COVID-19 Employee Testing: TAG Addresses Your Questions


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Recommendations for Industry

COVID-19 Employee Testing: TAG Addresses Your Questions

In previous issues, we have discussed the Biden Administration vaccine/testing mandate for businesses with 100+ employees, for which OSHA is still drafting the Emergency Temporary Standard (ETS). Because of the testing option, TAG has been receiving a number of questions on the availability, applicability, and efficacy of various tests.

While we don’t yet know what specifications OSHA will include in the ETS, if any, we can provide some information from various government sources on tests.

  • On September 17, the Department of Defense issued a statement on the $647 million in contracts it, in coordination with the Department of Health and Human Services (HHS), had awarded for four over-the-counter COVID-19 test kits. Those tests include: $205.2 Million Contract to OraSure Technologies, $284.2 Million Contract to Quidel Corp., $47.8 Million Contract to Abbott Rapid DX North America, and $109.8 Million Contract to Intrivo Holdings Corp. However, the release states only that the procurements “were funded through the American Rescue Plan Act to supply critical medical resources to the nation,” so we don’t know what availability the administration will be making for these tests.
  • With COVID having mutated since its original detection, this has affected the accuracy of some molecular, antigen, and serology tests. An FDA regularly updated webpage provides information on the Molecular Tests that it has found could be impacted by the mutations, making them less accurate. Thus far, FDA has listed four tests as potentially being impacted: Accula SARS-CoV-2 Test(Mesa Biotech Inc.), Linea COVID-19 Assay Kit (Applied DNA Sciences, Inc.), TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.), and Xpert Xpress SARS-CoV-2, Xpert Xpress SARS-CoV-2 DoD, Xpert Omni SARS-CoV-2 (Cepheid). While some are listed “out of an abundance of caution,” the impact should be reviewed and taken into consideration for these tests. 
  • Additionally, FDA has been issuing EUAs for certain Molecular Diagnostic Tests based on specific conditions of authorization required of the manufacturer and authorized laboratories. The list of 261 tests includes test attributes information, such as whether each is authorized for screening (of asymptomatic individuals without known exposure) pooling, multi-analyte, saliva, home collection, and/or home testing.

While this leaves a lot of questions about test selection, there is unlikely to be any further answers until OSHA publishes its ETS. If you do have general testing questions or would like assistance with your vaccine/testing program, please give TAG a call. We are continuing to stay updated on all things COVID-19 and can provide assistance.

RISK MATRIX

TAG’s Weekly Matrix is showing a downward trend in the Delta curve across the U.S., just as is being seen worldwide. There are, however, pockets of significant concern with high or increasing case rates. TAG recommends that businesses stay updated on the conditions in your local area to determine the level of risk and ensure continuing protections are being implemented.

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In Case You Missed It

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