This post is a follow-up to the original post shared on May 4 on Testing Failures Exposed in Times of COVID-19 Pandemic.
In an attempt to assess the performance of lab developed and commercially available molecular (RT-PCR) test kits for the diagnosis of SARS CoV-2 virus, the Foundation for Innovative and New Diagnostics (FIND) ran an independent comparative study of some test kits. FIND is a global non-profit organization that aims at driving innovation in the development and delivery of diagnostics of major diseases that affect the world’s poorest populations[i].
FIND had launched an expression of interest (EOI) to gather standardized information on the test kit components, performance data from the company’s internal testing, and information on their manufacturing and distribution systems. They then selected the tests for evaluation based on their scoring criteria[ii] and ran blinded tests to verify the analytical sensitivity (lower limit of detection – LOD) and diagnostic accuracy (specificity/cross-reactivity) of these COVID-19 testing kits[iii].
The testing involved analyzing 50 COVID-19 positive and 100 COVID-19 negative samples. The sensitivity analysis was quantified using an E gene standard, and the specificity analysis performed using an in-house PCR protocol that was optimized based on the Tib Molbiol assay[iv].
As of June 9, they have evaluated 21 kits and published results for 16 kits. The study is a work-in-progress with results being updated regularly.
