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
  • appropripate for use in 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 addtion, 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.

WHO reserves the right to apply other criteria in accordance with changing global health needs, the particular needs of WHO Member States, and/or the emergence of new and relevant technologies. Any review and/or amendment of the eligiblity criteria is carried out in consultation with WHO Member States, other UN agencies, WHO programmes and technical experts.

* Any exemptions must be agreed upon by WHO before the submission of the application. Please contact WHO at diagnostics@who.int 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
Human Immunodeficiency virus (HIV) Diagnosis of infection
  • Rapid diagnostic test (RDT)
  • Enzyme immunoassay (EIA)
  • Nucleic acid test (NAT)
HIV-1/HIV-2 Self testing
  • Rapid diagnostic test
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 Monitoring of infection
  • NAT
Hepatitis B surface antigen (HBsAg) Diagnosis and monitoring of infection
  • RDT
  • EIA
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

Rebranded products

WHO is aware that some manufacturers purchase finalized products from other companies, and then "rebrand" and place these products on the market under their own name or brand. Such products are also known as original equipment manufacturer products. WHO considers a rebranded product to be one that is manufactured under identical conditions at the same manufacturing site(s) as the original product. In other words, a rebranded product is identical in every respect (including the intended use) to the product manufactured by the original manufacturer, except that the product is labelled with the rebranded product name and product code, and bears the rebrander's name or brand. Rebranded products are outside the scope of prequalification, however, and not accepted for prequalification assessment.