The scenario in Nevada doesnt always represent the performance of the antigen tests in other contexts. Both tests received FDA approval just for use “within the very first 5 days of the start of signs.” Susan Butler-Wu, PhD, a scientific microbiologist at Los Angeles-based University of Southern California, said Nevadas data could be due to the off-label usage of tests created for specific populations however then administered to others..
Quickly after the tests were distributed, Nevada retirement home began to report conflicting results between some rapid tests and PCR laboratory outcomes. Of 39 favorable test arises from both BD and Quidel, 23 were found by PCR to be negative, a mistake rate of practically 60 percent, reports the NYT.
In August, the federal government dispersed the antigen tests, which can produce results in 15 minutes, to nursing homes across the U.S..
Kristen Cardillo, BDs vice president of global communication, said the company was “performing extensive examinations,” however that the company thinks the rate of reported incorrect positives is well within what is anticipated.
Douglas Bryant, president and CEO of Quidel, told press reporters it was “extremely likely” the PCR tests used to validate the test outcomes were erroneous. Jeannine Sharp Mason, Quidels director of marketing communications, told the NYT the company knew the scenario and remained “confident in the precision of our rapid antigen tests.”.
Some test arises from Quidel or Becton, Dickinson and Co. incorrectly designated healthy individuals as contaminated, prompting a statewide order to terminate use “up until the precision of the tests can be further assessed.” The state is now pivoting from antigen tests to viral RNA tests..
Nevada has suspended using two fast COVID-19 tests in nursing houses after the tests consistently delivered false-positives, according to an Oct. 2 regulation provided by the state health department.
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Gabrielle Masson –
Thursday, October 8th, 2020
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In their applications for FDA clearance, both BD and Quidel stated their tests had no incorrect positives, according to The New York Times. As the creators of the test, BD and Quidel are more most likely to use it properly, stated Valerie Fitzhugh, MD, a pathologist at New Brunswick, N.J.-based Rutgers University.
The scenario in Nevada doesnt necessarily represent the efficiency of the antigen tests in other contexts. © Copyright ASC COMMUNICATIONS 2020. Interested in LINKING to or REPRINTING this material? View our policies by clicking here.