人血清心脏肌钙蛋白I定量和定性测定比较

Comparison of qualitative and quantitative determination for cardiac troponin I

目的 比较心脏肌钙蛋白I(cTnI)定量和定性测定方法,评价其临床检测意义。方法 应用酶联免疫吸附试验(ELISA)和固相层析免疫法(敏感阈值0.2ng/ml)对517份人血清标本分别进行cTnI定量和定性测定。结果定性分析cTnI阴性组、弱阳性组、阳性组和强阳性组其定量测定cTnI平均浓度分别为0.1 95、0.658、3.580和53.730ng/ml。两法总符合率为94.39(488/517),相对特异性91.35％(169/185),相对敏感性96.08％(319,/332)。固相层析免疫法18次重复测定四组已知浓度标本总符合率均100％;ELISA法测定结果变异系数在10％左右,所测范围可由1×10-2mg/ml至1×102ng/ml,测定范围线性关系良好。结论 固相层析免疫法和ELISA法测定cTnI,两法结果较为符合,均有较好的准确度。前者稳定性较好,且操作更为简便快速,但对病情和疗效的观察有一定的限制。ELISA法检测结果明确,测定范围广,有助于病情和疗效观察,但精确度稍差。认为两法用于cTnI临床检测各有其长处,须把好试剂质量关和注重科学性。

Objective To compare the qualitative detection with the quantitative determination for cardiac troponin I (cTnI). Methods Solid-phase chromatographic immunoassay was used to qualitatively detect serum cTnI. ELISA test was used to quantitatively detect serum cTnI. Results The agreement of the two assay results was 94. 39% (488/517). The relative specificity and the relative sensitivity were 91. 35% (169/185) and 96. 08%(319/332) respectively. Conclusion The two test results were the same. The qualitative test was rapid and simple. The result was stable. The scope of the quantitative test was wide. The result was accurate.