Initial Public Health Response and Interim Clinical Guidance for the 2019 Novel Coronavirus Outbreak

United States, December 31, 2019-February 4, 2020

Anita Patel, PharmD; Daniel B. Jernigan, MD

Disclosures

Morbidity and Mortality Weekly Report. 2020;69(5):140-146. 

In This Article

Laboratory and Diagnostic Support

Chinese health officials posted the full 2019-nCoV genome sequence on January 10, 2020, to inform the development of specific diagnostic tests for this emergent coronavirus.[1] Within a week, CDC developed a Clinical Laboratory Improvement Amendments–approved real-time RT-PCR test that can diagnose 2019-nCoV respiratory samples from clinical specimens. On January 24, CDC publicly posted the assay protocol for this test (https://www.cdc.gov/coronavirus/2019-nCoV/lab/index.html). On January 4, 2020, the Food and Drug Administration issued an Emergency Use Authorization to enable emergency use of CDC's 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories. This authorization allows the use of the test at any CDC-qualified lab across the country. CDC is working closely with FDA and public health partners, including the American Public Health Laboratories, to rapidly share these tests domestically and internationally through CDC's International Reagent Resource (https://www.internationalreagentresource.org/). In addition, CDC uploaded the genome of the virus from the first reported cases in the United States to GenBank, the National Institutes of Health genetic sequence database of publicly available DNA sequences (https://www.ncbi.nlm.nih.gov/genbank/). CDC also is growing the virus in cell culture, which is necessary for further studies, including for additional genetic characterization. Once isolated, the virus will be made available through BEI Resources (https://www.beiresources.org/) to assist research efforts.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....