HCV Real-TM Quant PCR Kit Dx

Hepatitis C (HCV RNA) PCR kit
CE-IVD Real Time Amplification test for quantitative detection of HCV RNA with lyophilized and ready to use reagents (CE-IVD marked)

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Background

Hepatitis C virus (HCV) is RNA-containing, hepatotropic virus belonging to the Flaviviridae family. Contamination with HCV occurs at direct entering of the virus in blood. Most people with acute HCV infection are asymptomatic or have mild symptoms but they are unable to clear the virus and in approximately 80% of cases this leads to chronic infection. In 15 to 20% of patients chronic HCV infection progresses at a variable rate to cirrhosis, with a 1 to 4% annual risk of developing hepatocellular carcinoma. At present there are more than 170 million of infected people, which makes up 3 percent of the population of the world.
The leading position in laboratory diagnostics of HCV is taken by molecular-biological methods allowing: 1) early diagnostics of the acute viral infection; 2) establishment of indications to antiviral therapy; 3) choice of the optimum therapeutic regime.
ADVANTAGES OF SACACE HCV REAL TIME QUANT KIT
- CE-IVD marked
- Application of primers and probes in the most conservative area of the UTR region that allow effective detection of the majority of HCV genotypes (tested genotypes: 1a, 1b, 1c, 2a, 2b, 2c, 3a, 3b, 4a, 4c, 4d, 5a, 6a)
- Use of the Quantitative Internal Control (concentration reported in Data Card) which represents recombinant RNA-containing-structure which carried through all steps of analysis from nucleic acid extraction to PCR amplification. The presence of quantitative HCV Rec IC allows not only to monitor the extraction procedure and to check possible PCR inhibition but also to verify possible losses of the RNA during extraction procedure thus enabling to calculate precisely the HCV viral load.
- Presence in the reagents supplied with the kit of two positive controls of the extraction: Pos1 HCV low viral load and Pos2 HCV medium viral load that are quantitatively described in Data Card which carried through all steps and allow quality control of the conducted analysis
- Wide linear range of measurements (from 20 to 50.000.000 IU/ml).