The Food and Drug Administration on Monday issued an alert to patients and healthcare providers warning them of a risk of false negative results with a SARS-CoV-2 laboratory-based test from San Dimas, California-based Curative.
The agency asserted that the test, to which it granted Emergency Use Authorization in April, must be performed in accordance with its labeling to ensure correct results.
"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," the FDA wrote in a safety communication.
The PCR-based test is authorized for use on throat swab, nasopharyngeal swab, nasal swab, or oral fluid specimens for the detection of nucleic acid from SARS-CoV-2. The FDA statement highlighted that use of nasal swabs and oral fluid specimens is limited to symptomatic individuals within 14 days of COVID-19 symptom onset, and specimen collection must be directly observed and directed during the sample collection process by a trained healthcare worker at the specimen collection site.
"A negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions," the agency said. "A negative result does not exclude the possibility of COVID-19."
The agency further emphasized that the consequences of a false negative result include delayed treatment or lack of supportive treatment, and lack of monitoring of infected individuals and their close contacts for symptoms that can result in increased risk of spread of COVID-19 within the community.
Curative acquired Korvalabs in May and converted its sports doping test facility for COVID-19 testing. The firm has been performing testing for the Los Angeles County Fire Department and Sheriff's Department, the city of Long Beach, the states of Alaska and Florida, and the U.S. Air Force, as well as on samples collected at drive-through testing sites in California and Delaware.
In an email, Curative CEO Fred Turner said that the firm "disagrees with the assessment" made by FDA that the test has performance issues. The firm intends to publish the results of a large clinical trial soon, he said.
This story first appeared in our sister publication, Genomeweb.