Info for Laboratories about Coronavirus (COVID-19)


The CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay is a real-time reverse-transcriptase polymerase chain response (RT-PCR) take a look at that detects and differentiates RNA from SARS-CoV-2, influenza A virus, and influenza B virus in higher or decrease respiratory specimens. The assay supplies a delicate, nucleic-acid-based diagnostic instrument for analysis of specimens from sufferers within the acute part of an infection.

Why the Flu SC2 Multiplex Assay Is Essential

  • Serves as a single take a look at to diagnose an infection attributable to one in every of three viruses: SARS-CoV-2, influenza A, and influenza B
  • Permits laboratories to course of extra checks in a given interval
  • Provides public well being officers info they want of their efforts to regulate the unfold of COVID-19 and flu
  • Permits for ongoing flu surveillance whereas additionally testing for SARS-CoV-2
  • Conserves necessary testing supplies which can be in brief provide
  • Study extra concerning the advantages of the Flu SC2 Multiplex Assay.

The U.S. Meals and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for this take a look at on July 2, 2020.

The multiplex assay’s FDA-authorized Directions for Useexterior icon incorporates details about the take a look at and its supposed use, the take a look at process, and the take a look at efficiency traits. The FDA Letter of Authorizationexterior icon for the multiplex assay might be discovered on the EUA web siteexterior icon. The letter defines the approved use and the situations of authorization that apply to CDC and different testing laboratories that use this take a look at. Producers and take a look at builders desirous about the suitable of reference to the CDC Flu SC2 Efficiency information are inspired to learn these FAQs.

How Public Well being Laboratories Order the Flu SC2 Multiplex Assay

CDC’s Worldwide Reagent Useful resource (IRR) is working by means of the primary Public Well being Laboratory (PHL) in every state to allocate multiplex kits to their state’s community of regional and native PHLs.

In the course of the COVID-19 pandemic, state public well being laboratories can authorize county or metropolis laboratories of their state to carry out testing. These laboratories should be licensed below the Medical Laboratory Enchancment Amendments (CLIA) to carry out high- and/or moderate-complexity checks, have acceptable laboratory tools and coaching, and exhibit testing proficiency below their state laboratory’s stewardship to keep up their standing as an IRR-registered laboratory. The IRR doesn’t provide clinicians, hospitals, or healthcare professionals with testing kits straight. A listing of commercially obtainable primers and probes to be used with this take a look at will not be obtainable presently. Nonetheless, CDC has shared the primers and probes sequences, so different laboratories and corporations might manufacture their very own reagents.

Supplies included within the assay

The CDC Flu SC2 Multiplex Assay is a quadruplex assay that features:

  • One primer combine and one probe combine. Primers and probes goal:
    • Virus nucleocapsid (N) gene for particular detection of SARS-CoV-2
    • Matrix (M1) gene for particular detection of influenza A virus
    • Nonstructural 2 (NS2) gene for particular detection of influenza B virus
    • RNase P gene (RP) for particular detection of human nucleic acid that serves as an inner management
  • A optimistic management FluSC2PC that confirms all 4 targets within the assay are working appropriately

Different supplies labs must carry out the assay

The Flu SC2 Multiplex Assay requires using further approved supplies that aren’t included with the take a look at. These supplies embody PCR reagents, tools, and provides generally utilized in scientific laboratories resembling a microcentrifuge, microcentrifuge tubes, pipettes, and pipette suggestions. They’re described beginning on web page 5 within the approved Flu SC2 Multiplex Assay Directions for Useexterior icon. Two management supplies are additionally required however not offered. These supplies should produce anticipated outcomes for a take a look at to be thought-about legitimate, as outlined within the Flu SC2 Multiplex Assay Directions for Use. The controls are the next:

  • Human specimen management (HSC): A human cell tradition preparation used as an extraction procedural management to exhibit profitable restoration of nucleic acid, in addition to extraction reagent integrity. Acceptable options to HSC are listed within the Directions for Use.
  • No template management (NTC): Nuclease-free water included in every run. This management displays for reagent and system contamination.

Extra Sources for the Flu SC2 Multiplex Assay

Reality Sheets for the Flu SC2 Multiplex Assay

Extra Sources for Diagnostic Testing for COVID-19 and Flu

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