PARVOVIRUS B19 R-GENE®REAL TIME PCR ASSAYS - ARGENE® TRANSPLANT RANGE

The power of true experience

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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) • CMV HHV6,7,8 R-GENE® (69-100B)

REFERENCE1. Qiu et al. Human Parvoviruses. Clinical Microbiology Reviews 2017; 30: 43–113

ORDERING INFORMATION Parvovirus B19 R-GENE® - Ref. 69-019B

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

Gene target NS1 coding for non-structural protein NS1

Validated specimens Whole blood, Plasma, Serum, Bone marrow, Medullary plasma

Validated extraction platformsEMAG®, easyMAG®, MagNA Pure Compact, MagNA Pure LC, QIAsymphony SP, EZ1 Advanced XL, 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: 1.7 log10 copies/mLPlasma: 1.8 log10 copies/mLBone Marrow: 2.5 log10 copies/mL

Quanti� cation range

Whole Blood: 1.6 to 10.7 log10 copies/mLPlasma: 2.0 to 10.7 log10 copies/mLSerum: 2.5 to 10.7 log10 copies/mLBone Marrow: 3.2 to 10.2 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

CLINICAL CONTEXT1

Parvovirus B19 (B19V) is a DNA virus, classi� ed into 3 distinct genotypes, member of the Parvoviridae family. B19V infections are common worldwide, with regional epidemiological di� erences. Seroprevalence in the population increases with age, reaching 80% in adults. After primo-infection, B19V may persist in marrow and in many tissues. B19V infections, likely asymptomatic, can cause a wide range of diseases: � fth disease (erythema infectiosum) in healthy children, arthropathy in healthy adults, hydrops fetalis in pregnant women, transient aplastic crisis in patients su� ering from chronic hemolytic disorders, and chronic Pure Red Cell Aplasia (PRCA) in immunocompromised patients.

In transplant patients, chronic PRCA due to B19V occurs. Symptoms can be fever, cutaneous eruption, or joint pain. Because of lacks of typical signs, the diagnosis can be obscure. However, identi� cation of B19V infection causing PRCA is important, as e� ective antibody therapy is available and easily applied1.

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

• Detect and quantify the 3 Parvovirus B19 genotypes

PARVOVIRUS B19 R-GENE®