Robust and Accurate 2-Year Performance of a Quantitative Mass Spectrometry-Based Apolipoprotein Test in a Clinical Chemistry Laboratory

Analytical method validation was performed according to the Clinical and Laboratory Standards Institute (CLSI) protocols, and the intraassay CVs were 2.3% to 5.5% and total CVs were 2.5% to 5.9%.[...]results were interchangeable with immunoturbidimetric assays for apo A-I (Deming slope, 1.014) and for apo B-100 (Deming slope, 1.016) (1).Proper instrument performance was assessed on days when tests were run through the evaluation of a system suitability sample consisting of14 synthetic peptides and their stable isotope labelled (SIL) derivatives, all at 0.15 д-mol/L, which was analyzed before and after each batch to assess ion abundance, and should meet preset values to ensure analytical sensitivity, relative responses with CVs 15% from the target value to ensure proper fragmentation, and car ryover