FDA Warns About Risk for False Negatives From Curative COVID Test

Doug Brunk

Disclosures

January 05, 2021

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

The US Food and Drug Administration (FDA) has issued a safety communication about the potential for false results from a rapid COVID-19 test from Curative Inc, which is being used in Los Angeles and other large metropolitan areas in the United States.

The real-time reverse transcription polymerase chain reaction (PCR) test was developed by Menlo Park, California–based healthcare start-up Curative Inc. Results are analyzed by the company's clinical lab, KorvaLabs Inc. The test, which is authorized for prescription use only, received emergency use authorization from the FDA on April 16, 2020. By November 9, the company had processed 6 million test results, according to the company.

The FDA alert cautions that false negative results from any COVID-19 test can lead to delays in or the lack of supportive treatment and increase the risk for viral spread.

To mitigate the risk for false negatives, the agency advises clinicians to perform the Curative test as described in the product's Fact Sheet for Healthcare Providers. This includes limiting its use to people who have had COVID-19 symptoms for 14 days or less. "Consider retesting your patients using a different test if you suspect an inaccurate result was given recently by the Curative SARS-Cov-2 test," the FDA alert states. "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."

The alert also notes that a negative result from the Curative PCR test "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."

According to a press release issued by Curative on October 7, its PCR test is being used by the Department of Defense, as well as the states of Alaska, California, Colorado, Delaware, Florida, Georgia (Atlanta and Savannah), Illinois (Chicago), Louisiana, Texas, and Wyoming. The company also operates CLIA-certified laboratories in San Dimas, California, Washington, DC, and Pflugerville, Texas.

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