(WTAJ) — The FDA recently authorized the first at home testing kit for COVID-19, giving folks results in 30 minutes without having to leave their home.
While the new testing method will make it easier for patients to get tests quickly, the main concern with this new self-testing process is the risk of false-negative results.
Dr. Sarah Wheeler, Associate Medical Director of UPMC’s Clinical Immunopathology Department said there’s potential for false negative results.
“You can imagine little viral particles hanging out in your nasal passages, if you don’t collect enough of those little viral particles, we actually can’t detect them on the test,” she said.
Another issue could be testing at the wrong time.
“Early in disease course you might have very little virus, so it may be difficult for us to detect it, and then as you become symptomatic, you end up with more virus so we can then detect it, so if you’re tested too early in your disease course, we may not have a positive test, even though you do have an infection with SARS-COV-2,” Dr. Wheeler said.
While UPMC will vet the testing kit before prescribing it, the approval from the FDA is a sign that it works for a wide spectrum of patients.
“Because it is prescription, we will be following up with patients so if they’re continuing to be symptomatic or anything like that, obviously some additional testing may need to be done,” Dr. Wheeler said
This test has a positive percent agreement (PPA) of 94.1% and a negative percent agreement (NPA) of 98.0%. This means that positive results are correctly identified 94% of the time and negative results are correctly identified 98% of the time. This test has similar performance to other authorized high complexity laboratory PCR tests and exceeds the performance recommendations for prescription home-use tests (80% PPA and 98% NPA) as explained in FDA’s template. The performance is similar to or better than other authorized point of care tests.FDA Official
The kit is prescription only for patients older than 14 years old. Younger patients can still use the kit in a professional healthcare setting, like a doctor’s office or clinic. It most likely will not be available until the spring.