| HCV-Ab

The hepatitis C virus (HCV) is a small (55–65 nm in size), enveloped, positive-sense single-stranded RNA virus of the family Flaviviridae. The hepatitis C virus is the cause of hepatitis C and some cancers such as liver cancer (hepatocellular carcinoma, abbreviated HCC) and lymphomas in humans.Hepatitis C virus has a positive sense single-stranded RNA genome. The genome consists of a single open reading frame that is 9,600 nucleotide bases long.This single open reading frame is translated to produce a single protein product, which is then further processed to produce smaller active proteins. This is why on publicly available databases, such as the European Bioinformatics Institute, the viral proteome only consists of 2 proteins.
 

| Typical data

As the OD values of the standard curve may vary according to the conditions of the actual assay performance (e.g. operator, pipetting technique, wash technique or temperature effects), the operator should establish a standard curve for each test. Typical standard curve and data are provided below for reference only.

 

Concentration (NCU/mL)	0.8	0.4	0.2	0.1	0.05	0.025	0.0125	0
OD	2.52	1.96	1.38	0.97	0.55	0.31	0.19	0.08
Corrected OD	2.44	1.88	1.3	0.88	0.47	0.23	0.11	-

 

| Repeatability

Intra-assay Precision (Precision within an assay)：CV% < 10%; Inter-assay Precision (Precision between assays)：CV% < 10%
 

| Recovery

The recovery of Human HCV-Ab spiked at three different levels in samples throughout the range of the assay was evaluated in various matrices.

 

Sample Type	Range(%)	Average Recovery(%)
Serum(n=8)	84-101	96
Plasma(n=8)	92-105	102
Cell Culture Supernates(n=8)	96-109	105

 

| Linearity

Samples were spiked with high concentrations of Human HCV-Ab and diluted with Universal Diluent to produce samples with values within the range of the assay.

 

		Serum(n=4)	Plasma(n=4)	Cell Culture Supernates(n=4)
1 : 2	Range (%)	84-95	88-96	90-110
	Average (%)	92	93	96
1 : 4	Range (%)	89-103	87-108	105-115
	Average (%)	93	98	108