AUSTIN (KXAN) — Travis County health officials warn that even as options to do COVID-19 antibody testing grow across Central Texas, many still aren’t very reliable.
The Food and Drug Administration has given emergency authorization to 12 antibody tests so far. But the FDA’s Emergency Use Authorization isn’t the same as official FDA approval.
Other manufacturers seeking the emergency designation now must prove that their tests meet a specific performance threshold within 10 days of validating them.
Cedar Park-based AnyPlace MD’s CEO, Shane Stevens, says his company is working to increase accuracy.
“Unfortunately, there are some lower quality tests out there, and that’s given reputable folks that are in this business and trying to help a little bit of a harder time trying to get these products out to market and help people,” Stevens said.
AnyPlace MD is running drive-thru testing sites, swabbing people for current cases of COVID-19 and doing finger pricks to test for antibodies.
Stevens says his company uses antibody tests from both American manufacturers, and some overseas.
“There are tests that are better than others. And some of ours that we’re testing, the ones that were using, have the highest accuracy of all the tests,” Stevens said. “We’ve got five or six that we’ve sample validated, and those are the ones that we’re using.”
Stevens says he requires manufacturers to send videos of their sample validation testing, showing that the tests are producing true positives and true negatives, before shipping the tests to his company. Then, he says his team of doctors and molecular biologists test the antibody kits again, once they arrive.
Travis County Health Authority Dr. Mark Escott says Austin Public Health won’t offer antibody testing until it can access tests that have been FDA approved. He cautions against relying on those that aren’t, until then.
“We have cautioned folks there’s a lot of antibody testing out there that’s being very heavily marketed that probably does not have much clinical utility at this stage, still,” Escott said. “We’ve seen some more locally that on paper look good, you know they get 93-94% sensitivity, 99% specificity. But when you do the math based upon a 1% prevalence, four to five out of six of those positives are going to be false positive. So it’s important that doctors have that conversation with their patients before doing the testing, before charging the insurance.”