| ARA

Anti-Rituximab Antibody is a neutralizing antibody specifically directed againstthe therapeutic agent, produced by the body's immune system followingtreatment with rituximab, a monoclonal antibody that targets CD20. As a typicalexample of anti-dr μ g antibodies, its generation represents the host immuneresponse to exogenous therapeutic proteins and constitutes a key mechanismcontributing to the failure of biologic therapy
 

| 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 (μg/mL)	10	5	2.5	1.25	0.625	0.312	0.156	0
OD	2.69	1.89	1.32	0.8	0.47	0.31	0.16	0.1
Corrected OD	2.59	1.79	1.22	0.7	0.37	0.21	0.06	-

 

| Repeatability

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

| Recovery

The recovery of Human ARA 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)	85-103	96
Plasma(n=8)	94-105	102

 

| Linearity

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

 

		Serum(n=4)	Plasma(n=4)
1 : 2	Range (%)	82-95	87-96
	Average (%)	91	91
1 : 4	Range (%)	89-103	87-110
	Average (%)	95	98