![]() What kind of changes are about to happen in our lives? Is a child really on the way? Imagine a mother who has been trying to conceive for years. A lot is riding on the results of these tests. But it can also be a time where we're pretty unsure. If they are incorrectly determined not to have the virus, they could pose a risk to other patients in non-COVID wings, furthering the spread of the virus.Taking a pregnancy test can be an extremely exciting moment for any expectant mother. “If you get back a negative test and think, ‘I don’t have it and I can go to a mixer,’ and now everybody at the mixer has now been exposed to you.”Īdditionally, Procop explains, patients admitted to the hospital for unrelated reasons might still be carrying the virus. “It is a risk that if you tell somebody they’re negative and they’re truly positive that they will relax social distancing, not wear a face mask, etc., and could transmit the disease,” Procop tells NPR. The urgency of the situation has also caused the FDA to grant the tests approval under emergency use authorization, which foregoes much of the rigorous testing that would ordinarily be required. Abbott has sent letters to the healthcare facilities that have received some of the 600,000 tests, advising them to test directly with the swab, which yields the most reliable results.īecause the FDA cleared the test for use directly with the swabs as well as with transport media, Procop tells NPR that he wants additional clarification on the accuracy of the test, because of the more significant implications of false-negative results.ĭue to the nature of this novel coronavirus, manufacturers have had to scramble to not only develop tests capable of detecting the virus but also mass produce them and get them into the hands of frontline healthcare workers quickly. All of the samples in Procop’s study used this media rather than testing directly from the nasal swab. STAT also reports that Emily Miller, an OB-GYN at Northwestern University, referred to the test as “clinically not useful” to identify the virus in expectant mothers.Īccording to NPR, Abbott disagrees with Procop’s findings, stating that any errors might come from the use of viral transport media, which is commonplace in testing and helps extend the shelf life of the sample. “However, with lower loads of virus, a large fraction of these patients were not detected as positive,” he says. In Procop’s analysis, Abbott’s test had a false-negative rate of 14.8 percent.Īlan Wells, a pathologist at the University of Pittsburgh Medical Center, tells STAT that his facility is not using the test anymore because the viral load of the patient might play a role with testing accuracy, more readily identifying those with higher levels. ![]() The ID NOW machine was granted emergency use approval during the pandemic on March 27 and generated buzz after President Donald Trump unveiled it during a press conference. The test that turned out to be the least accurate is the one known for its speed. He and his team took 239 patient samples known to be positive for the virus and re-tested them using five products available through the US Food and Drug Administration’s (FDA) emergency use authorization. Gary Procop is the chairman of the commission of science, technology and policy for the American Society for Clinical Pathology, and is currently heading up COVID-19 testing at Cleveland Clinic. The full results, first reported by NPR, have not been published or peer-reviewed. After in-house testing of different available tests, one physician found that Abbott’s assay using its ID NOW device, which can provide results in 5–13 minutes, has a false-negative rate that nears 15 percent. ![]() As the SARS-CoV-2 pandemic continues with global cases nearing 2.5 million, clinicians have raised questions about the accuracy of available COVID-19 tests.
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