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SARS-COV-2 R-GENE®

Real-time PCR kit for the detection of SARS-COV-2, the causative pathogen of COVID-19

  • One all-in-one kit
  • Two triplex PCR
  • Results delivered in 4 to 5 hours
  • Validated on major extraction and amplification platforms
  • Validated in nasopharyngeal swabs, nasal swabs, oropharyngeal (throat) swabs and saliva
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SARS-COV-2 R-GENE® advantages

  • All-in-one kit for an efficient order management
  • Two triplex PCR for reliable diagnosis
    • PCR1
      • SARS-COV-2 N gene (FAM) / Internal Control (HEX) / SARS-COV-2 RdRp gene (CY5)
      • is performed as a first step for the detection of SARS CoV 2
    • PCR2
      • SARBECOVIRUS E gene (FAM) / Internal Control (HEX) / Cellular Control (CY5)
      • is optional and may be performed on the same eluate to monitor sample quality by confirming the presence of human cells
  • Internal control to check PCR processing & cellular control to check sampling for secured results
  • Results delivered in 4 to 5 hours for optimized workflow and better patient management
  • Laboratory workflow integration
    • Validated on major extraction and amplification platforms
    • For use on manual workflow or on automated workflow ARGENE® SOLUTION

Everything you need in one kit

The SARS-COV-2 R-GENE® kit is a molecular detection kit, using real-time PCR after viral nucleic acids extraction. Assay includes all necessary reagents optimized to detect SARS-COV-2 for in vitro diagnostic use:

  • Ready-to use master mix (including Taq polymerase)
  • Reverse transcriptase
  • Positive controls
  • Negative control
  • An Internal Control (IC1) checks the extraction process and the presence of amplification inhibitors in the sample (in PCR1)
  • A cellular control checks the sampling (in PCR2)

Easy procedure

Using SARS-COV-2 R-GENE® assay is easy. Just add the extracted RNA sample to the ready-to-use PCR master mix and start the reaction on the appropriate Real-Time PCR thermocycler, following optimized cycling program described in the “Instructions For Use”.

 

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SARS-COV-2 R-GENE® (423720) - Real Time Detection kit
Principle of the test Genomic detection of SARS-COV-2
Ordering information Reference: 423720

Designation: SARS-COV-2 R-GENE® - Real Time Detection kit
Technology Real-Time PCR / 5‘ nuclease technology
Gene target N gene (PCR 1), RdRp gene (PCR 1) and E gene (PCR 2)
Specimen Nasopharyngeal swabs, nasal swabs, oropharyngeal (throat) swabs and saliva
Detection limit LoD 95%: 0.43 TCID50/mL (equivalent to 380 copies/mL)
Controls included Extraction / Inhibition Control, Negative Control, Positive Controls, Cell control
Results within 120 minutes after extraction
Number of tests 120 tests (120 tests PCR1 + 30 tests PCR2)
Storage conditions -15°C/-31°C
Extraction platform

- EMAG®

- NUCLISENS® easyMAG®

- MagNA Pure Compact

- MagNA Pure 96

- QIAsymphony SP

- MGISP-960
Amplification platform - LightCycler 480 (System II)

- ABI 7500 Fast, ABI 7500 Fast Dx

- QuantStudio5, QuantStudio5 Dx

- Rotor-Gene Q

- CFX96
Status For in vitro diagnostic use, CE-IVD marking

 

Please consult your local bioMérieux representative for product availability in your country

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