Hepatitis C virus

Kit: EliGene® HCV LC Kit (ref.: 90059-LC)
Package size:
50 reactions
Possibility of quantification:
EliDNA HCV LC standard (included with kit)
Analytical specificity: Hepatitis C virus
Analytical sensitivity: 1 – 10 viruses in the amplified sample
Specimens: serum, plasma
Compatible instruments:
ABI 7000, 7300, 7500 (Applied Biosystems), LightCycler® 480 and LightCycler® Nano, LightCycler® 2.0 (Roche), RotorGene 6000 or RotorGene Q (Qiagen); MyGo Mini, MyGo Pro (IT-IS Life Science)
CE certification: CE 1023
Detected DNA region: genome (core protein)
Detection technology: Molecular Beacons probes
Description of the kit:
The EliGene® HCV LC kit is intended for detection and quantification of hepatitis C virus RNA. Kit contains reversion transcription in one mix with RealTime detection.
Clinical study description and results:
Within the frame of testing the functional characteristics of EliGene® HCV LC Kit overall 500 clinical specimens were analyzed. From these specimens, 300 HCV positive specimens and 200 HCV negative specimens were verified by COBAS AMPLICOR HCV MONITOR Test, version 2.0 (v2.0). The EliGene® HCV LC Kit diagnosed as HCV positive 299 specimens. 1 specimen was determined by the EliGene® HCV LC Kit as negative. The sensitivity and specificity of EliGene® HCV LC Kit is 98,78% and 100%, respectively. The correlation of the quantitative results of EliGene® HCV LC Kit and COBAS AMPLICOR HCV MONITOR Test, version 2.0 (v2.0) was analysed by linear regression, when the logarithmised results of both kits were plotted as scatterplots against each other. Correlation coefficient was calculated to R2=0,81.

100% sensitivity can be declared for the concentration of 50 IU/ml of serum isolated by Magneto 1ml Serum/Plasma DNA/RNA isolation kit (see page 34) - extraction volume: 1.0 ml, elution volume: 50 μl. The linear range of the EliGene® HCV LC Kit has been determined to cover concentrations from 50 IU/μl to at least 1 x 105 IU/ml.
Pathogen description:
Hepatitis C virus is enveloped RNA virus classified to Flaviviridae family. Virus genome consists of 9379 nucleotides. HCV represents heterogeneous group of viruses divided into 6 genotypes (groups) and more than 40 sub-types. EliGene® HCV LC Kit gives the positive results with genotypes 1a, 1b, 2a, 2b, 3a, 4a, 6 and 6b.

Today, the word prevalence about 175 milions persons infected by hepatitis C virus is assessed. Virus is disseminating mainly by parenteral way, the sexual transfer is observed rare. In our conditions, significantly risk group is represented by the injection drug consumers.
References:
Bannister BA, Begg NT, Gillespie SH. 2000. Infectious Disease. Blackwell Science, 2th Ed.