两种循环酶法检测血清同型半胱氨酸结果的可比性及偏倚评估

Comparability of results and bias estimation of two kinds of enzymatic cycling assay for detecting serum Hcy

目的对两种不同厂家同型半胱氨酸(Hcy)诊断试剂测定结果的可比性及偏倚评估进行研究,为血清Hcy诊断试剂的试验室认可提供试验数据。方法依据美国临床试验室标准化协会(CLSI)中的EP9-A2文件,用上海华臣和深圳奥萨试剂在Hitachi7600-020全自动生化分析仪上对40份患者血清分别进行Hcy测定,其中以华臣试剂为参比方法,以奥萨试剂为试验方法。用线性回归分析对医学决定水平处的预期偏倚和可信区间进行计算,根据生物学变异导出的可允许偏倚为标准,判断试剂的临床可接受性。结果两种试剂对患者血清Hcy测定结果显示,方法内重复性良好,无离群点。在医学决定水平处的系统偏倚临床可以接受。结论同一试验室一个检测项目存在2个或2个以上的试剂时,应进行试剂间的方法比对及偏倚评估,判断其临床可接受性,以保证检验结果的可比性。

Objective To study the comparability of results and bias evaluation of two different of homocysteine （Hcy） diagnos tic reagent produced by different manufacturers to provide the experimental data for laboratory accreditation of Hcy diagnostic rea- gent Methods According to EP9-A2 file of United States Clinical Laboratory Standards Institute （CLSI） ,Shenzhen OSA reagents and Shanghai Huachen（HC） reagent were adopted for detecting Hcy by the Hitachi7600-020 automatic biochemical analyzer on 40 serum specimens from the patients,in which the HC reagent was taken as reference method and the OSA reagent as the laboratory method. The linear regression analysis was used to calculate the expected bias and the confidence interval at the medical decision level. With the biological variation derived allowable bias as the standard, the clinical acceptability of reagents was judged. Results The detection results of serum Hcy by two kinds of reagent showed that the method reproducibility was good without outliers. The systematic bias at the medical decisions level was clinically acceptable. Conclusion If 2 or more than 2 reagents exist in a single item in the same laboratory, the method comparison and bias estimation should be performed for judging their clinical acceptaibility in order to ensure the comparability of the test results.