HUNTSVILLE, Ala. - As the number of positive COVID-19 cases continues to increase, a Huntsville wellness clinic has started to administer a blood test to determine if a person's immune system has created antibodies to attack the novel coronavirus.
Normally, Synergy Wellness Clinic focuses on physician-approved mental health and addiction treatment programs. But one physician said they saw a need for widespread COVID-19 testing and wanted to fill it.
"We saw a deficit in the amount of testing that was available to the community," explained Dr. Steven Werdehoff, clinic partner and emergency medicine physician. "We saw that we might be able to provide the antibody testing for anybody who wanted to get tested."
Antibodies are proteins in the immune system that develop days after an infection establishes itself in the body. The antibody test requires a small blood sample and is achieved by a finger prick.
A spokesperson with the Alabama Department of Public Health said the antibody tests are not yet FDA validated:
As a whole, these tests, although approved by the Federal Drug Administration (FDA) for distribution by commercial manufacturers, or development and use by laboratories, are not reviewed or validated by the FDA, nor do they have Emergency Use Authorization (EUA) before being made available for use.
The ADPH said its uncertain about the validity of the tests.
“We as physicians are concerned that the antibody testing might pick up again a false reactivity from another coronavirus,” said Dr. Karen Landers with the state health department.
Landers said the department is concerned antibody tests are not sensitive enough to detect COVID-19 specifically.
"People may have negatives that are false negatives in terms of if their body hasn't mounted an immune response yet, because it's not testing for the virus, it's only testing for the antibodies to the virus," Landers said.
Werdehoff said while that may be true, he and his partners have confidence in the method and its results.
“We have had a patient that we knew was positive and tested them, and they were positive on the test and that was reassuring,” he said. “We've had several positives throughout the day today, so I believe the test does what it says it does, the test for the IGG and IGM antibodies to the COVID virus.”
The clinic provides the antibody tests for a fee of $50. Werdehoff said the fee covers test supplies, personal protective equipment used to administer the tests and helps pay the employees on site.
“One of our partners is based out of Houston and he had some contacts and was able to procure these tests from Wuhan, China,” Werdehoff said.
Anyone can register to be tested without a doctor's order. Once you're registered, the clinic gives you a time slot to show up at its mobile testing site in Jones Valley. The clinic says results will be texted to you within 10 minutes after the test is administered.
Werdehoff said the Huntsville-based clinic has already tested more than 80 people, including a number of medical professionals.
“They’re on the front lines. They're seeing patients who are COVID positive, and they want to know if they've been exposed or, you know, have built up the antibodies to this virus,” Werdehoff said. “So that's been a surprise that we've seen several nurses and physicians come through that want to be tested.”
It can be difficult for people who are asymptomatic to get tested, Werdehoff said. That's where he says this test can be a useful tool.
“You will build immunity even if you haven't had symptoms so it can be valuable to know. 'Hey have I already been exposed? Am I building an immune response to the COVID virus?'"
Though antibodies are said to make people immune to reinfection, Werdehoff explained it’s still not clear if someone who has fought off the COVID-19 virus once, can contract it again. He urges people to continue to follow CDC guidelines and practice social distancing even if they have COVID-19 antibodies.
Synergy Wellness said it has only had five people test positive for COVID-19 so far. The clinic plans to send those results to the state.
The department of public health said, at this time, antibody test positives will not be counted as a COVID-19 positive. Those cases will require an additional nasal swab test for confirmation.
Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Disease, told CNN he expects to see a large number of antibody tests around the country within a week.