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Curative COVID-19 test can have ‘false negative results,’ FDA warns

Coronavirus

AUSTIN (KXAN) — Curative said Wednesday its COVID-19 test performance and labeling have not changed, in response to a Food and Drug Administration warning that some of Curative’s tests may be indicating people do not have the coronavirus when they really do.

The FDA’s notice posted on Monday urged healthcare providers to consider having their patients get “re-tested” if they received a test from this company recently.

Curative said Monday it is working with the FDA but is confident in its data. On Wednesday it said its test has been validated and is being offered under an Emergency Use Authorization. It reiterated that it “is labeled with specific warnings, precautions, and limitations that FDA reiterated in the Safety Communication.”

“Testing sensitivity and accuracy on behalf of our patients is at the heart of our work. Curative will be providing additional updates and information soon,” Curative CEO Fred Turner said in a statement.

The free Curative test is used at standalone kiosks and mobile vans throughout Texas. Those who visit them set up an appointment and then self-administer the test by swabbing inside their mouths.

Alana Goycochea has taken two tests from Curative and said the process was much quicker and easier than other COVID-19 tests she had taken over the last year. Plus, for her husband, the oral swab given by Curative was not as uncomfortable as the nasal swab administered by some tests. Still, she said the accuracy of a test was their main priority.

“It’s so scary for people because, of course, you want to know — especially with a condition where you very well may not have any symptoms, but may still be spreading it,” she said. “You’re getting that test for that peace-of-mind, so that you are not possibly harming those around you. So, that is really concerning.”

Its website says it has 90% clinical sensitivity with results in 48 hours that come from KorvaLabs, Inc. Stephanie Whittle, a spokesperson for the company in Texas, reiterated that 90% accuracy rate in an interview with KXAN in November.

In the summer, Texas Department of Emergency Management (TDEM) launched the Curative oral swabs at many of their mobile sites as a way to increase testing capacity in the state. Seth Christensen, a spokesperson for the agency, told KXAN at the time that the Curative test increases the state’s testing capacity by 25,000 tests a day.

By December, people were lining up at the Palmer Events Center in Austin and other spots for Curative tests. Whittle said Curative was testing 35 to 45,000 people each day across the state.

A map on Texas.gov shows you where you can get these tests, along with other COVID-19 tests. Right now, several Curative testing operations are still operational, according to this map.

A spokesperson for Austin Public Health said Austin-Travis County has a testing relationship the Curative testing site in Pflugerville, but noted that site was managed by the TDEM. They could not tell us how many people locally had been administered these tests.

Earlier this year, Texas Department of Criminal Justice utilized these tests in prisons across the state as well.

A spokesperson for TDEM said they would be monitoring findings and data released by the FDA and Curative. They said Curative was “only one of the multiple COVID-19 tests utilized by the state pursuant to the FDA’s Emergency Use Authorization.”

The FDA authorized the Curative test in April but says it regularly monitors testing after they’ve been authorized.

“Risks to a patient of a false negative result include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events,” the FDA wrote in a release.

The FDA said it’s important tests are performed correctly to reduce the risk of false results, including having a healthcare provider observe people collecting samples. It also said the test is supposed to be used for people who have had symptoms arise within 14 days of testing.

“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 said Wednesday.

The FDA on Monday recommended healthcare providers use a different test if they suspect recent results may not be correct, but those who were tested more than two weeks ago don’t need to be retested unless they suspect they may have the virus.

“A negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. A negative result does not exclude the possibility of COVID-19,” the FDA wrote.

Houston emergency physician and President of the Texas Medical Association Dr. Diana L. Fite said their association was aware the FDA had raised concerns about curative’s tests.

With cases in Texas breaking records, she said, “This highlights that testing alone won’t get us out of this. We still need to rely heavily on masking, social distancing, hand hygiene, and vaccinating as many Texans as we can.” 

The FDA notice asks anyone who’s had an issue with the Curative test to report it to the agency. Patients with concerns about their Curative results were also encouraged to contact their doctors.

KXAN has reported in the past, the cost of the test is covered by compensation from the CARES Act — making the test free for the public. Insurance is not required but those who do have insurance will be asked to provide it. The insurance will be billed but company representatives said the person getting tested will not get billed because it is covered by the federal government under the CARES Act.

Goycochea chose the tests mostly for their convenience, but she said the fact that it was free was a major bonus. She said she worried about what this means for people who need access to testing, but can’t afford to pay for a different company or brand’s test.

“They are relying on Curative,” she said.

Copyright 2021 Nexstar Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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