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血清總膽酸測定常見干擾值的確立

The establishment of common interference values in the determination of serum total bile acid

摘要


目的:在羅氏Cobas c501全自動生化分析儀上確立檢測血清總膽酸的常見干擾值:溶血指數(Hemolysis index, H)、黃疸指數(Icterus index, I)、脂血指數(Lipemia index, L)。方法:設立最大允許干擾值dmax 為0.67 umol/L,用希森美康(SYSMEX)專用干擾檢查A試劑盒,參考EP7-A2文件要求,進行干擾物實驗,對干擾物濃度及干擾程度之間的關係進行分析,並確立各干擾值。結果:溶血干擾:為正干擾,回歸方程y = 0.135x + 5.509,相關係數R2=0.999;黃疸干擾:為正干擾,回歸方程y = 0.069x + 5.413,相關係數R2 =0.998;脂血干擾:為正干擾,回歸方程y= 0.063x + 6.273,相關係數R2=0.992。結論:在羅氏Cobas c501全自動生化分析儀上,檢測血清總膽酸,當H≦10、I≦20、L≦15時,所產生的干擾值≦dmax,檢測的結果能符合臨床診斷、治療的要求。

關鍵字

總膽酸 干擾值 指數 生化分析儀

並列摘要


Objective: To establish common interference values for detecting serum total bile acid on the Roche Cobas c501 automatic biochemical analyzer: Hemolysis index (H), Icterus index (I), and Lipemia index (L). Methods: The maximum allowable interference value dmax was set to 0.67 μmol/L, the SYSMEX special interference check A kit was used, the requirements of EP7-A2 were referred to, interference experiments were conducted, and the difference between the concentration of interference and the degree of interference was determined. The relationship was analyzed, and the interference value was established. Results: H Hemolysis interference: positive interference, regression equation y=0.135x+5.509, correlation coefficient R2=0.999; Icterus interference: positive interference, regression equation y=0.069x+5.413, correlation coefficient R2=0.998; lipemia interference: positive interference, regression equation y=0.063x+6.273, correlation coefficient R2=0.992. Conclusion: On the Roche Cobas c501 automatic biochemical analyzer, when detecting serum total bile acid, when H≤10, I≤20, and L≤15, the interference value generated is ≤dmax, and the detection result can meet the clinical diagnosis and treatment claim.

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