HCV Quantitative

During diagnosis of blood-borne infections, PCR technology has a great importance especially in blood banking and to detection very early infections before antibodies have been developed.

PCR technology solves the following blood banking tasks:

•  Ensuring infection safety during the period of “seronegative window”;

•  Providing information that no infectious agents were found in the blood or blood components with ambiguous results of enzyme multiplied immunoassay obtained;

•  Identifying true virus carriers among seropositive individuals.

With PCR it is possible to detect the RNA of hepatitis C virus not only in blood serum but also in liver biopsy specimens, which is important in confirming the role of hepatitis C virus in the formation of hepatocellular carcinoma. In such patients, hepatitis C virus RNA is detected in hepatocytes and in the absence of anti-HCV and HCV RNA in blood serum. Anti-HCV does not appear at all among a number of patients with self-limited course of infection.

The HCV Quantitative Real-Time PCR Kit is intended for research and diagnostic applications as well as for evaluation of the therapy efficacy. The HCV Quantitative Real-Time PCR Kit is an in vitro Nucleic Acid Test (NAT) – based pathogen detection and quantification product. The HCV Quantitative Real-Time PCR Kit is designed to detect and quantitate Hepatitis C Virus (HCV) nucleic acids in human blood plasma samples with an aid of Quantitative Real-Time Polymerase Chain Reaction (qPCR) method.

The HCV Quantitative Real-Time PCR Kit can be used in clinical practice for HСV diagnostics.

Sample: blood plasma

DNA extraction: PREP-NA DNA/RNA extraction kit

Analytical specificity: the HCV Quantitative Real-Time PCR Kit allows detection next HCV genotypes: 1a, 1b, 2a, 2b, 2c, 2i, 3, 4, 5a, 6. The samples containing HCV will be defined as positive and characterized quantitatively. The samples not containing HCV will be defined as negative.

Sensitivity: not less than 200 copies of HCV RNA per 1.0 mL of blood plasma.

Certification: RU/IVD