| β2-GP1 IgM

B2GP1 (β2-glycoprotein I) is a plasma glycoprotein and a member of the immunoglobulin superfamily, primarily synthesized in the liver. It plays a pivotal role in autoimmune diseases such as antiphospholipid syndrome (APS), serving as the major target antigen for antiphospholipid antibodies. B2GP1 possesses a unique molecular structure, comprising five complement control protein (CCP) domains, enabling it to bind negatively charged phospholipids like cardiolipin and participate in coagulation regulation and immune responses. In pathological conditions, the binding of B2GP1 to autoantibodies forms immune complexes, activating the complement system and endothelial cells, thereby leading to thrombosis, pregnancy complications, and other classic clinical manifestations of APS.
 

| 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	2.56	1.84	1.22	0.81	0.47	0.26	0.15	0.07
Corrected OD	2.49	1.77	1.15	0.74	0.4	0.19	0.08	-

 

| Repeatability

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

| Recovery

The recovery of Human β2-GP1 IgM 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)	89-112	99
Plasma(n=8)	84-113	103

 

| Linearity

Samples were spiked with high concentrations of Human β2-GP1 IgM 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 (%)	92-111	82-109
	Average (%)	98	94
1 : 4	Range (%)	91-107	88-108
	Average (%)	99	99