| HBsAg

HBsAg (also known as the Australia antigen) is the surface antigen of the hepatitis B virus (HBV). Its presence in blood indicates existing hepatitis B infection. The viral envelope of an enveloped virus has different surface proteins from the rest of the virus which act as antigens. These antigens are recognized by antibody proteins that bind specifically to one of these surface 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 (ng/mL)	100	50	25	12.5	6.25	3.12	1.56	0
OD	2.1	1.46	0.95	0.61	0.4	0.28	0.22	0.08
Corrected OD	2.02	1.38	0.87	0.53	0.32	0.2	0.14	-

 

| Repeatability

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

| Recovery

The recovery of Human HBsAg 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)	96-108	105

 

| Linearity

Samples were spiked with high concentrations of Human HBsAg 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 (%)	91	93	96
1 : 4	Range (%)	89-103	87-108	105-115
	Average (%)	94	98	108