Catalog Number: 06506780160
This Vitamin D assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults.
Store at 2-8 °C.
Traceability: This method has been standardized against LC-MS/MS15 which in turn has been standardized to the NIST standard.16
5.00-60.0 ng/mL or 12.5-150 nmol/L (defined by the Limit of Quantitation and the maximum of the master curve). Values below the Limit of Quantitation are reported as < 5.00 ng/mL (< 12.5 nmol/L). Values above the measuring range are reported as > 60.0 ng/mL (> 150 nmol/L).
Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ)
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
Precision was determined using Elecsys reagents, pooled human sera and controls in a modified protocol (EP5-A2) of the CLSI (Clinical and Laboratory Standards Institute): 2 runs per day in duplicate and each for 21 days (n = 84). The following results were obtained:
1) A comparison of the Elecsys Vitamin D assay (y) using samples measured with LC-MS/MS (x) gave the following correlations (ng/mL):
The specificity was assessed with the following analytes at 50 % binding of B0.