The CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel is ready for distribution to qualified laboratories for detection of 2019 novel coronavirus.
The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) on February 4, 2020, to enable emergency use of the test kit in the United States. CDC has produced EUA and Research Use Only (RUO) test kits that are now available to order by domestic and international public health partners through International Reagents Resource.
CDC’s diagnostic panel is intended for use by laboratories designated by CDC as qualified, and in the United States, certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests. This includes U.S. state and local public health laboratories and Department of Defense (DoD) laboratories. The test kits also will be shipped to qualified international laboratories, such as World Health Organization (WHO) Global Influenza Surveillance Response System (GISRS) laboratories.
“Today the test kits will start shipping to the over 100 US public health labs, each of these labs is required to perform international verification for CLIAA compliance prior to reporting out. This process is expected to take a few days. Initially 200 test kits will be distributed to US domestic laboratories and another 200 will be distributed to selected international laboratories,” said Dr. Nancy Messonier, Director of the CDC’s National Center for Immunization and Respiratory Diseases. “Each test kit can perform 700 to 800 patient samples. What that means is that by the start of next week, we expect there to be much enhanced capacity for laboratory testing closer to our patients..
Each laboratory that places an order will receive one diagnostic panel initially, and each panel can test 700-800 patient specimens.
The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel contains the following:
- 2019-nCoV_N1, 2019-nCoV_N2 and 2019-nCoV_N3 primers and probes that target the nucleocapsid (N) gene and are designed for both universal detection of SARS-like coronavirus as well as specific detection of the 2019-nCoV;
- RP primers and probes that target the Human RNase P gene; and
- nCoVPC, the 2019-nCoV positive control used in the assay.
Dr. Messonnier noted that the important role of state public health systems will be more visible to the general public in coming days. “States will now start testing for and confirming this virus and you may start hearing from states directly about confirmed cases. As always, their case count will be the most up-to-date…US public health system relies heavily on the work of state, local and territorial health departments who are on the front lines of outbreak responses. Their ability to detect and confirm this virus is critical.”
Sources: CDC, IRR