The CDC 2019 Novel Coronavirus (2019-nCoV) Actual-Time Reverse Transcriptase (RT)–PCR Diagnostic Panel detects the SARS-CoV-2 virus in higher and decrease respiratory specimens. It’s designed for use with an present RT-PCR testing instrument generally used to check for seasonal influenza virus.
The U.S. Meals and Drug Administration (FDA) gave Emergency Use Authorization (EUA) for this check on February 4, 2020. The diagnostic panel’s FDA-authorized Directions for Useexterior icon comprise details about the check, its supposed use, the check process, and efficiency traits. The EUA web siteexterior icon has revealed the FDA Letter of Authorizationexterior icon for the diagnostic panel. The letter defines the licensed use and the situations of authorization that apply to CDC and to testing laboratories that use this check.
On June 12, 2020, FDA granted an modificationexterior icon to the EUA for the CDC diagnostic check to handle world shortages of supplies wanted to carry out the check. This modification supplies alternate options for processing the check:
- 4 further extraction reagents that can be utilized within the present extraction strategies
- A further extraction instrument and related reagents
- A brand new course of that can be utilized instead of the extraction methodology when supplies for the present methodology are restricted
On July 13, 2020, FDA granted an modificationexterior icon, so as to add the Promega Maxwell® RSC 48 as a licensed extraction instrument to be used with the CDC 2019-nCoV rRT-PCR Diagnostic Panel.
On December 1, 2020, FDA licensed an modificationexterior icon so as to add:
- The choice to conduct pooled specimen testing for higher respiratory swab specimens
- Efficiency information generated with FDA’s reference panel
- Promega Maxwell CSC 48 as a specimen extraction choice
Easy methods to order the Actual-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel
The Worldwide Reagent Useful resource (IRR)exterior icon is distributing the diagnostic panel and provides to registered state and native public well being laboratories to allow them to carry out SARS-CoV-2 testing.
Throughout the SARS-CoV-2 pandemic, state public well being laboratories can authorize county or metropolis laboratories in every state to carry out testing. These laboratories should be licensed beneath the Medical Laboratory Enchancment Modification (CLIA) to carry out high-complexity assessments, have applicable laboratory gear and coaching, and reveal testing proficiency beneath their state laboratory’s stewardship to take care of their standing as an IRR-registered laboratory. The IRR doesn’t provide clinicians, hospitals, or healthcare professionals with testing kits instantly. Clinicians, hospitals, and healthcare professionals ought to check with the checklist of commercially accessible numerous primers and probespdf icon which are acceptable alternate options to the CDC-provided reagents. The checklist begins on web page 7 within the licensed CDC 2019-nCoV Actual-Time RT-PCR Diagnostic Panel Directions for Useexterior icon Bundle Insert.
Supplies included within the diagnostic panel
The CDC 2019-nCoV Actual-Time RT-PCR Diagnostic Panel incorporates 4 reagents:
- Three primer-probe mixes for:
- 2019-nCoV_N1: targets virus nucleocapsid (N) gene for particular detection of SARS-CoV-2
- 2019-nCoV_N2: targets virus nucleocapsid (N) gene for particular detection of SARS-CoV-2
- RP: targets human RNase P gene for detection of human nucleic acids; management for pattern integrity
- nCoVPC: noninfectious constructive management materials; yields a constructive lead to every assay included within the panel
If the diagnostic panel just isn’t accessible, see the up to date directions to be usedexterior icon for acceptable alternate options.
Different supplies labs might want to carry out the diagnostic panel
The CDC 2019-nCoV Actual-Time RT-PCR Diagnostic Panel requires the usage of further licensed supplies which are not included with the check. These supplies embody PCR reagents and objects which are generally utilized in medical laboratories, equivalent to a microfuge, microcentrifuge tubes, pipettes, and pipette suggestions. They’re described beginning on web page 6 within the licensed CDC 2019-nCoV Actual-Time RT-PCR Diagnostic Panel Directions for Useexterior icon package deal insert. Two management supplies are additionally required however not offered; these supplies should produce anticipated outcomes to ensure that a check to be thought-about legitimate, as outlined within the CDC 2019-nCoV Actual-Time RT-PCR Diagnostic Panel Directions for Useexterior icon. The controls are:
- Human Specimen Management (HSC): A human cell tradition preparation used as an extraction procedural management to reveal profitable restoration of nucleic acid, in addition to extraction reagent integrity. Acceptable alternate options to HSC are listed within the package deal insert.
- No Template Management (NTC): Nuclease-free water included in every run. Screens for reagent and system contamination.
Extra Sources on the CDC Diagnostic Panel
Truth Sheets for CDC 2019-nCoV Actual-Time RT-PCR Diagnostic Panel
Extra Sources for Diagnostic Testing