Infectious disease kit Hepatitis C Virus Antibody(Anti-HCV) for Automatic immunoassay analyzer in Infectious Disease

CLIA Reagents of Inflammation (Anti-HCV)

Hepatitis C Virus Antibody (Anti-HCV) in human serum.

The test has to be performed on the CIA fully auto analyzer (Including CIA 600, CIA 1200, CIA 1800).

Hepatitis C virus antibody Kit (CLIA) (hereinafter referred to as Anti-HCV) is used for the in vitro qualitative detection of Anti-HCV which is mainly for adjuvant treatment of hepatitis C

HCV is spherical, with diameter less than 80nm (in hepatocytes: 36-40nm, in blood: 36-62nm). It is single-stranded positive sense RNA virus, lipid-containing envelope surrounded the nucleocapsid and with spikes on the envelope. Sensitive and effective in vitro HCV cell culture system has not been found, but chimpanzees are sensitive to HCV.

HCV-RNA consists of approximately 9500-10000bp. There are 319-341bp and 27-55bp in the 5'3 ' non-coding region (NCR), with several forward and reverse repeated sequences which contains the gene associated with replication. In the downstream of 5 'non-coding region, there is an reading frame (ORF), wherein the genome order is 5'-C-E1-E2 / NS1-NS2-NS3-NS4-NS5-3', capable of encoding a precursor polyprotein with 3014 pcs of amino acids, may be affected by the host cells and its own protease, cleaved into separate viral proteins.

The viral proteins are three structural proteins: nucleocapsid protein with the molecular weight of 19KD (or core protein, C), 33KD (E1), and 72Kd (E2 / NS1) glycoprotein; and four kinds of non-structural proteins with molecular weight of 23KD, 52KD, 60KD, 116KD, corresponding to NS2, NS3, NS4, NS5. As GP72 corresponds with the plague virus surface protein or the first non-structural protein (NS1) of flavivirus, it is marked as E2 / NS1. E1 and E2 / NS1 glycoprotein produced neutralization against HCV. Function of NS2 and NS4 is unclear, and they were found closely together with the cell membrane. NS3 protein has helicase activity and unwind HCV-RNA molecule to assist RNA replication. NS5 has RNA-dependent polymerase activity and participats in HCV genome replication.

HCV has a significant high variability and heterogeneity. Nucleotide and amino acid sequences of HCV present large differences through the analysis and comparison of the known strain genomic sequence. And variability for each part of the HCV genome is not consistent, such as 5'-CR is the most conservative, homology is 92-100%, whereas 3'NCR region with a higher degree of variability. In the encoding gene of HCV, C region is most conservative; non-structural (NS) is more conservative; encoding envelope protein E2 / NS1 with highest variability is called hypervariable regions.

Adult patients with acute hepatitis C are relatively mild: ALT rose, mostly without jaundice but a few with mild or moderately elevated jaundice. Nausea, loss of appetite, weakness, dark urine, yellow eyes and other symptoms will appear. HCV infection alone rarely causes liver failure. In its natural state, only 15% of patients can spontaneously clear HCV and cure. Without antiretroviral intervention therapy, 85% of patients will develop into chronic hepatitis C; 50% of children with acute hepatitis C virus infection can clear HCV spontageously.