Clinical chemistry therapeutic drug monitoring IVDs

Intended purpose

The quality controls are intended to be used in clinical laboratories by trained professionals to detect systematic analytical deviations that may arise from reagent or analytical instrument variation when performing the quantitative determination of cyclosporine, sirolimus, tacrolimus and everolimus in human whole blood samples using liquid chromatography – tandem mass spectrometry (LC-MS/MS) systems. The internal standard is intended for in vitro diagnostic use to account for sample matrix effects in quantitative LC-MS/MS assays for the measurement of immunosuppressants in human specimens.