STEP BY STEP APPROACH TO EVALUATION AND 一步一步的评估和.pptVIP

STEP BY STEP APPROACH TO EVALUATION AND COMPARISON OF ANALYTICAL METHODS J M KUYL Department of Chemical Pathology NHLS Universitas UFS INTRODUCTION Quantitative analytical methods have become more reliable and more standardized. Emphasis moved away from methods development to the selection and evaluation of those commercial available methods that suit a particular laboratory best. Commercial kit methods are ready for implementation in the laboratory, often in a “closed” analytical system on a dedicated instrument. Furthermore, method evaluation is a costly exercise in terms of reagents, specimens, and labour and time of the professionals doing the evaluating. If not done properly it wastes laboratory revenue and time, if the method is accepted might lead to errors in medical decisions based on results the method generates on patient samples. Generally what happens is that laboratories are most concerned with getting the methods up and running that there is little time, or thought given, to selection and evaluation studies. The most common scenario is the implementation of readily available commercial kit methods, often in a “closed” analytical system on a dedicated instrument. When a new clinical analyzer is included in the overall evaluation process, various instrumental parameters also require evaluation. Information on most of these parameters should be available from the instrument manufacturer, who should also be able to furnish information on what user studies to conduct in estimating these parameters for an individual analyzer. Reasons for Selecting a New Method improve accuracy and / or precision over existing methods to reduce reagent cost to reduce labour cost new analyzer or instrument to measure a new analyte METHOD SELECTION Evaluation of need Application characteristics Method characteristics Analytical performance characteristics Scopes of Method Evaluation Studies Evaluation is the determination of the analytical performa