FireGene COVID-19 Nucleic Acid Detection Kit (Real Time RT-PCR Method)

FireGeneSKU: FG-COVPCR

CE Marking

- Completely lyophilized microspheres reagent.

- Transport and store in room temperature.

- Greatly simplifies detection procedures.

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Product Overview

Description

The Firegene Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit is a real-time multiplex RT-PCR test intended for the qualitative detection of SARS-CoV-2 viral RNA.

It is suitable for upper respiratory specimens, such as nasopharyngeal, oropharyngeal swab, and bronchoalveolar lavage specimens.

In a single RT-PCR reaction, it is able to detect ORF1ab and N RNA sequences, and in addition, human RNase P as an internal control.

Specifications

Product Type Molecular Detection
Applications RT-PCR, COVID-19 and COVID-19 Variants Detection
Compatible Sample Types Nasopharyngeal and oropharyngeal swab, and bronchoalveolar lavage specimens.
Target ORF1ab and N RNA sequences, and human Rnase P RNA sequence.
Method Real-time multiplex fluorescent RT-PCR
Prep Time < 70 minutes
Amount of Starting Material 100 copies/ml of SARS-CoV-2 virus
Supported Instruments Roche LC480 Real-Time PCR System or Thermo Fisher 7500 Real-Time PCR System
Storage 2- 30°C
Shelf-life 12 months


Results

Variability - ORF1ab & N Gene (Inter-batch Variability <5%)

ORF1ab Linearity & LoD

The Lower Limit of Detection (LoD) is defined as the lowest concentration of ORF1ab RNA that can be consistently detected (typically in >=95% of 20 swab samples tested): 3 copies/rxn or 100 copies /mL swab

N Linearity & LoD

The Lower Limit of Detection (LoD) is defined as the lowest concentration of N RNA that can be consistently detected (typically in >=95% of 20 swab samples tested): 3 copies/rxn or 100 copies/mL swab

Restrictions

Research Use Only in the United States.

CE Marked IVD for EU Market.

Components

- Tube x 96: RT-PCR Mix, lyophilized microsphere – Primers, probes, reaction buffer, Mg2+, dNTPs, M-MLV Reverse Transcriptase, Taq DNA Polymerase (96 preps)

- Tube × 1: Positive Control (PC), lyophilized microsphere – Synthetic RNA

- Tube × 1: Negative control (NC) – Negative control (NC)

Online Inquiry

Inquire the FireGene COVID-19 Nucleic Acid Detection Kit (Real Time RT-PCR Method) by filling out the form below. Free shipping within the United States for lyophilized products.

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