S.E. Williams | Executive Editor
Earlier this week, the U.S. Food and Drug Administration (FDA) alerted patients and health care providers of the risk of false results, particularly false negative results with the Curative COVID-19 test.
According to the FDA communications, “Risks to a patient of a false negative result include delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of the spread of COVID-19 within the community, or other unintended adverse events.”
The agency advised, to reduce the risk of false negative results, it is important to perform the test in accordance with its authorization and as described in the authorized labeling. See Fact Sheet for Healthcare Providers.
“When the test is not performed in accordance with its authorization or as described in the authorized labeling, there is a greater risk that the results of the test may not be accurate,” officials stressed.
FDA also provided this important information for health care providers, patients, and caregivers regarding the use of the test as follows: The collection of nasal swabs and oral fluid specimens is limited to symptomatic individuals within 14 days of COVID-19 symptom onset; specimen collection must be directly observed and directed during the sample collection process by a trained health care worker at the specimen collection site; and, a negative result 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.
Patients are encouraged to talk to their health care provider if you think you were tested with the Curative COVID-19 test—the name displayed on the Fact Sheet that must be provided to individuals with his/her test result report reads Curative SARS-Cov-2 test.
Report any problems experienced with the Curative SARS-Cov-2 test to the FDA, including suspected inaccurate results to the FDA at 1-866-300-4374 or 301-796-8240. The line is open 24 hours a day, every day of the week.
On Sunday, January 10 the Los Angeles County Department of Health announced it would discontinue use of the Curative test at its pop-up testing sites. According to reports, the change was scheduled to begin this week.
Riverside County who has contracts with Curative, said it is reviewing the FDA advisory and in the meantime, according to county spokesperson Brooke Federico in an email to SCNG, said it plans to continue using the test.