bioMérieux announces the CE marking of NEPHROCHECK® test on VIDAS®

03 February, 2021

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SARS-COV-2 RESPI R-GENE®

Real-time PCR kit for the detection of SARS-CoV-2, Influenza A, Influenza B, RSV A&B and hMPV A&B

  • One all-in-one kit
  • Same eluate, same run, five viral answers:
    • Flu-like symptoms: SARS-CoV-2, Influenza A, Influenza B with PCR 1
    • If clinically needed: Add RSV & hMPV with PCR 2
  • Cell control for sample quality validation
  • Validated in nasopharyngeal swabs
  • Validated on major extraction and amplification platforms
  • Results delivered in 4 to 5 hours

SARS-COV-2 R-GENE® advantages

  • All-in-one kit for an efficient order management
  • Same eluate, same run, five viral answers:
    • Flu-like symptoms: SARS-CoV-2, Influenza A, Influenza B with PCR 1
    • If clinically needed: Add RSV & hMPV with PCR 2
  • Cell control for sample quality validation is included in PCR1, reducing false negatives for increased safety
  • 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 ARGENE® SOLUTION for automated workflow
  • Parallel testing possible with additional ARGENE® Respiratory assays

Everything you need in one kit

The SARS-COV-2 RESPI R-GENE® kit is a molecular qualitative detection kit for in vitro diagnostic use, using real-time PCR technology after nucleic acid extraction. This assay includes all necessary reagents optimized to detect SARS-CoV-2, Influenza A, Influenza B, RSV A&B and hMPV A&B:

  • Ready-to use master mix (including Taq polymerase)
  • Reverse transcriptase
  • Positive controls
  • Negative control
  • A cellular control included in PCR1 to check the sample quality

Easy procedure

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

 

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Ordering information SARS-COV-2 RESPI R-GENE® - Ref.: 423732
Kit content

All included

Positive controls, Negative Control, Cell control

Gene targets

PCR1 (96 tests)

SARS-CoV-2 : N & RdRp (670 nm)

Influenza A : M gene (530 nm)

Influenza B : M gene (560 nm)

Cell control : HPRT1 (610 nm)

PCR2 (96 tests)

RSV A/B : N gene (530 nm)

hMPV A/B : M gene (560 nm)

Number of tests 96 tests
Validated Specimen Nasopharyngeal swabs
Validated Platforms Extraction Amplification
  • EMAG®
  • NUCLISENS® easyMAG®
  • MGISP-960
  • QIAsymphony SP
  • MagNA Pure 96
  • ABI 7500 Fast
  • ABI 7500 Fast Dx
  • QuantStudio 5
  • QuantStudio 5 Dx
  • CFX96
Shelf Life 12 months at launch
Regulatory Status For In vitro Diagnostic use (CE-IVD)
Storage conditions -15°C / -31°C

 

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

test

bioMérieux announces the expansion of the CE marking of its molecular biology ARGENE® SARS-CoV-2 diagnostic test to include saliva specimens.

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