Matrix effects and the performance and selection of quality-control procedures to monitor PO2 measurements

Abstract

We have assessed how variation in the matrix of control materials would affect error detection and false-rejection characteristics of quality-control (QC) procedures used to monitor PO2 in blood gas measurements. To determine the expected QC performance, we generated power curves for S(mat)/S(meas) ratios of 0.0-4.0. These curves were used to estimate the probabilities of rejecting analytical runs having medically important errors, calculated from the quality required by the CLIA '88 proficiency testing criterion and the precision and accuracy expected for a typical analytical system. When S(mat)/S(meas) ratios are low, the effects of matrix on QC performance are not serious, permitting selections of QC procedures based on simple power curves for a single component of variation. As S(mat)/S(meas) ratios increase, single-rule procedures generally show a loss in error detection, whereas multirule procedures, including the 3(1)s control rule, show an increase in false rejections. An optimized QC design is presented.