- 期刊
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酶法、苦味酸法測定血漿肌酐在兩檢測系統的偏倚評估
Bias evaluation on the results of plasma creatinine with enzymatic and picric acid method in different biochemical detecting system
摘要
目的：通過方法學比對和偏倚評估，探討不同方法測定血漿肌酐在不同檢測系統檢測結果的可比性。方法：依據EP9-A2文件要求，以羅氏Cobas 6000（X系統），雅培Architect c8000（Y系統），分別用肌酐酶法、苦味酸法檢測40份新鮮患者血漿中肌酐濃度，以美國臨床實驗室修正法規（CLIA,88）規定的室間質量評價允許範圍的1/2為臨床接受範圍，比較不同系統的可比性以及偏倚的可接受性。結果：兩種方法在兩檢測系統批間精密度均<3%；兩種方法在兩系統檢測肌酐相關係數均>0.975，分別為0.999、0.998、0.999、0.998、0.995、0.998，以系統X為目標檢測系統，肌酐濃度有超過"CLIA'88"規定的室間質量評價允許範圍的1/2待評估檢測系統。結論：兩檢測系統檢測肌酐的精密度符合臨床要求，臨床接受性性能偏倚評估有為臨床不完全接受的情况。
並列摘要
Objective: To explore the comparability of plasma creatinine level using different methods and different biochemical detecting systems. Methods: Two different kinds of biochemistry detection systems (ROCHE COBAS 6000 as system X, ABBOTT Architect c8000 as systems Y) were used to assess 40 clinical specimens for the plasma creatinine level using enzymatic and picric acid method according to EP9-A2 file. The collected data were treated with statistical analysis. Results: The correlation coefficient of each detection system was above 0.975 and the reliability coefficient of them were 0.999, 0.998, 0.999, 0.998, 0.995, 0.998, respectively. The CV values of creatinine detection systems did not exceed 3.0% .System X Was regarded as reference detection system and its values were used to evaluate the acceptability of system Y. As a result the values of the two creatinine detection systems partly exceeded permitted error of clinic assessment. Conclusion: The precision of creatinine results in the 2 kinds of detection systems met the clinical requirement. However incomparability existed in the bias evaluation of clinical acceptability.