FDA Alerts Doctors After Preliminary Data Reveals Rapid COVID Test Can Miss Nearly 50% Of Cases
The agency is launching an investigation into Abbott's 15-minute test, which has been touted and used by the White House. A preliminary study released this week found that it can miss nearly half of positive coronavirus cases.
The Associated Press:
FDA Probes Accuracy Issue With Abbott's Rapid Virus Test
Federal health officials are alerting doctors to a potential accuracy problem with a rapid test for COVID-19 used at thousands of hospitals, clinics and testing sites across the U.S., including the White House. The Food and Drug Administration said late Thursday it is investigating preliminary data suggesting Abbott Laboratories’ 15-minute test can miss COVID-19 cases, falsely clearing patients of infection. The test is used daily at the White House to test President Donald Trump and key members of his staff, including the coronavirus task force. (Perrone, 5/15)
NPR:
FDA Cautions About Accuracy Of Widely Used Abbott Coronavirus Test
The Trump Administration has promoted the test as a key factor in controlling the epidemic in the U.S. and is used for the daily testing that is going on at the White House. As first reported on NPR, as many as 15 to 20 out of every 100 tests may produce falsely negative results. A subsequent study released this week indicated that the test could be missing as many as 48% of infections. (Neel and Hagemann, 5/14)
The Wall Street Journal:
Abbott Will Change Coronavirus Test Instructions For Second Time
Abbott Laboratories said Thursday that it would change the instructions for using its fast coronavirus test for a second time, days after a preliminary study by a major medical center found the device frequently gave negative results for patients who were infected with the virus. The change will tell users that negative results produced by Abbott’s ID Now device are “presumptive” and should be verified with an alternative test for patients with signs of the virus. That means sacrificing the device’s quick turnaround time for some patients as tests are repeated using methods that can take much longer. (Weaver, 5/14)
In other news on testing —
The New York Times:
Coronavirus In Wuhan: Inside China's Plan To Test 11 Million People
Wuhan, the Chinese city where the coronavirus pandemic began, has announced an ambitious plan to test all of its 11 million residents for the virus in the coming days, a campaign that will be closely watched by governments elsewhere. The testing drive, which is likely to require the mobilization of thousands of medical and other workers, shows the ruling Communist Party’s resolve to prevent a second wave of infections as it tries to restart China’s economy. The plan was announced this week after Wuhan reported six coronavirus cases, breaking a streak of more than a month without any new confirmed infections. (Wee and Wang, 5/14)
Modern Healthcare:
AMA Issues Guidance On Using Coronavirus Antibody Tests
The American Medical Association is warning doctors against using tests designed to identify people already exposed to the coronavirus to make healthcare decisions for individual patients. Antibody tests — also known as serological testing — are emerging for the novel coronavirus. The tests, which are being developed by private lab companies and regulated by the Food and Drug Administration, are being touted to determine the prevalence of COVID-19. (Castellucci, 5/14)
