Antibody test gets emergency OK
Bio-Rad is first Bay Area firm to receive such an authorization.
A Hercules company has received emergency use authorization from the U.S. Food and Drug Administration for an antibody test that could help determine who has been infected by the coronavirus.
BioRad Laboratories is the first Bay Area company to receive such an authorization for an antibody test from the FDA, according to the agency’s website. Nine antibody tests have been granted similar authorizations. In a letter to BioRad, the FDA said emergency use of its test is “limited to authorized laboratories.”
The serological, or bloodbased, tests are designed to detect antibodies produced by the body in response to coronavirus infection. They are seen as key to eventually determining the extent of previous infection in communities, which could help determine the risk of future outbreaks.
However, it is not yet clear how long coronavirus antibodies remain in the body after infection or whether the antibodies can prevent reinfection and provide possible immunity to the virus. Experts have said it may still be too early to fully interpret the results of antibody testing.
BioRad said in a news release that it produced a “total antibody test,” which checks for several
“The total antibody test approach enables detection of antibodies in the majority of patients eight days after the onset of symptoms, versus an IgGonly approach.”
Dara Wright, executive vice president of BioRad clinical diagnostics group
major antibodies that can appear at different stages of response to infection. One other total antibody test has received emergency use approval from the FDA, per its website. Four tests that have received an emergency authorization test for only the antibody IgG, which can take time to form after an infection.
“The total antibody test approach enables detection of antibodies in the majority of patients eight days after the onset of symptoms, versus an IgGonly approach,” Dara
Wright, executive vice president of BioRad’s clinical diagnostics group, said in a statement.
BioRad said its test showed diagnostic sensitivity (ability to correctly diagnose the presence of the virus) of 98% and specificity (accuracy of negative results) of 99% in clinical evaluation.
In its letter to BioRad, the FDA wrote that based on evidence, “it is reasonable to believe that your product may be effective in diagnosing recent or prior infection with SARSCoV2 by identifying individuals with an adaptive immune response to the virus that causes COVID19.”
The letter also specifies the test has not been FDAapproved. The authorization will be effective until the end of the declared public health emergency.
On its website, the FDA states it may allow nonapproved products “to be used in an emergency to diagnose, treat, or prevent serious or lifethreatening diseases or conditions ... when there are no adequate, approved, and available alternatives.”