Considered the coronavirus holy grail, antibodies are believed to give us some level of immunity from the virus. They form after a person fights off COVID-19 and can be detected through a serological test, better known as an antibody test.
"There are some really great companies building antibody tests, and there are some not so great, bad actors, building antibody tests. So you have to be really careful," says Jon Carder, co-founder and CEO of Vessel, a San Diego company created four years ago to provide in-home wellness tests.
Early in the pandemic, the U.S. Food and Drug Administration allowed these tests to be sold and distributed without federal review, as long as the company notified the FDA it was offering a test, performed self-validation studies, and included a disclaimer on the test results.
The FDA is now cracking down on the bad actors, creating a list of tests that should no longer be distributed.
Only a handful of manufacturers have been granted FDA Emergency Use Authorization, meeting a certain threshold for accuracy.
Carder says states and even countries have been fooled by the bad actors, purchasing inadequate tests.
"We were talking to a city government, a big city, and were blown away when we got a response that they were thinking about buying antibody tests from a certain manufacture who had claimed they were FDA approved. And the state had sort of taken their word for it, and they weren't," said Carder.
Vessel had been preparing to release its in-home wellness tracker, which tests for health markers like vitamins, minerals, toxins, and cortisol.
When the pandemic hit, the company adapted its technology to be used in the fight against COVID-19.
"We take existing antibody tests, the good ones, the ones that are accurate and that the FDA has approved for emergency use, and we enable those to be done safely and accurately at home," said Carder.
They've created a kit with step-by-step instructions to do the blood test at home. The test card is then scanned through the Vessel app and provides results from a medical professional within a half-hour.
The FDA has already approved in-home tests to diagnose active infections – but Carder says the sample must be sent to a lab, and the user must have symptoms or another qualification to get one. And he says they can be costly.
"Ours could be one of the first, or the first, antibody test done at home, no lab needed," said Carder.
Just this week, the FDA issued three warning letters to companies making false claims on their in-home antibody tests.
Vessel has completed its usability studies and is now in clinical trials with the FDA.
"Our job is to prove it can be done safely at home and to show that via clinical trials. The FDA really makes the call if they're going to enable antibody testing at home," said Carder.
He says the test would be cost-effective, anywhere from $20-$30, or around $50 with medical consultation.
If approved by the FDA, Carder estimates millions of people could be tested within the first few months.
"There's something really great about the peace-of-mind that comes from doing a test, and that may be one of the biggest benefits," said Carder.
But while the FDA is only approving the most accurate tests, none are 100 percent accurate and could still lead to false positives.
