CDC Begins Shipping Coronavirus Test Kits to U.S. & International Laboratories
GoLocalProv News Team
CDC Begins Shipping Coronavirus Test Kits to U.S. & International Laboratories
The test kit comes as there are now 11 confirmed cases of the virus in the U.S., 14,500 cases in China and more than 300 people have died.
“Our goal is early detection of new cases and to prevent further spread of the coronavirus. 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,” said CDC Director Robert R. Redfield, M.D.
GET THE LATEST BREAKING NEWS HERE -- SIGN UP FOR GOLOCAL FREE DAILY EBLASTAccording to the CDC, initially, about 200 test kits will be distributed to U.S. domestic laboratories and a similar amount will be distributed to select international laboratories.
The tests are being shipped through the International Reagent Resource (IRR), a CDC-established mechanism that distributes laboratory reagents domestically and globally.
About the Test Kits
The test kit, called the Centers for Disease Control and Prevention (CDC) 2019-Novel Coronavirus (2019-nCov) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel (CDC 2019-nCoV Real Time RT-PCR), is designed for use with an existing RT-PCR testing instrument that is commonly used to test for seasonal influenza.
According to the CDC, the kit has not been FDA cleared or approved, however, distribution and use of the test kits follows the U.S. Food and Drug Administration (FDA) February 4, 2020, issuance of an Emergency Use Authorization (EUA).
The kit is intended for use with upper and lower respiratory specimens collected from people who meet CDC criteria for 2019-nCoV testing.
The test uses a technology that can provide results in four hours from initial sample processing to result.
Each kit can test approximately 700 to 800 patient specimens.