CDC Ships Coronavirus Test Kits to Local U.S. Laboratories

Posted on February 7, 2020

The CDC started shipping laboratory test kits to detect 2019 novel coronavirus (2019-nCoV) to qualified local U.S. laboratories yesterday. These kits will allow local health departments to identify coronavirus patients. Previously, samples had to be sent to the CDC for testing.

The test kit can provide results in four hours from initial sample processing to result. The CDC says it is initially distributing about 200 of the test kits. Each kit can test 700 to 800 patient specimens.

The kit is called the 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). It works with an existing RT-PCR testing instrument that is used for seasonal flu.

CDC Director Robert R. Redfield, M.D. says, "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."

Use of the test kits have also been approved by the FDA through an emergency use authorization.

FDA Commissioner Stephen M. Hahn, M.D, says in a statement: "Since this outbreak first emerged, we've been working closely with our partners across the U.S government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible. This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting the public health. Our collaboration with the CDC has been vital to rapidly developing and facilitating access to this diagnostic test. The FDA remains deeply committed to utilizing our regulatory tools and leveraging our technical and scientific expertise to advance the availability of critical medical products to respond to this outbreak in the most expeditious, safe and effective manner possible."

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