The authors state that the FDA has been slow to approve these tests. As far as I can tell from the FDA's "COVID-19 Emergency Use Authorization" page, that's true. The authors argue that the time has come to ask the FDA why it isn't moving faster on an EUA for this technology.
Health care law (including regulatory and compliance issues, public health law, medical ethics, and life sciences), with digressions into constitutional law, statutory interpretation, poetry, and other things that matter
Friday, September 11, 2020
The Case for the Saliva-Based Antibody Test, Rather than PCR Test, to Reopen Society Safely
Co-authors A. David Paltiel & Rochelle P. Walensky write in today's Health Affairs blog that we shouldn't be put off by the 30% false-negative rate of antigen testing (as compared to the PCR test, which is great at identifying the virus (sensitivity) but has a relatively high rate of specificity (it can be fooled into giving a positive result long after the virus has left the individual, and therefore long after the individual has ceased to be infectious). The key distinction pressed by the authors is "infection" vs. "infectiousness." Their claim is that the antigen test is pretty lousy as a test for the presence of the virus but actually quite good as a test for infectiousness. It's a pretty persuasive case for the rapid-return, inexpensive test, which has been touted by some, as well criticized by others.
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COVID-19
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