HCV

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 PCR detection Kit is intended for research and diagnostic applications. The HCV PCR detection Kit is an in vitro Nucleic Acid Test (NAT) based pathogen detection product. The HCV PCR detection Kit is designed to detect Hepatitis C Virus (HCV) nucleic acids in human blood plasma.

The HCV PCR detection Kit can be used in clinical practice for HCV diagnostics.

Sample: blood plasma

DNA extraction: PREP-NA DNA/RNA extraction kit

Analytical specificity: the HCV PCR detection 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. 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