| Anti-GBM IgG

Goodpasture syndrome (GPS), also known as anti-glomerular basement membrane disease, is a rare autoimmune disorder in which antibodies attack the basement membranes of the lungs and kidneys, leading to pulmonary hemorrhage, glomerulonephritis, and renal failure. It is recognized that these antibodies target the alpha-3 subunit of type IV collagen, which is referred to as the Goodpasture antigen. Anti-glomerular basement membrane antibodies (anti-GBM antibodies) are specifically detected in Goodpasture syndrome but are not found in microscopic polyangiitis. Although anti-GBM antibodies primarily attack the kidneys and lungs, systemic symptoms such as malaise, weight loss, fatigue, fever, and chills are also common, and joint pain is frequently observed.
 

| 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	2.79	2.46	1.65	0.94	0.57	0.35	0.28	0.05
Corrected OD	2.74	2.41	1.6	0.89	0.52	0.3	0.23	-

 

| Repeatability

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

| Recovery

The recovery of Human Anti-GBM IgG 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)	81-111	99
Plasma(n=8)	82-107	100

 

| Linearity

Samples were spiked with high concentrations of Human Anti-GBM IgG 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