Abstract

Objective To evaluate the quality of nine mutual recognition projects in clinical chemistry of 15 three grade first class hospitals in Shanxi Province, and to establish a reference test system, in order to ensure the traceability and comparability of clinical chemical mutual recognition testing projects. Methods The results of the laboratory internal quality control (IQC) and external quality assessment (EQA) from 15 three grade first class hospitals in 2016-2017 were enrolled in this study. Three detection systems were grouped according to Beckman, Roche, and Hitachi, considering the Clinical Laboratory Improvement Amendment′88 (CLIA′88) allowed the total error (TEa) standard, the correlation regression analysis was carried out on the results of interventricular quality assessment. Results Analysis by Microsoft Excel software showed that the cumulative IQC coefficient (CV%) was<1/4 TEa, the absolute average bias of the EQA (Bias%) was < 1/2 TEa, and the σperformance was mostly above a good level; the correlation coefficient (r) between the two systems was≥0.975 and the slope (b) was≥0.90. Conclusions The results of the three detection systems including IQC CV%, EQA Bias%, and σperformance all meet the standard requirements. The three detection systems′EQA results are highly consistent, and can be used as traceable reference detection systems for the mutual recognition of clinical chemical test results in Shanxi Province. Key words: Reference detection system; Comparability; Traceability; Accuracy

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