HHV6 R-GENE®REAL TIME PCR ASSAYS - ARGENE® TRANSPLANT RANGE

The power of true experience

CLINICAL CONTEXT1,2

Human herpesvirus 6 (HHV-6) is a DNA virus, member of the Herpesviridae family, that includes two species: HHV-6A and HHV-6B. This is an ubiquitous virus with a seroprevalence reaching more than 90% in adult population. Primary infection most often occurs before 2 years old, causing roseola infantum. After primo-infection, HHV-6 remains latent in various cells including monocytes, macrophages, endothelial cells, bone marrow progenitors and central nervous system cells. As a noticeable di� erence with other human herpesviruses, genomic HHV-6 DNA can be integrated into the cell chromosomes (ciHHV-6) in about 1% of the general population. During speci � c pathological states (e.g. immunocompromised patients), HHV-6 can be reactivated and impact several organs.

In transplant patients, HHV-6 reactivation may result in a wide clinical spectrum: bone marrow suppression, graft rejection, pneumonitis, encephalitis, hepatitis, fever, skin rash... Among these patients, hematopoietic stem cell transplant recipients are particularly at risk of developing an HHV-6 reactivation (about 50% within the � rst 4 weeks after cell transfer). Severe complications linked to this active infection include delayed engraftment, graft versus host disease, and HHV-6 encephalitis.

HHV6 R-GENE®

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

• for low to high throughput analysis

• Same procedure for all the ARGENE® TRANSPLANT kits

• Detect and quantify the 2 species HHV-6A & HHV-6B (without subtyping)

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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) • BK Virus R-GENE® (69-013B) • Parvovirus B19 R-GENE® (69-019B)

REFERENCE1. Agut et al. Laboratory and clinical aspects of human herpesvirus 6 infections. Clinical Microbiology Reviews 2015; 28(2): 313-3352. Komaro� et al. Summary of the 10th International Conference on Human Herpesviruses-6 and -7 (HHV-6A, -6B, and HHV-7). Journal of Medical Virology 2017; 1-6

TECHNICAL INFORMATION ORDERING INFORMATION HHV6 R-GENE® - Ref.69-006B

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

Gene target U57 gene coding for major capsid protein

Validated specimens Whole blood, Plasma, CSF, BAL

Validated extraction platforms EMAG®, NUCLISENS® easyMAG®, MagNA Pure 96, QIAsymphony SP

Validated ampli� cation platforms ABI 7500 Fast, ABI 7500 Fast Dx, LightCycler 480 (System II), Rotor-Gene Q, CFX96

Limit of Detection (LoD 95%) Whole blood, plasma, CSF, BAL: 2.3 log10 copies/mL

Quanti� cation Range Whole blood, plasma, CSF, BAL: 2.7 to 8.0 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