Some coronavirus test kits distributed by the Centers for Disease Controls are flawed, and have resulted in “inconclusive” readings, resulting in delayed results, the CDC reported Thursday.
There are at least 570 confirmed cases of coronavirus in more than 25 countries and territories outside mainland China, where the outbreak started. Just 15 cases have been confirmed in the U.S., though the number of sick and dead surged in the Hubei Province in China, where the virus has killed more than 1,100 people in recent weeks.
The CDC sent out 200 test kits to labs in the U.S. and to more than 30 countries after getting emergency-use authorization from the Food and Drug Administration.
“We are looking into all of these issues to understand what went wrong,” said Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases at the CDC, on a press call with reporters. “This is really part of a normal process and procedure, and we have the quality control set up specifically to allow us to identify these kinds of problems.”
The issue with the test is likely a reagent, or chemical substance, per The Wall Street Journal. As a result, the CDC will have to remanufacture the substance before sending it back out.
“Obviously, a state wouldn’t want to be doing this test and using it to make clinical decisions if it isn’t working as well, as perfectly, at the state as it is at CDC,” Messonnier said.