| HBcrAg

Hepatitis B virus core antigen-associated antigen (HBcrAg) is regarded as an additional marker of hepatitis B virus (HBV) infection. HBcrAg combines the antigenic reactivity produced by denatured hepatitis Be antigen (HBeAg), HBV core antigen and artificial core-associated protein (p22cr). HBcrAg has a good correlation with intrahepatic cccDNA, total intrahepatic HBV DNA and serum HBV DNA, and has a relatively small correlation with HBV surface antigen (HBsAg).
 

| 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 (mU/mL)	100	50	25	12.5	6.25	3.12	1.56	0
OD	2.6	1.48	0.94	0.57	0.39	0.26	0.18	0.07
Corrected OD	2.53	1.41	0.87	0.5	0.32	0.19	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 HBcrAg 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 HBcrAg 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	109