FDA issues warning over Curative self-administered tests

FDA issues warning over Curative self-administered tests

Olivia Sandusky

The drive-thru self administered tests found at the La Quinta Wellness Center, Indio Fairgrounds and Rancho Mirage Library are all from Curative Inc. 

This week, the FDA posted a warning saying curative tests run the risk of “false results, particularly false negatives.”

One reason listed was due to the way the tests are given.

“If the swab is not obtained correctly, one runs the risk of having a false negative test, meaning that you really do carry the virus but the swab was not obtained correctly and therefore the result are negative,” said Dr. Mark Casanova, specialty internal medicine at Baylor Scott and White. 

The testing sites in Indio, Rancho Mirage, and La Quinta have all partnered with Curative Inc. within the last few months.

Hundreds of patients are tested daily, and experts say, false negatives can lead to community spread.

“People take a negative test as they don’t have covid, they do not need masking, and they do not have to change their behavior. That is not how these tests should be read,” said Dr. Alan Wells, a pathologist with the University of Pittsburgh. 

The FDA’s alert also says the risk can be eliminated if the test is carried out correctly, and Curative provides informational videos to help with the process.

“Let’s watch the oral collection instructions video together and pause along the way so you know what to look for,” team member Jay says in one video.

Patients are urged by the FDA to talk to their doctors about getting retested if they suspect their results are inaccurate, and experts say other precautions may need to be taken.

“I believe that it’s good to get tested. But it is hard to rely upon those results.  It could have been too early in the course where the results weren’t positive yet.  I would recommend just staying home with your isolated family and not moving into large parties,” said Dr. Edgar Bulloch, the Chief Medical Officer with Borrego Health. 

On Tuesday, the Riverside County Public Health System released this statement:

“Positive test results from PCR tests, including Curative’s self-administered test, are almost always correct. Self-administered tests, regardless of the vendor, have more potential to create false negative results compared to tests administered by a health professional.

This is because sometimes people don’t follow the instructions precisely, even though they intend to do so. If there isn’t enough of viral material in the sample for any reason, it won’t be positive.

Staff members are available to explain the process to ensure residents perform the self-administered test correctly. It’s important to remember that you can be negative one day and positive the next, even with the gold standard PCR swab test and even if the test is done according to instructions.

I don’t recommend everyone who did a Curative test and tested negative be immediately retested. If someone close to you is positive and you aren’t, or you start getting sick but you recently tested negative, I would strongly advise you consider getting tested again.

Please continue to observe all the precautions with good hygiene, social distancing and facial coverings, and stay home if you’re sick.”

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