HometownMcLennan County


FDA warns Curative COVID-19 tests can produce false negatives

Administered in Waco between Nov. 30 - Dec. 23
COVID Testing
Posted at 3:35 PM, Jan 07, 2021
and last updated 2021-01-07 16:35:48-05

WACO, TX — The FDA has issued a warning to health care providers and those who have received a Curative SARS-Cov-2 COVID-19 test after it was reported that several tests administered under the brand produced a number of false negatives.

Curative tests were last administered in Waco between November 30, 2020, and December 23, 2020, meaning anyone who might have produced a false negative should no longer have the virus because it's been 14 days since the last test was given.

However, Kelly Craine with the Waco-McLennan County Public Health District says this is the exact reason we need to be in tune with our bodies.

"That's why we always say if you're feeling those symptoms, whatever your testing situation is, make sure you respond to those symptoms," she said.

It's a tricky science and all about timing when receiving a COVID-19 test.

"I've known people who have tested and then the day after they started feeling symptoms," Craine said.

Since it's nearly impossible to tell if your COVID-19 test is a false negative, the FDA says it's important to be inquisitive about which test you're receiving.

Amy Mersiovsky, Director of the Dept. of Nursing at Texas A&M University Central Texas, says although the FDA is reporting that false negatives are possible with the Curative test, it isn't enough to stop administering them.

"The FDA tries to track any adverse outcomes and the providers can make those reports on the FDA website. If there is enough data, the FDA can decide to change the emergency use authorization," she explained.

With the FDA's emergency use authorization, the Curative test can still be administered until enough false negative reports come in. Patients can be re-tested within two weeks of the first test to determine if a false negative is possible.

"That would clue the health care profession that my patient probably had a false negative," Mersiovsky said.

The provider should then report the false test to the FDA. This is why it's important for the patient to be aware of how they feel, COVID-19 symptoms or not.

"Still contact your doctor. There may be another issue. It's important if you're not feeling well to see your doctor, whatever the cause is," Craine said.

The FDA has given the following tips for both health care providers, patients and caregivers about the Curative COVID-19 Test:

Be aware of the important information regarding the use of the Curative SARS-Cov-2 test, which is described in the test’s authorized labeling, including the following:

  • Collection of nasal swabs and oral fluid specimens is limited to symptomatic individuals within 14 days of COVID-19 symptom onset.
  • Specimen collection must be directly observed and directed during the sample collection process by a trained health care worker at the specimen collection site.
  • 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.
  • Health care providers: Consider retesting your patients using a different test if you suspect an inaccurate result was given recently by the Curative SARS-Cov-2 test. If testing was performed more than two weeks ago, and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.
  • Patients and caregivers: Talk to your health care provider if you think you were tested with the Curative SARS-Cov-2 test (the test name is displayed on this test’s authorized Fact Sheets and, generally, the Fact Sheets must be provided with test result reports) and you have concerns about your test results.
  • Report any problems you experience with the Curative SARS-Cov-2 test to the FDA, including suspected inaccurate results.