In an effort to speed up coronavirus diagnoses in the U.S., the Food and Drug Administration (FDA) this week granted state laboratories permission to use the rapid coronavirus diagnostic test created by the Centers for Disease Control and Prevention (CDC).
The test was previously only available at CDC laboratories. States with suspected coronavirus cases would send respiratory secretions, namely nasal or oral swabs, from patients to the CDC for testing, forcing state officials to await the results before confirming a case.
Now, however, the test — 2019-nCoV Real-Time RT-PCR Diagnostic Panel — will be available to state public laboratories after the FDA issued a so-called "emergency use authorization" on Tuesday.
Nancy Messonnier, director of the Center for the National Center for Immunization and Respiratory Diseases (NCIRD), which is a part of the CDC, told reporters during a teleconference that the testing kits were shipped out to qualified laboratories on Wednesday.
Scott Becker, the executive director of the Association of Public Health Laboratories (APHL), told Reuters that laboratories could start using the tests about four or five days after receiving them. At first, their results will also be sent to the CDC for confirmation purposes, he added.
“We hope to send at least one to every state health department and maybe more than one,” Dr. Joe Bresee, an epidemiologist with the CDC, told Reuters.
Though the move could help speed up testing time, the FDA warned in a news release that negative results “do not preclude 2019-nCoV infection and should not be used as the sole basis for treatment or other patient management decisions.”
“Negative results must be combined with clinical observations, patient history, and epidemiological information,” it added.
The death toll from coronavirus reached 490 on Wednesday. More than 24,000 people have been infected worldwide. Overall, at least 25 countries have reported cases of coronavirus.
Currently, the U.S. has confirmed 11 cases -- six in California, one in Arizona, one in Washington state, one in Massachusetts and two in Illinois. No deaths have been reported in the U.S., and the large majority of cases still remain in China.