Another issue is that most antibody tests look for “neutralizing antibodies” only - ie those that, via the antibodies alone, prevent viral infection. (This typically (always?) means blocking the receptor domain). The problem with this is that:
A) many other aspects of the immune system are ignored. (There was a mab study that found the best metric to measure antibodies efficacy was not ‘blocking’ but engagement with the immune system). B) one of the antibody tests turned up a surprising number of negatives among those known to have been infected.
Hopefully #B will not repeat (ie just testing error), but I suspect it’s a real thing because related types of artifacts showed up in SARS. (Worst outcomes tied to high antibody test just as younger patients here were more likely to be negative on antibody test)
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.