Health officials in California's San Diego County ordered a "pop-up" drive-through COVID-19 testing operation to shut down out of concern its tests "may not be producing reliable and verifiable results" and "may exacerbate the spread of COVID-19 ... (which) places the public's health at risk."
The county asked the clinic to produce information about the tests it was using, including its CLIA (Clinical Laboratory Improvement Amendments) certificate and to submit test results to the county health officials.
"We have yet to get that information, so we issued an order asking them, or directing them to no longer do that test," said Eric McDonald, MD, MPH, medical director of the county's epidemiology and immunization branch. "We were concerned that their rules and regulations weren't being followed according to state law."
reportedly sprang up Monday in a MiraCosta College parking lot in Cardiff. Its website advertised that the clinic offered both nasopharyngeal viral PCR tests for $125, with test results available within two or three days, and a "finger poke" COVID-19 IgM and IgG serology antibody test for $75, with partial results in 15 minutes, telling "if you have antibodies to COVID-19." One could get both tests for $175.
Eligible candidates paid money online in order to get an appointment, and then waited in long lines to get through the testing tents. The clinic's website said customers "may be able to submit this for reimbursement from the government or your insurance, but we cannot guarantee this."
Through mid-afternoon Wednesday, dozens if not hundreds of cars lined up in front of several white canopies, as numerous COVID Clinic staff members processed documentation from each passenger seeking the test. One of them who was not identified said the test was "90% accurate" but could not say who made the test, or who processed the specimens.
California isn't the only state dealing with potentially bogus COVID-19 testing sites. In Louisville, Kentucky, officials called and were using dangerous procedures such as not changing gloves after testing each person. Indiana's attorney general also about fake tests.
Public Health at Risk
In addition to asking the owners of to shut down, the county , ordering the college to shut the operation down.
"We have concerns that COVID Clinic's testing process is not complying with State law and therefore may not be producing reliable and verifiable results," the letter said. "Numerous people have paid for the tests at your campus and are presumably relying on the veracity of the tests. Public reliance on such test results, and the failure of COVID Clinic to report such tests, may exacerbate the spread of COVID-19, and due to the severity of the pandemic this places the public's health at risk."
The action was taken on behalf of and at the request of the California Department of Public Health, the agency with enforcement powers, but which did not have inspectors to cover the whole state, he said.
The information is necessary to assure that the test is useful, which is "when it's positive, it really means positive and when negative it really means negative," McDonald said.
"It appears that these tests are not fully vetted, and are not being conducted in accordance with guidelines and communication with officials," said Ted Mazer, MD, a past president of the California Medical Association. "We need to be sure that testing such as this is done accurately, so that it is meaningful for the patients who choose to avail themselves of it."
"We need to know the information given is accurate. False information can be injurious," Mazer added.
'I Would Get Out of Line'
The county apparently had the most concern about the antibody tests and the laboratory that was conducting them. But when asked Wednesday afternoon why the tests were still being administered, and if it was okay if they still offered the nasopharyngeal swab tests, McDonald said sharply, "I can tell you my reaction: that is, if I were in line waiting for a test, I would get out of line."
McDonald said that the antibody test the clinic may have been offering may have indicated whether someone was exposed to a coronavirus, but "there are other coronaviruses that may cause what we call cross reactivity, that is, if you were exposed to a coronavirus that causes the common cold. Serology might tell you just that and not what you really need to know about this specific virus. That requires some very sophisticated laboratory work."
County officials said they would make sure by Wednesday night that the operation had shut down, at least until it could verify the validity of the testing procedures it was using, and began reporting results of the tests to the county so that public health prevention measures could be taken. "They shouldn't be doing either of these tests," McDonald said.
The FDA has to date authorized three COVID-19 antibody tests, two of them on Wednesday. Notably, the agency is allowing serology tests to be as long as the manufacturer attests to having validated them.
McDonald emphasized that if and when the COVID Clinic organizers produce valid documentation, they could resume the operation.
The COVID Clinic, whose website said it was run by Matthew Abinante, DO, of Elevated Health in Huntington Beach, California, did not return calls requesting comment on Wednesday, nor did Elevated Health. It is not known whether a similar clinic operating in Orange County, also listed on the COVID Clinic website, is still operating.
It is also not known if any of the clinic's customers will ask for, or will get, any of their money back.