CDC confirmed the problems with the coronavirus test, and with using its flu-surveillance network to screen for the virus. But the agency declined to answer further questions on the matter.
The delay in establishing additional screening capacity could impede the U.S. government’s ability to detect scattered cases before they snowball into larger outbreaks, former FDA Commissioner Scott Gottlieb told POLITICO.
“By that point, it may be harder to contain spread, and we’ll be forced to rely on mitigation tactics to just limit the impact of the virus,” he said.
More than 75,000 cases of coronavirus infection have been confirmed globally as of Thursday, and more than 2,100 people have died, according to the World Health Organization. The vast majority of cases are in China, where the virus first emerged, although countries such as Japan, South Korea and Iran are also battling local outbreaks.
In the United States, efforts to expand use of the CDC test have struggled after one of the three reagents upon which the test depends delivered inconclusive results during quality checks, said Kelly Wroblewski, APHL’s director of infectious diseases. Samples that test positive at any of the three labs are still being sent to CDC for retesting.
CDC has not told public health labs when it will distribute a second version of the diagnostic test, Wroblewski said. That has left many labs struggling to decide if it is worth continuing to pursue verification of the current version, because they will have to go through the process again once the CDC revises its testing procedure, she added.
Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, told reporters on Feb. 14 that the public health agency is reformulating the original test and is moving quickly to get the revised version to labs. FDA would have to authorize any changes to the coronavirus test before the CDC could distribute a new one.
But concerns about money also threaten the rollout of state and local coronavirus testing. Over the weekend, more than 20 Senate Democrats called for additional cash after Trump administration officials told senators during a Feb. 12 briefing that HHS would soon exhaust existing funding for its response to the virus.
“We strongly urge the administration to transmit an emergency supplemental request that ensures it can and will fully reimburse states for the costs they are incurring as part of this response,” the senators wrote in a letter to HHS Secretary Alex Azar and OMB Director Mick Mulvaney.
The diagnostic test can cost up to $250 to run, depending on procedures and volume of tests a lab performs, according to Wroblewski. But it is unclear who is paying for personnel costs and other items such as personal protective gear, machines to extract RNA and sample transportation, according to APHL.
“This is a national-level response, so we would hope the federal government would have an interest in supporting a national-level response,” Kyriacopoulos said. “Labs are much more interested in beginning to get the work done. But figuring out how to pay for it is not far behind.”