| GHbA1c

Glycated hemoglobin A1c (GHbA1c) is a major component of glycated hemoglobin and is widely used for screening, diagnosis, and monitoring of hyperglycemia.GHbA1c levels also reflect the progression of diabetic microvascular lesions.GHbA1c represents 70–90% of GHbA1, and is the glycated form of GHbA1. GHbA1c results from the glycosylation of the hemoglobin β chain N-terminal of proline, which reflects the plasma glucose concentration. The GHbA1c concentration is influenced primarily by both hemoglobin and plasma glucose concentration. However, studies have shown that factors such as race, age, diet, medication and concomitant diseases may also alter GHbA1c levels.
 

| 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)	80	40	20	10	5	2.5	1.25	0
OD	2.1	1.4	0.88	0.58	0.37	0.27	0.2	0.07
Corrected OD	2.03	1.33	0.81	0.51	0.3	0.2	0.13	-

 

| Repeatability

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

| Recovery

The recovery of Rat GHbA1c 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	95
Plasma(n=8)	92-106	103
Cell Culture Supernates(n=8)	96-108	104

 

| Linearity

Samples were spiked with high concentrations of Rat GHbA1c 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	88-95	90-110
	Average (%)	91	93	96
1 : 4	Range (%)	89-103	88-108	105-114
	Average (%)	94	98	107