IVD Protocol for the evaluation of nucleic acid tests for the diagnosis of tuberculosis (TB NAT) Guideline/guidance
IVD Protocol for the performance evaluation of nucleic acid tests for the quantitative detection of hepatitis B virus DNA for WHO prequalification assessment V 1.1 Nov 2023 Guideline/guidance
IVD Protocol for the performance evaluation of rapid diagnostic tests for the detection of Vibrio cholerae O1 or O1/O139 for WHO prequalification assessment V 2.2 Nov 2023 Guideline/guidance
IVD Public announcement to TB in vitro diagnostics manufacturers, procurement agencies and national TB programmes on inclusion of WHO Prequalification for TB in vitro diagnostics PDF Advocacy material
IVD Public announcement to TB IVDs manufacturers, procurement agencies and national TB programmes: Extension of WHO GTB recommendation PDF Information note
IVD Public Report for Alinity m MPXV AMP Kit and Alinity m MPXV CTRL Kit, (MPXV 12644-027-00) PDF Report
IVD Risk-based classification of diagnostics for WHO prequalification) (PQDx_172 v1, 13 May 2014) PDF Guideline/guidance
IVD Technical Guidance Series (TGS) 1 - Standards applicable to the WHO Prequalification of in vitro diagnostic medical devices PDF Guideline/guidance
IVD Technical Guidance Series (TGS) 2 - Establishing stability of in vitro diagnostic medical devices PDF Guideline/guidance
IVD Technical Guidance Series (TGS) 4 - Test method validation for in vitro diagnostic medical devices Guideline/guidance
IVD Technical Guidance Series (TGS) 5 - Designing instructions for use for in vitro diagnostic medical devices PDF Guideline/guidance
IVD Technical Specifications Series (TSS) 10 - In vitro diagnostic medical devices used for the qualitative and quantitative detection of Hepatitis C RNA Guideline/guidance
IVD Technical Specifications Series (TSS) 11 - In vitro diagnostic medical devices used for the quantitative detection of HIV-1 nucleic acid Guideline/guidance
IVD Technical Specifications Series (TSS) 13 - Rapid diagnostic tests to detect hepatitis B surface antigen Guideline/guidance
IVD Technical Specifications Series (TSS) 14 - Immunoassays to detect hepatitis B virus surface antigen Guideline/guidance
IVD Technical Specifications Series (TSS) 15 - In vitro diagnostic medical devices used for the quantitative detection of Hepatitis B DNA Guideline/guidance
IVD Technical Specifications Series (TSS) 16 - Hepatitis C rapid diagnostic tests for professional use and/or self-testing, 2021 update Report
IVD Technical Specifications Series (TSS) 18 - Haemoglobin A1c point of care analysers for professional use PDF Guideline/guidance
IVD Technical Specifications Series (TSS) 19 - In-vitro diagnostic medical devices for monitoring of blood glucose in capillary blood Guideline/guidance
IVD Technical Specifications Series (TSS) 20 - In vitro diagnostic medical devices used for the qualitative detection of SARS-CoV-2 nucleic acid Guideline/guidance
IVD Technical Specifications Series (TSS) 21 - SARS-CoV-2 antigen rapid diagnostic tests for professional use and self-testing Guideline/guidance
IVD Technical Specifications Series (TSS) 24 - In Vitro diagnostic medical devices used for the qualitative detection of Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis nucleic acid PDF Guideline/guidance
IVD Technical Specifications Series (TSS) 25 - Rapid diagnotic tests to detect Neisseria gonorrhoeae antigen PDF Guideline/guidance
IVD Technical Specifications Series (TSS) 26 - Rapid diagnostic tests to detect Chlamydia trachomatis antigen PDF Guideline/guidance
IVD Technical Specifications Series (TSS) 27 - Syphilis Rapid Diagnostic Tests for Professional Use and/or Self-testing PDF Guideline/guidance
IVD Technical Specifications Series (TSS) 9 - Immunoassays to detect HIV antibody and/or antigen PDF Guideline/guidance
IVD Template for public comments to draft TSS 22 – Haemoglobin point of care analysers. Submit comments to diagnostics@who.int by 17 June 2024 XLSX Guideline/guidance
IVD Template for public comments to draft TSS 3 – Malaria rapid diagnostic tests second edition. Submit comments to diagnostics@who.int by 17 June 2024 XLSX Guideline/guidance
IVD The Assessment Process for Listing of WHO Prequalification Evaluating Laboratories for IVDs PDF Guideline/guidance
IVD The assessment process for listing of WHO prequalification evaluating laboratories for IVDs (PQDx_248 v1.0, 23 May 2016) PDF Guideline/guidance
IVD Transitioning Emergency Use Listing for in vitro diagnostics to prequalification assessment - Questions and Answers PDF
IVD TSS 23 – Rapid diagnostic tests to detect mycobacterial lipoarabinomannan (LAM) antigen in urine Guideline/guidance
IVD TSS 23– Rapid diagnostic tests to detect mycobacterial lipoarabinomannan (LAM) antigen in urine, draft for comment. Comments to be submitted by 17 June 2024 PDF Guideline/guidance
IVD TSS 24 - In Vitro diagnostic medical devices used for the qualitative detection of Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis nucleic acid Guideline/guidance