Diazyme's Folate assay has an excellent linearity range up to 20 ng/mL. The method comparison gave a correlation coefficient of 0.9841, a slope of 0.941 and y-intercept of 0.287 ng/mL. Precision of the Diazyme Folate assay was evaluated according to the CLSI EP5-A2 guidelines and has Within-Run precision from 3.7% - 6.4%, a Between-Run from 1.7% - 4.5% and a Total Precision of 5.4% - 7.5%. The Folate assay displays outstanding sensitivity with an LOB of 0.27 ng/mL; LOD of 0.91 ng/mL; and a LOQ determined to be 2.0 ng/mL.
The test is based on the principle of α-complementation of the enzyme β-galactosidase and the competition between an enzyme donor-folate conjugate, a folate binding protein and folate in a serum sample. Samples with higher folate concentrations produce higher β-galactosidase activities and vice versa. A nitro-phenyl-ß-galactoside derivative (NPG) is used as the enzyme substrate. The reaction's product has maximum absorbance at 415 nm. The folate concentration of a sample is proportional to the measured β-galactosidase activity.
The Diazyme Folate Assay is a homogeneous enzyme method in-tended for use in the quantitative analysis of folate in human serum. Folic acid measurements are used in the diagnosis and treatment of anemias. For in-vitro diagnostic use only.
|Kit||DZ690A||R1/R2/R3/R4 (Four Vial Liquid Stable)||Four Vial Liquid Stable, |
|Calibrator||DZ690A-CAL||Cal: 5 Level|| |
|Control||DZ690A-CON||Con: 2 Level|| |