At the University of California, Los Angeles, the chief of the microbiology section of the medical center’s clinical lab was so concerned about his supply of RNA extraction kits made by the company Qiagen that he recently sent an email to colleagues at the university’s research labs asking if they had any. “While our investigators were eager to help, none were using the kit in their labs,” said Elaine Schmidt, a spokeswoman for the medical center.
Eric Blank, the chief program officer at the Association of Public Health Laboratories, said his group has also been hearing about back orders of the extraction kits and other supplies. Now that independent labs are able to run their own tests, “it is increasing at a very rapid pace,” Mr. Blank said. “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 major manufacturer of the RNA extraction kits, said in a statement this week that because of the coronavirus outbreak, demand is “challenging our capacity to supply certain products” and that it was increasing production in sites in Germany, Spain and Maryland.
Roche, another supplier of lab materials and equipment, said in a statement: “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 also said they are watching for potential shortages. The F.D.A. said this week it was “monitoring this issue and has heard from some manufacturers with questions about alternative reagents, extraction methods and platforms.” It said it was offering guidance to labs and updates on the issue 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.
Source: Read Full Article