BD probes COVID-19 false positives with point-of-care systems

Dive Brief:

BD is investigating reports of false positive coronavirus test results in nursing homes from diagnostics run on its point-of-care Veritor Plus system, The Wall Street Journal reported and the company confirmed Tuesday morning.
A BD spokesperson said the company is aware that "a small number of nursing homes in the U.S. are reporting multiple false positive results" from tests run on its machines, which the spokesperson said diverges from the company's findings in clinical studies in which sampling data showed 98% to 100% specificity, or negative percent agreement.
FDA issued a letter to healthcare providers in July about a different false positive issue with an earlier BD coronavirus test — a molecular diagnostic first authorized in April for use on its BD Max instruments — that had a 3% rate of false positives in a company-run study.

Dive Insight:

The portable Veritor Plus systems are used to process antigen-based coronavirus tests, meant to detect virus proteins and return results more quickly than gold-standard PCR tests. BD currently has just three antigen test competitors in the U.S.: Quidel, Abbott and LumiraDx. The rapid, point-of-care nature of the tests and machines have made them a target for the federal government and states seeking to distribute the faster testing technology.

In mid-July, the Department of Health and Human Services announced it was acquiring antigen tests and associated instruments from both BD and Quidel to distribute to nursing homes, a setting where staff are tested regularly. The Trump administration later backed that effort by invoking the Defense Production Act to expedite shipments to 14,000 nursing homes.

The BD spokesperson clarified Tuesday that its agreement with HHS has it providing tests to more than 11,000 nursing homes, and is in contact with facilities where false positive reports have surfaced. "Following our standard quality management system processes, upon learning of these reports, BD immediately contacted the sites, and we are actively investigating the situation to obtain additional details," the company's statement said.

Also this summer, HHS and Department of Defense awarded BD a $24.3 million contract to establish and expand U.S. production of the tests used on the Veritor analyzers. And last week, the state of Maryland announced it acquired 250,000 of the BD antigen tests, the first such agreement since Gov. Larry Hogan set up a 10-state compact working to gain access to the tests.