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.

Materials included in the diagnostic panel

CDC’s laboratory test kit for the SARS-CoV-2 virus.

The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel contains four reagents:

• Three primer-probe mixes for:
  • 2019-nCoV_N1: targets virus nucleocapsid (N) gene for specific detection of SARS-CoV-2
  • 2019-nCoV_N2: targets virus nucleocapsid (N) gene for specific detection of SARS-CoV-2
  • RP: targets human RNase P gene for detection of human nucleic acids. Control for sample integrity.
• nCoVPC: noninfectious positive control material. Yields a positive result in each assay included in the panel.

Other materials labs will need to perform the diagnostic panel

The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel requires the use of additional authorized materials that are not included with the test. These materials include PCR reagents and items that are commonly used in clinical laboratories, such as a microfuge, microcentrifuge tubes, pipettes, pipette tips, etc. They are described starting on page 6 in the authorized CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel Instructions for Useexternal icon Package Insert. Two control materials are also required but not provided; use of these materials provide  expected results for a test to be considered valid, as outlined in the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel Instructions for Use. The controls are:

• Human Specimen Control (HSC): A human cell culture preparation used as an extraction procedural control to demonstrate successful recovery of nucleic acid, as well as extraction reagent integrity. Acceptable alternatives to HSC are listed in the package insert.
• No Template Control (NTC): Nuclease-free water included in each run.  Monitors for reagent and system contamination.

More Resources on the CDC Diagnostic Panel

Fact Sheets for CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel

More Resources for Diagnostic Testing

Source: https://tools.cdc.gov/api/embed/downloader/download.asp?m=403372&c=407324