| FⅧ

factor VIII (FVIII), also known as anti-hemophilia factor (AHF), is an essential clotting protein that is encoded by the F8 gene. Defects in this gene result in hemophilia A, an X-linked bleeding disorder. Factor VIII is produced in the liver's sinusoidal cells and endothelial cells outside the liver throughout the body. This protein circulates in the bloodstream in an inactive form, bound to another molecule called von Willebrand factor, until an injury that damages blood vessels occurs.
 

| 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)	20	10	5	2.5	1.25	0.625	0.31	0
OD	2.29	1.29	0.71	0.43	0.29	0.2	0.18	0.07
Corrected OD	2.22	1.22	0.64	0.36	0.22	0.13	0.11	-

 

| Repeatability

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

| Recovery

The recovery of Human FⅧ 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	102

 

| Linearity

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

 

		Plasma(n=4)
1 : 2	Range (%)	88-96
	Average (%)	92
1 : 4	Range (%)	88-108
	Average (%)	98