In todays e-mail
https://www.cdc.gov/media/releases/2020/p0206-coronavirus-diagnostic-test-kits.html?deliveryName=USCDC_1052%20DM19438
Shipping of CDC 2019 Novel Coronavirus Diagnostic Test Kits Begins
Distribution of CDC Diagnostic Test Kits Will Expand Laboratory Capacity to Detect 2019-nCoV
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 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 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.
That is great news.
The lab of Dr. Charles Chiu at UCSF in Mission Bay recently discovered that its already-existing test could detect the virus. Chiu is now working on improving the test for mouth and throat swabs and confirming the results against a Centers for Disease Control and Prevention test. If adopted, the new test could determine within four to six hours if someone is infected with the virus