FDA Approves Labs to Start Screening for Coronavirus, Expands Diagnostic Test
The U.S. Food and Drug Administration (FDA) on Tuesday cleared emergency use approval for state public health laboratories to begin testing for the new flu-like coronavirus from China using kits made by the Centers for Disease Control and Prevention (CDC).
The clearance may assist in accelerating testing in the U.S. for the novel coronavirus, which has infected 11 people in the nation as of February 3.
WHO has declared the flu-like virus a global health crisis, and experts say a lot is still hidden, including how the virus is transmitted and how deadly it’s.
Beforehand, states had to send samples to the CDC for testing. With the permission, state public health labs can order test kits and in addition start the work of verifying the tests inside their labs to make sure their scientists are utilizing it appropriately, Scott Becker, the executive director of the Association of Public Health Laboratories (APHL), stated in a telephone interview.
Once the labs have the equipment, Becker estimates they may begin testing within five or six days. Initially, labs are also required to send samples to the CDC to confirm their outcomes.
A CDC epidemiologist, Dr. Joe Bresee, who is engaged in the epidemic response, mentioned the kits include a set of reagents or enzymes that can give labs all of the necessary instruments they need to test samples for the virus.
The agency hopes to share the kits with nations that may not presently have the ability to perform their own testing, Bresee stated.
Earlier Tuesday, a bipartisan team of 38 U.S. legislators from across the nation wrote an open letter to the CDC asking the company to share tests with states quickly.
Under the emergency use support, testing is limited to certified labs selected by the CDC.