원문정보
초록
영어
When one makes a decision based on a quantified value, one must know the precision
of the value, the LOD and the ROQ. According to the guideline for the validation of the
ICH, the precision of an analytical value by ELISA can be described from the standard
deviation or related standard deviation (RSD) by repeated experiments at various
concentrations of the analyte. We developed a mathematical model for predicting
precision without performing repeated experiments using ELISA. When the model is
applied to ELISA, the RSD of measurements is expressed as the error parameters and
the calibration curve. The optimum conditions for ELISA, such as the reaction time, the
concentration of the antibodies, and the concentration of the enzyme-conjugated antigen
(antibody) have been determined by trial and error. In this study, to reduce the number
of optimization experiments, the initial screening of the candidate antibodies and the
determination of the optimal reaction conditions has often been carried out on the basis
of the kinetic properties against the antigen of interest. The LOD and ROQ were
determined from a model describing the calibration curve and precision profile of the
ELISA.