We Can’t sacrifice accuracy for the sake of speed
With the U.S. outbreak almost guaranteed to extend for several more months, or possibly years, some experts want the FDA to require better proof of tests’ accuracy so doctors and health officials know how many infections might not be detected.
In recent weeks, preliminary findings identified potential problems with some COVID-19 tests. Inaccurate test results could leave thousands of Americans with the erroneous assumption that they are virus-free, giving people a false sense of confidence and contributing to new outbreaks of the disease as states reopen.
At the onset of the pandemic, the FDA was under tremendous pressure to get tests to the states; however, now that testing is widely available, it’s time to raise the bar. Unfortunately, no screening test is 100% accurate. For example, as reported in Modern Healthcare, rapid flu tests miss 20% of all cases, a factor doctors consider when treating patients with symptoms who test negative. Similarly, accuracy has also been questioned with blood antibody tests that look for signs of past infections. As a result, the FDA has asked several test makers to do follow-up studies to ensure accuracy.