ABSTRACT: Method comparison is an important step of every verification and validation procedure in a laboratory setting. As the industry improves, old analyzers are often replaced with new ones. To ensure the reliability of laboratory results, and to prevent bias in patient results monitoring, proper laboratory method comparison should be made. Although the comparison of the two methods seems like a well-known part of verification protocol, still many operative challenges need to be addressed. Experimental steps, sample management, adequate statistical analysis and results interpretation according to limits of acceptance need to be thoroughly planned and approached. Limits of acceptance should be determined a priori and based on what is assumed clinically acceptable. A primary role of the laboratory is to minimize the amount of error so test interpretation, patient care, and consumer safety are not compromised.
In this presentation, the basic concepts of a method comparison study will be addressed. The main focus will be on the experimental protocol for comparison of quantitative methods, including remarks on statistical methods and results interpretation, and present an example of a method comparison experiment
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