| Omalizumab

Omalizumab is an injectable medication to treat severe persistent allergic forms of asthma, nasal polyps, urticaria (hives),and immunoglobulin E-mediated food allergy.Omalizumab is a recombinant DNA-derived humanized IgG1 monoclonal antibody which specifically binds to free human immunoglobulin E (IgE) in the blood and interstitial fluid and to the membrane-bound form of IgE (mIgE) on the surface of mIgE-expressing B lymphocytes.Its primary adverse effect is anaphylaxis.
 

| 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)	50	25	12.5	6.25	3.12	1.56	0.78	0
OD	2	1.56	1.14	0.76	0.49	0.33	0.24	0.1
Corrected OD	1.9	1.46	1.04	0.66	0.39	0.23	0.14	-

 

| Repeatability

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

| Recovery

The recovery of HumanOmalizumab 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)	84-108	90
Plasma(n=8)	92-106	97
Cell Culture Supernates(n=8)	95-111	99

 

| Linearity

Samples were spiked with high concentrations of HumanOmalizumab 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 (%)	84-98	88-96	90-110
	Average (%)	90	91	95
1 : 4	Range (%)	89-103	87-108	105-115
	Average (%)	96	93	105