The US Centers for Disease Control and Prevention began shipping coronavirus test kits to state labs this week on Wednesday, the agency announced.
The tests, which can produce results in as little as four hours, will allow states to confirm their own cases of the novel coronavirus, rather than waiting for confirmation from the CDC. Previously, the CDC was the only lab in the United States able to test for the novel coronavirus.
“Our goal is early detection of new cases and to prevent further spread of the coronavirus,” CDC Director Dr. Robert R. Redfield said in a statement Thursday. “Distribution of these diagnostic tests to state laboratories, U.S. government partners and more broadly to the global public health community will accelerate efforts to confront this evolving global public health challenge.”
The CDC says will distribute about 200 test kits to domestic labs and another 200 to international labs. Each test kit can perform 700 to 800 patient samples.
The diagnostic is authorized to be used for patients who meet CDC criteria for testing, and by qualified labs designated by the CDC or certified to perform high-complexity tests. These include 115 US labs such as state and local public health labs and Department of Defense labs, as well as 191 international labs.
About the test: It’s known as a reverse transcriptase polymerase chain reaction test (RT-PCR) and can detect the virus from nasal or oral swabs when used with an existing RT-PCR instrument — the same one often used to test for seasonal influenza, the agency says.
Negative results do not preclude infection with the virus, the FDA noted in a press release, adding that negative results must be combined with clinical observations, patient history and epidemiological information. The FDA issued an emergency use authorization on Tuesday for the test, though it is not technically FDA-approved.
As of Wednesday, the CDC has listed a total of 293 people under investigation for the novel coronavirus in 36 states since January 21, according to an update posted to the agency's website.
There are 12 confirmed cases of the novel coronavirus in the United States. Six cases have been confirmed in California, one in Massachusetts, one in Washington state, one in Arizona, one in Wisconsin and two in Illinois. This includes two instances of known person-to-person transmission, one in Illinois and one in California.