Laboratories across the nation at the moment are dealing with potential shortages of key supplies and chemical compounds wanted to run exams for the novel coronavirus, as instances unfold to greater than two-thirds of the states and the worldwide pandemic strains testing assets even additional.
Some lab administrators say they’re already starting to run low of the provides wanted to extract RNA from nasal swabs, a essential preliminary step that’s separate from the hundreds of thousands of check kits that the federal authorities has promised to ship to each state. Others say they’re weighing whether or not to borrow some supplies from different analysis labs that aren’t concerned in creating or operating coronavirus exams.
And some lab administrators are nervous concerning the future availability of the reagents, or chemical components, used within the exams themselves. Several labs have additionally stated that they’ve had hassle getting virus samples which might be wanted to validate the exams to verify they’re correctly figuring out constructive samples.
Public well being officers and well being care suppliers have clamored to get sufficient exams following a botched rollout of testing kits by the Centers for Disease Control and Prevention — and a delay by the Food and Drug Administration in permitting impartial labs to develop their very own check — that led to weeks of delays in detecting the unfold of the virus within the nation.
“The lack of testing in the United States is a debacle,” stated Dr. Marc Lipsitch, a professor of epidemiology on the Harvard T.H. Chan School of Public Health. “We’re supposed to be the best biomedical powerhouse in the world and we’re unable to do something almost every other country is doing on an orders of magnitude bigger scale.”
Today, public well being labs in each state say they’re operating the exams, and tutorial and business labs have been scrambling to extend their capacities to test for the virus.
But Washington, New York and California are main states with lots of of instances, as officers warned once more on Wednesday that the numbers will proceed to rise.
People are additionally reporting that they nonetheless can’t get examined, in some instances as a result of medical doctors and hospitals are evaluating sufferers based mostly on their signs and whether or not these are indicative of the virus or common flu.
The RNA extraction kits “are usually things we wouldn’t ever even wonder if they were running out, because they’re always around,” stated Michael Mina, an assistant professor of epidemiology on the Harvard T.H. Chan School of Public Health. “But in this case, because everyone in the world is trying to extract RNA right now, they seem to be low.”
At the University of California, Los Angeles, the chief of the microbiology part of the medical middle’s scientific lab was so involved about his provide of RNA extraction kits made by the corporate Qiagen that he lately despatched an e mail to colleagues on the college’s analysis labs asking if that they had any. “While our investigators were eager to help, none were using the kit in their labs,” stated Elaine Schmidt, a spokeswoman for the medical middle.
Eric Blank, the chief program officer on the Association of Public Health Laboratories, stated his group has additionally been listening to about again orders of the extraction kits and different provides. Now that impartial labs are capable of run their very own exams, “it is increasing at a very rapid pace,” Mr. Blank stated. “It just depends on how rapidly the manufacturers of some of these other ancillary materials needed to run the tests can ramp up their production.”
Qiagen, a main producer of the RNA extraction kits, stated in a assertion this week that as a result of of the coronavirus outbreak, demand is “challenging our capacity to supply certain products” and that it was growing manufacturing in websites in Germany, Spain and Maryland.
Roche, one other provider of lab supplies and tools, stated in a assertion: “Our manufacturing network has robust business continuity plans for dealing with the impact of a potential health crisis and is actively assessing and monitoring this evolving health situation.”
The F.D.A. and C.D.C. have additionally stated they’re expecting potential shortages. The F.D.A. stated this week it was “monitoring this issue and has heard from some manufacturers with questions about alternative reagents, extraction methods and platforms.” It stated it was providing steering to labs and updates on the problem on its website.
But the extraction kits are not the only supply item with uncertain availability. The American Society for Microbiologists said Tuesday that it was “deeply concerned” about a potential shortage of the reagents needed to conduct the tests as well as other materials. “Increased demand for testing has the potential to exhaust supplies needed to perform the testing itself,” the society said.
On Monday, the C.D.C. revised its guidelines to allow for the collection of one specimen swab instead of the previously required two, a move that the society said would cut the required amount of testing reagents in half.
Dr. Robert Redfield, the director of the C.D.C., told Politico on Tuesday that the agency was keeping an eye on the supply of materials needed to do the tests. But, when asked how the agency would deal with a shortage of RNA extraction kits, he said: “I don’t know the answer to that question.”
Integrated DNA Technologies, which is manufacturing coronavirus test kits for the C.D.C., said in a statement that beginning next week, it expects to be able to provide enough shipments of C.D.C. kits that would allow for five million tests a week. The company added that “is accustomed to scaling up to meet customer demand and does not anticipate needing to hire additional staff.”
Labs have also said they have had a difficult time getting so-called positive controls, or samples of the virus to ensure the tests are working properly.
“We have requested these from a couple of vendors, but it has taken some time to get registered to have the controls shipped,” said Dr. Jim Dunn, the director of medical microbiology and virology at Texas Children’s Hospital in Houston, which is now running its own test for coronavirus for the hospital’s patients.
Veronique Greenwood and Denise Grady contributed reporting.