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 thetechnical 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 (IVDs) to identify glucose-6-phosphate dehydrogenase (G6PD) activity

TSS 3 Malaria rapid diagnostic tests

TSS 4 In vitro diagnostic medical devices (IVDs) 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 Hepatitis C rapid diagnostic tests for professional use and/or self-testing (version 2 interim)

TSS 8 Immunoassays to detect hepatitis C antibody and/or antigen

DRAFT TSS 9 Immunoassays to detect HIV antibody and/or antigen

DRAFT TSS 10 In vitro diagnostic (IVD) medical devices used for the qualitative and quantitative detection of hepatitis C RNA

DRAFT TSS 11 In vitro diagnostic (IVD) medical devices used for the quantitative detection of HIV-1 nucleic acid

DRAFT TSS 12 In vitro diagnostic (IVD) medical devices used for the qualitative detection of HIV-1 and HIV-2 nucleic acid

DRAFT TSS 13 Rapid diagnostic tests to detect hepatitis B surface antigen

DRAFT TSS 14 Immunoassays to detect hepatitis B virus surface antigen

DRAFT TSS 15 In vitro diagnostic (IVD) medical devices used for the quantitative detection of hepatitis B nucleic acid