A few weeks ago, I found a site listing over 200 companies working on COVID tests. This was mostly for the RNA test, for diagnosis, and the majority of vendors were in China. Antibody tests were fewer. Some of the best tech comes from China, some of the not-best too. It can be very difficult to take any action against Chinese companies if they have not delivered on their promises. The FDA normally would spend months or years approving a rapid test, but things are frantic right now and corners are being cut. Unlike Abbot Labs, these companies don’t give details about their product in English and the FDA and CDC are taking manufacturers claims at face value for now, but figure 90% specificity is adequate, in other words, one out of 10 people told they have antibody protection don’t.
Rapid tests usually use lateral flow testing systems. Lateral flow studies work by embedding antibodies in a media strip, applying the patient’s sample on the other end of the strip, adding a reagent and letting the antibody diffuse through the media to the antigen. Where the sample and antibody meet, an indicator molecule will change color if the antigen specific to the antibody is present, normally forming a line at the boundary.
You can go crazy trying to decide if you see a line or not, and considerable variation exists between testers looking for a red stripe on the Strep tests for example. Lateral flow studies relying on the eyeball are often not very sensitive, or, give false negatives, but tend to be very specific, so a positive test correlates very well with the presence of whatever the antigen is.
The sensitivity can be improved a lot by having a machine read the test, usually by measuring fluorescence releasesd by tagged antibodies. If the antigen is viral RNA, a sophisticated test can even use reverse transcriptase and PCR to amplify the RNA sequences. Putting a new machine on the market is much harder than creating a lateral flow test strip, but COVID testing capability has been successfully added to several manufacturers machines.
I think that testing is not very reliable without good design, manufacturing and quality control, and that isn’t all there yet.