| Daratumumab

Daratumumab is an anti-cancer monoclonal antibody medication. Daratumumab was granted breakthrough therapy drug status in 2013, for multiple myeloma. It was granted orphan drug status for multiple myeloma, diffuse large B cell lymphoma, follicular lymphoma, and mantle cell lymphoma.
 

| 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)	5000	2500	1250	625	3125	156.25	78.12	0
OD	2.23	1.79	1.27	0.8	0.51	0.32	0.22	0.12
Corrected OD	2.11	1.67	1.15	0.68	0.39	0.20	0.10	-

 

| Repeatability

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

| Recovery

The recovery of HumanDaratumumab 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)	84-104	94
Plasma(n=8)	90-106	97
Cell Culture Supernates(n=8)	95-111	100

 

| Linearity

Samples were spiked with high concentrations of HumanDaratumumab 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 (%)	92	90	95
1 : 4	Range (%)	89-103	87-108	105-115
	Average (%)	95	92	105