Calibrationcomma; Quality Controlcomma; and Stability of a Quantitative Enzyme Immunochromatographic Method for Therapeutic Drug Monitoring

摘要

We describe a noninstrumented quantitative method for therapeutic drug monitoring (AccuLevel test) that uses a factory-calibrated unit test format and a novel single-level approach to quality control. The AccuLevel method is based on the principles of immunochromatography, which provides a number of convenient protocol advantages without sacrificing assay performance or quality assurance. Most of the benefits of the immunochromatographic method derive by virtue of the fact that quantification is dependent on enzyme migration rather than enzyme activity. Since migration height is almost solely a function of a highly stable, immobilized, dry antibody reagent, the AccuLevel test is extremely insensitive to environmental factors. The predictable and uniform dependence of quantification on antibody site concentration allows complete reliability with a single-level control. These features of stability, factory calibration, and unitized test components make the AccuLevel immunochromatography method amenable to new quality control schemes.