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Standard Operating Procedure for the Surveillance of Mpox

 

Effective Date: [Date]

Version: 1.0

Prepared by: [Name/Department]

Approved by: [Name/Department]

 

 

Status 

Definition 

A

Tested / reflects current policy and updates

B

Possible gaps / may not reflect latest policies and updates / users need to apply due diligence

C

Outline / being updated / users should cross reference other materials (job aids, training resources)

D

Draft / consider as being under development 

E

Work in progress / template created 

 

1. Introduction

  • Purpose:
     The purpose of this SOP is to outline the procedures for the surveillance of mpox in a comprehensive step by step manner to ensure timely detection, reporting, and response to outbreaks. It defines the roles and responsibilities of all involved actors to ensure coordinated efforts.
  • Scope:
     This SOP applies to all public health entities, healthcare providers, laboratories, and other stakeholders involved in mpox surveillance.
  • Definitions:
    • Mpox: A zoonotic viral disease with symptoms similar to those seen in smallpox patients, though clinically less severe.
    • Surveillance: Systematic collection, analysis, and interpretation of health data.
  • Legal Framework:
     Reference to national and international health regulations guiding the surveillance and control of mpox.

2. Actors Involved and Their Roles

2.1 Epidemiology (Epi) Unit 
  • Role:  This is the central body responsible for overseeing the entire surveillance process.
  • Responsibilities:
    • Develop national guidelines and protocols for mpox surveillance.
    • Coordinate with the STI unit, regional health authorities, and laboratories.
    • Provide training and resources to the STI unit, healthcare providers and other stakeholders.
    • Analyse surveillance data and disseminate findings.
    • Report cases to international bodies like the World Health Organization (WHO).
    • Report cases to IHR
2.2 Sexually Transmitted Infections (STI) Unit 
  • Role:  The STI unit reports directly to the Epi Unit and is responsible for the complete reporting, and investigation including contact tracing of all cases. 
  • Responsibilities:
    • Utilise mpox national guidelines 
    • Do follow up reporting and investigation including contact tracing of people who have had mpox (referred by local health units / healthcare providers).
    • Submit relevance surveillance data to the Epi Unit. 
    • Take samples of people suspected to have mpox and ship to the national laboratory following national guidelines for shipping of samples. 
    • Check with laboratory for results 
    • Inform persons of their test results 
2.3 Health Units (HU)
  • Role:  The HU is the frontline body responsible for detecting and managing mpox cases within the community.
  • Responsibilities:
    • Conduct passive surveillance of mpox.
    • Assist the STI and Epi Unit in the response
    • Ensure timely reporting of suspected cases to the STI and Epi unit.
    • Engage in public health education and community outreach.
    • Implement control measures to prevent the spread of mpox.
    • Take samples of people suspected to have mpox and ship to the national laboratory following national guidelines for shipping of samples. 
    • Check with laboratory for results 
    • Inform persons of their test results.
2.4 Healthcare Providers (HCPs)
  • Role: Healthcare providers are responsible for the initial detection and clinical management of mpox cases.
  • Responsibilities:
    • Identify and report suspected cases of mpox to health units.
    • Collect and submit clinical samples for laboratory testing.
    • Provide clinical care to patients according to national guidelines.
    • Educate persons with mpox and those that accompany them about mpox prevention and control.
2.5 Laboratories
  • Role: Laboratories play a crucial role in the confirmation of mpox cases.
  • Responsibilities:
    • Provide instructions for sample collection and packaging in accordance with applicable guidelines.
    • Receive samples and laboratory form; inform the relevant unit about rejection of sample as necessary.
    • Conduct diagnostic testing for mpox.
    • Report laboratory results to healthcare providers and health units according to established reporting channels.
    • Maintain quality controls in testing procedures.
    • Share data with Epi and STI Unit and collaborate on epidemiological studies.
    • Training on collection, conservation of samples and transportation.
2.6 Surveillance at Point of Entry
  • The immigration officers must share the Health Alert Notice card containing information to all travelers

 

3. Surveillance Procedures

Step 1: Case Detection – Healthcare Providers / Laboratory Personnel

 

  1. Immediate Reporting:  

Report all suspected cases to the STI unit immediately for follow up. (Case definitions below)

Suspected mpox case definition: 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

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 anorectal 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 mpox case definition : 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 anorectal 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 link 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). (Note: no capacity for orthopoxviral infection in the ECC)

Confirmed mpox case definition : A person with laboratory confirmed MPXV infection by detection of unique sequences of viral DNA by real-time polymerase chain reaction (PCR) and/or sequencing. 

 

  1. Isolate cases to prevent the spread of diseases 
  • Use personal protective equipment for the management of cases in isolation
  • In the case of institutional isolation, this can be done after the opinion and evaluation of the care provider
  • In the case of community isolation, it is advisable to wait until the rash has fully healed and a fresh layer of skin has formed
  • All case records except demographic information and HIV/STI status must be available and shared with STI and Epi Unit; this is to better organize investigations, prevent leaks and facilitate feedback to the health institution or people directly concerned.
  • Relevant demographic information and HIV/STI status will be shared only on a need-to-know basis. 

 

  1. Testing 

Methods for collecting, preserving and transporting specimens:

  • Rigorous adherence to infection prevention and control guidelines must be ensured during specimen collection and handling
  • Only sterile, synthetic swabs (including but not limited to polyester, nylon, or Dacron) with plastic, wood, or thin aluminum (wire) shafts should be used to collect suspected or confirmed mpox specimens for diagnostic testing Do not use cotton swabs.
  • Collect two swabs from 2-3 lesions, ideally from different parts of the body, or from lesions that differ in appearance at the same location. 
  • Vigorously swab each lesion to ensure adequate viral DNA is collected.   
  • Place swabs from lesions, crusts, and exudate in separate tubes, and label accordingly.
  • Samples can can be transported as dry swabs in capped sterile tubes or placed in viral transport media (VTM).

The recommended specimen types for laboratory testing of Mpox virus: 

  • swabs of lesion surface
  • exudate
  • lesion crusts 

Unroofing or aspiration of lesions (or otherwise using sharp instruments for mpox testing) before swabbing is unnecessary, and not recommended due to the risk for sharps injury. Lesions found in different phases (lesion surface or crust from healing lesion) can be swabbed.

 

  1. Treat clients according to national guidelines 

 

Step 2 – Reporting (STI Unit / Healthcare Providers)

Definition of mpox contact :

A person who has been exposed to an infected person during the infection period i.e., the period beginning with the onset of the index case’s first symptoms and ending when all scabs have fallen off, and who has one or more of the following exposures with a probable or confirmed case of mpox:

  • direct skin-to-skin and skin-to-mucosal physical contact (such as touching, hugging, kissing, intimate or 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
  • respiratory exposure (i.e., possible inhalation of) or eye mucosal exposure to lesion material (e.g., scabs/crusts) from an infected person
  • the above also apply for health workers potentially exposed in the absence of proper use of appropriate personal protective equipment (PPE)

 

Complete the reporting form handed over from the Healthcare Provider as required (at the end of the document). 

Conduct an investigation (at the end of document).  An investigation team may be made up of :

  • 1 or 2 trained staff from STI Unit
  • 1 or 2 health professional from the establishment reporting the case
  • 1 nurse or medical technologist

Deliverables of the investigation team :

Investigation of suspected cases:

  • Completion of the investigation form 
  • Identification of contacts and samples to be taken from contacts which fulfils the suspected case definition
  • Collection, conservation and transport of specimens
  • Submit the investigation forms to relevant entities.

Contact tracing

  • Locate and follow up on contacts (home visit, telephone follow-up)
  • Preliminary assessment of each contact
  • Samples to be taken from contacts which fulfils the suspected case definition
  • Collection, conservation and transport of specimens
  • Submit information collected to relevant entities 

 

Note :

  • Direct contacts without symptoms will be put into quarantine for a period of 21 days.
  • Contacts placed in community isolation can receive a minimum of 2 visits before the end of their isolation.
  • After 21 days without the appearance of symptoms after contact with a confirmed or probable case, contacts can leave quarantine
  • If the contact shows signs and symptoms related to mpox, consider it as a suspected case and test the person.

 

Step 3: Data Management (STI and Epi Unit)

  • Data should be cleaned and analysed 
  • Preparation of a report should be done on the evolution of the epidemiological situation of the disease
  • Dissemination of a weekly situation report 

Indicators for monitoring the quality of mpox surveillance include:

  • Proportion of suspected cases for which laboratory tests were carried out.
  • Proportion of probable and confirmed cases with complete information on clinical and risk factors.
  • Proportion of suspected cases for which test results are available within 24 hours of sample being taken. 

 

Annex 1 

Indicators for Monitoring the Quality of Mpox Contact Tracing

  • Proportion of suspected, probable and confirmed cases with identified contacts.
  • Number of contacts becoming suspected
  • Proportion of contacts with complete tracking information.
  • Number of contacts asymptomatic following during 21 days or until becoming symptomatic

 

Mpox (monkeypox) Case Reporting Form / Case Investigation Form 

No

Information

Variable

Description

List

Section 1. Case demographics

1

Record ID

RecordID

Unique case identifier 

TEXT

2

Reporting Country

ReportingCountry

The country reporting the case

[Countries, or territories]

3

Case classification

CaseClassification

Classification of the case

  • Confirmed
  • Probable
  • Unknown

4

Date of diagnosis

DateOfDiagnosis

First date of clinical or lab diagnosis

DATE

(yyyy-mm-dd)

5

Age in years

Age

Age of case in years (report 0 if < 1 year)

NUM 

6

Sex

Sex

Sex at birth of the reported case

  • Female 
  • Male
  • Other
  • Unknown

7

Sexual behavior

SexualBehavior

Sexual behavior of the case

  • MSM = MSM/homosexual or bisexual male
  • Non-MSM
  • UNK = Unknown or undetermined

8

Is the case a healthcare worker?

HealthCareWorker

Is the case a healthcare worker?

  • Yes
  • No
  • Unknown

Section 2. Medical history 

9

Pregnancy status

Pregnant

Is the case pregnant or post-partum?

  • Yes, Pregnancy, trimester is unknown
  • Yes, Pregnancy, 1st trimester, the 1st trim is from week 1 to the end of week 12
  • Yes, Pregnancy, 2nd trimester, the 2nd trim is from week 13 to the end of week 26
  • Yes, Pregnancy, 3rd trimester, the 3rd trim is from week 27 to the end of the pregnancy
  • Post-partum (<6 weeks)
  • No = No
  • NA
  • Unknown

10

Immunosuppressed status

Immunosuppression 

Is the case immunosuppressed 

  • YD = Yes, due to disease
  • YM = Yes, due to medication
  • YRU = Yes, reason unknown 
  • No = No
  • UNK = Unknown

11

HIV status

HIVStatus

Does the case have HIV?

  • POS = Positive
  • NEG = Negative
  • UNK = Unknown

Section 3. Clinical presentation 

12

Symptoms

Symptoms

The case presents/has presented ANY symptoms

  • Yes
  • No
  • Unknown

12b

If symptomatic, date of symptoms onset

DateOfOnset

Date the case had the first symptoms

DATE

(yyyy-mm-dd)

13

Hospitalization

 

Hospitalisation

Has the case been hospitalized? (select all those that apply)

  • YISOL = yes for isolation purposes
  • YTREAT = yes due to clinical need
  • YUNK = yes for unknown reason
  • NO = No
  • UNK = Unknown

14

Intensive care

IntensiveCare

Case admitted to an intensive care unit or high dependency unit

 

  • Yes
  • No
  • Unknown

15

Outcome/Status of case

 

 

Outcome

What is the outcome or status of the case

  • Alive
  • Died
  • Unknown (lost to follow-up)

15b

If Outcome is Death, report the date of death

DateOfDeath

Date in which the case died

DATE

(yyyy-mm-dd)

Section 4. Exposure 

Below exposures refer to the period from the consultation to 3 weeks prior to onset of symptoms or diagnosis

16

Travel history

Travel

Has the case traveled to another country in the last three weeks?

  • Yes 
  • No
  • Unknown

16b

Travel country

TravelCountry

Which was the last country the case travelled to in the last three weeks?

[Country, or territory]

17

If Contact Animals is Yes, type of animals

AnimalContact

Which types of animals did the case have contact with? (select all those that apply)

 

  • PET = Household pets excluding rodents
  • PETRODENTS = Rodent pets
  • WILD = Wild animals excluding rodent
  • WILDRODENTS = Wild rodents
  • Other (specify)

18

Based on the previously reported information, which is the most likely mode of transmission 

Transmission

Based on the previously reported information, which is the most likely mode of transmission

  • 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
  • OTHER = Other transmission
  • FOMITE = Contact with contaminated material (e.g., bedding, clothing, objects)
  • PTP = Person-to-person (excluding mother-to-child, healthcare-associated or sexual transmission)
  • SEX = Sexual transmission
  • TRANSFU = parenteral transmission, including intravenous drug use and transfusion
  • UNK = Unknown

Section 5. Laboratory information

19

Clade of monkeypox virus 

Clade 

Clade of monkeypox virus if sequencing conducted 

  • Clade I 
  • Clade II
  • UNK=Unknown