AUSTIN (KXAN) — The Food and Drug Administration warned patients and healthcare providers that some of Curative's COVID-19 tests may be indicating people do not have the coronavirus when they really do. Curative said it is working with the FDA but is confident in its data.
"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. Its website says it has 90% clinical sensitivity with results in 48 hours that come from KorvaLabs, Inc. In December, people lined up at the Palmer Events Center in Austin for Curative tests. The Texas Department of Criminal Justice uses the tests in prisons as well.
The FDA approved 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's also says the test is supposed to be used for people who have had symptoms arise within 14 days of testing. It recommends 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. Patients with concerns about their Curative results can contact their doctors.
"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. It asks anyone who's had an issue with the Curative test to report it to the FDA.
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