Researchers develop a mathematical means of assessing COVID-19 tests false-negative rate
Even with more than 1.5 million Americans receiving a COVID vaccine each day, officials estimate it will take many more months before enough people are protected from the deadly virus. Until then, and potentially beyond, experts agree that opening up schools, restaurants and other public places as safely as possible will rely on widespread testing for SARS-CoV-2, the virus that causes COVID-19.
As of June 2020, the U.S. Food and Drug Administration (FDA) had granted emergency use authorization for more than 85 different viral DNA test kits or assays each with widely varying degrees of sensitivity and unknown rates of accuracy. However, with no existing gold standard test for the novel coronavirus, there s little data on which to judge these various tests usefulness to municipalities efforts to safely re-open for business.
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A research team at Beth Israel Deaconess Medical Center has developed a mathematical model to estimate the false negative rate for COVID-19 tests.
According to a study published earlier this month in
Clinical Infectious Diseases, the assay limit of detection (or the smallest amount of viral DNA detectable that a test will catch 95% or more of the time) meaningfully affects clinical performance of COVID-19 tests.
The highest LoDs on the market will miss a majority of infected patients, the researchers found. For getting back to business as usual, we all agree we ve got to massively ramp up testing to figure out who s negative and who s infectious – but that s only going to work optimally if you can catch all the positive cases, said corresponding coauthor Dr. James E. Kirby, director of the Clinical Microbiology Laboratories at BIDMC, in a press release announcing the findings.
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