Here’s a question from a reader:
There are urgent care clinics advertising a COVID-19 test that has results in 10 minutes, but they say these tests are not FDA approved. What does that mean exactly?
— David Youngblood, Norman
Dr. Prescott Prescribes
The Food and Drug Administration generally treats tests that diagnose for illness as “medical devices.” As such, the FDA must approve such tests before they’re offered to patients.
The approval process is typically a lengthy one. But for urgent situations — like the one we now face — Congress has created an expedited path that’s known as an Emergency Use Authorization.
This process allows emergency FDA approval with less data than is typically required. The FDA reports that it’s been reviewing and approving these applications within the space of a single day in some cases. Reports we’ve heard support this, with developers telling us the FDA has routinely been approving COVID-19 diagnostic tests with 24 to 48 hours of submission.
When I hear accounts like David’s, I’m left scratching my head. Because if facilities are using tests that generate accurate and reliable results, obtaining FDA approval should neither be slow nor difficult to come by.
This brings me to a simple recommendation: If a clinic is using a diagnostic test that doesn’t have FDA approval, go somewhere else to get tested.
I want to be sure, however, to distinguish diagnostic testing from antibody testing, which is just beginning to emerge. Diagnostic testing tells you whether you currently have the virus. Antibody testing aims to tell you if you had it.
The FDA has given antibody test developers the option to waive initial review. That means that when you take an antibody test, chances are no federal regulator has kicked its tires.
The technology behind these tests is relatively simple. But this doesn’t guarantee reliable results. Just look at Great Britain, which spent $20 million to obtain millions of antibody tests — only to find they generated so many false results as to be worthless.
As of this writing, scores of antibody tests were being marketed across the US. But only one, Cellex, had obtained FDA approval.
Unless I knew the test I was getting had FDA approval, I’d hold off. Otherwise, there’s no telling whether you can trust the results.