SAN ANTONIO — While a negative COVID-19 test is usually accompanied by a sigh of relief, the Food and Drug Administration on Monday warned a specific type of test being administered at free testing sites throughout San Antonio could return false results.
The FDA’s warning highlighted the "risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test.” According to the City of San Antonio’s website, more than half of the free testing locations in the city are Curative kiosks.
Dr. Ruth Berggren, a professor of medicine and infectious diseases specialist at UT Health Science Center San Antonio’s Long School of Medicine, said the Curative test should not be written off as a “fly by night” test. She said the test, like any, is only effective when used correctly.
Berggren also noted that Curative tests should be administered to individuals who have symptoms of COVID-19, and the individual should submit to testing within 14 days of the onset of their symptoms. She said the test also needs to be administered under observation and appropriately.
KENS 5 observed Curative patients on Wednesday being directed and observed throughout the administration of their tests, as required by the FDA.
“Some of our laboratory experts think that as time has gone by and with the increased volume of people, that maybe the observation of the person collecting the swab or the instructions have gotten a little bit less stringent,” Berggren said. “That also contributes to the concern about rising false negativity rates for this test.”
While the FDA states the test is intended for individuals who are symptomatic, the City of San Antonio’s list of testing locations is separated by locations that are free and locations that may vary in cost for individuals who do not have health insurance. There is no mention of the fact that the eight free, privately-run Curative locations across the city are for individuals who are symptomatic.
However, for city-run testing sites, such as the AT&T Center, Cuellar Community Center, Freeman Coliseum and Ramirez Community Center, there is a differentiation between symptomatic and asymptomatic individuals.
Dr. Colleen Bridger, who is both the assistant city manager and interim director of Metro Health, said the city-run testing sites administer the Curative tests as prescribed under the FDA’s emergency use authorization: to individuals who are symptomatic.
“Per the FDA’s emergency use authorization of these tests, the city has been using Curative tests for symptomatic individuals,” Bridger said in an emailed statement. "We intentionally partnered with Community Labs to provide testing for asymptomatic individuals at our no-cost test sites.”
Berggren advised people who are seeking testing to avoid submitting to a Curative test if they are not experiencing symptoms of COVID-19.
“If you have symptoms, it is valuable to get a Curative test and there's nothing wrong with it,” Berggren explained. “But please don't get a Curative test if you're asymptomatic because it's not going to mean anything unless it's positive. If you're asymptomatic and you get a positive Curative test, you can still believe that. You just can't be confident of it if it comes back negative.”
A spokesperson for Curative said via e-mail Wednesday that “Curative has the most clinically sensitive test available at scale.”
Read the full statement from Curative:
“Curative’s test has been validated and is being offered during the pandemic under an Emergency Use Authorization, and is labeled with specific warnings, precautions, and limitations that FDA reiterated in the Safety Communication. The test performance and labeling, however, have not changed, nor has the company observed any changes in test performance. We have been working with the agency to address their concerns and these limitations, and we will continue to work interactively with FDA through the Emergency Use Authorization process.
We understand that the Safety Communication seeks to ensure that Curative’s test is administered and performed according to the labeling and limitations in the EUA.
Curative will continue to work actively with FDA to provide additional data required to address the limitations and precautions. Curative remains committed to following FDA and CMS regulations in the development, testing, and use of our Emergency Use Authorized test, and in providing medical devices and services that meet or exceed our customer's expectations operating in accordance with these requirements.”
Berggren said those who get a positive result from a Curative test, even if asymptomatic, should trust the positive result, as positive results are highly reliable.
The FDA advises health care providers to administer a different test if they suspect their patient received an inaccurate result. The agency also encourages patients to talk to their health care providers if they have concerns about their Curative test results.