COVID-19 TaqMan RT-PCR Detection Kit (E/RdRP genes) Dx
Intended for in vitro diagnostics use.
COVID-19 TaqMan RT-PCR Detection Kit (E/RdRP genes) Dx
Overview
- CE-IVD marked in accordance with EU Directive 98/79/EC
- For use in in vitro diagnostic workflows
- SARS-CoV-2 detection based on the Charité/Berlin protocol (E/RdRP genes) recommended by WHO
- Primer & Probe Mixes contain all E gene/RP and RdRP gene assays in individual tubes
- All assays are premixed to the working concentrations recommended by the Charité/Berlin protocol
- Positive Control contains the three SARS-related target genes: E gene, RdRP gene as well as the human RP (internal control)
- Includes our convenient ready-to-use 2X One-Step RT-PCR Master Mix
- Find out more information about our complete COVID-19 workflow
Norgen’s COVID-19 TaqMan RT-PCR Kit (E/RdRP genes) Dx is an in vitro diagnostic test for the qualitative detection of SARS-CoV-2 specific RNA using a multiplexed TaqMan® fluorescence detection assay (FAM and HEX/VIC) based on the Charité/Berlin protocol. The assay is designed for use with RNA isolated from nasopharyngeal swabs, oropharyngeal swabs and saliva samples collected from individuals with clinical signs/symptoms related to SARS-CoV-2 infection for in vitro diagnostic use.
Product Description
Norgen’s COVID-19 TaqMan RT-PCR Kit (E/RdRP genes) Dx includes 2XOne-Step RT-PCR Master Mix and 2 primer/probe mixes, a positive control and a negative control (nuclease-free water). The first primer/probe mix is used for first line screening and contains the E gene/RP that targets the SARS-CoV-2, SARS-CoV and bat-SARS-related CoVs Envelope gene(E gene -FAM) in addition to the human RNase P transcript (RP-HEX/VIC) as an internal control target to monitor for PCR inhibition, and to validate the quality of the sample and the detection result. The second Primer/Probe Mix is only required as a confirmatory/discriminatory step with samples showing positive amplification of the E gene. This second Primer/Probe Mix is for the RdRP gene and detects two RNA-dependent RNA Polymerase (RdRP) targets where the first RdRP target is SARS-CoV-2 specific (FAM) while the second RdRP target is to detect SARS-CoV-2, SARS-CoV and bat-SARS-related CoVs (HEX). The provided E gene/RdRP/RP Positive Control contains an in vitro RNA transcript for the three SARS-related target genes: E gene, RdRP gene as well as the human RP gene (internal control).
Positive results are indicative of SARS-CoV-2 RNA detection, however clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out co-infection with other viruses and therefore the agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Any negative results must be combined with clinical observations, patient history, and epidemiological information.
Norgen’s COVID-19 TaqMan RT-PCR Kit (E/RdRP genes) Dx is intended for use by professional users including clinical laboratory personnel experienced and trained in molecular biology techniques including real-time PCR and in vitro diagnostic procedures.
Norgen’s COVID-19 TaqMan RT-PCR Kit (E/RdRP genes) Dx was developed and validated to be used with the BioRad CFX96 Touch™ Real-Time PCR Detection System.
Details
Supporting Data
Storage Conditions and Product Stability
• All kit components should be stored at -20°C upon arrival
• Repeated thawing and freezing (> 3x) of the Master Mix and Positive Control should be avoided, as this may affect the performance of the assay. If the reagents are to be used only intermittently, they should be frozen in aliquots.
• All reagents can be used until the expiration date specified on their labels.
Component | Cat. DxTM67200 (500 rxns) |
---|---|
E gene/RP Primer & Probe Mix Dx | 850 μL |
RdRP gene Primer & Probe Mix * | 850 μL |
E/RdRP/RP Positive Control Dx † | 500 μL |
2X One-Step RT-PCR Master Mix Dx | 12 mL |
Nuclease-Free Water (Negative control) | 4 x 1.25 mL |
Product Insert | 1 |
* Confirmatory/Discriminatory assay.
† Contains an in vitro RNA transcript for the three SARS-related target genes: E gene, RdRP gene as well as the human RP (internal control).