BK VIRUS R-GENE®REAL TIME PCR ASSAYS - ARGENE® TRANSPLANT RANGE

The power of true experience

CLINICAL CONTEXT1,2

BK virus (BKV) is a DNA virus, member of the Polyomaviridae family. This is an ubiquitous virus with a seroprevalence reaching 90%. First infection, usually asymptomatic, most often occurs in early childhood. After primary infection, BKV migrates to the primary sites of latency, such as the kidney and the urothelium. During speci� c physiological or pathological states (e.g immunocompromised patients), BKV can be reactivated.

In transplant patients, BKV infection is linked to two major complications: BKV associated nephropathy in kidney transplant patients and BKV associated hemorrhagic cystitis in hematopoietic stem cell transplant patients1, 2.

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BK VIRUS R-GENE®

bioMérieux S.A. • 69280 Marcy l’Etoile • France • Tel.: + 33 (0)4 78 87 20 00 • Fax: +33 (0)4 78 87 20 90www.biomerieux.com

OTHER ARGENE® TRANSPLANT KITS• EBV R-GENE® (69-002B) • CMV R-GENE® (69-003B) • HSV1 HSV2 VZV R-GENE® (69-004B) • ADENOVIRUS R-GENE® (69-010B)

• Parvovirus B19 R-GENE® (69-019B) • CMV HHV6,7,8 R-GENE® (69-100B)

REFERENCES1. Gilis et al. High burden of BK virus-associated hemorrhagic cystitis in patients undergoing allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplantation 2014; 49: 664–6702. Sueur et al. Toward Standardization of BK Virus Monitoring: Evaluation of the BK Virus R-gene Kit for Quantification of BK Viral Load in Urine, Whole-Blood, and Plasma Specimens.

J Clin Microbiol. 2014; 52(12): 4298-304.

ORDERING INFORMATION BK Virus R-GENE® - Ref. 69-013B

Type of kit Real-time detection and quanti� cation kit

Gene target Gene located in the Small T Antigen (StAg) area coding for StAg protein

Validated specimens Whole blood, Plasma, Urine

Validated extraction platformsEMAG®, easyMAG®, MagNA Pure Compact, MagNA Pure LC, MagNA Pure 96, QIAsymphony SP, QIAamp DNA Blood Mini Kit, DNA Extraction kit (ref. 67-000)

Validated ampli� cation platformsLightCycler 2.0, LightCycler 480 (System II), ABI 7500, ABI 7500 Fast, ABI 7500 Fast Dx, ViiA 7, StepOne, Rotor-Gene Q, CFX96

Limit of Detection (LoD 95%)Whole Blood: 2.6 log10 copies/mLPlasma: 2.3 log10 copies/mLUrine: 2.5 log10 copies/mL

Quanti� cation Range Whole Blood: 2.6 to 8.4 log10 copies/mLPlasma: 2.3 to 9.0 log10 copies/mLUrine: 2.5 to 9.1 log10 copies/mL

Controls includedExtraction / Inhibition Control, Negative Control, Positive Control (QS3), 4 Quanti� cation Standards, Sensitivity Control

Number of tests 90 tests

Storage conditions -15°C / -31°C

Status For in vitro diagnostic use, CE-IVD marking

TECHNICAL INFORMATION

KEY FEATURES

• Ready-to-use reagents

• Complete qualitative and quantitative kit

• Validated on most relevant sample types

• Validated with the major extraction and ampli� cation platforms

• Designed for low to high throughput analysis

• Same procedure for all the ARGENE® Transplant kits