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ARGENE® Transplant

For Viral Infection Management in Transplant Patients

Our real-time PCR assays permit rapid and speci­fic detection of various viral infections prior to viral diseases. This is of vital importance in the management of the transplant patients, to prevent rejection and to allow patient survival.

  

Disclaimer: Product availability varies by country. Please consult your local bioMérieux representative for product availability in your country.

Overview

Detecting Active Viral Infections

By using our quantitative real-time PCR assays to monitor patients, at prede­fined intervals after transplantation, clinicians can detect active infections before symptoms arise. 

Optimized detection and monitoring of infection in immunocompromised patients is critical to ensure the best patient management. Our ARGENE® Transplant range offers rapid and specific detection even prior to clinical symptoms, making it an ideal solution. This helps improve options for management, measure the effectiveness of treatment, and monitor for relapse. For even more comprehensive testing, you can use the broad ARGENE® range to quantify different viruses in one sample or analyze various samples for one virus at the same time.

  • Sensitive and reproducible
    • Reliable measurement of viral infection
    • Wide linear range    
  • Standardized
    • Uniform processing with ARGENE® range of products & harmonized test profiles for multiple assays in one run
    • Protocol to convert quantification results into IU/mL with the WHO 1st International Standard (only valid for some of the viruses detected by the transplant range)
  • Flexible
    • Validated for use with various sample types
    • Use manual or automated sample preparation such as nucliSENS® easyMAG® and EMAG® and assay setup system such as ESTREAM® liquid handling platform
    • Qualified with the major real-time PCR platforms

Everything You Need in 1 Kit

The ready-to-use R-GENE® molecular detection kit measures viral load in DNA extracts from different clinical samples. This 5’ nuclease-based real-time PCR assay amplifies a specific region of the viral genome for detection and quantification.

  • Four Quantification Standards ensure accurate viral load measurement
  • Sensitivity Control validates the performance of the assay
  • An Internal Control (IC2) checks the extraction process, including lysis, and the presence of amplification inhibitors in the sample
  • All necessary reagents optimized to detect and quantify viral infection for in vitro diagnostic use are ready to use:
    • Less technician time
    • Less risk of manipulation or dilution error
    • Less risk of contamination

Easy Procedure

Using R-GENE® assays is so simple, all you need to do is add the sample extracted DNA to the ready-to-use PCR master mix and start the reaction on the appropriate Real-Time PCR thermocycler, following the optimized cycling program described in the “Instructions For Use” document.

ARGENE Transplant

ARGENE® Expertise

  • Simplicity: complete kits, ready-to-use reagents, same pipetting procedure
  • Seamless Integration: validated for use on multi-specimens, multi-extraction and multi-amplification platforms
  • Lab Efficiency: common internal control, harmonized extraction and amplification protocols, multiple targeted detection from one extracted sample

Assays

KIT DESIGNATIONREFERENCESTYPE OF KITNUMBER OF TESTSREGULATORY STATUS*
EBV R-GENE®69-002BReal-time detection and quantification kit90For In vitro diagnostic use (IVDR)
CMV R-GENE®69-003BReal-time detection and quantification kit
90For In vitro diagnostic use (IVDR)
HSV1&2 VZV R-GENE®69-014BReal-time detection and quantification kit120For In vitro diagnostic use (IVDR)
ADENOVIRUS R-GENE®69-010BReal-time detection and quantification kit90For In vitro diagnostic use (IVDR)
BK Virus R-GENE®69-013BReal-time detection and quantification kit90For In vitro diagnostic use (IVDR)
Parvovirus B19 R-GENE®69-019BReal-time detection and quantification kit90For In vitro diagnostic use (IVDR)
HHV6 R-GENE®69-006BReal-time detection and quantification kit90For In vitro diagnostic use (IVDR)

*IVDR: CE marked under EU regulation 2017/746

EBV R-GENE® (69-002B) 
Principle of the test

Genomic detection and quantification of EBV

Ordering information

Reference 69-002B

Designation: EBV R-GENE® Real-Time Detection and Quantification kit

Technology

Real-Time PCR / 5‘ nuclease Taqman technology

PCR design & Gene targetBXLF1 gene coding for thymidine kinase
Kit contentAll included (Amplification premix, Internal control, Negative control, Quantification standards)

Controls included

Extraction + Inhibition control, Sensitivity control, Negative control

Specimens
  • Whole blood 
  • Plasma
  • Cerebrospinal Fluid (CSF)
  • Bronchoalveolar Lavage (BAL)
Dynamic Range of QuantificationFrom 500 copies/mL and 1.00E+07 copies/mL
Results within

75 minutes (extraction step not included)

Reporting unit

Copies/mL or convert to IU/mL with WHO 1st International Standard

Validated Extraction platforms
  • EMAG® 
  • NUCLISENS® easyMAG®
  • MagNA Pure 96
  • QIAsymphony SP
Validated Amplification platforms
  • Applied Biosystems
    • 7500 Fast
    • 7500 Fast Dx
    • QuantStudio 5
    • QuantStudio 5 Dx
  • LightCycler 480 (System II)
  • CFX96
  • CFX Opus 96
  • Rotor‑Gene Q

Number of tests

90 tests

Storage conditions-15°C/-31°C
StatusFor in vitro diagnostic use (CE marked under EU IVD regulation 2017/746)

CMV R-GENE® (69-003B)
Principle of the test

Genomic detection and quantification of CMV

Ordering information

Reference 69-003B

Designation: CMV R-GENE® Real-Time Detection and Quantification kit

Technology

Real-Time PCR / 5‘ nuclease Taqman technology

PCR design & Gene targetppUL83 protein
Kit contentAll included (Amplification premix, Internal control, Negative control, Quantification standards)

Controls included

Extraction + Inhibition control, Sensitivity control, Negative control

Specimens
  • Whole Blood
  • Plasma
  • Cerebrospinal Fluid (CSF)
  • Bronchoalveolar Lavage (BAL)
  • Urine
  • Amniotic Fluid
  • Saliva Swabs
Dynamic Range of Quantification500 copies/mL and 7.2E+07 copies/mL
Results within

75 minutes (extraction step not included)

Reporting unit

Copies/mL or convert to IU/mL with WHO 1st International Standard

Validated Extraction platforms
  • EMAG® 
  • NUCLISENS® easyMAG®
  • MagNA Pure 96
  • QIAsymphony SP
Validated Amplification platforms
  • Applied Biosystems
    • 7500 Fast
    • 7500 Fast Dx
    • QuantStudio 5
    • QuantStudio 5 Dx
  • LightCycler 480 (System II)
  • CFX96
  • CFX Opus 96
  • Rotor‑Gene Q

Number of tests

90 tests

Storage conditions-15°C/-31°C
StatusFor in vitro diagnostic use (CE marked under EU IVD regulation 2017/746)

HSV1&2 VZV R-GENE® (69-014B)
Principle of the test

Genomic detection and quantification of HSV-1, HSV-2 and VZV

Ordering information

Reference 69-014B

Designation: HSV1&2 VZV R-GENE® Detection and Quantification kit

Technology

Real-Time PCR / 5‘ nuclease Taqman technology

PCR design & Gene target
  • HSV-1: US7
  • HSV-2 : UL27
  • VZV : gp19 protein
Kit contentAll included (Amplification premix, Internal control, Negative control, Quantification standards)

Controls included

Extraction + Inhibition control, Sensitivity control, Negative control

Specimens

For qualitative and quantitative detection:

  • Whole blood for HSV-1, HSV-2 and VZV.
  • Blood plasma for HSV-1, HSV-2 and VZV.
  • Cerebrospinal fluid (CSF) for HSV-1, HSV-2 and VZV.
  • Bronchoalveolar lavage (BAL) for HSV-1 and HSV-2.

For qualitative detection:

  • Throat swabs for HSV-1 and HSV-2.
  • Anogenital swabs for HSV-1 and HSV-2.
  • Mucocutaneous swabs for HSV-1, HSV-2 and VZV.
Dynamic Range of Quantification
  • Whole blood & blood plasma (for HSV-1, HSV-2 and VZV): 500 copies/mL and 1.0E+08 copies/mL
  • BAL (for HSV-1 and HSV-2): 500 copies/mL and 1.0E+08 copies/mL
  • CSF: 
    • HSV-1: 250 copies/mL and 1.0E+08 copies/mL
    • HSV-2: 100 copies/mL and 1.0E+08 copies/mL
    • VZV: 500 copies/mL and 1.0E+08 copies/mL
Results within

75 minutes (extraction step not included)

Reporting unit

Copies/mL or convert to IU/mL with WHO 1st International Standard

Validated Extraction platforms
  • EMAG® 
  • NUCLISENS® easyMAG®
  • MagNA Pure 96
  • QIAsymphony SP
Validated Amplification platforms
  • Applied Biosystems
    • 7500 Fast
    • 7500 Fast Dx
    • QuantStudio 5
    • QuantStudio 5 Dx
  • LightCycler 480 (System II)
  • CFX96
  • Rotor‑Gene Q

Number of tests

60 tests for HSV1 and HSV2, 60 tests for VZV

Storage conditions-15°C/-31°C
StatusFor in vitro diagnostic use (CE marked under EU IVD regulation 2017/746)

ADENOVIRUS R-GENE® (69-010B)
Principle of the test

Genomic detection and quantification of ADENOVIRUS

Ordering information

Reference 69-010B

Designation: ADENOVIRUS R-GENE® - Real-Time Detection and Quantification kit

Technology

Real-Time PCR / 5‘ nuclease Taqman technology

PCR design & Gene targetHexon gene
Kit contentAll included (Amplification premix, Internal control, Negative control, Quantification standards)

Controls included

Extraction + Inhibition control, Sensitivity control, Negative control

Specimens
  • Whole Blood
  • Plasma
  • Bronchoalveolar Lavage (BAL)
  • Stool
Dynamic Range of Quantification
  • Whole Blood: 1,500 copies/mL and 1.0E+08 copies/mL
  • Plasma & BAL: 500 copies/mL and 1.0E+08 copies/mL
  • Stool: 1,500 copies/g and 1.0E+09 copies/g
Results within

75 minutes (extraction step not included)

Reporting unit

Copies/mL or convert to IU/mL with WHO 1st International Standard

Validated Extraction platforms
  • EMAG® 
  • NUCLISENS® easyMAG®
  • MagNA Pure 96
  • QIAsymphony SP
Validated Amplification platforms
  • Applied Biosystems
    • 7500 Fast
    • 7500 Fast Dx
    • QuantStudio 5
    • QuantStudio 5 Dx
  • LightCycler 480 (System II)
  • CFX96
  • CFX Opus 96
  • Rotor‑Gene Q

Number of tests

90 tests

Storage conditions-15°C/-31°C
StatusFor in vitro diagnostic use (CE marked under EU IVD regulation 2017/746)

BK Virus R-GENE® (69-013B)
Principle of the test

Genomic detection and quantification of BK Virus

Ordering information

Reference 69-013B

Designation: BK Virus R-GENE® - Real-Time Detection and Quantification kit

Technology

Real-Time PCR / 5‘ nuclease Taqman technology

PCR design & Gene targetSmall T Antigen (StAg)
Kit contentAll included (Amplification premix, Internal control, Negative control, Quantification standards)

Controls included

Extraction + Inhibition control, Sensitivity control, Negative control

Specimens
  • Whole Blood
  • Plasma
  • Urine
Dynamic Range of Quantification
  • Whole Blood: 439 copies/mL and 1.0E+06 copies/mL
  • Plasma: 218 copies/mL and 1.0E+06 copies/mL
  • Urine: 315 copies/mL and 1.2E+09 copies/mL
Results within

75 minutes (extraction step not included)

Reporting unit

Copies/mL or convert to IU/mL with WHO 1st International Standard

Validated Extraction platforms
  • EMAG® 
  • NUCLISENS® easyMAG®
  • MagNA Pure 96
  • QIAsymphony SP
Validated Amplification platforms
  • Applied Biosystems
    • 7500 Fast
    • 7500 Fast Dx
    • QuantStudio 5
    • QuantStudio 5 Dx
  • LightCycler 480 (System II)
  • CFX96
  • Rotor‑Gene Q

Number of tests

90 tests

Storage conditions-15°C/-31°C
StatusFor in vitro diagnostic use (CE marked under EU IVD regulation 2017/746)

Parvovirus B19 R-GENE® (69-019B)
Principle of the test

Genomic detection and quantification of Parvovirus B19

Ordering information

Reference 69-019B

Designation: Parvovirus B19 R-GENE® - Real-Time Detection and Quantification kit

Technology

Real-Time PCR / 5‘ nuclease Taqman technology

PCR design & Gene target
NS1 gene
Kit contentAll included (Amplification premix, Internal control, Negative control, Quantification standards)

Controls included

Extraction + Inhibition control, Sensitivity control, Negative control

Specimens
  • Whole Blood
  • Plasma
  • Bone Marrow
Dynamic Range of Quantification

500 copies/mL and 1.00E+10 copies/mL

Results within

75 minutes (extraction step not included)

Reporting unit

Copies/mL or convert to IU/mL with WHO 1st International Standard

Validated Extraction platforms
  • EMAG® 
  • NUCLISENS® easyMAG®
  • MagNA Pure 96
  • QIAsymphony SP
Validated Amplification platforms
  • Applied Biosystems
    • 7500 Fast
    • 7500 Fast Dx
    • QuantStudio 5
    • QuantStudio 5 Dx
  • LightCycler 480 (System II)
  • CFX96
  • Rotor‑Gene Q

Number of tests

90 tests

Storage conditions-15°C/-31°C
StatusFor in vitro diagnostic use (CE marked under EU IVD regulation 2017/746)

HHV6 R-GENE® (69-006B) 
Principle of the test

Genomic detection and quantification of HHV6

Ordering information

Reference 69-006B

Designation: HHV6 R-GENE® - Real Time Detection and Quantification kit

Technology

Real-Time PCR / 5‘ nuclease Taqman technology

PCR design & Gene targetU57 gene
Kit contentAll included (Amplification premix, Internal control, Positive & Negative control, quantification standards)

Controls included

Extraction + Inhibition control, Sensitivity control, Negative control

Specimens
  • Whole Blood
  • Plasma
  • Cerebrospinal Fluid (CSF)
  • Bronchoalveolar Lavage (BAL)
Dynamic Range of Quantification
  • 500 copies/mL and 9.0E+07 copies/mL
Results within

75 minutes (extraction step not included)

Reporting unit

Copies/mL or convert to IU/mL with WHO 1st International Standard

Validated Extraction platforms
  • EMAG® 
  • NUCLISENS® easyMAG®
  • MagNA Pure 96
  • QIAsymphony SP

Validated Amplification platforms

 

  • Applied Biosystems
    • 7500 Fast
    • 7500 Fast Dx
    • QuantStudio 5
    • QuantStudio 5 Dx
  • LightCycler 480 (System II)
  • CFX96
  • Rotor‑Gene Q

Number of tests

90 tests

Storage conditions-15°C/-31°C
StatusFor in vitro diagnostic use (CE marked under EU IVD regulation 2017/746)

Resources

ARGENE® Transplant Range Brochure

PARVOVIRUS B19 R-GENE® Brochure

BK Virus R-GENE® Brochure

ADENOVIRUS R-GENE® Brochure

EBV R-GENE® Brochure

CMV R-GENE®  Brochure

HHV6 R-GENE®  Brochure