| FⅨ

Coagulation Factor IX (FIX), also known as Christmas factor, is one of the serine proteases involved in coagulation. It belongs to peptidase family S1. Deficiency of this protein causes haemophilia B. Factor IX is produced as a zymogen, an inactive precursor. It is processed to remove the signal peptide, glycosylated and then cleaved by factor XIa (of the contact pathway) or factor VIIa (of the tissue factor pathway) to produce a two-chain form, where the chains are linked by a disulfide bridge. Factors VII, IX, and X all play key roles in blood coagulation and also share a common domain architecture.
 

| 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	2.51	1.76	1.14	0.72	0.46	0.3	0.22	0.09
Corrected OD	2.42	1.67	1.05	0.63	0.37	0.21	0.13	-

 

| Repeatability

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

| Recovery

The recovery of Human FⅨ spiked at three different levels in samples throughout the range of the assay was evaluated in various matrices.

 

Sample Type	Range(%)	Average Recovery(%)
Plasma(n=8)	92-105	103

 

| Linearity

Samples were spiked with high concentrations of Human FⅨ and diluted with Universal Diluent to produce samples with values within the range of the assay.

 

		Plasma(n=4)
1 : 2	Range (%)	89-96
	Average (%)	93
1 : 4	Range (%)	87-108
	Average (%)	98