SANTA MARIA, Calif. - Hardy Diagnostics is importing thousands of COVID-19 antibody test kits from China to help patients across the country.
“The benefit of these kits is that it tests for the antibodies in the blood stream that the patient develops in response to the Covid infection,” said CEO and President Jay Hardy with Hardy Diagnostics.
Dr. Kevin Ferguson with Marian Regional Medical Center says the hospital is already using these tests on patients. “Antibody tests will tell you that if you had an illness a week or two ago, it will help you determine whether or not the prior illness was COVID-19.”
Ferguson notes that these antibody tests can not be used to diagnose active disease, but rather provide information on whether you’ve had COVID-19 in the past.
"Active disease needs to be diagnosed by a molecular technique known as PCR," said Ferguson.
The tests have not yet been approved by the FDA.
“The tests have emergency use authorization by the FDA. They’re not considered cleared or approved. So it’s important that they are interpreted in the context of clinical findings by medical professionals who consistently monitor the performance characteristics of the test,” said Ferguson.
The tests are designed to let people know if they may have had COVID-19.
“Have they been exposed before or have they never had the disease? This kit will help tell them that information,” said Hardy.
Hardy Diagnostics will import more than 10,000 antibody kits this week to be distributed across the country.