Description
Description
The U.S. FDA has granted Emergency Use Authorization (EUA) for the Reliance SARS-CoV-2 RT-PCR Kit.
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 Reliance SARS-CoV-2 RT-PCR Kit is unlikely to be impacted by mutations in the SARS-CoV-2 Omicron variant.
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.
- SARS-CoV-2 RT-PCR Oligos
- Reliance One-Step Multiplex RT-qPCR Supermix
- Exact Diagnostics SARS-CoV-2 Standard
- Exact Diagnostics SARS-CoV-2 Negative
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.
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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).