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ARGENE®

R-GENE® Real-time PCR assays for use on open platforms

Built on more than 30 years of expertise in virological diagnosis, ARGENE®  offers a range of complete and ready-to-use PCR kits, for use on most open real-time PCR systems, for infectious diseases diagnosis.

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R-GENE® Real-Time PCR assays

R-GENE® assay ranges provide an extensive menu of parameters. Offering sensitivity and specificity, R-GENE® assays enable to provide rapid and reliable results for the management of viral infections. Time-to-results for all kits is within 2 hours (after extraction).

Standardized

  • Uniform processing within the R-GENE® range of products
  • Harmonized protocol for multiple assays in one run
  • Protocol to convert quantification results from copies/mL into IU/mL with WHO International Standards (available for CMV, EBV, B19V, BKV, HHV6)

CE-IVD assays

  • On major extraction platforms (including NUCLISENS® easyMAG® and EMAG®)
  • On major real-time PCR systems
  • On most relevant specimen types

Ease-of-use

  • Just add the extracted sample to the ready-to-use PCR master mix and start the PCR on the appropriate thermocycler
  • Use manual or automated assay setup platform such as ESTREAM®
  • “A la carte” testing

All-inclusive

  • Ready-to-use amplification master mix, Positive control and negative control
  • Internal control 
  • In quantitative assays, 4 Quantification Standards and 1 Sensitivity Control
KIT DESIGNATION REFERENCE TYPE OF KIT NUMBER OF TESTS REGULATORY STATUS*

ARGENE® TRANSPLANT RANGE
EBV R-GENE® 69-002B Real-time detection and quantification kit 90 For In vitro diagnostic use (IVDR)
CMV R-GENE® 69-003B Real-time detection and quantification kit 90 For In vitro diagnostic use (IVDR)
HSV1&2 VZV R-GENE® 69-014B Real-time detection and quantification kit 120 For In vitro diagnostic use (IVDR)
ADENOVIRUS R-GENE® 69-010B Real-time detection and quantification kit 90 For In vitro diagnostic use (IVDD)
BK Virus R-GENE® 69-013B Real-time detection and quantification kit 90 For In vitro diagnostic use (IVDR)
Parvovirus B19 R-GENE® 69-019B Real-time detection and quantification kit 90 For In vitro diagnostic use (IVDR)
HHV6 R-GENE® 69-006B Real-time detection and quantification kit 90 For In vitro diagnostic use (IVDR)

ARGENE® RESPIRATORY RANGE
Rhino&EV/Cc R-GENE 71-042 Real-time detection kit 60 For In vitro diagnostic use (IVDR)
COVID-19 R-GENE® 424017 Real-time detection kit 96 For In vitro diagnostic use (IVDD)
SARS-COV-2/FLUA/FLUB/RSV R-GENE® 424433 Real-time detection kit 96 For In vitro diagnostic use (IVDR)

ARGENE® BIOMARKER RANGE
TTV R-GENE® 423414 Real-time detection and quantification cation kit 90 For In vitro diagnostic use (IVDR)

OTHER ARGENE® PRODUCTS
ENTEROVIRUS R-GENE® 69-005B Real-time detection kit 90 For In vitro diagnostic use (IVDD)
Parechovirus R-GENE® 71-020 Real-time detection kit 60 For In vitro diagnostic use (IVDD)
HSV1 HSV2 R-GENE® 71-021 Real-time detection kit 60 For In vitro diagnostic use (IVDR)
VZV R-GENE® 71-022 Real-time detection kit 60 For In vitro diagnostic use (IVDR)
MONKEYPOX R-GENE® 424556 Real-time detection kit 96 For research use only
JC Virus R-GENE® Primers/Probe 71-004 Primers/Probe Mix 60 For research use only
DICO Extra R-GENE® 71-101 Processing Control 100 For research use only
RICO Extra R-GENE® 71-105 Processing Control 100 For research use only
CELL Control R-GENE® 71-106 Processing Control 100 For In vitro diagnostic use (IVDD)
RNA Internal Control R-GENE® 71-110 Processing Control 60 For general laboratory use
DNA Internal Control R-GENE® 71-120 Processing Control 60 For general laboratory use

*IVDR : CE marked under EU regulation 2017/747
*IVDD : CE marked under EU directive 98/79/CE 

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

All products for:Antimicrobial Resistance ManagementBacteriaBIOFIRE®CNS pathogensEnterovirusFungiHuman herpes virusesHealthcare-Associated InfectionsMolecular diagnosticsMultiplex testingBacterial infectionsReal-time amplificationCentralized testingCNS infectionsSepsis ManagementFungal infections

BIOFIRE® FILMARRAY® Meningitis/Encephalitis (ME) Panel

The BIOFIRE® FILMARRAY® Meningitis-Encephalitis (ME) Panel enables rapid and accurate automated testing for common pathogens that cause central nervous system infections, including viruses, bacteria and yeast.

  • Simple: 2 minutes of hands-on time
  • Fast: Turnaround time of about an hour
  • Comprehensive: Simultaneously tests for 14 targets
  • Accurate: 94.2% sensitivity and 99.8% specificity
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Simple, comprehensive meningitis/encephalitis testing

The BIOFIRE® FILMARRAY® Meningitis/Encephalitis (ME) Panel tests cerebrospinal fluid (CSF) for the 14 most common pathogens responsible for community acquired meningitis or encephalitis including viruses, bacteria and yeast. The Panel received FDA De Novo clearance in October 2015*. It is designed for use with the integrated BIOFIRE® FILMARRAY® system, an FDA, CE-IVD, and TGA certified multiplex PCR system.  With sample preparation, amplification, detection and analysis in one automated system, total run time is about an hour, with only 2 minutes of hands-on time.

Meningitis affects more than 1.2 million people and bacterial meningitis causes 120,000 deaths globally each year 1. It often affects healthy people, but environmental factors and immunocompromised conditions (due, for example, to HIV or chemotherapy) are significant risks. Meningitis can cause brain damage, hearing loss, blindness and death. Symptoms can appear suddenly and escalate quickly, so rapid diagnosis is critical to patient outcomes.  Yet, due to overlapping symptoms, rapid identification of the causative agents is not possible based on clinical indications alone.2,3

 

Now, the unique BIOFIRE® ME Panel is the first system to be able to simultaneously test for 14 targets on a single CSF sample. This provides accurate identification with a rapid one-hour turnaround, helping clinicians to quickly ensure appropriate care. Testing CSF for multiple organisms has previously been problematic because it may be difficult to obtain enough fluid from the patient to run multiple tests4. The BIOFIRE® FILMARRAY® ME Panel can contribute to better antimicrobial resistance management by avoiding unnecessary antibiotic use; reducing lengths of hospital stays and decrease costs5.

  • Simple: 2 minutes of hands-on time
  • Fast: Turnaround time of about an hour
  • Comprehensive: Simultaneously tests for 14 targets
  • Accurate: 94.2% Sensitivity and 99.8% specificity

 

The other available panels are:

14 target pathogens at once

BIOFIRE® FILMARRAY® ME Panel targets:

Bacteria Viruses
  • Escherichia coli K1
  • Haemophilus influenzae
  • Listeria monocytogenes
  • Neisseria meningitidis
  • Streptococcus agalactiae
  • Streptococcus pneumoniae
  • Cytomegalovirus (CMV)
  • Enterovirus (EV)
  • Herpes simplex virus 1 (HSV-1)
  • Herpes simplex virus 2 (HSV-2)
  • Human herpesvirus 6 (HHV-6)
  • Human parechovirus (HPeV)
  • Varicella zoster virus (VZV)
 
Yeast
  • Cryptococcus neoformans/gattii (C. neoformans/C. gattii)

 

References:

1) http://www.comomeningitis.org/news-and-events/world-meningitis-day. Accessed April 3, 2015

2) Bamberger DM. Am Fam Physician. 2010;82:1491-1498.

3) NINDS. Meningitis and Encephalitis Fact Sheet. Updated November 24, 2014. Accessed January 6, 2015.

4) FDA allows marketing of the first nucleic acid-based test to detect multiple pathogens from a single sample of cerebrospinal fluid- FDA press release, October 8, 2015

5) K.M. McNabb et al. Implementation of a Rapid Molecular Meningitis Panel. Poster 2017.  New Hanover Regional Medical Center. Wilmington, North Carolina

Panel Specification

Sample Handling
Performance Parameters
Sample Type: Cerebrospinal Fluid Hands-on time: Approx. 2 minutes
Sample Volume: 200 μL Run turnaround time: About an hour
 

Technical Notes:

Instructions for Use and Manuals

Product Support Documents:

EC Declarations of conformity:

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

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