Document published by the source itself

Performance Evaluation

How WHO independently verifies assay performance and operational fitness for resource-limited settings.

Technical guidanceWHO Regulation and PrequalificationRevised in 2025 to sit ahead of, and separately from, prequalification

Source

WHO’s performance evaluation of in vitro diagnostics (IVD) aims at independently verifying the performance and operational characteristics of an IVD, including those that are considered essential for such IVD’s use in resource-limited settings.

This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.

Key takeaways

How WHO independently verifies assay performance and operational fitness for resource-limited settings.

Review and references

Source

Compiled from public manufacturer materials and regulatory sources. Not independently verified and not reviewed by a named clinician.

Published

2026-10-09

Updated

2026-10-09

Disclaimer

professional use

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