국내 임상검사실의 검사법 평가절차 현황 고찰

Abstract

Background: The aim of this study was to investigate the current status of method evaluation in Korea. Methods: A questionnaire was provided to domestic medical laboratory professionals to survey the method evaluation practices of their institutions. The survey consisted of 32 questions divided into four parts: precision, linearity, method comparison, and others. Results: In total, 60 institutions responded to this questionnaire survey. According to the responses, the statistical programs used for method evaluation varied among the institutions and test items. The 5×5 protocol was mainly used for precision testing, with the manufacturer’s claim being the main acceptance criterion. Linearity was most often evaluated on the basis of the recovery rate, and more than half of the institutions directly used the dilution factor provided by the manufacturer without verifying it. Method comparison was mainly conducted with 40 samples, and the results were analyzed using the least squares linear regression or Passing–Bablok regression analysis methods. The respondents indicated a low use of critical difference as a criterion for judging parallel tests. The institutions varied greatly in detection capabilities, carryover, reference interval, and qualitative testing. Conclusions: Among the laboratories, variations in method evaluation protocols and the current status were observed. This is the first study to elucidate the current status of method comparison in medical laboratories. Further studies as well as continuous education and management are needed to provide standardized domestic guidelines for method evaluation and to improve the quality of laboratories.