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Disease/health condition - Mpox infection
Mpox nucleic acid amplification test
Setting:
2. Laboratory
Tiered Testing Service:
Regional or provincial hospital with laboratory National reference laboratory
Assay format
NAAT
Information History
First added in 2024
Purpose type
Diagnosis
Purpose
To confirm a diagnosis of mpox
Specimen types
Lesion material
WHO prequalified or recommended products
N/A
GMDN

66370

Mpox virus nucleic acid IVD, kit, nucleic acid technique (NAT)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from mpox virus in a clinical specimen, using a nucleic acid technique (NAT).

The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024
EMDN

W0105040532

MONKEYPOX VIRUS / MPOX - NA REAGENT

The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
WHO supporting publications
World Health Organization (2024). Diagnostic testing and testing strategies for mpox: interim guidance, 12 November 2024. World Health Organization. https://doi.org/10.2471/B09166
Technical specifications
N/A
Related Medical Devices in MeDevIS
SAGE IVD recommended including this test in the EDL on the basis of the scientific validity of the analyte and the availability of WHO guidelines and technical reports, including recommendations for the use of this test. The selection of disease specific tests for the EDL also took into account relevant priority diseases for WHO such as NCDs including DM, CVD and cancer, HIV infection, malaria, NTDs, STIs, tuberculosis, viral hepatitis B and C, among others.
N/A
The inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test.
N/A