[**] VERSANT HBV DNA 1.0 Testi (kPCR)VERSANT kPCR Moleküler Sistem için Yüksek Hassasiyetli Viral Yük Testi

VERSANT HBV DNA 1.0 Testi (kPCR)VERSANT kPCR Moleküler Sistem için Yüksek Hassasiyetli Viral Yük Testi

VERSANT® HBV DNA 1.0 Testi (kPCR)* plazma ve serumda insan hepatit B virüsü (HBV) kantitatif tespiti için kullanılan, gerçek-zamanlı polimeraz zincir reaksiyon (kPCR) testidir. Bu test, VERSANT kPCR Moleküler Sistem* üzerinde uygulanıyor. Siemens’in nükleik asit ekstraksiyon teknolojisiyle birlikte kullanıldığında, enfekte bireylerde insan hepatit B virüsünün doğrudan kantitasyonu için güvenilir ve hassas bir yöntem sunuyor.

  • HBV Viral Yük Testini Daha Yüksek Verimlilikle Uygulayın
  • Sıra Dışı Test Performansı
  • Otomatik ve Esnek Teknoloji
  • Sağlam Test Tasarımı
  • Optimal Test Standardizasyonu

Özellikler ve Faydalar

  • Efficient and reproducible extraction, amplification, and detection of HBV-1 DNA
  • Up to 41 patient samples per run
  • Results in about 4 hours and 30 minutes

  • Quality extraction of nucleic acids ensures accuracy
  • Highly sensitive and specific assay performance provides confidence
  • Outstanding precision across a wide dynamic quantitation range produces reliable results
  • Excellent quantitation of all genotypes (A-H) provides clinicians with the information they need to manage therapy

  • Primary-tube sampling supports a variety of tube types and sizes
  • Positive patient sample identification with barcode ID
  • Flexible run sizes with 4 runs per kit over 4 weeks
  • Sample input requirement of 500 μL (with dead volume depending on sample tube size)

  • Ultrasensitive kinetic PCR technology
  • Maximum stability and reproducibility with calibrators and controls made from rDNA
  • No contamination monitoring needed due to amplicon contamination control with UNG (Uracil N-glycosylase)
  • Enhanced sensitivity and specificity with BLACK HOLE QUENCHER reagent (Biosearch Technologies)
  • Non-competitive internal control to monitor extraction and PCR efficiency
  • Targets the highly conserved overlapping region within the HBV surface antigen (S) and pol (P) genes
  • Detects all genotypes A-H

Teknik Detaylar

The VERSANT HBV DNA 1.0 Assay (kPCR) is a real-time polymerase chain reaction (PCR) assay for quantitative detection of human hepatitis B virus (HBV) DNA in plasma or serum of HBV-infected individuals. The assay is intended to be used in conjunction with clinical presentation and other laboratory markers of disease status to aid in the management of HBV-infected individuals undergoing antiviral therapy.

  • Referenced to the WHO 2nd Hepatitis B Virus (HBV) DNA International Standard (NIBSC 97/750) for IU/mL
  • Conversion factor: 1 IU/mL = 1.4 copies/mL
  • 13-700,000,000 IU/mL
  • Limit of detection (LOD) = 13 IU/mL
  • 2 log IU/mL – 30.3 to 34.6% (0.13 - 0.16 log SD)
  • 3-4 log IU/mL – 22.3 to 29.1% (0.10 - 0.13 log SD)
  • 5-9 log IU/mL – 20 to 30.9% (0.09 - 0.13 log SD)

Catalog No. Description

10282480 VERSANT HBV-1 DNA 1.0 (kPCR) Kit, IVDD Box 1 (48 tests) *

10282481 VERSANT HBV-1 DNA 1.0 (kPCR) Kit, IVDD Box 2 (48 tests) *

10286026 VERSANT Sample Preparation 1.0 Reagents Box 1 (96 tests) *

10286027 VERSANT Sample Preparation 1.0 Reagents Box 2 (96 tests) *  

*IVDD, CE marked. Not available for sale in the U.S. Product availability varies from country to country and is subject to local regulatory requirements.