Many Coronavirus tests hurried out

When the new coronavirus began spreading in the U.S. at lightning speed, the Food and Drug Administration used its emergency authorities to authorize large numbers of quickly developed tests. However, the tests were based primarily on a small number of studies reporting they could successfully detect the novel virus. That’s a very different scenario from extensive patient studies that can take weeks or sometimes months, which experts say are required to provide a real sense of testing accuracy.

The FDA’s rapid response came after it was at first criticized for the prolonged launch of new tests during a public health crisis and after the Centers for Disease Control and Prevention bungled in getting its test out to states. Associated Press journalist, Matthew Perrone reported many commercial test makers submitted results from just 60 samples—the minimum number required. Requiring more comprehensive studies of coronavirus tests could provide valuable information, but it could also strain the FDA’s already overextended staff and resources.

According to Jaline Gerardin, an expert in disease modeling, “nationally, we’d likely save tens of thousands of lives if test turnaround times were shortened.”

Testing speed is also a crucial factor in managing a pandemic outbreak. With significant increases in testing demand, the average time to deliver test results is four to six days and, in some cases, longer. According to Jaline Gerardin, an expert in disease modeling at Northwestern University, “nationally, we’d likely save tens of thousands of lives if test turnaround times were shortened.”

Knowing whether a patient has the coronavirus means healthcare workers know how to respond and address questions such as:

  • What is the best course of treatment for the patient?
  • Where in the hospital should patients be placed, especially in communities with dedicated COVID-19 wards?
  • Should medical staff attending to the patient conserve or deploy personal protective equipment?

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.

Accuracy has 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.

How accurate are Coronavirus tests used in the U.S.?

Currently, most COVID-19 tests in the U.S. don’t provide data on how often the tests incorrectly free patients of the virus or falsely detect infection. Public health experts say we need larger patient studies to evaluate a test’s actual performance. The government’s emergency authorization process currently requires test makers only to prove that a test “may be effective” instead of the standard requirement to demonstrate “safety and effectiveness.” Once the U.S. government declares the crisis over, they will have to meet that higher threshold again.

Some healthcare experts are concerned doctors and patients have put too much confidence in the current array of tests when many patients with COVID-19 could be receiving false-negative results. Even a modest error rate can have severe consequences during an outbreak like COVID-19. For example, a test 95% accurate at detecting the virus that is used on 1 million people would result in 50,000 people being incorrectly told that they don’t have the virus.

Some healthcare experts are concerned doctors and patients have put too much confidence in the current array of tests when many patients with COVID-19 could be receiving false-negative results.

Since the beginning of the pandemic

From the start of this global outbreak, the U.S. has been plagued by COVID-19 testing problems. Although improved, testing remains a significant obstacle that will continue to affect the country’s ability to track potential new outbreaks as communities try to resume a more normal life. However, as serious as the testing delays seem now, public health experts warn, they will undoubtedly get worse in the fall once flu season arrives. Whether there will be a dramatic surge similar to a “wave” remains to be seen. But the virus hasn’t let up and neither can we.