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Disease/health condition -
Sexually transmitted infections (STIs), Cancer
Human papillomavirus nucleic acid amplification test
Assay format
NAAT
Information History
First added in 2018
Changed in 2020
Purpose type
Screening
Purpose
To screen for cervical cancer.
Specimen types
Cervical cells collected in test-specific transport fluid/vials
WHO prequalified or recommended products
GMDN
49994
Human papillomavirus (HPV) 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 one or multiple strains of human papillomavirus (HPV) 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 2005-2024EMDN
W0105041002
SCREENING HIGH-RISK HPV - NA REAGENTS
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/emdnWHO supporting publications
World Health Organization. (2020). Introducing and scaling up testing for human papillomavirus as part of a comprehensive programme for prevention and control of cervical cancer: a step-by-step guide. World Health Organization. https://iris.who.int/handle/10665/336668 ; The Spanish version published by PAHO: https://iris.paho.org/handle/10665.2/66304 ; World Health Organization. (2014). Comprehensive cervical cancer control: a guide to essential practice, 2nd ed. World Health Organization. https://iris.who.int/handle/10665/144785 ; Spanish version published by PAHO at http://iris.paho.org/xmlui/handle/123456789/28512 ; Portuguese version published by PAHO at http://iris.paho.org/xmlui/handle/123456789/31403 ; World Health Organization. (2010). Human papillomavirus laboratory manual, 1st ed., 2009. World Health Organization. https://iris.who.int/handle/10665/70505 ; World Health Organization. (2020). WHO technical guidance and specifications of medical devices for screening and treatment of precancerous lesions in the prevention of cervical cancer. World Health Organization. https://iris.who.int/handle/10665/331698 ; World Health Organization. (2023). Laboratory and point-of-care diagnostic testing for sexually transmitted infections, including HIV. World Health Organization. https://iris.who.int/handle/10665/374252 ; World Health Organization. (2021). WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, 2nd ed. World Health Organization. https://iris.who.int/handle/10665/342365 ; World Health Organization. (2022). Human papillomavirus (HPV) nucleic acid amplification tests (NAATs) to screen for cervical pre-cancer lesions and prevent cervical cancer: policy brief. World Health Organization. https://iris.who.int/handle/10665/352495 ; World Health Organization. (2021). WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention: use of mRNA tests for human papillomavirus (HPV), 2nd ed. World Health Organization. https://iris.who.int/handle/10665/350652
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