HOUSTON – As people across the Houston area have begun seeking out COVID-19 antibody tests, concerns linger over the relaxed rules in which many of these tests were brought to market.
“You know it’s garbage in, garbage out. If you have bad data out there, you can’t make good decisions,” said Dr. Eric Blank, chief program officer with the Association of Public Health Laboratories (APHL).
The APHL helps draft public health lab protocols and guidelines as well as works with labs across the country and with the federal government to respond to public health emergencies like the coronavirus pandemic. Officials with the APHL said as many as 90 companies are now offering COVID-19 antibody tests.
Given the state of emergency, the U.S. Food and Drug Administration allowed companies to bring antibody tests to market without its approval. These companies still have to notify the FDA tests are being administered and notify customers their test have not yet been reviewed and approved by the FDA.
Still, Blank and his colleagues worry that a lack of independent oversight could lead to skewed data on the extent of this pandemic. Blank said the APHL is cautioning its members to wait until more tests are verified by the FDA before collecting large amounts of data and then using that data to make a decision.
Also, APHL’s director of infectious diseases, Dr. Kelly Wroblewski worries potentially inaccurate tests could lead to a false sense of security.
“I know there’s been talk about using this test to ease restrictions but I do think we need to be cautious when we move in that direction," said Wroblewski.
Until more tests are verified as reliable, Wroblewski said the general public needs to stick to well-known healthcare facilities or labs when getting an antibody test. Plus, Wroblewski said not enough research has been done to determine what level of antibodies are needed to provide immunity or how long that immunity will last.
Officials with the APHL did say they were optimistic the FDA was going to give more tests its Emergency Use Authorization (EUA) designation in the coming days and months. An EUA means a particular test is still under review, but enough results have been verified to deem the test reliable.
Pat and Carol Prokop own Arcpoint labs in Sugar Land, which is part of a nationwide chain. Pat Prokop understands the public’s unease with so many tests flooding the market.
“They’ve done nothing with the FDA, they’ve shown no testing, they’re just launching it out there and saying, ‘Hey, here I am with another test,'” said Prokop.
Arcpoint is a licensed lab using nationally recognized and established protocols, he said. Plus, their parent company is working to earn FDA authorization for its antibody test, Prokop said. He suggests asking several questions before choosing a facility to administer an antibody test.
“What approvals are they going for? What results have they offered up? What kind of protocol are they offering up?” Prokop said.
Christus Healthcare announced Tuesday it has found what it believes to be a reliable antibody test. Officials with the healthcare provider are first administering the tests to its employees, some hospitalized patients and those in need of emergency surgery.
Christus Executive Vice President and Chief Clinical Officer, Dr. Sam Bagchi said he’s concerned many people with on-going health concerns are not getting treatment for fear of contracting the virus.
“People are nervous to get out and get care they need for non-COVID conditions, so that’s, we think antibody testing will be critical to get back to non-COVID healthcare,” said Bagchi.
Bagchi said Christus has been working with the FDA and expects their test will soon be given EUA. Christus also announced Houston-based Healgen Scientific is the manufacturer of its tests.
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