Doctors say COVID-19 antibody tests aren't FDA approved, should be taken with caution

SCOTTSDALE, Ariz. - Thousands of people are paying out of pocket to take a COVID-19 antibody test at private labs in the valley.

The test can run anywhere from $60 to $150.

At a lab in Scottsdale, it’s a quick finger prick, your blood sample is added to a testing stick, and in about 10 minutes, it reveals whether or not you have antibodies in your system for coronavirus.

But doctors warn that so far, these tests are not Food and Drug Administration (FDA) approved.

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Arcpoint Labs of Scottsdale says its test, which measures two prominent antibodies, is the same brand that was used in South Korea.

“The one we use has a pretty high sensitivity accuracy rate, so the IgM is over 97% and IgG is over 99%,” explained Tim Terrill, manager at Arcpoint Labs of Scottsdale.

IgM and IgG are the antibodies the test checks for.

The demand for the test skyrocketed in the past week. Currently, the lab completes about 200 tests a day.

Anthony Williams took the COVID-19 antibody test, saying, “We were on a cruise that got extended 15 days, subsequent to disembarking. 100 tested positive, 2 people died, my wife's brother is in [the intensive care unit] on a ventilator.”

He says he and his wife just completed their 14-day self quarantine and have not had any symptoms.

They hope to test positive and donate their plasma to help others, but doctors say people should be cautiously optimistic about the results.

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Nearly all the COVID-19 antibody tests being marketed have only received emergency authorization from the FDA.

“That crucial step where the FDA does its own test is missing. Desperate times call for desperate measures. So the FDA said you can go ahead and skip that step but you can't say its FDA approved," said emergency physician Dr. Frank LoVecchio.

He adds, “If somebody tests positive, more likely than not it’s accurate. If someone tests negative, does that mean they haven’t been exposed? Maybe, maybe not.”

Currently there is a waiting list to be tested and the average wait right now is about a week long.