Use of the total error concept, the accuracy profiles and the accuracy index in the pre-study validation of an enzyme-linked immunosorbent assay

Abstract

The use of the Total Error approach for validating the analytical methods incorporates the expression of the sum of trueness and precision. This analysis also uses the Accuracy Profiles based on tolerance intervals (or prediction intervals) to determine whether a calibration model will provide quality results and to predict the control of risk in accepting an inadequate methodology. In order to evaluate the use of the Total Error, the Accuracy Profiles and the Accuracy Index approaches for validating bioassays, these tools were used in the pre-study of validation of an ELISA for determining the ovalbumin contents in vaccines. And it covered the range of 33-167% of target concentration (5.0 ug/mL) and the control interval below this range (0.33-2.5%). The pre-study validation showed that this assay demonstrates complying accuracy, precision, linearity and accuracy in the concentration range of 1.25-10μg/mL; and it is a reliable methodology to assess the ovalbumin contents. The Total Error approach is a validation tool that shows superior performance, when compared to the classical analysis, which assesses the trueness and precision components separately, and it is qualified to identify the deficiencies in the accuracy of a bioassay.