Biotech Values

[DewDiligence]

Re: Sensitivity/specificity of COVID-19-antibody tests

https://www.biocentury.com/article/304887

While Cellex Inc. is the only company to receive EUA* for a serological test against COVID-19, 90 test developers have taken advantage of the opportunity to launch COVID-19 serological assays without any agency review.

…Cellex’s FDA-authorized test has a sensitivity of 93.8% and a specificity is 95.6%; it was tested at two Chinese hospitals in a total of 128 and 250 patients that tested positive and negative for COVID-19 via RT-PCR, respectively.

*Emergency Use Authorization.