INDIANAPOLIS (WTHR) - Labs across the country are racing to provide COVID-19 antibody testing.
The tests are supposed to tell you whether you're immuned to the virus. Government leaders say results could help get the nation back to work.
But 13 Investigates shows you why local and federal officials are warning: not so fast.
Inside a small office suite near a popular northwest side grocery, a local lab boast of big claims.
"COVID-19 antibody testing gives results in 10-minutes to determine if you either had the virus or have been exposed."
And the bigger question, are you now immuned?
"I really hesitate to encourage people to do a lot of testing to see if they're immune at this time," said Dr. Kris Box, State Health Commissioner.
According to Dr. Box, the testing is supposed to detect our immune response, or the antibodies our bodies create during infection to help us fight off the virus. But before you run out to get a tests 13 Investigates has a warning: there are major concerns about testing accuracy and reliability.
In Indiana, Arcpoint Labs offers testing.
A tipster told 13 Investigates the Indiana franchise is charging $75 dollars for the finger stick antibody blood test.
But all we found Monday was a note on the door announcing the lab would be closed for two days due to off-site antibody testing.
Late Monday afternoon, John Constantine, the President and CEO of Arcpoint Labs told 13 Investigates, the company will transition out of "point-of-contact" antibody testing over the next two weeks to adhere to FDA guidelines.
Constantine said the Arcpoint learned less than a week ago that the FDA now requires a company to be what's known as a "high complexity facility" in order to conduct antibody testing.
Arcpoint does not have that designation.
"Of all the tests that are on the market right now, the FDA has sent us specific warnings. There's only one that has an EUA, (Emergency Use Authorization), meaning that they've been approved to do this type of testing," explained Dr. Box.
Cellex of North Carolina, is the only company reviewed and authorized by the FDA under the Emergency Use Authorization. And even its approval comes with warnings.
The FDA states in its letter to Cellex: "Emergency use of this test is limited to authorized laboratories."
"Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits …outweigh the known and potential risks…"
Cellex also provides patient information about its test.
Even with all that, Dr. Box says the FDA is taking it slow.
"They're not really confident of the testing there," she added.
According to the FDA, at least 70-other labs are seeking the same status as Cellex but have not been reviewed. That includes a test widely used by the Chinese CDC.
On it's website, BioMedomics, the North Carolina maker of the test said it planned to ship out tests this month, with a disclaimer advising it has not been reviewed by the FDA but is permitted to distribute and use under FDA's health emergency policy. That policy does allow early marketing and use with certain requirements.
The FDA says the problem is some unnamed labs are claiming FDA approval. The Agency says it is going after those labs to stop inaccurate test results from giving people around the country false hopes of immunity.
Meanwhile, Constantine told 13 Investigates Arcpoint would be using Access Medical Labs in Florida to handle its antibody testing.
He said Access uses the appropriate reagents in its processing to meet FDA approval.
It means Arcpoint will have to ship its samples to the lab for results.