Technical Specifications Series

The Technical Specifications Series (TSS) set out the performance evaluation criteria for meeting prequalification requirements. Each TSS document provides information on the minimum performance requirements for WHO prequalification that should be met by a manufacturer to ensure that the in vitro diagnostic that is being submitted for prequalification is safe and performs optimally. (A transition period is being applied for those products prequalified before the relevant TSS document was issued. Manufacturers must comply with the technical specifications in the relevant TSS document within three years of its publication.)

Compliance with prequalification technical specifications is verified during re-inspection. Failure to comply with the relevant technical specifications will result in the delisting of the product concerned from the WHO List of Prequalified IVDs.

• TSS 1 - Human immunodeficiency virus (HIV) rapid diagnostic tests for professional and/or self-testing
• TSS 2 - In vitro diagnostic medical devices to identify glucose-6-phosphate dehydrogenase (G6PD) activity
• TSS 3 - Malaria rapid diagnostic tests
• TSS 4 - In vitro diagnostic medical devices used for the detection of high-risk human papillomavirus (HPV) types in cervical cancer screening
• TSS 5 - Rapid diagnostic tests used for surveillance and detection of an outbreak of cholera
• TSS 6 - Syphilis rapid diagnostic tests
• TSS 7 - see 2021 version update TSS 16 below
• TSS 8 - Immunoassays to detect hepatitis C antibody and/or antigen
• DRAFT TSS 9 - Immunoassays to detect HIV antibody and/or antigen
• TSS 10 - In vitro diagnostic medical devices used for the qualitative and quantitative detection of hepatitis C RNA
• TSS 11 - In vitro diagnostic medical devices used for the quantitative detection of HIV-1 nucleic acid
• TSS 12 - In vitro diagnostic medical devices used for the qualitative detection of HIV-1 and HIV-2 nucleic acid
• TSS 13 - Rapid diagnostic tests to detect hepatitis B surface antigen
• TSS 14 - Immunoassays to detect hepatitis B virus surface antigen
• TSS 15 - In vitro diagnostic medical devices used for the quantitative detection of hepatitis B DNA
• TSS 16 - Hepatitis C rapid diagnostic tests for professional use and/or self-testing, 2021 update
• TSS 17 -  In vitro diagnostic medical devices used for the qualitative detection of Mycobacterium tuberculosis complex DNA and mutations associated with drug-resistant tuberculosis
• TSS 18 - Haemoglobin A1c point of care analysers for professional use - Draft for public comment. Commenting period closed 28 February 2023
• TSS 19 - In-vitro diagnostic medical devices for monitoring of blood glucose in capillary blood - Draft for public comment. Commenting period closed 9 June 2023
• TSS 20 - In vitro diagnostic medical devices used for the qualitative detection of SARS-CoV-2 nucleic acid
• TSS 21 - SARS-CoV-2 antigen rapid diagnostic tests for professional use and self-testing