FDA warns COVID-19 test could produce false negatives. It's used at 100+ sites in California

FDA warns COVID-19 test could produce false negatives. It's used at 100+ sites in California More than 100 California COVID-19 testing sites could be producing false-negative results, according to the FDA. Nicole Hayden USA TODAY

More than a hundred COVID-19 testing sites throughout California could be producing a substantial number of false-negative results, according to the U.S. Food and Drug Administration. 

The FDA released a statement this week alerting patients and health care providers to the risk of false results with a particular type of SARS-Cov-2 test from Curative, a start-up medical testing company founded in 2020.

According to Curative's website, it has more than 100 testing sites scattered throughout California, including large clusters in the Inland Empire, Bay Area and Los Angeles County. Some of those sites are in partnership with local counties.

As the Curative tests are self-administered, there is a chance of the swab not being conducted properly, leading to inaccurate results, according to the FDA.

A false-negative test could mean individuals do not self-isolate, leading to increased spread of the virus within the community.

Curative issued a statement this week defending its test: "Curative's test has been validated and is being offered during the pandemic under an Emergency Use Authorization, and is labeled with specific warnings, precautions and limitations that FDA reiterated in the safety communication,'' the company said. ...