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- W67289208 abstract "This chapter presents assay methods comparison study. The evaluation of new assay methods or test-kits is a common exercise in the clinical laboratory. Among the many technical and economic points that have to be considered in assessing the characteristics of a new assay method will be the degree of correspondence between the test results delivered by the new assay method and those obtained by a reference assay method for the same analyte. In the development and evaluation of a new assay method, one of the primary concerns of the analyst will be the verification of the method's accuracy. For many analytes, particularly those that are of ill-understood or heterogeneous molecular composition, no such consensus reference framework exists. The accuracy of assay methods for such analytes cannot, therefore, be established in terms of an assay comparison study. An assay comparison study provides the most direct approach to assessing this question, any systematic discrepancy between the results delivered by the new and existing assay methods indicating the need for a new clinical reference framework for the results of the new assay method. In this situation, any systematic disparity between the test results is of an entirely relative nature. As neither method has any valid claim to represent the true amount of analyte present in a test specimen, they could of course agree completely about the wrong results, one method being as biased as the other." @default.
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- W67289208 date "1991-01-01" @default.
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- W67289208 title "Assay method comparison studies" @default.
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- W67289208 doi "https://doi.org/10.1016/b978-0-7506-1345-3.50013-3" @default.
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