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Imegen-SARS-CoV-2

Description

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

Format

96 rxn

Technology

Reverse transcription in real time

Reference

IMG-356

Compatible equipment

7500 FAST Real-Time PCR System (ThermoFisher), StepOne Plus Real-Time PCR System (Thermo Fisher), CFX96 Real-Time PCR System (BioRad), LightCycler 480 (Roche)

Kit Health in Code
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  • Multiplexed qualitative assay that allows determining the presence of 3 specific targets of SARS-CoV-2 and one human endogenous target by studying two multiplexed rRT-PCR reactions.
  • The human endogenous gene, RNase P, allows the quality of the sample to be evaluated.
  • Detection limit: 10 copies.
  • 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.
  • Approved by the Carlos III Health Institute (ISCiii).

Imegen SARS-CoV-2 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 COVID-19 by their medical specialist.

  • Sample type: RNA purified from respiratory samples
  • Required sample amount: 12 µL
  • Number of reactions per sample: 2
  • Number of targets: 4
  • Manual working time: 10 – 30 min
  • Duration of the rRT-PCR program: 1h 20 min
  • Compatible Platforms: 7500 FAST Real-Time PCR System (ThermoFisher Scientific), StepOne Real-Time PCR System (ThermoFisher Scientific), CFX96 Touch Real-Time PCR System (BioRad), CFX96 Real-Time PCR System (BioRad), Light Cycler 480 PCR System (Roche)
Imegen-SARS-CoV-2: Instructions for use
Imegen-SARS-CoV-2: Validation Report
Imegen-SARS-CoV-2: MSDS
Analysis certificate

Imegen-SARS-CoV-2

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