SAN FRANCISCO (CBS SF) — The coronavirus antibody test could be critical in reopening the country and economy, but many experts say these tests are often inaccurate.
The test is center to what researchers are calling “herd immunity” and supposed to give an indication if a person has been exposed to the disease and has antibodies circulating in their blood targeting the virus.
However, the growing concern is the accuracy of these tests, especially those from companies that don’t have the proven experience or quality control. The Food and Drug Administration has allowed about 90 companies to sell their antibody tests.
“It’s going to be a mess and confusing until we figure out which of these tests are performing at a high level,” said UC Berekeley Epidemiologist Art Reingold.
The FDA loosened its standards in mid-March as the coronavirus outbreak grew, allowing companies to sell without submitting any evidence that they actually work.
“A lot of new companies have no experience building diagnostic based tests and they just rush through quality checks without much research. Those are the ones that are going to have problems,” said ModMab Therapeutic’s Jagath Junutula, who’s been studying antibodies for decades.
Junutula says he’s concerned about the number of companies flooding the market.
“Companies are putting on their websites to go buy these tests and it’s gonna be a problem,” said Junutula.
“Performance assessments for serological tests will begin soon, and we expect to start seeing results shortly thereafter,” said the FDA in a statement issued on Saturday.
Some companies are offering ten-to-fifteen minute tests in the range of $125 to $200 including one based in the Bay Area. Some of the tests are lab based. Others tests are not.
“These tests are under development. They’re not really ready for use in a clinical setting. I personally do not recommend people get tested at this point in time,” ,” said Reingold.
“The quality check has to happen before released to customers, quality control is the key,” said Junutula.
Experts say the danger of inaccurate tests is they can end up putting people at risk of contracting the disease and transmitting it to others.