Reliance SARS-CoV-2 RT-PCR Assay Kit

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Overview

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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Description

Description

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

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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.

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

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 uses Reliance One-Step Multiplex RT-qPCR Supermix to perform both reverse transcription and amplification in one step.

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

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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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 U.S. FDA Emergency Use Authorization (EUA).

Documents

Documents

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