Reliance SARS-CoV-2 Flu A Flu B RT-PCR Assay Kit

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Overview

Real-time PCR detection of multiple RNA targets from the SARS-CoV-2 virus as well as the Influenza A and Influenza B viruses with high sensitivity and speed.

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Description

Description

The US FDA has granted Emergency Use Authorization (EUA) for the Reliance SARS-CoV-2 Flu A Flu B RT-PCR Assay Kit.

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The Reliance SARS-CoV-2, Flu A, and Flu B RT-PCR Assay Kit is a molecular in vitro diagnostic test providing real-time PCR detection of multiple RNA targets from the SARS-CoV-2 virus as well as the Influenza A and Influenza B viruses with high sensitivity and speed.

This kit contains all the reagents required to perform a fast and sensitive RT-PCR test to detect and differentiate RNA from the SARS-CoV-2 virus, Influenza A, and/or Influenza B in upper respiratory tract specimens including nasopharyngeal swabs, and anterior nasal swabs from patients with signs and symptoms of infection who are suspected of having COVID-19.

The oligonucleotide primers and probes have the same sequences as the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay (EUA received on July 2, 2020). An additional primer/probe set to detect the human RNase P (RP) gene in control samples and clinical specimens is also included. RNA amplification is provided by the Reliance One-Step Multiplex RT-qPCR Supermix.

Features and Benefits

  • Highly sensitive, one-step RT-PCR workflow
  • Multiplexed assay panel design, with three sets of high-specificity primers, that detects three viruses simultaneously
  • Convenient kit package with full process controls included
  • Compatible with most popular qPCR systems: Bio-Rad CFX96 and CFX Dx, and AB7500 Fast Dx

Kit Components

The kit contains all the required reagent components for 200 reactions. The kit is stored at –20°C.

 

Reliance SARS-CoV-2, Flu A, and Flu B RT-PCR Assay Kit Results Interpretation

SARS-CoV-2 SC2 Result Flu A M1 Result Flu B NS2 Result Internal Control RP Result Interpretation
Positive
(Cq<40)
Negative
(Cq≥40 or N/A)
Negative
(Cq ≥ 40 or N/A)
Positive or Negative SARS-CoV-2 detected
Negative
(Cq≥40 or N/A)
Positive
(Cq<40)
Negative
(Cq ≥ 40 or N/A)
Positive or Negative Influenza A detected
Negative
(Cq ≥ 40 or N/A)
Negative
(Cq ≥ 40 or N/A)
Positive
(Cq < 40)
Positive or Negative Influenza B detected
Negative
(Cq ≥ 40 or N/A)
Positive
(Cq < 40)
Positive
(Cq < 40)
Positive or Negative Influenza A and Influenza B detected
Positive
(Cq<40)
Positive
(Cq < 40)
Negative
(Cq ≥ 40 or N/A)
Negative
(Cq ≥ 40 or N/A)
Influenza A and SARS-CoV-2 detected
Positive
(Cq < 40)
Positive
(Cq < 40)
Positive
(Cq < 40)
Positive or Negative Influenza A and Influenza B and SARS-CoV-2 detected
Positive
(Cq < 40)
Negative
(Cq ≥ 40 or N/A)
Positive
(Cq < 40)
Positive or Negative Influenza B and SARS-CoV-2 detected
Negative
(Cq ≥ 40 or N/A)
Negative
(Cq ≥ 40 or N/A)
Negative
(Cq ≥ 40 or N/A)
Positive
(Cq < 40)
Virus not detected. Consider testing for other respiratory viruses
Negative
(Cq ≥ 40 or N/A)
Negative
(Cq ≥ 40 or N/A)
Negative
(Cq ≥ 40 or N/A)
Negative
(Cq ≥ 40 or N/A)
Invalid Result

 

FDA Emergency Use Authorization*

This product has not been FDA cleared or approved, but has been authorized for emergency use by the FDA under an EUA.

This product has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A virus, influenza B virus and not for any other viruses or pathogens.

The emergency use of this product is only authorized for the duration of the declaration that circumstances justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3 (b)(1), unless the declaration is terminated, or authorization is revoked sooner.

*For more information on the intended use of this EUA, please refer to the Instructions for Use (IFU).

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Specifications

Specifications

Sample Type
Human upper respiratory tract specimens
Target Organism Class
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Influenza A, and Influenza B
Viral Target Detected
3’ carboxy terminus of Nucleocapsid gene for SARS-CoV-2 (N), Human RNase P (RP) gene, M1 protein gene for Flu A, and NS2 protein gene for Flu B
Total Run Time
2 hours (excluding RNA extraction)
System Compatibility
Bio-Rad CFX96 Touch, CFX96 Dx, and CFX Opus 96 Real-Time PCR Systems
ThermoFisher Scientific Applied Biosystems (AB) 7500 Fast Dx Real-Time PCR Instrument
Shipping Conditions
Dry ice
Shelf Life
6 months

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12015361
Pkg of 1, RT-PCR assay kit for the detection of SARS-CoV-2, Flu A, and Flu B viral RNA; includes oligonucleotides, RT-qPCR supermix, positive and negative controls, sufficient to perform 200 tests. For use only under the US FDA Emergency Use Authorization (EUA)

Controls

Controls

COVFLU_qsd_SARSCoV2FluRSV_tn.jpg
COVFLU
Unassayed external control used to monitor the presence of SARS-CoV-2, Influenza A, Influenza B, Respiratory Synctial Virus (A) (5 x 1.0 mL)
COVFLUNEG_qsd_SARSCoV2FluRSV_tn.jpg
COVFLUNEG
Negative unassayed external control used to monitor the absence of SARS-CoV-2, Influenza A, Influenza B, Respiratory Synctial Virus (A) (5 x 1.0 mL)

Documents

Documents

Number Description Options
7448
Reliance SARS-CoV-2 RT-PCR Assay Kits Product Information Sheet
10000135012
Reliance SARS-CoV-2 Flu A Flu B RT-PCR Assay Kit Instructions for Use
10000135008
Reliance SARS-CoV-2 Flu A Flu B RT-PCR Assay Kit - Fact Sheet for Patients
10000135010
Reliance SARS-CoV-2 Flu A Flu B RT-PCR Assay Kit - Fact Sheet for Health Care Providers