Indication - Human papillomavirus (HPV) Infection
HPV nucleic acid test (NAT)
Facility level:
Assay formats
Status history
First added in 2018
Changed in 2020
Purpose type
For cervical cancer screening
Specimen types
Cervical cells collected in test-specific transport fluid
WHO prequalified or recommended products
WHO supporting documents
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. https://www.who.int/publications/i/item/9789240015166; WHO human papillomavirus laboratory manual, first edition (2009) http://apps.who.int/iris/handle/10665/70505; Comprehensive cervical cancer control. https://apps.who.int/iris/handle/10665/144785; Global strategy to accelerate the elimination of cervical cancer as a public health problem. https://www.who.int/publications/i/item/9789240014107; WHO technical guidance and specifications of medical devices for screening and treatment of precancerous lesions in the prevention of cervical cancer. https://apps.who.int/iris/handle/10665/331698;
ICD11 code: 1A9Y

Summary of SAGE IVD recommendation

The selection of the disease specific diagnostics tests for the EDL took into account the relevant priority diseases for the WHO such as HIV infection, tuberculosis, malaria, viral hepatitis B and C, syphilis and HPV infection. For these diseases there are WHO guidelines and technical reports, including recommendations for the appropriate IVDs. These documents are the result of significant evidence review and formed the basis for the inclusion of these IVDs in the EDL.

Details of submission from 2020

The inclusion of this entry was based on WHO guidelines and technical reports that include recommendations for the appropriate IVDs.