The World Health Organization has proposed new criteria for COVID-19 diagnostic assays and is seeking advice from developers and evaluators before its finalized.

All the requirements contained in WHO guidelines for WHO policy recommendation and prequalification will still apply but this new criteria will lay out some of the considerations that will be relevant in WHO’s case-by-case assessments of COVID-19 assays in the future.

The new criteria or ‘Target Product Profiles (TPP) describe the minimally acceptable profiles for four tests:

• Point of care test for suspected COVID-19 cases and their close contacts to diagnose acute SARS-CoV-2 infection in areas where reference assay testing is unavailable, or turnaround times obviate clinical utility - click here to help.
• Test for diagnosis or confirmation of acute or subacute SARS-CoV-2 infection, suitable for low or high-volume needs: click here to help.
• Point of care test for prior infection with SARS-CoV-2: click here to help.
• Test for prior infection with SARS-CoV-2 for moderate to high volume needs: click here to help. 

WHO are asking stakeholders to complete surveys before the 19th of August. 

You can view the ‘COVID-19 Target product profiles for priority diagnostics to support response to the COVID-19 pandemic v.0.1’ in draft form here