COVID-19 infections from variant strains are quickly spreading across the U.S., but there’s one big problem: Lab officials say they can’t tell patients or their doctors whether someone has been infected by a variant.
Federal rules around who can be told about the variant cases are so confusing that public health officials may merely know the county where a case has emerged but can’t do the kind of investigation and deliver the notifications needed to slow the spread, according to Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.
“It could be associated with a person in a high-risk congregate setting or it might not be, but without patient information, we don’t know what we don’t know,” Hamilton said. The group has asked federal officials to waive the rules. “Time is ticking.”
The problem is that the tests in question for detecting variants have not been approved as a diagnostic tool either by the Food and Drug Administration or under federal rules governing university labs — meaning that the testing being used right now for genomic sequencing is being done as high-level lab research with no communication back to patients and their doctors.
Amid limited testing to identify different strains, more than 1,900 cases of three key variants have been detected in 46 states, according to the Centers for Disease Control and Prevention. That’s worrisome because of early reports that some may spread faster, prove deadlier or potentially thwart existing treatments and vaccines.
Officials representing public health labs and epidemiologists have warned the federal government that limiting information about the variants — in accordance with arcane regulations governing clinical labs — could hamper efforts to investigate pressing questions about the variants.
The Association of Public Health Laboratories and the Council of State and Territorial Epidemiologists earlier this month jointly pressed federal officials to “urgently” relax certain rules that apply to clinical labs.
Washington state officials detected the first case of the variant discovered in South Africa this week, but the infected person didn’t provide a good phone number and could not be contacted about the positive result. Even if health officials do track down the patient, “legally we can’t” tell him or her about the variant because the test is not yet federally approved, Teresa McCallion, a spokesperson for the state department of health, said in an email.
“However, we are actively looking into what we can do,” she said.
Lab testing experts describe the situation as a Catch-22: Scientists need enough case data to make sure their genome-sequencing tests, which are used to detect variants, are accurate. But while they wait for results to come in and undergo thorough reviews, variant cases are surging. The lag reminds some of the situation a year ago. Amid regulatory missteps, approval for a COVID-19 diagnostic test was delayed while the virus spread undetected.