RevoDx HBV qPCR Kit

Hepatitis B virus (HBV) is a highly infectious virus from the Hepadnaviridae family, with a partially double-stranded DNA genome. It can cause acute and chronic liver diseases, with chronic infections sometimes leading to cirrhosis or liver cancer. HBV is transmitted through blood and body fluids, often mother-to-child, or via sexual and parenteral routes. Infection typically occurs in childhood and is usually asymptomatic, leading frequently to chronic infection.
Worldwide, around 400 million people are chronically infected, causing about 1 million deaths annually. HBV prevalence ranges from 0.1% to 20% depending on age at infection, with high rates of chronic infection among those infected perinatally. In Turkey, HBV seropositivity is 2-10%, classifying it as an intermediate endemic region.

 

Intended Use

RevoDx HBV qPCR Kit is a real-time PCR test intended for quantification of Hepatitis B virus (HBV) DNA in human serum or plasma (EDTA) using RevoDx Viral Nucleic Acid Purification Kit and BIO-RAD CFX96 or Tianlong Gentier 96 Real-Time PCR Detection System for amplification, detection and analysis. RevoDx HBV qPCR Kit is intended to assist in the management of patients with chronic HBV infection and to form a strategy for anti-viral therapy in conjunction with all relevant clinical and laboratory findings. RevoDx HBV qPCR Kit is not intended to screen blood and blood products for the presence of HBV DNA or to confirm the diagnosis of infection with HBV.

 

Features

  • Validated for use with fresh or frozen human serum or plasma collected in EDTA anticoagulant.
  • Quantification Standards ranging from 1 x 104 IU/mL to 1 x 107 IU/mL
  • Exogenous internal control
  • The Limit of Detection (LoD) value is 10 IU/mL
  • Linear range is between 43 IU/mL and 1 x 109 IU/mL
  • Diagnostic specificity is ≥ 99 %
  • Can detect and quantify all HBV genotypes
  • Whole system failure rate is ≤1 %
  • For research use only

 Ordering Information

Product Name

Package

Cat. No.

RevoDx HBV qPCR Kit

100 tests

IP201901-100

RevoDx HBV qPCR Kit

250 tests

IP201901-250

RevoDx HBV Qualitative qPCR Kit

 

Intended Use

RevoDx HBV Qualitative qPCR Kit is a real-time PCR test intended for the qualitative detection of Hepatitis B virus (HBV) DNA in human serum or plasma (EDTA)

 
 
 
 
 
 

Features

  • Validated for use with fresh or frozen human serum or plasma collected in EDTA anticoagulant.
  • Exogenous internal control
  • The Limit of Detection (LoD) value is 10 IU/mL
  • Diagnostic specificity is ≥ 99 %
  • Can detect and quantify all HBV genotypes
  • Whole system failure rate is ≤1 %
  • For research use only

 Ordering Information

Product Name

Package

Cat. No.

RevoDx HBV Qualitative qPCR Kit

100 tests

IP201922-100

RevoDx HBV Qualitative qPCR Kit

250 tests

IP201922-250

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