Diagnostics, Policy

Interest in rapid Covid-19 antigen tests continues despite accuracy concerns

Earlier this month, Ohio Gov. Mike DeWine received a false-positive result from a rapid antigen test for Covid-19, raising concerns about the tests’ accuracy. The assay’s maker, Quidel, said it is investigating the case.

The governor of Ohio receiving inaccurate results from a rapid Covid-19 test has raised alarms about the tests’ reliability, but it has not necessarily dampened interest in them.

Earlier this month, it was reported that Ohio Gov. Mike DeWine received a result from a rapid antigen test stating that he was infected with Covid-19. But when he took two consecutive polymerase chain reaction, or PCR tests, both came out negative. Ohio is part of an interstate compact – which also includes Maryland, Louisiana, Michigan, Massachusetts and Virginia, among others – formed on Aug. 4 to purchase 3 million rapid antigen tests. The tests used are made by San Diego-based Quidel and Franklin Lakes, New Jersey-based Becton Dickinson.

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In an emailed statement, Dan Tierney, a spokesperson for Gov. DeWine, wrote that the consortium is considering multiple testing types and companies, but has not yet made a decision. DeWine had used Quidel’s Sofia SARS Antigen test and was tested as part of a protocol that the White House had set up for individuals meeting with the president.

“We take the story regarding Governor DeWine very seriously and are investigating this case under our quality management system,” Quidel spokesperson Jeannine Mason wrote in an emailed statement. “We are trying to understand the specifics of the issue in order to get to [the] root cause.”

However, she added that there is currently nothing to indicate a performance issue with the test.

Meanwhile, BD spokesperson Troy Kirkpatrick write in an email that the company’s Covid-19 antigen test is similar to the flu and streptococcus tests on the BD Veritor Plus system, which has about 25,000 devices being used across the country.

“These clinicians understand the accuracy of antigen testing, including the need to confirm negative results through a molecular test,” Kirkpatrick wrote. “This is the same guidance for flu and strep tests, so this is not a new concept.”

In a phone interview, Dennis Schrader, COO and head of the Medicaid division at the Maryland Department of Health, noted that antigen testing is one part of a three-component testing plan that also includes PCR and antibody testing. The interstate compact is currently working with the National Association of State Procurement Officials to develop the procurement of tests in a coordinated way, he added.

“If other vendors get into the marketplace, we’re going to have an agile process,” Schrader said. “That’s why NASPO is involved, so they can facilitate that with us.”

Photo: Maksim Tkachenko, Getty Images