Coronavirus Antibody Tests Surrounded By Doubt, Worry Over Accuracy
(CBSDFW.COM) - Back in January, University of Texas at Austin professor Michael Webber attended the Consumer Electronics Show in Las Vegas. Shortly after, he started feeling very sick.
"The symptoms that I had matched the description in the news around mid-January of the coronavirus that was just emerging," he said.
He assumed he had the virus, but had no proof. Then a few months later, COVID-19 antibodies tests hit the market. Webber took the finger prick test and tested positive, but in recent weeks there's been concern some tests are flawed.
"I like everybody am worried about the accuracy of the test and that there are risks of false negatives and false positives," he said. "You want to know about it's specificity and it's accuracy and it's precision and that kind of thing. I'm a guy who likes data as a professor so I certainly want to know how good the test are."
Right now, there are more than 200 tests are on the market, but so far only the 12 have been authorized for emergency use by the U.S. Food & Drug Administration.
- Cellex Inc.
- Ortho Clinical Diagnostics, Inc.
- Chembio Diagnostic System, Inc.
- Mount Sinai Laboratory
- Autobio Diagnostics Co. Ltd.
- Ortho-Clinical Diagnostics, Inc.
- DiaSorin Inc.
- Abbott Laboratories Inc.
- Bio-Rad Laboratories, Inc.
- Wadsworth Center, New York State Department of Health
- Roche Diagnostics
- EUROIMMUN US Inc.
The FDA is now tightening the reins, ordering all test manufacturers to submit data proving their products are accurate.
"They're trying to be a little bit more cautious in saying okay this test is out there and that's okay because you at least alerted us, but now you need to make sure that it's accurate and you need to send us this data," University of North Texas Health Science Center professor Dr. Crystal Howell said.
"The test that they chose for me looks like one of the better ones," Webber said.
He wonders how long his immunity will last.
"While the antibody test does give me one more piece of data, one more piece of information and some peace of mind that I have the antibodies, it actually doesn't answer all the questions," Webber said. "There's still a lot of precautions I have to take."
He's waiting and watching to see what happens before returning to his regular routine.