Federal data source updates, Nov. 8

As cases spike, the Department of Health and Human Services (HHS) is focusing on rapid testing as a means to control the pandemic. But data on this type of testing continue to be widely unavailable.

  • HHS funds new COVID-19 testsOn October 31, HHS and the Department of Defense announced a $12.7 million contract with InBios International, a Seattle-based diagnostic testing company. The contract aims to help InBios increase its production capacity for two COVID-19 tests: a rapid antigen test called the SCoV-2 Ag Detect Kit and an antibody test called the SCoV-2 Detect IgM/IgG Food & Drug Administration (FDA).
  • HHS distributes antigen tests to HBCUs: At the end of September, the Trump administration announced that Historically Black Colleges and Universities (HBCUs) would be one category of priority sites for the distribution of Abbott BinaxNOW antigen tests, of which the administration has purchased 150 million. This promise is now coming to fruition; HHS announced on October 31 that 389,000 BinaxNow tests have been distributed to 83 HBCUs in 24 states, at no cost to the schools. How these schools will use the tests and report their testing data, however, remains to be seen.
  • FDA reminds antigen test providers to use them properly: The FDA issued a letter to clinical laboratory staff and health care providers on November 3, reminding them that antigen tests may incur false positives when the instructions for these tests’ use are not correctly followed. FDA recommendations include using antigen tests for symptomatic individuals, handling tests correctly, and using PCR tests to confirm results in low incidence counties. As I’ve discussed in this newsletter before, incorrect use of antigen tests may lead to misleading results that waste clinical resources or instill false confidence in people who receive false negatives.
  • HHS needs better testing oversight and data: Two new articles in STAT News this past week have discussed COVID-19 test regulation and reporting. An investigation by Kathleen McLaughlin finds that laboratory developed tests, diagnostic tools developed by and for specific facilities, fall in a “regulatory gray area” which makes it easy for innacuracies to slip past the FDA and HHS. Meanwhile, an op-ed by OB-GYN Joia Crear-Perry points out the public health danger in allowing demographic data on testing to be lost when rapid tests are not incoporated into reporting pipelines.

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