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 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 |
| HIV | Diagnosis of infection |
|
| HIV-1/HIV-2 | Self-testing |
|
| HIV-1/HIV-2 | Monitoring of infection |
|
| Hepatitis C virus (HCV) | Diagnosis of infection |
|
| HCV | Aid to diagnosis of infection and monitoring of anti-viral therapy |
|
| Hepatitis B surface antigen (HBsAg) | Diagnosis and monitoring of infection |
|
| Hepatitis B virus | Monitoring of infection and anti-viral therapy |
|
| Malaria parasites | Diagnosis of infection |
|
| Human papilloma virus | Diagnosis of infection (for cervical cancer prevention) |
|
| G6PD enzyme | Enzyme deficiency detection |
|
| Toxigenic Vibrio cholerae | Detection of outbreaks or surveillance for the disease |
|
| Treponema pallidum (syphilis) | Screening and aid to diagnosis of infection |
|
| Mycobacterium tuberculosis complex and resistance to first and/or second line anti-TB drugs | Diagnosis of infection |
|
|
SARS-CoV-2 |
Diagnosis of infection |
|
| Blood glucose | Monitoring of diabetes |
|
| HbA1c |
Monitoring response to therapy in people with diabetes or as an aid to diagnosis of type 2 diabetes |
|
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.