The agency at that point had received 15 “adverse event reports” about Abbott’s ID NOW rapid COVID test suggesting that infected patients were wrongly told they did not have the virus, which had already led to the deaths of tens of thousands of Americans. The warning followed multiple academic studies showing higher “false negative” rates from the Abbott device, including one from New York University researchers who found it missed close to half of the positive samples detected by a rival company’s test.
But then, in a move that confounded lab officials and other public health experts, a senior FDA official later that month said coronavirus tests provided outside lab settings would be considered useful in fighting the pandemic even if they miss 1 in 5 positive cases—a worrisome failure rate.
The FDA has now received a total of 106 reports of adverse events for the Abbott test, a staggering increase. The agency has not received a single adverse event report for any other point-of-care tests meant to diagnose COVID-19, an agency spokesperson said.