As the U.S. is facing a shortage of a critical component of COVID-19 diagnostic tests, some labs are borrowing kits from colleagues, the FDA updated a policy allowing labs to use a different type of diagnostic kit and the CDC has offered to look into the shortage.
The first step in diagnosing COVID-19 is by using something called an RNA extraction kit. A key part of those kits are substances called reagents, which are now in short supply as demand for testing has spiked, Politico reported.
Qiagen, a diagnostic company based in Germany, makes many of the reagents for RNA extraction kits used in the U.S. The company told USA Today it is increasing its production to three shifts a day, seven days a week at its plants in Germany and Spain. It also said it is hiring more employees and increasing manufacturing at a facility in Maryland.
"This now is an unprecedented situation," a Qiagen spokesperson told USA Today. "Demand is exploding, especially in the United States ... and this is stretching our capacity."
Some labs have had to borrow testing components from colleagues, according to USA Today.
CDC director Robert Redfield, MD, told Politico the agency is looking into the shortage and that he is "not confident" that labs have a sufficient supply of testing materials.
The FDA is also contacting labs testing for COVID-19 to "understand their supply issues and assist where we can," a spokesperson told Politico.
The FDA also approved a change to allow labs to use a test kit from Roche instead of Qiagen, but lab technicians would need to be trained to use it, which could take up to a week.
The American Society for Microbiology posted a warning on its site that the shortage could slow diagnostic testing for COVID-19.