| Trastuzumab

Trastuzumab, sold under the brand name Herceptin among others, is a monoclonal antibody used to treat breast cancer and stomach cancer.It is specifically used for cancer that is HER2 receptor positive.It may be used by itself or together with other chemotherapy medication.Trastuzumab is given by slow injection into a vein and injection just under the skin.Common side effects include fever, infection, cough, headache, trouble sleeping, and rash.Other severe side effects include heart failure, allergic reactions, and lung disease.Use during pregnancy may harm the baby.Trastuzumab works by binding to the HER2 receptor and slowing down cell replication.
 

| 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	2.52	1.96	1.38	0.97	0.55	0.31	0.19	0.08
Corrected OD	2.44	1.88	1.3	0.89	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 Trastuzumab 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 Trastuzumab 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