Self-administered Covid-19 tests used at valley sites can have ‘false negative results’, FDA warns
A new alert from the FDA is warning of potentially inaccurate results from self-administered Curative tests, including those from testing sites in Indio, Rancho Mirage and La Quinta.
The Food and Drug Administration wrote Monday that Curative's tests can give "false results, particularly false-negative results" if not performed properly.
Last month, Riverside County made the switch from nasal and throat swab PCR tests to Curative's self-swab PCR tests, which county officials said is a less invasive option.
"There are a number of people who are not as inclined to get an invasive swab at the back of their nose or back of their throat," said county spokeswoman Brooke Federico.
The county hopes that with a more comfortable test, more people will get tested. It's also reportedly shortened the time it takes for labs to return results.
The switch comes at the cost, though, of accuracy.
The county said the previously offered nasal and throat swabs were 98 percent accurate. Curatives self-administered swabs are 90 percent accurate.
In a statement to News Channel 3, Riverside County Public Health Officer Dr. Cameron Kaiser wrote in part: "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."
The FDA's notice urged health care providers to consider having patients "re-tested" if an inaccurate result from a Curative tests is suspected.
"If somebody is sick, experiencing symptoms, and they had a negative result they may want to consider getting another test," Federico said.
Dr. Kaiser's full statement reads:
"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."
