Diagnostics and Laboratory Technology

WHO Prequalification of Diagnostics Programme

The WHO prequalification of diagnostics programme aims to increase access to affordable diagnostic technologies of assured quality that are appropriate for use in resource limited settings. The programme provides Member States, UN agencies and other partners with technical information and advice on the quality of currently available HIV/AIDS, malaria and hepatitis B and C test kits and technologies.

Prequalification of diagnostics is a prerequisite for UN procurement ensuring that public monies are spent in a cost effective manner, on quality diagnostics.

Overview of prequalification of diagnostics

Submission of the application form is the first step in the prequalification assessment process.

The manufacturer is requested to sign a letter of agreement and to pay a fee.

The product dossier is reviewed with the purpose of gaining an understanding of the product and how it performs.

The manufacturing site inspection is carried out to assess the adequacy and effectiveness of the manufacturer’s quality management system and the correct implementation of documented procedures.

Laboratory evaluation of the product occurs following a successful review of the product dossier. The laboratory evaluation to assess the operational and performance characteristics of the product is carried out by a specified WHO Collaborating Centre.

If a product meets the prequalification requirements then it can become eligible for inclusion in UN procurement tenders.

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