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

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

Overview

Analytical Sensitivity for Samples with SARS-CoV-2, Flu A, and Flu B

The LOD range for SARS-CoV-2 is 125–250 viral copies/ml, for Flu A it is 1.26–2.52 TCID50/ml, and for Flu B it is 0.23 TCID50/ml on all instruments tested.

Instrument SARS-CoV-2 Flu A** Flu B**
CFX96 Touch 125 copies/ml 2.52 TCID50/ml 1,002 copies/ml 0.23 TCID50/ml 862 copies/ml
CFX96 Dx 250 copies/ml 2.52 TCID50/ml 1,002 copies/ml 0.23 TCID50/ml 862 copies/ml
CFX Opus 96 250 copies/ml 2.52 TCID50/ml 1,002 copies/ml 0.23 TCID50/ml 862 copies/ml
AB7500 Fast Dx 250 copies/ml 1.26 TCID50/ml 501 copies/ml 0.23 TCID50/ml 862 copies/ml

LOD units

  • Copies/ml — number of copies of viral RNA detected per milliliter of sample.
  • TCID50/ml — represents the “Median Tissue Culture Infectious Dose” per milliliter of sample, and is used to verify viral titer. TCID50 signifies the concentration at which 50% of the cells are infected when the sample is inoculated with a diluted solution of viral fluid.

*The Qiagen Viral RNA Mini Kit was the nucleic acid purification method used.
** Live cultured virus

Clinical Evaluation for Samples Containing SARS-CoV-2, Flu A, and Flu B

The performance of the Bio-Rad Reliance SARS-CoV-2, Flu A, and Flu B RT-PCR Assay Kit was evaluated with clinical nasopharyngeal swab samples using 32 individual negative clinical samples, 41 confirmed SARS-CoV-2 positive clinical samples, 69 confirmed Influenza B positive clinical samples, and 69 confirmed Influenza A positive clinical samples. Clinical study results show a 100% percent positive agreement (PPA) and a 100% negative percent agreement (NPA) with a 95% confidence interval.

SARS-CoV-2 Samples Processed with the Reliance SARS-CoV-2, Flu A, and Flu B RT-PCR Kit

RT-PCR Kit Comparator #1 and #2
Positive
Comparator #1 and #2
Negative
Total PPA
[95% CI]
NPA
[95% CI]
Test positive 41 0 41 97.6%
[87.7–99.6%]
100%
Inconclusive 0 0 0
Test negative 1* 0 1
Total 42 0 42



Influenza A Samples Processed with the Reliance SARS-CoV-2, Flu A, and Flu B RT-PCR Kit

RT-PCR Kit Comparator #3 and #4
Positive
Comparator #3 and #4
Negative
Total PPA
[95% CI]
NPA
[95% CI]
Test positive 69 0 69 100%
[94.7100%]
100%
Inconclusive 0 0 0
Test negative 0 0 0
Total 69 0 69



Influenza B Samples Processed with the Reliance SARS-CoV-2, Flu A, and Flu B RT-PCR Kit

RT-PCR Kit Comparator #4
Positive
Comparator #4
Negative
Total PPA
[95% CI]
NPA
[95% CI]
Test positive 43 0 43 100%
[91.8100%]
100%
Inconclusive 0 0 0
Test negative 0 0 0
Total 43 0 43



Negative Samples Processed with the Reliance SARS-CoV-2, Flu A, and Flu B RT-PCR Kit

RT-PCR Kit Comparator #4
Positive
Comparator #4
Negative
Total PPA
[95% CI]
NPA
[95% CI]
Test positive 0 0 32 100%
[89.3100%]
100%
Inconclusive 0 0 0
Test negative 32 0 1
Total 32 0 32

Clinical evaluations. Testing of samples containing SARS-CoV-2, Influenza A, or Influenza B and negative samples in a 2 x 2 comparison of the comparator tests with the Bio-Rad Reliance SARS-CoV-2, Flu A, and Flu B RT-PCR Assay Kit.

*The discordant sample was adjudicated using the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay (EUA), which confirmed the negative results for SARS-CoV-2.

SARS-CoV-2, Flu A, and Flu B Assay Data Examination and Interpretation

Results are for the identification and differentiation of SARS-CoV-2 RNA from Influenza A RNA and Influenza B RNA. These viruses are generally detectable in upper respiratory specimens during the acute phase of their infection.

  • Positive results are indicative of the presence of the respiratory virus(es) indicated
  • Negative results do not preclude infection with respiratory virus(es) and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information
SARS-CoV-2
N1 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)
Positive or Negative 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

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
  • Specifications
  • Ordering
  • Controls
  • Documents

Description

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

Contact a Genomics Specialist

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

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

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)

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Exact Diagnostics SARS-CoV-2, Flu, RSV Run Control Positive

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)

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Exact Diagnostics SARS-CoV-2, Flu, RSV Run Control Negative

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)

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Documents

Number Description Options
10000135012 Reliance SARS-CoV-2 Flu A Flu B RT-PCR Assay Kit Instructions for Use Click to download
7448 Reliance SARS-CoV-2 RT-PCR Assay Kits Product Information Sheet Click to download

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