COVID antibody tests- The Real Story
As usual the media has managed to confuse patients about antibody testing. First understand this – NO COVID-19 antibody test is validated by the FDA. The FDA only is giving diagnostic companies an EUA – Emergency use authorization for their COVID-19 antibody tests. That just means the FDA places a temporarily stamp of approval after a company submitted an application for EUA and also submitted internal trial data that their test is right most of the time. 12 companies were granted Emergency Use Authorization so far, which really means nothing when it comes to a trusted regulatory agency verifying the accuracy of the test. So we are relying on for profit company’s own data as to the accuracy of their results. Remember Theranos anyone? I spoke to one large national company, Quest Diagnostic about their COVID-19 antibody test’s accuracy and here is what she told me.
“The sensitivity of the SARS-CoV-2 IgG assay: is clinical performance of 90-100% (assessed as percent agreement of serology results on known COVID-19 PCR positive cases). A false negative IgG may occur if sample is drawn earlier than 10 days post onset of symptoms or due to immunosupression. Specificity of 99% to 100%. This was assessed by performing cross-reactivity studies utilizing serum samples positive for antibodies to other respiratory viruses, as well as panels of samples from pre-COVID times…false positive rates are minimal…”
So bottom line they claim to be 90-100% sensitive and if positive 99% to 100% accurate. So sounds like it’s a overall very good test, and especially if it’s positive. Now again, FDA has not independently tested the accuracy of these tests. And Quest has not submitted for a FDA EUA as of my knowledge today.
Currently, there are only 12 companies that have the FDA EUA. However yesterday the FDA is now requiring all lab companies to submit their data like I explained above to them for review and an Emergency Use Authorization approval. Here are the 11 companies with EUA approvals by the FDA, note Ortho Clinical Diagnostics has 2 tests.
Ortho Clinical Diagnostics which has 2 tests
Chembio Diagnostic Systems
Mount Sinai Lab
Autobio Diagnostic Co
Wadsworth Center, NY State Department of Health
Euroimmune US Inc
In 10 days expect over a hundred companies added to this list if they can pass that minimum FDA standard.
In my strong opinion, given the national health and economic implications of sorting who is theoretically immune and who is vulnerable to SARS-COVID-19 infection and the role the SARS-COVID-19 antibody test will play in that determination, the FDA MUST perform internal test validation and verification. We should not just trust companies internal data on a small number of tests.