循环酶法检测血清同型半胱氨酸方法学评价及其在肿瘤诊断中的应用

目的评估循环酶法试剂盒检测血清同型半胱氨酸(Hcy)的分析性能,探讨Hcy在肿瘤诊断中的临床应用价值。方法应用美国临床实验室标准化协会的标准化评价方案评价循环酶法测定血清Hcy的精密度、比对试验、回收试验、线性范围等。同时检测806例肿瘤患者,67例健康体检者(健康对照组)血清Hcy水平。数据分析采用方差分析、两独立样本t检验、相关性分析等。结果精密度:循环酶法测定血清Hcy低、高水平的批内变异系数(CV)分别为2.69%、3.35%,日间CV分别为1.87%、2.80%,精密度良好;Hcy水平2.00~40.00μmol/L,检测线性良好(r~2=0.997 3);比对试验:与西门子ADVIA Centaur XP检测系统比较,Hcy检测结果相关性良好(r~2=0.970 8,n=40),两种检测方法检测结果均值比较差异无统计学意义(P0.05);平均回收率为95.2%~103.1%;肿瘤患者血清Hcy水平较健康对照组明显升高,差异有统计学意义(P0.05)。结论循环酶法测定血清Hcy方便、快速、准确可靠,其精密度和线性范围可满足临床需求,适合在临床实验室使用;肿瘤患者血清Hcy较健康对照组显著升高,与多种肿瘤相关,可作为肿瘤标志物用于肿瘤的早期筛查。

Evaluation of enzymatic cycling assay for the detection of serum homocysteine and its clinical value of diagnosing the cancer

Objective To evaluate the analytical performance of serum homocysteine (Hcy) by circulating enzyme assay kit and to explore the clinical application value of Hcy in the diagnosis of cancer .Methods The precision ,the comparison test ,the recovery test and the linear range of the serum Hcy were evaluated by the standardized evaluation program of American Clinical Laboratory Standards Association (CLSI) .Serum Hcy levels were measured in 806 cancer patients and 67 healthy controls (healthy controls) . The data were analyzed by ANOVA ,independent sample t test ,correlation analysis and other statistical methods .Results Preci‐sion:cyclic enzyme method for the determination of serum Hcy low ,high levels of intra‐assay coefficients of variation (CV) were 2 .69% ,3 .35% ;Daytime CV were 1 .87% ,2 .80% ,respectively .The level of Hcy was 2 .00 -40 .00 μmol/L ,and the linearity was good (r2 =0 .997 3) .Comparison test :compared with the SIEMENS Centaur XP DVIA detection system ,the results of Hcy test showed good correlation (r2 =0 .970 8 ,n=40) ,there was no significant difference between the two detection methods in the mean of the test results(P>0 .05) .The average recovery rate was 95 .2% -103 .1% .The level of serum Hcy in tumor patients was high‐er than that in healthy control group ,and the difference was statistically significant (P< 0 .05) .Conclusion Our results suggest that the enzymatic cycling assay is a convenient ,rapid ,accurate and reliable method for detecting the serum concentration of Hcy , and meet the requirements of clinical test ,as well as it is suitable in the clinical laboratories for precision ,accuracy and linear rang . The serum Hcy level of patients with cancer was significantly higher than healthy controls ,are related to the multiple cancer ,which can be used as a tumor marker for clinical early screening of cancer .