25-Hydroxyvitamin D

Catalog Number: 06506780160

INTENDED USE

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.

RESULTS ARE DETERMINED VIA A CALIBRATION CURVE WHICH IS INSTRUMENT-SPECIFICALLY GENERATED BY 2-POINT CALIBRATION AND A MASTER CURVE PROVIDED VIA THE REAGENT BARCODE.

STORAGE AND STABILITY

Store at 2-8 °C.

CALIBRATION

Traceability: This method has been standardized against LC-MS/MS​15 which in turn has been standardized to the NIST standard.​16

CALIBRATION MUST BE PERFORMED ONCE PER REAGENT LOT USING FRESH REAGENT (I.E. NOT MORE THAN 24 HOURS SINCE THE REAGENT KIT WAS REGISTERED ON THE ANALYZER). RENEWED CALIBRATION IS RECOMMENDED AS FOLLOWS:

CONTROLS FOR THE VARIOUS CONCENTRATION RANGES SHOULD BE RUN INDIVIDUALLY AT LEAST ONCE EVERY 24 HOURS WHEN THE TEST IS IN USE, ONCE PER REAGENT KIT, AND FOLLOWING EACH CALIBRATION.

LIMITS AND RANGES

Measuring range

MEASURING RANGE

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).

LOWER LIMITS OF MEASUREMENT

Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ)

SPECIFIC PERFORMANCE DATA

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

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:

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

METHOD COMPARISON

1) A comparison of the Elecsys Vitamin D assay (y) using samples measured with LC-MS/MS (x) gave the following correlations (ng/mL):

ANALYTICAL SPECIFICITY

The specificity was assessed with the following analytes at 50 % binding of B0.