The CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel detects the SARS-CoV-2 virus in upper and lower respiratory specimens. It is designed to be used with an existing RT-PCR testing instrument commonly used to test for seasonal influenza.
The U.S. Food and Drug Administration (FDA) gave Emergency Use Authorization (EUA) for this test on February 4, 2020. The panel’s FDA-authorized Instructions for Useexternal icon contain information about the test, its intended use, test procedure, and performance characteristics. The EUA websiteexternal icon has published the FDA Letter of Authorizationexternal icon for the diagnostic panel. The letter defines the authorized use and the conditions of authorization that apply to CDC and to testing laboratories that use this test.
How to order the Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel
The International Reagent Resource (IRR)external icon is distributing the diagnostic panel and supplies to registered state and local public health laboratories so they can perform SARS-CoV-2 testing.
During the SARS-CoV-2 pandemic, state public health laboratories can authorize county or city laboratories in each state. These laboratories must be certified under the Clinical Laboratory Improvement Amendment (CLIA) to perform high complexity tests, have appropriate laboratory equipment and training, and demonstrate testing proficiency under their state laboratory’s stewardship in order to maintain their status as an IRR registered laboratory. The IRR does not supply clinicians, hospitals, and health care professionals with testing kits directly.Clinicians, hospitals, and health care professionals should refer to the list of commercially available lots of primers and probespdf icon that are acceptable alternatives to the CDC-provided reagents. The list is noted starting on page 7 in the authorized CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel Instructions for Useexternal icon Package Insert.