of CDC 2019 Novel Coronavirus Diagnostic Test Kits Begins
of CDC Diagnostic Test Kits Will Expand Laboratory Capacity to Detect
A CDC-developed laboratory
test kit to detect 2019 novel coronavirus (2019-nCoV) began shipping on
February 6, 2020, to select qualified U.S. and international
laboratories. Distribution of the tests will help improve the global
capacity to detect and respond to the 2019 novel coronavirus.
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
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 test uses a technology that can provide
results in four hours from initial sample processing to result.
The test kit has not been FDA
cleared or approved, however, distribution and use of the test kits
follow the U.S. Food and
Drug Administration (FDA) February 4, 2020, issuance of an Emergency Use
Authorization (EUA). The tests are being shipped through the International
Reagent Resource (IRR), a CDC-established mechanism that
distributes laboratory reagents domestically and globally.
Initially, about 200 test kits will be distributed to U.S. domestic
laboratories and a similar amount will be distributed to select
international laboratories. Each test kit can test approximately 700 to
800 patient specimens. Additional test kits will be produced and made
available for ordering in the future from the IRR. At this time, each
laboratory that places an order will receive one 2019-nCoV test kit.
The IRR is accepting orders for 2019-nCoV tests from qualified
laboratories. This includes 115 qualified U.S. laboratories, such as
state and local public health laboratories and Department of Defense
(DoD) laboratories, as well as 191 qualified international laboratories,
such as the World Health Organization (WHO) Global Influenza Surveillance
Response System (GISRS) laboratories.
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 2019 Novel
Coronavirus Website for the latest information and
guidance on 2019-nCoV. The CDC will continue to update its guidance
as the 2019-nCoV situation evolves.
entire CDC Press
Release for more information.
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