Cellex this week became the first lab to receive Emergency Use Authorization from the US Food and Drug Administration for a coronavirus serology test, as 360Dx reports.
The test, dubbed qSARS-CoV-2 IgG/IgM Rapid Test, is an immunoassay that detects IgG and IgM in blood serum, plasma, or whole blood samples, it adds. As 360Dx notes, FDA has said that serology tests that don't intend to diagnose disease don't have to notify the agency or seek an EUA prior to marketing in the US, but that tests to diagnose disease do.
Such antibody-based tests could potentially tell whether someone has had a SARS-CoV-2 infection, the Verge adds, saying that they could be used to gauge the portion of the population that was infected with SARS-CoV-2 and possibly determine who may be immune and could venture back out into the world. It notes, though, that this sort of tests may not be as good at identifying ongoing infections.
But as the Los Angeles Times reports, the US doesn't have a plan in place for broad serology testing, unlike Germany and the UK. It says that a cohesive effort will be needed so that data from testing could be used to inform plans to resume life-as-usual.
"You have to have a national database," Peter Beilenson, county health officer for Sacramento, tells the LA Times. "It's protecting the population. Whether it's against war or viruses, that's their role."