Status of applications to the Prequalification of Diagnostics Programme
This page provides an overview on the status of applications submitted to the prequalification of diagnostics programme.
|Total number of applications received of in-vitro diagnostics|
|Virus / Parasite||Rapid Tests||ELISA||Other*||Total|
Please note: these tables are updated monthly; while every attempt is made to provide current data, very recent information may not yet be reflected here.
Figures above include withdrawn and closed applications but exclude pilot product.
* Includes HIV/HCV; HIV/Syphilis; Other formats (not RDT and EIA).
Status of products undergoing the Prequalification of Diagnostics assessment procedure
The information provided in the following tables gives an overview of the status for each product undergoing any of the three stages that form the prequalification assessment.
The indication “stage complete” for a product for any one of the stages does not imply it meets the acceptance criteria for that stage nor does it imply that the product has been prequalified.
The indication “R” means that information has been requested from the manufacturer and WHO is awaiting their reply and/or submission of additional documentation.
For the full list of products that have been prequalified, please refer to the WHO List of Prequalified Diagnostic Products.
HIV rapid tests
HIV EIA/other HIV tests
Hepatitis C tests
Hepatitis B tests
HIV virological technologies