Bisexual

NA = No applicable O = Other

UNK = Unknown or undetermined

This variable captures sexual behaviour over the past 30 days..

SexWorker

Field: SexWorker

Coding: N = No

UNK = Unknown

Y = Yes Information if case is a sex worker (defined as exchanged sex for money or goods) in the past 3

months from diagnosis of mpox.

Specimen type

Field: SpecimenMPX

Coding: CRUST = lesion crust

CSF = Cerebrospinal fluid SWAB = lesion swab

OROPH = Oropharyngeal swab SER = Serum

SEM = Semen

URINE = Urine RECTAL = Rectal swab

GENITAL = Genital swab O = Other specimen (specify in SpecimenOther)

UNK = Unknown Type of specimen used for diagnosis. Note this is a repeatable field.

Specimen other specified

Field: SpecimenMPXOther

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Coding: TEXT

Specimen not captured in the coded values for Specimen variable as indicated by O response for

Specimen variable.

Transmission mode (mandatory)

Field: TransmissionMPX

Coding: ANIMAL = Animal to human transmission

HAI = Healthcare-associated LAB = Transmission in a laboratory due to occupational exposure

MTCT = Transmission from mother to child during pregnancy or at birth

O = Other transmission (specify in TransmissionMPXOther) FOMITE = Contact with contaminated material (e.g bedding, clothing, objects)

PTP = Person-to-person (excluding: mother-to-child during pregnancy or at birth, healthcare-associated or sexual transmission)

SEX = Sexual transmission

TRANSFU = Transfusion recipient UNK = Unknown

Most likely mode of transmission. Note this is a repeatable field.

Transmission mode other specified

Field: TransmissionMPXOther

Coding: TEXT

Transmission mode not captured in the coded values for TransmissionMPX variable as indicated by O

(Other) response for TransmissionMPX variable.

Travel

Field: Travel

Coding: N = No travel

UNK = Unknown

Y = Yes

Case travelled outside country of residence in the three weeks before onset of symptoms or date of

diagnosis.

Travel places

Field: TravelPlaces

Coding: NUTS_GAUL

UNK = Unknown

Regions (up to NUTS3 level) visited in the three weeks before onset of symptoms. Select the most detailed NUTS level possible. If the region visited is not in an EU/EEA country, then use GAUL

nomenclature. Note this is a repeatable field.

Vaccination status relative to current mpox event/outbreak

Field: VaccPoxCurrentStatus

Coding: VaccStatusMpx: NOTVACC = 0 dose unvaccinated

1DOSE = 1 dose 2DOSE = 2 doses

3DOSE = 3 doses

DOSEUNK = Vaccinated with unknown number of doses UNK = Unknown vaccination status

Information on whether the case was recently vaccinated against smallpox/mpox and number of vaccine doses received, in relation/response to the current mpox event/outbreak.

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Annex 2 – Case definitions

Please refer to Surveillance, case investigation and contact tracing for Monkeypox: Interim guidance

for more details on the current WHO mpox case definition.

Note that suspected cases should not be reported in TESSy.

The previously used ECDC interim case definitions for mpox are available in the Monkeypox Reporting

Protocol versions 1.0 to 3.0.

Patients who fulfil the criteria for suspected or probable cases should be tested with a monkeypox virus

specific PCR assay or an orthopoxvirus specific PCR assay which is then confirmed through sequencing.

If negative, these records should be removed from TESSy.

WHO outbreak case definition for mpox

As of March 2024

Suspected case:

i) A person who is a contact of a probable or confirmed mpox case in the 21 days before the onset of signs or symptoms, and who presents with any of the following: acute onset of fever (>38.5°C),

headache, myalgia (muscle pain/body aches), back pain, profound weakness, or fatigue.

OR

ii) A person presenting with an unexplained acute skin rash, mucosal lesions or lymphadenopathy

(swollen lymph nodes). The skin rash may include single or multiple lesions in the ano-genital region or elsewhere on the body. Mucosal lesions may include single or multiple oral, conjunctival, urethral,

penile, vaginal, or ano-rectal lesions. Ano-rectal lesions can also manifest as ano-rectal inflammation

(proctitis), pain and/or bleeding.

AND

for which the following common causes of acute rash or skin lesions do not fully explain the clinical picture: varicella zoster, herpes zoster, measles, herpes simplex, bacterial skin infections,

disseminated gonococcus infection, primary or secondary syphilis, chancroid, lymphogranuloma venereum, granuloma inguinale, molluscum contagiosum, allergic reaction (e.g., to plants); and any

other locally relevant common causes of papular or vesicular rash.

Probable case:

A person presenting with an unexplained acute skin rash, mucosal lesions or lymphadenopathy (swollen

lymph nodes). The skin rash may include single or multiple lesions in the ano-genital region or elsewhere on the body. Mucosal lesions may include single or multiple oral, conjunctival, urethral,

penile, vaginal, or ano-rectal lesions. Ano-rectal lesions can also manifest as ano-rectal inflammation

(proctitis), pain and/or bleeding.

AND

One or more of the following:

• has an epidemiological linka to a probable or confirmed case of mpox in the 21 days before symptom onset

• has had multiple and/or casual sexual partners in the 21 days before symptom onset

• has a positive test result for orthopoxviral infection (e.g., OPXV-specific PCR without MPXV-

specific PCR or sequencing) b

Confirmed case:

A person with laboratory confirmed MPXV infection by detection of unique sequences of viral DNA by

real-time polymerase chain reaction (PCR)c and/or sequencing.

Discarded case:

A suspected or probable case for which laboratory testing of lesion fluid, skin specimens or crusts by PCR and/or sequencing is negative for MPXVc . Conversely, a retrospectively detected probable case for

Page 24 of 24

which lesion testing can no longer be adequately performed (i.e., after the crusts fall off) and no other

specimen is found PCR-positive, would remain classified as a probable case. A suspected or probable

case should not be discarded based on a negative result from an oropharyngeal, anal or rectal swab or

from a blood test alone.

a The person has been exposed to a probable or confirmed monkeypox case. A contact is defined as a person who has been exposed to a person with suspected (clinically compatible), probable or

confirmed mpox during the infectious period and who has one or more of the following exposures: • direct skin-to-skin,skin-to-mucosal or mouth-to-mucosal physical contact (such as touching, hugging,

kissing, intimate oral or other sexual contact) • contact with contaminated materials such as clothing

or bedding, including material dislodged from bedding or surfaces during handling of laundry or cleaning of contaminated rooms • prolonged face-to-face respiratory exposure in close proximity

(inhalation of respiratory droplets and possibly short-range aerosols) • respiratory (i.e., possible inhalation) or mucosal (e.g., eyes, nose, mouth) exposure to lesion material (e.g., scabs/crusts) from

a person with mpox • The above also apply for health workers potentially exposed in the absence of

proper use of appropriate personal protective equipment (PPE).

b PCR on a blood specimen may be unreliable and should also not be used alone as a first line

diagnostic test. If blood PCR is negative and was the only test done, this is not sufficient to discard a case that otherwise meets the definition of a suspected or probable case. This applies regardless of

whether the blood PCR was for OPXV or MPXV-specific.

c Confirmation of MPXV infection should consider clinical and epidemiological information. Positive

detection using an OPXV PCR assay followed by confirmation of MPXV via PCR and/or sequencing or

detection using MPXV PCR assay indicates confirmation of MPXV infection. Positive detection using OPXV PCR assay alone can be considered strongly indicative of MPXV in countries where other OPXVs

(such as buffalopox or other OPXV) have not been found. Currently, the WHO mpox case definition considers an OPXV-positive case as a probable case. Countries with no significant co-circulation of

OPXVs other than MPXV may adapt testing strategies according to available resources and, in

conjunction with the clinical and epidemiological information available, consider OPXV PCR positive cases as confirmed mpox. Vigilance for the remote possibility of a smallpox emergence or other

potentially pathogenic OPXV must always be maintained.

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