HSV1&2 VZV R-GENE® HSV1 HSV2 R-GENE® VZV R-GENE®

Real-time PCR kit for the detection and quantification of Herpes Simplex viruses (HSV) 1 & 2 and Varicella-Zoster Virus (VZV) DNA

  • Reliable quantification and detection of HSV1& 2 in one PCR tube and VZV
  • Ready to use kits including internal control & controls (quantification standards and/or positive controls)
  • CE-IVD on various relevant sample types as well as on all major extraction platforms & real-time PCR systems

HSV-1, HSV-2 and VZV are responsible for a wide spectrum of clinical conditions from rashes to encephalitis in both immunocompetent and immunocompromised people. That’s why you want optimized detection and monitoring of HSV-1, HSV-2 and VZV infection. In the ARGENE® range, you will find a set of 3 assays, offering rapid and specific detection, to choose upon your needs and your laboratory workflow. You can detect infection prior to clinical symptoms to improve options for management and test patients during treatment to measure its effectiveness. You can also test after treatment to monitor for relapse. For even more comprehensive testing, you can use the R-GENE® range to quantify various viruses from one sample or simultaneously analyze various samples for a single type of virus.

  • Sensitive and reproductible
    • HSV1&2 VZV R-GENE® :
      • Reliable simultaneous detection and measurement of HSV-1 & HSV-2
      • Accurate detection and quantification of VZV
      • Wide linear range
    • HSV1 HSV2 R-GENE®
      • Reliable detection of HSV-1 & HSV-2 in one tube
    • VZV R-GENE®
      • Accurate detection of VZV
  • Standardized
    • Uniform processing within ARGENE® Transplant range of products and ENTEROVIRUS R-GENE® and  Parechovirus R-GENE®.
    • Harmonized test profiles for multiple assays in one run.
  • Flexible
    • Validated on most relevant specimen types
    • Validated with major extraction and amplification platforms
    • For use on automated workflow ARGENE® SOLUTION

Everything you need in one kit

HSV1&2 VZV R-GENE® kit is a ready-to-use molecular detection kit that measures the viral load of HSV-1 & HSV-2 in one tube and VZV using real-time PCR after viral DNA extraction. This 5’ nuclease-based real-time PCR assay amplifies a specific region of each virus genome.

  • 4 Quantification Standards ensure accurate HSV-1, HSV-2, VZV viral load
  • 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
  • Includes all necessary reagents optimized to detect and quantify HSV-1 &  HSV-2 (60 tests), and VZV (60 tests) for in vitro diagnostic use

HSV1 HSV2 R-GENE® and VZV R-GENE® are ready-to-use molecular detection kits. HSV1 HSV2 R-GENE® measures the presence of HSV-1 & HSV-2 in the same tube using real-time PCR after viral DNA extraction. VZV R-GENE® measures the presence of VZV. Those 5’ nuclease-based real-time PCR assays amplify a specific region of each virus genome.

  • An Internal Control (IC2) checks the extraction process, including lysis, and the presence of amplification inhibitors in the sample
  • Positive and Negative controls
  • Includes all necessary reagents optimized to detect HSV-1 & HSV-2 (60 tests) and VZV (60 tests) for in vitro diagnostic use

Easy procedure

Using HSV1& 2 VZV R-GENE®, HSV1 HSV2 R-GENE® and VZV R-GENE® kits are easy. Just add the extracted DNA sample 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”.

Technical specifications for 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: HSV1&2 VZV R-GENE® Detection and Quantification kit
Technology Real-Time PCR / 5' nuclease Taqman technology
Parameters HSV-1 HSV-2 VZV
Gene target US7 UL27 gp19 protein
Validated specimens CSF
Whole blood
Plasma
BAL
Mucocutaneous swabs (qualitative only)
Anogenital swabs (qualitative only)
Throat swabs (qualitative only)
CSF
Whole blood
Plasma
BAL
Mucocutaneous swabs (qualitative only)
Anogenital swabs (qualitative only)
Throat swabs (qualitative only)
CSF
Whole blood
Plasma
BAL
Mucocutaneous swabs (qualitative only)
Limit of Detection
(LOD 95%)
CSF: 2.4 log10 copies/mL
Whole Blood, Plasma, BAL: 2.7 log10 copies/mL
Swabs: 3.0 log10 copies/mL
CSF: 2.0 log10 copies/mL
Whole Blood, Plasma, BAL:
2.0 log10 copies/mL
Swabs: 3.0 log10 copies/mL
CSF: 2.5 log10 copies/mL
Whole Blood, Plasma:
2.7 log10 copies/mL
Swabs: 3.0 log10 copies/mL
Quantification Range CSF: 2.4 log10 to 8.0 log10 copies/mL
Whole blood, Plasma, BAL : 2.7 log10 to 8.0 log10 copies/mL 
CSF: 2.0 log10 to 8.0 log10 copies/mL
Whole blood, Plasma, BAL: 2.7 log10 to 8.0 log10 copies/mL 
CSF: 2.7 log10 to 8.0 log10 copies/mL
Whole blood, Plasma  : 2.7 log10 to 8.0 log10 copies/mL 
Validated Extraction platform EMAG®, NUCLISENS® easyMAG®, MagNA Pure 96, QIAsymphony SP
Validated Amplification platform ABI 7500 Fast, ABI 7500 Fast Dx, LightCycler 480 (System II), Rotor-Gene Q, CFX96
Controls included Extraction / Inhibition Control, Negative Control, Positive Control (QS3), 4 Quantification Standards, Sensitivity Control
PCR Protocol Same PCR program as other ARGENE® Transplant kits
Same PCR program as ENTEROVIRUS R-GENE® and Parechovirus R-GENE®
Number of tests 60 tests for HSV1&2, 60 tests for VZV
Storage conditions -15°C / -31°C
Regulatory status For in vitro diagnostic use, CE-IVD marking

 

Technical specifications for HSV1 HSV2 R-GENE®  (71-021)
Principle of the test Genomic detection of HSV1 and HSV-2 
Ordering information Reference 71-021: HSV1 HSV2 R-GENE® Detection kit
Technology Real-Time PCR / 5' nuclease Taqman technology
Parameters HSV-1 HSV-2
Gene target US7 UL27
Validated specimens CSF
Whole blood
Plasma
BAL
Mucocutaneous swabs
Anogenital swabs
Throat swabs
CSF
Whole blood
Plasma
BAL
Mucocutaneous swabs
Anogenital swabs
Throat swabs
Limit of Detection
(LOD 95%)
CSF: 2.4 log10 copies/mL
Whole Blood, Plasma, BAL: 2.7 log10 copies/mL
Swabs: 3.0 log10 copies/mL
CSF: 2.0 log10 copies/mL
Whole Blood, Plasma, BAL: 2.0 log10 copies/mL
Swabs: 3.0 log10 copies/mL
Validated Extraction platform EMAG®, NUCLISENS® easyMAG®, MagNA Pure 96, QIAsymphony SP
Validated Amplification platform ABI 7500 Fast, ABI 7500 Fast Dx, LightCycler 480 (System II), Rotor-Gene Q, CFX96
Controls included Extraction / Inhibition Control, Negative Control, Positive Control
PCR Protocol Same PCR program as other ARGENE® Transplant kits
Same PCR program as ENTEROVIRUS R-GENE® and Parechovirus R-GENE®
Number of tests 60 tests
Storage conditions -15°C / -31°C
Regulatory status For in vitro diagnostic use, CE-IVD marking

 

Technical specifications for VZV R-GENE® (71-022)
Principle of the test Genomic detection of VZV
Ordering information Reference 71-022 : VZV R-GENE® Detection kit
Technology Real-Time PCR / 5' nuclease Taqman technology
Parameters VZV
Gene target gp19 protein
Validated specimens CSF
Whole blood
Plasma
Mucocutaneous swabs
Limit of Detection
(LOD 95%)
CSF: 2.5 log10 copies/mL
Whole Blood, Plasma: 2.7 log10 copies/mL
Swabs: 3.0 log10 copies/mL
Validated Extraction platform EMAG®, NUCLISENS® easyMAG®, MagNA Pure 96, QIAsymphony SP
Validated Amplification platform ABI 7500 Fast, ABI 7500 Fast Dx, LightCycler 480 (System II), Rotor-Gene Q, CFX96
Controls included Extraction / Inhibition Control, Negative Control, Positive Control
PCR Protocol Same PCR program as other ARGENE® Transplant kits
Same PCR program as ENTEROVIRUS R-GENE® and Parechovirus R-GENE®
Number of tests 60 tests
Storage conditions -15°C / -31°C
Regulatory status For in vitro diagnostic use, CE-IVD marking

 

Fast facts on HSV-1, HSV-2 and VZV

What are HSV-1, HSV-2 and VZV?

There are eight human Herpesviridae, of which Herpes Simplex Virus Types 1 (HSV-1) and 2 (HSV-2) and Varicella Zoster Virus (VZV) are the most common in immunocompetent patients. The primary infection of HSV-1 and HSV-2 and VZV is generally limited to the mucous membranes and the skin. Usually benign, the infections linked with these viruses can nevertheless develop into severe clinical forms such as encephalitis, meningitis, retinitis and neonatal infections. After primary infection, the viruses persist in the host in a latent state. However, when assisted by chronic or transient immunosuppression, they can be reactivated, causing recurrent infections. In these severe and often atypical infections, the implicated virus cannot be identified. For many years various antivirals have proven their worth in efficiently treating these pathologies if prescribed early and at appropriate doses.

Who is most at risk?

Both immunocompetent and immunodepressed people can be affected by these viruses. Among the severe forms of HSV-1, HSV-2 or VZV infections in adults, HSV-1-induced encephalitis – of which there are 1/250,000 to 1/1,000,000 cases per year – can still be fatal if untreated. Encephalitis caused by HSV-2 or VZV usually has a more favorable prognosis. However, neonatal encephalitis can be traced to both HSV-1 and HSV-2 viruses, but the HSV-2 virus is responsible for the most serious neurological disorders. VZV virus has long been associated with encephalitis in immunodepressed patients. More recently, viral genome detection techniques have also increasingly shown VZV in meningo-encephalitis type infections in immunocompetent subjects.

What are the benefits of HSV-1, HSV-2 and VZV testing?

Conventional immunological culture and detection techniques are suitable for diagnosing the benign skin infections for which these viruses are responsible. However, they are unsuitable for severe infections of the central nervous system (CNS) and congenital infections. In severe infections, it is essential to obtain an early and rapid diagnosis of the infection. Quantitative HSV-1, HSV-2 and VZV DNA PCR tests are the ideal tool for CNS specimens and to follow congenital infections. Real-Time quantitative PCR-based assays for HSV-1, HSV-2 and VZV can be used to detect the presence of the virus and keep track of the course of the infections by monitoring the effectiveness of active treatment and for relapse after treatment.

 

Publications

Evaluation of the new HSV1&2 VZV R-GENE® kit for HSV1, HSV2 and VZV load measurement.
M. Solis, H. Khiri, A. Beby-Defaux, F.Gallais,D. Boutolleau, S. Fafi-Kremer
ESCV 2019

Evaluation of the new HSV1&2 VZV R-GENE® and the CELL control R-GENE® kits for the quantification of herpes simplex virus 1 genome in broncho-alveolar lavage from patients with bronchopneumonitis
D. Boutolleau, M. Boivin, C. le Clec’h, I. Hourcq, S. Burrel
ESCV 2019

Comparative evaluation of the new HSV1&2 VZV R-GENE® and a real-time PCR laboratory-developed tests for the detection and quantification of varicella-zoster virus (VZV) genome in clinical samples
D. Boutolleau, M. Boivin, C. le Clec’h, I. Hourcq, S. Burrel
ESCV 2019

Evaluation of the analytical performance of the new HSV1&2 VZV R-GENE® kit – results on HSV1 and HSV2
M. Bertrand, M. Bonabaud, M. Dube, P. Marechal, M. Muntaner, C. Vidal, A. Derome, F. Gelas, M. Joannes
ESCV 2019

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