'Positive and negative, four hours apart': Accuracy of COVID-19 testing in question - 11Alive.com WXIA
Early studies show 1 in 3 tests are false. 11Alive investigates why.
ATLANTA Millions of diagnostic tests have flooded the market since the COVID-19 pandemic began. As states still report slow testing times and lack of tests available, a new concern has emerged. Can we trust the test results? Shaun Smith has COVID-19 and at the same time he doesn't. At least that's what the tests show. How could I have been positive and negative in the same day?" asked Smith. With an underlying health condition, Smith was told he needed surgery. However, to get that surgery he had to be tested to make sure he didn't have the virus. He was tested at Atlanta's Piedmont Hospital at 8:15 a.m. on May 2. The hospital called him to say, kind of got some bad news for you. We have to cancel your surgery. You tested positive for COVID, remembers Smith. To get a second test, Smith went that same afternoon to a driv-up testing center run by CVS at Georgia Tech. At 12:08 p.m. he was told that this test came back negative for COVID-19. Positive and negative, four hours apart from each other," said Smith. RELATED: COVID-19 testing locations in Georgia The FDA has issued 48 emergency use authorizations for commercial COVID-19 tests. With thousands of people dying everyday, there simply wasn't any time for the extensive review the agency normally conducts to validate safety and accuracy before approval. We don't know what kind of test Piedmont used for Smith's positive test, but CVS uses the Abbott machine that returns results in minutes. All of these diagnostic tests are molecular, which means they detect a COVID infection by looking for for the unique genetic signature of the virus. We dont know which of Shauns results was wrong, because all lab tests are susceptible to some degree of both false positive and false negative results The Piedmont lab report warns "negative results do not preclude SARS-CoV-2 infection." While the Abbott's emergency authorization requires the company to "track adverse events, including any false results," and to report them back to the FDA. RELATED: Coronavirus model cited by White House now projects 134K US deaths by August The Reveal, 11Alive's investigative team, reached out to Abbott to learn more about the process. The company told us "we continue to collect accuracy data in the field." "We saw in other countries, Spain in particular, they had to pull some tests back because they were giving bad results," said infectious disease expert Dylan George. George helped run the White House response to the Ebola outbreak in 2014-2015. THE IMPACT OF FALSE RESULTS He says the biggest concern for false positives is PPE resources and the usage of equipment like ventilators could be used on someone who doesn't actually need it. For me the concern of false negatives is perhaps even more, because then you would have an individual who actually is infected, out in the community and having the assurance from a test, and theyre interacting with individuals, as if they are not infected," explained George. You have allowed people to think that they were negative, and sending them out into the streets and said, hey, youre OK,' and theyre not really OK. And theyre going out into the community and living their regular life, and spreading the virus," said Smith. Early studies show false-negative rates as high as one in three. With at least 8 million diagnostic tests conducted in the United States thus far, even a 99 percent accuracy rate would still mean 80,000 tests returned false results. RELATED: Tracking COVID-19: Georgia Coronavirus Interactive map Because of the lack in accuracy, we have no way to tell how many people are infected or who they are. Having that assurance and not thinking that theyre infected could lead to more spread in the community, so those false negatives are very concerning in terms of spread throughout the community," said George. As for Smith, Piedmont said he has to wait 21 days to be retested before they'll do his surgery. Now Im sitting here worried about, you know, am I at the beginning phases of COVID, or am I at the ending phase of COVID," questioned Smith. 11Alive is focusing our news coverage on the facts and not the fear around the virus. We want to keep you informed about the latest developments while ensuring that we deliver confirmed, factual information. We will track the most important coronavirus elements relating to Georgia on this page. Refresh often for new information. 'Sensational' Forbes article about Georgians' risk for COVID-19 deleted after raising concerns 'Profit off the pandemic': Homeowners fear fines, legal action from HOA for unkept yards VA still using controversial drug on Georgia veterans with COVID-19 despite FDA warning The financial toll of Covid-19: Beating the virus comes at a cost Spot check: Grocery stores lax on employee masks Experts worry about safety of elderly after governor's order limiting nursing home neglect lawsuits