The LA County Department of Health Services (DHS) announced Sunday that it will discontinue the use of the Curative COVID-19 PCR tests at county-run pop-up testing sites. The change, which will take place this week, comes nearly a week after the U.S. Food and Drug Administration warned of the risk of false negative results with the Curative test.
In its warning, the F.D.A. recommended that collection of specimens be limited to symptomatic individuals within 14 days of first experiencing symptoms and done at the direction of a trained health care worker. Health care providers were even told to “Consider retesting your patients using a different test if you suspect an inaccurate result was given recently by the Curative SARS-Cov-2 test.”
According to the Los Angeles Times, “In June, L.A. County discontinued its use of Curative’s oral swab testing at its main testing sites. Public Health Director Barbara Ferrer said at the time that nasal tests produced fewer false negatives.”
However, Curative provided a limited number of tests at county-supported pop-up testing sites beginning in mid-December. Between Dec. 13, 2020 and Jan. 2, 24,241 Curative tests were administered at those sites. That made up about 10% of all COVID-19 tests administered at county-supported test sites during that same time frame. The Curative tests will be replaced with Fulgent Genetics tests.
In a statement, Curative defended its tests. “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. “The test performance and labeling, however, have not changed, nor has the company observed any changes in test performance. We have been working with the agency to address their concerns and these limitations, and we will continue to work interactively with FDA through the Emergency Use Authorization.”
All COVID-19 tests have a risk of false negative results, which means that you may test negative when you actually have COVID-19. That is because the sensitivity depends on how well the sample was collected and the concentration of viral RNA in the sample. “There is no reliable way to detect early infection, meaning that infection often spreads before symptoms develop,” county officials said in a statement. “Nevertheless, PCR tests, including the Curative test, remain better at detecting disease than other tests, including rapid tests.”
If you cannot get a test through a health care provider, find a test site near you through the L.A. County testing website. Even if you test negative, you should self-isolate for 14 days after exposure or 10 days after symptoms start. You may still have COVID-19 and spread it to others.