Introduction
The following information outlines the instrument performance and expected results obtainable from the SCIEX IVD-MS™ Kit for 25-OH-Vitamin D3/D2 in Serum/Plasma when using an AB SCIEX API 3200MD™ or 3200MD QTRAP® LC/MS/MS system. This reagent kit is intended for in vitro diagnostic use for the quantification of the main metabolites of vitamin D3 and D2, 25-Hydroxycholecalciferol and 25-Hydroxyergocalciferol, in patient serum and plasma samples by LC-MS/MS (liquid chromatography-tandem mass spectrometry).
Calibration is performed using a lyophilized multilevel plasma calibrator set of known concentration. Lyophilized plasma control samples at clinically relevant low and high concentrations serve to establish the target analyte range. The method uses a deuterated 25-OH- Vitamin D3 as an internal standard to correct for sample and instrument variability. Samples are analyzed using an atmospheric pressure chemical ionization (APCI) source for maximum sensitivity.
Separation is performed using a SCIEX IVD-MS™ 25-OH-Vitamin D3/D2 analytical and trap column in conjunction with the HPLC configuration defined in system requirements below for an overall LC run time of 5.0 minutes. This method was evaluated using SCIEX IVD-MS™ 25-OH-Vitamin D3/D2 multilevel calibrators. Control sample responses were obtained at clinically relevant low and high 25-OH-Vitamin D3 and 25-OH-Vitamin D2 concentrations. %CV values for the target analytes were obtained using 10 replicates at these low and high concentrations. The achieved lower limits of quantification (LLOQ) for each analyte are given in the Performance Criteria below.
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