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EliGene<sup>®</sup> HBV UNI Kit

EliGene® HBV UNI Kit

Pack Size: 50 reactions

Product Code: Z10-90037-UNI

Compatible instruments: UNI Kit intended for LightCycler®2.0

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Note: Euro Equivalents shown for information only.

Clinical study description and results: 500 clinical specimens were analysed,of which 300 were HBV positive specimens and 200 were HBV negative specimens when tested by artus® HBV TM PCR Kit. The EliGene® HBV RT Kit and EliGene® HBV UNI Kit diagnosed 229 specimens as HBV positive . 1 specimen from Nigeria was determined by the EliGene® HBV RT Kit and EliGene® HBV UNI Kit as negative. The sensitivity and specificity of EliGene® HBV RT Kit and the EliGene®HBV UNI Kits is 98.78% and 100%, respectively. EliGene® HBV RT Kit and the EliGene® HBV UNI Kit shows 99.8% (499 from 500 specimens) correlate with the detection of HBV DNA as determined by artus® HBV TM PCR Kit. 100% sensitivity can be declared for both kits for the concentration of 5IU/ml of serum corresponding to concentrationof 0.1 IU/ml of isolated specimen by Magneto 1ml Serum/Plasma DNA/RNA isolation kit - extraction volume: 1.0ml, elution volume: 50?l. The linear range of the EliGene® HBV RT Kit and EliGene® HBV UNI Kit has been determined to cover concentrations from 0.1 IU/?l to at least 1 x 105 IU/?l.

Pathogen description: Hepatitis B virus is a small DNA virus assigned to 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 characterised 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 may be 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 spreads between people who have unprotected sexual intercourse, drug users who share needles and syringes and health care workers in contact with potentially contminated 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% live 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.

References: Bannister BA, Begg NT, Gillespie SH. 2000. Infectious Disease. Blackwell Science, 2th Ed. Ho SKN, Yam W-C, Leung ETK, Wong L-P, Leung JKH, Lai K-N, Chan TM. 2003. Rapid quantification of hepatitis B virus DNA by real-time PCR using fluorescent hybridization probes. J Med Microbiol. 52(5): 379-402.

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Ways to contact us

t: +44 (0)1296 714222
f: +44 (0)1296 714806

Botolph Claydon, Buckingham, MK18 2LR, United Kingdom

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TCS Biosciences Ltd
t: +44 (0)1296 714222  •  f: +44 (0)1296 714806  •  e:
Botolph Claydon, Buckingham, MK18 2LR, United Kingdom

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