The FDA has authorized the emergency use of six at-home COVID-19 diagnostic tests, but experts are worried about the accuracy of such tests, The Wall Street Journal reported.
At-home tests were created to give people with disabilities, compromised immune systems and limited transportation access the ability to get tested for COVID-19.
The testing kits also appeal to companies that want to test their workers before reopening, as well as to colleges and universities that want to test their faculty and students.
A Frost & Sullivan analyst predicted that sales of at-home diagnostic tests could reach $816 million this year, according to the Journal.
But where and when samples are collected can affect the accuracy of the test results, Alan Wells, MD, medical director at UPMC Clinical Laboratories and a professor of pathology at the University of Pittsburgh told the Journal.
Most at-home tests use samples from either nasal or nasopharyngeal swabs or saliva. A sample taken from saliva or a nose swab could return a false negative result if the disease has moved to the lungs, which it often does, Dr. Wells said. Samples taken from the nostril or saliva increase the rate of false negatives by 10 percent to 20 percent.
Some test makers have sent trained nurses or other healthcare workers to people's homes to help them collect samples, but this limits the number of people who can take the test, the Journal reported.
Experts also said they are worried that labs won't have the capacity to run all of the at-home tests, and expressed concern about access to them and the affordability of them. The at-home test developed by Rutgers University in New Brunswick, N.J., costs $150; Everlywell's test costs $109; and PrivaPath Diagnostics test costs $129, according to the Journal, and patients have only received partial reimbursement.
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