CDC Ships 2019-nCoV Test Kits

The US Centers for Disease Control and Prevention (CDC) announced today the initial shipments of the CDC-developed laboratory test kit to detect the novel coronavirus known as 2019-nCoV.

The CDC said in a press release on February 5, 2020, the initial distribution was to selected, qualified U.S. and international laboratories.

About 200 test kits were distributed to U.S. domestic laboratories and a similar amount will be distributed to international laboratories. 

Currently, the World Health Organization says 15 laboratories have been identified to provide reference testing support for 2019-nCoV.

Each test kit can test approximately 700 to 800 patient specimens.

This test kit, called the 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.

The CDC 2019 novel coronavirus test is intended for use with upper and lower respiratory specimens collected from people who meet CDC criteria for 2019-nCoV testing. 

The CDC test uses technology that can provide results in 4 hours from initial sample processing to result.

“Our goal is early detection of new cases and to prevent further spread of the coronavirus,” said CDC Director Robert R. Redfield, M.D., in this press release. 

“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 test 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).

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of 2019-nCoV under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Check the CDC website for the latest information and guidance on 2019-nCoV. The CDC will continue to update its guidance as the 2019-nCoV situation evolves.

For additional information, visit the CDC 2019 Novel Coronavirus Website. 

2019-nCoV outbreak news is published by Coronavirus Today.