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FDA Studies Which Tests are Best for the Omicron Variant. (Hint: not all tests are created equal)

The omicron variant, B.1.1.529, of SARS-CoV-2, was designated by the United States as a Variant of Concern (VOC) on November 30, 2021. The first confirmed case of omicron in the United States was identified on December 1, 2021. 

The omicron variant has significantly more mutations than previous SARS-CoV-2 variants, particularly in its S-gene, the gene that encodes the virus's spike protein....The FDA is collaborating with the National Institutes of Health's (NIH) RADx program to study the performance of antigen tests with patient samples that have the omicron variant. RADx recently performed preliminary studies evaluating the performance of some antigen tests using patient samples containing live virus, which represents the best way to evaluate true test performance in the short-term. Early data suggests that antigen tests do detect the omicron variant but may have reduced sensitivity. 

The following at-home tests were authorized by the FDA (emergency use authorization) for at-home use as of 12/22/2021 in order to self-diagnose (note there may be evidentiary concerns with accepting these results as noted below and it should be noted for OSHA purposes that a self-test that is self-reported is not sufficient by itself):

https://www.mynews13.com/fl/orlando/news/2021/12/21/know-what-s-legit--fda-list-shows-all-approved-over-the-counter-covid-19-tests

Cal/OSHA guidance allows for both antigen and PRC tests. Cal/OSHA standards are different than workers’ compensation standards. 

In order to be eligible for the workers’ compensation presumption in California per SB 1159, there must be a positive PCR or test of equivalent or greater sensitivity along with all the other elements of each presumption. The FDA approved tests do not all have equivalent or greater sensitivity so additional investigation may be required. The above FDA-approved tests were approved expeditiously due to an emergency situation and testing of the test products is ongoing. 

In workers’ compensation cases there is a problem of proof when an at-home test is not witnessed. For purposes of a workers’ compensation claim (presumptive or not), an at-home test that meets the required level of sensitivity should also be taken in full view of a healthcare representative to verify that the test was taken correctly, that the test result is related to the sample given, the date of the test, and that the person whose sample was used led to the result. Most at-home tests also state that a second at-home test should be administered approximately 48 hours after the first to further validate the results.

As more of these cases are litigated, it will be interesting to see how they are weighed.  Studies like the ones ongoing at the FDA should be very helpful to the workers' compensation community developing a good understanding of what types of tests can or should be used in specific settings. 

The FDA reports: "Early data suggests that antigen tests do detect the omicron variant but may have reduced sensitivity." Some at-home tests have been shown ineffective at picking up Omicron.

Tags

californialaw, workerscompensation, riskmanagement, osha
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