GeneProof Hepatitis B Virus (HBV) PCR Kit applies PCR technology to detect DNA of HBV virus in patient samples. The kit has CE-IVD certification for in vitro Diagnostic Use.

Category:

HBV (Hepatitis B Virus) is a dangerous virus causing hepatitis B in humans. HBV is the second leading cause of cancer following smoking, cause of 60-80% of hepatic cancer cases and 50% of cirrhosis cases. In the world, there are an estimated 2 billion people infected with HBV, 400 million chronic HBV carriers of which 75% are from Asia. Every year, nearly 1 million people die for diseases associated with HBV infection such as cirrhosis and liver cancer.

Nowadays, HBV-DNA quantification plays an important role in HBV virus testing. HBV-DNA is used in clinical testing to diagnose activity and amount of HBV virus, which is the basis for HBV treatment. The kit is
designed for 
in vitro diagnostics and provides qualitative and quantitative detection.
 

▶ Detection ability

  • Specificity: HBV genotype A-H, pre-core mutants HBV (HBeAg negative), 100%
  • Sensitivity (LOD): reaches up 36.9792 IU/ml (1 IU/ml = 4,2 copies/ml)  with probability of 95% (on HBV NIBSC 02/264/01 using manual extraction GeneProof PathogenFree DNA Isolation Kit.

▶ Technology

The HBV detection consists in amplification of a specific conservative DNA sequence of an open reading frame X (ORFx) and in measurement of fluorescence increase. The HBV presence is indicated by the FAM fluorophore fluorescence growth. The detection kit takes advantage of the ”hot start” technology, minimizing non-specific reactions and assuring maximum sensitivity.

– Internal Standard (IS) is included in the PCR kit, controlling the possible inhibition of the PCR and the DNA  extraction process quality (ISEX version

Ready to Use MasterMix contains uracil DNA glycosylase (UDG), eliminating possible contamination of the PCR  with amplification products

▶  Validated Specimen: plasma, serum

▶ Certification: CE-IVD for in vitro Diagnostic Use

▶ Order information

Product Name

Cat. No

Package

GeneProof Hepatitis B Virus (HBV) PCR Kit

HBV/ISEX/025

HBV/ISEX/050

HBV/ISEX/100

25 reactions

50 reactions

100 reactions