COVID-19 TaqMan RT-PCR Kit (E/RdRP genes- Charité/Berlin protocol) - CE-marked (for IVD)User Manual
|Product Category:||TaqMan Real-Time PCR Kits|
|Pathogen Detection:||Human Pathogen Detection|
|CE / IVD Marking:||Yes|
- 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)
- Convenient ready-to-use 2X One-Step RT-PCR Master Mix
- Manufactured under ISO 13485:2016
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.
The kit 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.
The 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.
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.