Performance of a matrix-comprehensive in-house validation study by means of an especially designed software Original Research Article

The matrix-comprehensive in-house validation concept is based on complex mathematic-statistical calculations. In order to be able to integrate this concept into the laboratory routine, a software (InterVal) based on this concept was developed. InterVal is databank-oriented and allows the establishment of the desired experiment plans, an easy data input, the calculation of all relevant validation parameters like the analytical limits CCα and CCβ, precision, recovery, calibration curve(s) and the respective prediction intervals. Moreover, it delivers the power curve of the method and a quantitative assessment of the influence of individual factors with regard to the dispersion and calibration function, therefore providing comprehensive information on the robustness of the method. The data are stored according to quality assurance requirements. Reports on design, measurement results and the calculated validation parameters may be produced via mouse click.