Reliance SARS-CoV-2 RT-PCR Assay Kit

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Reliance SARS-CoV-2 RT-PCR Assay Kit

Overview

Limit of Detection Result

The LOD range is 125–250 viral copies/ml on all instruments independent of nucleic acid purification method with the exception of CFX384 Touch, which has an LOD of 500 cp/ml when used with the Thermo Fisher’s MagMAX Viral/Pathogen Nucleic Acid Isolation Kit.

Instrument QiaAMP Viral Mini Kit MagMAX Viral/Pathogen Kit
CFX96 Touch 125 copies/ml 250 copies/ml
CFX96 Dx 125 copies/ml 125 copies/ml
AB7500 250 copies/ml 250 copies/ml
CFX384 Touch 250 copies/ml 500 copies/ml
CFX Opus 96 250 copies/ml 125 copies/ml
CFX Opus 384 250 copies/ml 250 copies/ml
Clinical Evaluation Result

The performance of Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit with nasopharyngeal swab clinical samples was evaluated using 34 individual negative clinical samples and 34 confirmed 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.

Reliance SARS-CoV-2 RT-PCR Comparator test positive Comparator test negative Total PPA [95% CI] NPA [95% CI]
Test positive 34 0 34 100%
[89.9%-100%]
100%
[89.9%-100%]
Inconclusive 0 0 0
Test negative 0 34 34
Total 34 34 68
SARS-CoV-2 Assay Data Examination and Interpretation

Results are for the identification of SARS-CoV-2 RNA, which is generally detectable in upper respiratory specimens during the acute phase of the infection.

  • Positive results are indicative of the presence of SARS-CoV-2 RNA
  • Negative results do not preclude SARS-CoV-2 infection 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
SARS-CoV-2
N2 Result
Internal Control
RP Result
Interpretation
Positive
(Cq < 40)
Positive
(Cq < 40)
Positive or Negative SARS-CoV-2 detected
Either target is positive
(Cq < 40)
Positive or Negative Inconclusive
Negative
(Cq ≥ 40 or N/A)
Negative
(Cq ≥ 40 or N/A)
Positive
(Cq < 40)
SARS-CoV-2 not detected
Negative
(Cq ≥ 40 or N/A)
Negative
(Cq ≥ 40 or N/A)
Negative
(Cq ≥ 40 or N/A)
Invalid Result

The Reliance SARS-CoV-2 RT-PCR Test provides real-time PCR detection of multiple RNA targets from the SARS-CoV-2 virus with great sensitivity and speed.


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Ordering Information


Description

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

Contact a Genomics Specialist

The Reliance SARS-CoV-2 RT-PCR Test provides real-time PCR detection of multiple RNA targets from the SARS-CoV-2 virus with great sensitivity and speed. It is designed to detect nucleic acid from SARS-CoV-2 in nasopharyngeal swabs specimen from individuals suspected of COVID-19 by their healthcare provider.

We have performed a variant analysis of our SARS-CoV-2 kit and the performance is unlikely to be affected by the variants.
See the IFU for details.

Two primer/probe sets are the sequences reported by the Center for Disease Control and Prevention (CDC) for detection of SARS-CoV-2, selected from regions of the virus nucleocapsid (N1 and N2) genes. An additional primer/probe set to detect the human RNase P (RP) gene is also included in the panel as an internal control. RNA that is isolated and purified from control samples and clinical specimens is added to the master mix, which is composed of reverse transcriptase whereby RNA is converted into cDNA and then amplified, using the Bio-Rad Reliance One-Step Multiplex RT-qPCR Supermix. 

The kit contains all materials necessary for the efficient detection of SARS-CoV-2, including independently developed Exact Diagnostics positive and negative molecular controls.

Features and Benefits

  • Highly sensitive one-step RT-PCR workflow
  • Specifically designed panel with three sets of primers/probes in a single multiplex assay
  • Convenient kit package with full controls included
  • Compatible with most popular PCR instrument platforms (CFX and AB7500 Fast Systems)

Kit Components

The kit contains all the required reagents for 200 reactions. The kit should be stored at –20 °C.

Reliance SARS-CoV-2 RT-PCR Assay Data Examination and Interpretation

SARS-CoV-2
N1 Result
SARS-CoV-2
N2 Result
Internal Control
RP Result
Interpretation
Positive
(Cq < 40)
Positive
(Cq < 40)
Positive or Negative SARS-CoV-2 detected
Either target is positive
(Cq < 40)
Positive or Negative SARS-CoV-2 inconclusive
Negative
(Cq ≥ 40 or N/A)
Negative
(Cq ≥ 40 or N/A)
Positive
(Cq < 40)
SARS-CoV-2 not detected
Negative
(Cq ≥ 40 or N/A)
Negative
(Cq ≥ 40 or N/A)
Negative
(Cq ≥ 40 or N/A)
Invalid Result

Results are for the identification of SARS-CoV-2 RNA, which is generally detectable in upper respiratory specimens during the acute phase of the infection.

  • Positive results are indicative of the presence of SARS-CoV-2 RNA
  • Negative results do not preclude SARS-CoV-2 infection 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

FDA Emergency Use Authorization:

This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and, The emergency use of this product is only authorized for the duration of the declaration that circumstances exist 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Related Products


Specifications

Product Line Reliance
Sample Type Human upper respiratory tract specimens
Target Organism Class Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Viral Target Detected N1 and N2 regions of the N gene and Human RNase P (RP) gene
Total Run Time 2 hours (excluding RNA extraction)
System Compatibility Bio-Rad CFX Opus 96, CFX96 Touch, CFX96 Dx, CFX Opus 384, and CFX384 Touch Real-Time PCR Detection Systems, and the ThermoFisher Scientific Applied Biosystems (AB) 7500 Fast Real-Time PCR Instrument
Shipping Conditions Dry ice
Shelf Life 6 months

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Reliance SARS-CoV-2 RT-PCR Assay Kit, 200 x 20 µl rxns

12014115
Pkg of 1, RT-PCR assay kit for the detection of SARS-CoV-2 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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Documents

Number Description Options
7448 Reliance SARS-CoV-2 RT-PCR Assay Kits Product Information Sheet Click to download
10000132460 Reliance SARS-CoV-2 RT-PCR Assay Kit, Instructions For Use Click to download
10000130224 Reliance SARS-CoV-2 RT-PCR Assay Kit, Fact Sheet for Patients Click to download
10000130226 Reliance SARS-CoV-2 RT-PCR Assay Kit, Fact Sheet for Healthcare Providers Click to download
10000141028 Bio-Rad Research Use Instrument Operation Manual Addendum Click to download

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