1. Intended Use
HCV real time RT-PCR kit is used for the detection of HCV in serum or plasma by using real time
High sensitivity: lower detection line 103 IU/ml
High specificity: test result will be positive, only to hepatitis C virus.
Short operating time: 2 and a half hours totally
Good stability: kept for 12 months at –20℃; CV≤5%;
2. Product Description
HCV is an enveloped RNA virus in the flaviviridae family which appears to have a narrow host range.
It is a major cause of acute hepatitis and chronic liver disease, including cirrhosis and liver cancer.
Globally, an estimated 170 million persons are chronically infected with HCV and 3 to 4 million
persons are newly infected each year. Twenty percent of persistently infected individuals will develop
liver cirrhosis, and hepatocellular carcinoma occurs in up to 2.5% .HCV is spread primarily by direct
contact with human blood. The major causes of HCV infection worldwide are use of unscreened blood
transfusions, and re-use of needles and syringes that have not been adequately sterilized.
HCV real time RT-PCR kit contains a specific ready-to-use system for HCV detection (for
genotypeⅠ～Ⅳ) by Reverse Transcription Polymerase Chain Reaction (RT-PCR) in the real-time
PCR system. The master contains Super Mix for the specific amplification of HCV RNA. The reaction
is done in one step real time RT-PCR. The first step is a reverse transcription (RT): HCV RNA is
transcribed into cDNA. Then, a thermostable DNA polymerase is used to amplify the specific gene
fragments by polymerase chain reaction. Fluorescence is emitted and measured by the real time
systems´ optical unit. The detection of amplified HCV DNA fragment is performed in fluorimeter
channel FAM with the fluorescent quencher BHQ1. In addition, the kit can be used for identification
of possible PCR inhibition by measuring the HEX/VIC/JOE fluorescence of the internal control (IC).
An external positive control defined as 1×107IU/ml is supplied to allow the determination of the gene
load. For further information, please refer to section 9.3 Quantitation.