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In Vitro Diagnostics Eligible for WHO Prequalification

In Vitro Diagnostics Eligible for WHO Prequalification

Applications for WHO prequalification of in vitro diagnostics (IVDs) are accepted only from the legal manufacturer of the product. The definition of an IVD manufacturer is based on the definition used by the Global Harmonization Task Force, and later adopted by the International Medical Device Regulators Forum. This internationally accepted approach has been adopted to ensure that there is a clear understanding of the term “manufacturer” across international markets.

Eligibility principles

Any IVD submitted for prequalification must be:

  • needed for a specified disease or disease state
  • appropriate for use in resource-limited settings
  • requested by a WHO Member State(s)
  • recommended for use by WHO disease-specific testing guidelines.

Eligibility criteria

In addition, a number of eligibility criteria are applied. That is, each product submitted for prequalification must:

  • be manufactured by the original product manufacturer
  • commercially available when submitted for prequalification assessment*
  • of interest to UN organizations and other agencies carrying out procurement of IVDs
  • belong to a product category for which there are as yet no or few prequalified products.

* Any exemptions must be agreed upon by WHO before the submission of the application. Please contact WHO at if you have any questions regarding product eligibility with regard to your product's commercial availability.

IVD products currently eligible for submission for prequalification

Analyte/pathogen Intended use Technology
HIV Diagnosis of infection
  • Rapid diagnostic test (RDT)
  • Enzyme immunoassay (EIA)
  • Nucleic acid test (NAT)
HIV-1/HIV-2 Self-testing
  • RDT
HIV-1/HIV-2 Monitoring of infection
  • Flow cytometer for enumeration of lymphocyte subset including CD4+ T cells,  or a technology that can be used at or near the patient (POC)
  • NAT for measuring viral load
Hepatitis C virus (HCV) Diagnosis of infection
  • RDT
  • EIA
HCV Aid to diagnosis of infection and monitoring of anti-viral therapy
  • NAT
Hepatitis B surface antigen (HBsAg) Diagnosis and monitoring of infection
  • RDT
  • EIA
Hepatitis B virus Monitoring of infection and anti-viral therapy
  • Quantitative NAT
Malaria parasites Diagnosis of infection
  • RDT
Human papilloma virus Diagnosis of infection (for cervical cancer prevention)
  • NAT
G6PD enzyme Enzyme deficiency detection
  • Technologies/formats to be used at or near to POC
Toxigenic Vibrio cholerae Detection of outbreaks or surveillance for the disease
  • RDT
Treponema pallidum (syphilis) Screening and aid to diagnosis of infection
  • RDT
Mycobacterium tuberculosis complex and resistance to first and/or second line anti-TB drugs Diagnosis of infection
  • Qualitative NAT
SARS-CoV-2 Diagnosis of infection
  • Rapid diagnostic tests
  • Qualitative nucleic acid tests

The scope of IVD medical devices eligible for WHO prequalification are outlined in the guidance document. This document is regularly updated as new IVDs are added to the prequalification scope.