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BK Virus R-GENE®

Real-time PCR kit for the detection and quantification of BK virus (BKV) DNA

  • Accurate quantification of BK viral load over a wide linear range
  • Ready-to-use kit with internal control & quantification standards
  • CE-IVD on all major extraction platforms and real-time PCR systems as well as on different samples types

 

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BK Virus R-GENE® advantages

BK virus has been identified as an important pathogen in interstitial nephropathy in kidney transplant patients (which could leads to organ rejection) and hemorrhagic cystitis in hematopoietic stem cell transplant patients. Due to these concerns, optimized detection and monitoring of BK virus infection is important. BK Virus R-GENE® is an ideal solution, offering rapid and specific detection. You can detect infection prior to clinical symptoms, which helps improve options for management. You can also test patients during treatment to measure the effectiveness of treatment and after treatment to monitor for relapse. Plus – for more comprehensive testing – using the broad R-GENE® range lets you quantify various viruses for one sample or analyze various samples for one virus at the same time.

  • Sensitive and reproducible
    • Reliable measurement of BK virus infection
    • Wide linear range
  • Standardized
    • Uniform processing with R-GENE® range of products (CMV R-GENE®, HSV1 HSV2 VZV R-GENE®, CMV HHV6,7,8 R-GENE®, ADENOVIRUS R-GENE®, EBV R-GENE®, Parvovirus B19 R-GENE®)
    • Harmonized test profiles for multiple assays in one run
  • Flexible
    • Validated for use with various samples types
    • Use manual or automated sample preparation, such as eMAG®, and assay setup systems, such as eSTREAM® liquid handling platform
    • Qualified with the major real-time PCR platforms

Everything you need in one kit

The BK Virus R-GENE® kit is a ready-to-use molecular detection kit. It measures the viral load of BK virus using real-time PCR after viral DNA extraction. It works by amplifying and simultaneously detecting a specific region of the BK virus genome using 5’ nuclease Taqman technology.

  • Four Quantification Standards ensure accurate measurement of BK Virus viral load
  • A Sensitivity Control validates the assay’s performance
  • An Internal Control (IC2) checks the extraction process, including lysis, & the presence of amplification inhibitors in the sample
  • Includes all necessary reagents optimized to detect and quantify BK virus for in vitro diagnostic use
  • Supplementary reagents also available: JC Virus R-GENE® Primers/Probe

Easy procedure

Using the BK Virus R-GENE® kit is 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”.

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BK Virus R-GENE® (69-013B)
Principle of the test Genomic detection and quantification of BK virus
Ordering information Reference 69-013B - BK Virus R-GENE® - Real Time Detection and Quantification kit
Technology Real-Time PCR / 5‘ nuclease technology
Gene target Small T Antigen (StAg)
Specimen types validated Whole blood, Plasma, Urine
Limit of Detection (LoD) -Whole blood: 2.6 Log copies/mL
-Plasma: 2.3 Log copies/mL
-Urine: 2.5 Log copies/mL
Dynamic Range of Quantification -Whole blood: from 2.6 to 8.4 Log copies/mL
-Plasma: 2.3 to 9.0 Log copies/mL
-Urine: 2.5 to 9.1 Log copies/mL
Controls included Extraction/Inhibition Control, Negative Control, Quantification Standards Sensitivity Control
Results within 90 minutes after extraction
Reporting unit Copies/mL (possibility to convert into IU/mL)
Number of tests 90 tests
Storage conditions -15°C/-31°C 
Validated Extraction platform  EMAG®
NUCLISENS® easyMAG®
MagNA Pure Compact
MagNA Pure LC
MagNA Pure 96
QIAsymphony SP
Validated Amplification platform ABI 7500 Fast, ABI 7500 Fast Dx
LightCycler 480 (System II)
Rotor-Gene Q
CFX96
Status For in vitro diagnostic use

 

Fast facts on BK Virus

What is BK Virus?

A polyomavirus belonging to the papovaviridae family, BK virus infects the human population – it is believe that 60 to 100% of people carry a latent form. Primary infection is asymptomatic and migrates through the respiratory tract during early childhood. Thereafter, the virus migrates to the primary sites of latency, such as the kidney and the urothelium. In general, the prevalence of BK virus in urine lies between 0.3% and 6%, but this prevalence increases with the level of immunosuppression.

Who is most at risk?

Kidney transplant patients and hematopoietic stem cell transplant patients are most at risk due to immunosuppression. The reactivation of symptoms is associated with urinary tract infections and manifests itself as hemorrhagic cystitis (in bone marrow transplant patients), urethral stenosis, tubulo-interstitial nephropathy and interstitial nephritis (in kidney transplant patients). Interstitial nephritis is an opportunistic and emerging renal tropism infection and is the major cause of organ rejection.

What are the benefits of BK Virus testing?

Real-Time PCR-based assays for BK virus enable rapid and specific detection prior to clinical symptoms to help improve outcomes. This is especially important for monitoring the potential reactivation of BKV in renal transplant patients. Early diagnosis of BK nephropathy has been shown to positively impact the organ survival. Testing helps keep track the course of the infection and monitor for relapse after treatment.

 

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