HCV

HCV hepatitis C virus

Recombinant Antigens and master sheet product

Hepatitis C virus (HCV) belongs to the family of hepatotropic viruses, and infection with this virus can lead to liver damage. It is the main cause of chronic hepatitis, cirrhosis, and liver cancer. Epidemiological studies have shown that global HCV infection rates exceed 185 million, with only 15% to 25% of infected individuals able to clear the virus through their immune response. The remaining 75% to 85% of infected individuals will develop chronic hepatitis C (CHC). Among CHC patients, 15% to 30% will develop cirrhosis, ultimately leading to liver cancer. In addition, HCV infection can result in various extrahepatic manifestations, most commonly diabetes mellitus, cardiovascular disease, chronic kidney disease, and depression.

HCV belongs to the Flaviviridae family, with a genome consisting of a single positive-strand RNA of 9.7 nt in length, containing a 5' UTR and an open reading frame with a 3' UTR. The open reading frame encodes for a large precursor protein that is cleaved by protease into structural proteins, mainly consisting of core and envelope proteins (E1, E2), and non-structural proteins including p7, NS2, NS3, NS4A, NS4B, NS5A, and NS5B.

Due to the lack of proofreading function in the key enzyme for virus proliferation, RNA-dependent RNA polymerase (RdRp), the HCV viral genome exhibits a high degree of variability. HCV strains can be divided into 8 genotypes and nearly 100 subtypes.Due to the genetic diversity of the hepatitis C virus, there is still a lack of effective vaccines for hepatitis C.In the treatment of HCV, the Peg-IFN and ribavirin combination therapy (PR regimen) was once the mainstay treatment for CHC. However, due to its limited efficacy and significant side effects, it has gradually been replaced by various types of direct-acting antiviral (DAA) regimens developed subsequently. These drugs include non-structural proteins 3/4A protease inhibitors, NS5A inhibitors, NS5B polymerase nucleotide analogue inhibitors, and potent CYP3A4 inhibitors. By using two or more of these drugs in combination.

Despite the development of highly effective drugs with a high cure rate, the majority of patients with HCV infection remain untreated. Due to the ease of chronicization, the lack of overt clinical symptoms in early HCV infection, and the general lack of HCV screening, only about 20% of hepatitis C patients are diagnosed. Therefore, early screening for hepatitis C is particularly important. Clinical laboratory techniques include ELISA, GICA, CMIA, ECLIA, and fluorescent qPCR. The flexible combination of these detection techniques can minimize misdiagnosis and missed diagnosis during the optimal window period. HCV-RNA and HCV-cAg detection are important indicators currently used clinically to diagnose hepatitis C.

Performance evaluation based on HCV recombinant antigen

A. On the chemiluminescent immunoassay platform, there is a high correlation with the results from Abbott's result.

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B. On the ELISA platform, the evaluation result of our product on Chinese HCV National serologic reference panel is as follows (indirect method)

Sample No.	ELISA Result	LFA Result	Sample No.	ELISA Result	LFA Result	Sample No.	ELISA Result	LFA Result
N1	0.007	Negative	P1	2.780	Positive	L1	0.805	Positive
N2	0.005	Negative	P2	3.199	Positive	L2	0.368	positive
N3	0.009	Negative	P3	2.951	Positive	L3	0.322	Positive
N4	0.007	Negative	P4	0.323	Positive	L4	/	Negative
N5	0.008	Negative	P5	3.090	Positive
N6	0.005	Negative	P6	2.997	Positive
N7	0.007	Negative	P7	2.578	Positive
N8	0.008	Negative	P8	3.199	Positive
N9	0.006	Negative	P9	1.480	Positive
N10	0.033	Negative	P10	3.154	Positive
N11	0.009	Negative	P11	2.966	Positive
N12	0.006	Negative	P12	2.980	Positive
N13	0.005	Negative	P13	2.938	Positive
N14	0.006	Negative	P14	2.913	Positive
N15	0.007	Negative	P15	2.872	Positive
N16	0.004	Negative	P16	3.115	Positive
N17	0.007	Negative	P17	2.953	Positive
N18	0.348	Negative	P18	3.201	Positive
N19	0.007	Negative	P19	3.007	Positive
N20	0.005	Negative	P20	0.980	Positive
N21	0.004	Negative	P21	2.853	Positive
N22	0.005	Negative	P22	0.944	Positive
N23	0.005	Negative	P23	1.842	Positive
N24	0.000	Negative	P24	0.748	Positive
N25	0.006	Negative	P25	2.827	Positive
N26	0.007	Negative	P26	3.252	Positive
N27	0.007	Negative	P27	0.481	Positive
N28	0.006	Negative	P28	0.538	Positive
N29	0.042	Negative	P29	0.130	P/N
N30	0.006	Negative	P30	0.928	Positive

C. On the ELISA platform, the results of the CHIINA National Serologic Reference Panel are as follows (sandwich method)

Sample No.	Result	Sample No.	Result	Sample No.	Result
N1	0.004	P1	2.906	L1	1.250
N2	0.001	P2	0.904	L2	1.279
N3	0.004	P3	0.947	L3	1.441
N4	0.003	P4	0.913	L4	0.06
N5	0.001	P5	2.984	CV	1.363
N6	0.001	P6	2.827
N7	0.001	P7	0.974
N8	0.001	P8	3.022
N9	0.004	P9	2.970
N10	0.001	P10	2.933
N11	0.004	P11	2.931
N12	0.001	P12	0.648
N13	0.030	P13	2.904
N14	0.002	P14	2.949
N15	0.002	P15	2.945
N16	0.002	P16	2.976
N17	0.003	P17	2.863
N18	0.472	P18	2.931
N19	0.004	P19	2.886
N20	0.002	P20	2.503
N21	0.005	P21	2.891
N22	0.003	P22	2.828
N23	0.003	P23	2.973
N24	0.003	P24	2.745
N25	0.007	P25	2.460
N26	0.005	P26	2.866
N27	0.003	P27	0.952
N28	0.004	P28	0.760
N29	0.004	P29	0.243
N30	0.005	P30	0.432

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