Differing Covid tests in July led to conflicting results for 65 Vermonters. Quidel says the tests were accurate. Dr. Mark Levine, the state’s health commissioner, says that drawing conclusion is “inappropriate.”
National test manufacturer Quidel has announced that it stood by the July results of 65 positive Covid tests, which the state Department of Health declared were false positives.
Early last month, 65 people tested positive via rapid antigen test at Manchester Medical Center, leading to fears of a Covid outbreak. The Department of Health said otherwise: all but four of those people tested negative in subsequent PCR testing, the nose swab test preferred by the state. All but one of an additional 1,613 people without symptoms tested at pop-up testing sites also tested negative.
A company investigation into the results “found no testing site or product-related issues,” according to a Thursday release.
Quidel Corporation CEO and president Douglas Bryant countered by blaming the state’s test. “We conducted a very thorough investigation for this unique complaint in Vermont and believe that it was highly likely that our [antigen test] results were true positives and that the subsequent PCR method used to re-test was at risk of providing inaccurate results.”
Quidel inspected the testing site at Manchester Medical Center, conducted an analysis of the Center’s data, and reviewed approximately 110,000 test results generated at 526 sites in 33 other states, Bryant said. The Food and Drug Administration concurred with the company’s review, he said.
Health Commissioner Mark Levine said Bryant’s PCR test statement was “inappropriate, and not supported by data.” The contact tracing and subsequent testing did not point to an outbreak, Levine said. There was also no community spread after Manchester Medical Center’s positive tests.
The PCR test “is known as a reliable test,” Levine said. “If [Vermonters] need to get tested, they should have a high degree of confidence in their results.”
The Department of Health has been in contact with the Centers for Disease Control and Prevention about which tests should be used, Levine said. He didn’t go so far as to say that antigen tests were unreliable.
Levine attributed the varying conclusions on differing approaches to the investigation. Quidel and the FDA looked solely at the antigen test, he said. The CDC and the Department of Health are focused on epidemiology.
“We wish we had a more conclusive answer about the whole situation,” Levine said.