EliGene® HBV (RUO)

Intended use

EliGene® HBV UNI is intended for the detection and the quantification of Hepatitis B virus DNA. For research use only.

Principle of the method

This detection kit is based on RealTime PCR method. In this kit primers and labeled probes (FAM and HEX) for the detection of HBV DNA and for the detection of internal control are used.

Compatible instruments

The following list represents instruments on which the above mentioned kits were tested. Please contact us for compatibility with other instruments.

• Applied Biosystems: ABI 7000, 7300, 7500FAST
• Roche: LightCycler® 480, LightCycler® Nano
• Qiagen: RotorGene 6000 nebo Q
• Bio-Rad: CFX96 Touch Real-Time PCR Detection System
• Bio Molecular Systems: MIC qPCR Cycler

Clinical material and recommended DNA isolation procedure

Clinical material: Serum, plasma

Manual: Chemagic Viral DNA/RNA Kit (Chemagen-PerkinElmer)
Automatic: Prepito Viral DNA/RNA1k Kit (Chemagen-PerkinElmer)

General information

Hepatitis B virus is a small DNA virus divided into Hepadnaviridae family. Eight different genotypes signed by alphabetical letters A to H, have been previously described. Since the proposal of the four described genotypes (A–D), four others (E–H) have been characterized during the two last decades. Recently, a ninth genotype evidenced in North-West China, India, Lao and Vietnam and tentatively termed “I” was suggested, although it is still subject to debate and as being a recombinant strain with a genotype C backbone. Finally, very recently, a tenth genotype provisionally assigned to genotype “J” was proposed for a Japanese patient's HBV isolate.
Hepatitis B (HB) is transmitted by the exchange of body fluids e.g. blood, semen, breast milk and saliva. The virus spread between people who have unprotected sexual intercourse, drug users who share needles and syringes and health care workers in contact with potentially contaminated blood or body fluids.
It is estimated that one third of the world's population has serological evidence of past or present infection with HBV and that 350 to 400 million people are still chronically infected, of whom 78 % lived in Asia, 16 % in Africa, 3 % in South America and the remaining 3% in Europe, North America and Oceania.
HBV infection has a broad spectrum of clinical diseases, ranging from acute hepatitis (including fulminant hepatic failure) to a low viraemic asymptomatic “inactive” carrier state or to progressive chronic hepatitis that may lead to cirrhosis with an annual rate of 2 to 5 % in HBe-positive patients and hepatocellular carcinoma (HCC) with a cumulative 5-year incidence of 15 to 20 %. Both HBV-related end-stage liver disease and HCC are responsible for around 1 million deaths per year.

For research only