Marin keeping virus tests despite accuracy warning
FDA said the oral swab could deliver false negative results
A new type of coronavirus test being provided to Marin residents could be generating inaccurate results, according to new guidance from federal officials.
The U.S. Food and Drug Administration warned this month that the tests, made by the biotechnology company Curative, come with a risk of false negative results.
In order to reduce the risk of inaccurate results, the tests should only be given to people with symptoms of coronavirus, the FDA said.
The tests, which use an oral swab, can be self-administered by patients. But the FDA warned that “specimen collection must be directly observed and directed during the sample collection process by a trained health care worker.”
“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 department’s guidance says.
While the FDA warning led Los Angeles County officials to stop providing the tests to residents there, Marin County’s health department said it will continue to offer Curative testing.
Health officials announced last month that Marin County had partnered with Curative to offer up to 500 of the company’s tests per day to anyone, regardless of whether they have health insurance or symptoms of the virus.
The free tests are being provided at seven locations in Bolinas, Larkspur, Novato, San Anselmo, San Rafael and Sausalito.
According to county officials, staff members at the testing sites give each patient a swab. Patients are told to cough before swabbing saliva from the inside of the cheeks and roof of the mouth. The swab is then sealed in a container and returned to the staff, who send them to laboratories for processing.
In an announcement, county officials acknowledged the FDA warning but said that “done properly, Curative’s oral swabbing method has a higher clinical sensitivity than most SARSCoV-2 tests available.”
The announcement said
that Curative tests in Marin “are performed under the guidance of on-site trained test administrators, to ensure the test is conducted in line with FDA-approved directions.”
“We are not abandoning Curative,” Marin County spokeswoman Laine Hendricks said in an email. “Since the start of Curative testing in Marin County, more than 1,000 positive cases have been confirmed using their oral swab test.”
“We know there are people
in our community who are actively infected but remain undiagnosed,” Hendricks said. “Increased testing improves our ability to ascertain additional cases, helping to engage the isolation/quarantine process earlier and prevent further transmission.”
A spokesman for Curative said the company’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 test performance and labeling, however,
have not changed, nor has the company observed any changes in test performance.”
The Curative tests are free for the county, according to Dr. Lisa Santora, Marin County’s deputy public health officer. Curative bills each patient’s health insurance provider. For people who don’t have health insurance, the company seeks reimbursement from the federal government through the Coronavirus Aid, Relief and Economic Security Act, she said.
The schedule for Curative testing sites in Marin:
Bolinas: Mondays, 10 a.m. to 12:30 p.m., Bolinas
Fire Station, 100 Mesa Road Larkspur: Thursdays, 10 a.m. to 4 p.m., Piper Park, 250 Doherty Drive Novato: Fridays, 10 a.m. to 4 p.m., Novato Library, 1720 Novato Blvd. San Anselmo: Tuesdays, 10 a.m. to 4 p.m., United Market, 100 Red Hill Ave. San Geronimo: Mondays, 10 a.m. to 4 p.m., San Geronimo Golf Course parking lot, 5800 Sir Francis Drake Blvd. San Rafael: Mondays and Wednesdays, 8 a.m. to 2 p.m., Tuesdays, Thursday and Sundays, 11 a.m. to 5 p.m., Armory Parking Lot on Armory Drive Sausalito: Wednesdays, 10 a.m. to 4 p.m., Lot #2, 5098 Humboldt Ave.