Prequalification of In Vitro Diagnostics: Scope Expansion

Effective 1 September 2026, WHO is expanding the scope of its prequalification programme for in vitro diagnostics (IVDs) to include:

• Interferon-Gamma Release Assays (IGRAs) for tuberculosis infection testing; and
• Targeted Next-Generation Sequencing (tNGS) assays for tuberculosis diagnosis.

The updated eligibility criteria and pre-submission form are now available on the WHO website.

Resources:  

In Vitro Diagnostics Eligible for WHO Prequalification | WHO - Prequalification of Medical Products…

PQDx_015 PQ Pre-Submission Form.docx

PQ Webinar: Prequalification of IVDs scope expansion to tNGS and IGRA for TB | WHO - Prequalificati…