[**] 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
Bizle İletişime Geçin

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.