Diazyme's Vitamin B12 Assay has an excellent linearity range up to 2000 pg/mL. The method comparison gave a correlation coefficient value of 0.9847, slope of 0.969 and an y-intercept of -5.77 ng/mL. Precision of the Diazyme Vitamin B12 assay was evaluated according to the CLSI EP5-A2 guidelines on the Roche Modular P analyzer and has a Within-Run precision from 2.3% - 8.2%, a Between-Run from 0.6% - 4.2% and a Total Precision of 3.1% - 9.3%. The Vitamin B12 assay displays outstanding sensitivity with an LOB of 30.6 pg/mL; LOD of 63.3 pg/mL; and a LOQ determined to be 96.7 pg/mL.
The Vitamin B12 assay principle is for the Roche Modular P chemistry analyzer. The test is based on the principle of β-complementation of the enzyme β-galactosidase and the competition between an enzyme donor-vitamin B12 conjugate, an anti-vitamin B12 protein (Intrinsic Factor) and the Vitamin B12 content of a serum sample. Samples with higher Vitamin B12 concentrations produce higher β-galactosidase activities and vice versa. A nitro-phenyl-β-galactoside derivative is used as the enzyme substrate. The reaction's product has maximum absorbance at 415 nm. The Vitamin B12 concentration of a sample is proportional to the measured β-galactosidase activity.
The Diazyme Vitamin B12 Assay is for the quantitative determination of Vitamin B12 levels in human serum. Measurements of vitamin B12 may be used in the diagnosis of B12 deficiency. For in vitro diagnostic use only.
|Kit||DZ689A-K||R1/R2/R2/R3/R4 (Four Vial Liquid Stable)||Four Vial Liquid Stable, |
|Calibrator||DZ689A-Cal||Cal: 5 Level|| |
|Control||DZ689A-Con||Con: 2 Level|| |