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Imegen-SARS-CoV-2 Plus RNaseP

Description

Detection of SARS-CoV-2 coronavirus in respiratory samples by detecting the E, S and ORF1ab genes and the endogenous human RNaseP gene by real-time reverse transcription (rRT-PCR)

Format

96 rxn

Technology

Reverse transcription in real time

Reference

IMG-376

Compatible equipment

7500 FAST Real-Time PCR System (ThermoFisher), QuantStudio 5 Real-Time PCR System (ThermoFisher)

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Characteristics
Technology
Technical specifications
Documentation

Multiplexed qualitative assay that allows determining the presence of 3 SARS-CoV-2 targets and one human endogenous target by studying two multiplexed rRT-PCR reactions.
The human endogenous gene, RNaseP, allows evaluating the process of obtaining the respiratory sample, the quality of the sample and the process of extracting nucleic acids.
Detection Limit: 20 copies (FDA Acceptance Criteria)
Genomic inclusiveness: In silico design based on 3,123 genomes (GISAID)
It complies with the quality requirements specified by ISO 13485 and ISO 14001 in relation to the materials used in its manufacturing process.
For in vitro diagnostic use.

Imegen SARS-CoV-2 Plus RNaseP is a real-time reverse transcription PCR test intended for the qualitative detection of extracted SARS-CoV-2 RNA in nasal swab, nasopharyngeal swab, and oropharyngeal swab specimens collected from the upper respiratory tract. of individuals suspected of having COVID-19 by their medical specialist.

Sample type: RNA purified from respiratory samples
Required sample amount: 6 µL
Number of reactions per sample: 1
Number of targets: 4
Manual working time: 10 – 30 min
Duration of the rRT-PCR program: 1h 20 min
Supported Platforms: 7500 FAST Real-Time PCR System (ThermoFisher Scientific), QuantStudio 5 Real-Time PCR System (ThermoFisher Scientific)

Imegen-SARS-CoV-2 Plus RNaseP: Instructions for use

Imegen-SARS-CoV-2 Plus RNaseP: MSDS

Analysis certificate