New data submitted to FDA proves rapid antigen test at Texas MedClinic to be as accurate in detecting COVID-19 as PCR test
July 31, 2020
Quidel COVID-19 rapid antigen test, PCR test results match 96.7 percent of the time
COVID-19 rapid antigen test manufacturer Quidel presented updated data to the U.S. Food and Drug Administration (FDA) for continued Emergency Use Authorization (EUA) that shows the rapid antigen test to be as accurate as the PCR test in detecting COVID-19.
Quidel was the first manufacturer to receive EUA from the FDA for a rapid antigen test on May 8. Named Sofia® 2 SARS Antigen FIA, the rapid point-of-care test uses a fluorescent immunoassay analyzer for the rapid detection of SARS-CoV-2 in a nasal or nasopharyngeal specimen.
In Quidel’s original FDA EUA, the rapid antigen test was 100 percent accurate with positive tests as compared to PCR, but negative tests were less accurate than a PCR test. Further studies have validated that the Quidel Sofia® SARS Antigen FIA offers sensitivity, or accuracy of negative tests, that is comparable to PCR. The PCR test is not 100 percent accurate with negative results but is considered the current standard for COVID-19 testing.
Both PCR and antigen tests are most accurate 5 days after the onset of symptoms or 8 days after exposure.
South and Central Texas urgent care provider Texas MedClinic has been on the frontlines of COVID-19 testing since the onset of the pandemic. Due to extensive backlog in PCR test results, the urgent care provider began searching for an alternative COVID-19 test that was accurate and fast. The Quidel rapid antigen test, which provides results in 15 minutes, was unveiled at all 19 clinics on May 20. Since that time, over 65,000 COVID-19 rapid antigen tests have been administered at the clinics, testing an average of 1,200 people each day.
“We have used Quidel’s rapid flu and strep tests for over a decade and trust their diagnostic technology. Providing patients with results in 15 minutes allows our physicians to provide medical direction and counsel on isolation and quarantine immediately, which is paramount in keeping the virus at bay,” said Texas MedClinic Chief Operating Officer and practicing physician Dr. David Gude. “We knew the rapid antigen positive tests were 100 percent accurate. The new data shows the Quidel rapid antigen test results, both positive and negative, match that of the PCR test 96.7 percent of the time. That means we can have the same confidence we would have with a negative test result from a PCR test.”
Gude emphasizes that there is not perfect test that is 100 percent accurate in both negative and positive tests for COVID-19, including the PCR test. “In comparison, flu tests on average are 75 percent accurate,” said Gude. “Regardless of test results, those who are symptomatic or who have been exposed must take the appropriate steps to isolate.”
Texas MedClinic continues to work closely with local health authorities in the counties where they have clinics, sharing data and results, as well as assisting with testing needs. Texas MedClinic was proud to partner with San Antonio Metropolitan Health District and Southwest Regional Advisory Council to provide free drive-thru testing for uninsured patients at their clinic located on SW Military Drive until the city rolled testing back to the Freeman Coliseum.
COVID-19 rapid antigen testing is available for both symptomatic and asymptomatic individuals. Asymptomatic patients must check-in online, expediting the testing process. Symptomatic patients may register online to reduce their wait, but if no available time slots are open, they can still walk in for evaluation and testing. Cost for a doctor visit/consultation and the rapid antigen COVID-19 test are covered by insurance plans.
“With the surge in COVID-19 cases in our region, our clinics have seen unprecedented volume from those wanting a rapid antigen test. We understand that people are anxious to be tested or seen by a doctor; we just ask for patience as we try fit everyone in. Our goal is to keep our South, Central Texas community well, helping health authorities prevent the spread of the virus, by providing efficient, effective, and compassionate medical care,” said Gude.
Consistent with the CDC and San Antonio Metropolitan Health Department, Texas MedClinic is encouraging the community, patients and staff to continue social distancing of 6 feet from another person, wear masks, continue frequent hand washing for at least 20 seconds, and disinfect high-touch areas to curb the spread of the virus.16