【摘要】 目的初步评价心肌肌钙蛋白I(cTnI)的酶联荧光免疫定量测定方法的临床应用性能。方法依据美国临床实验室标准化委员会(NCCLS)颁布的《定量临床检验方法的初步评价;批准指南(EP10-A)》提供的方法,按特定的顺序连续5d测定高、中、低浓度标准品中的cTnI,对MINIVIDAS测定cTnI的方法进行初步评价。结果当标准品中的cTnI浓度为0.602μg/L、7.911μg/L、15.22μg/L时,cTnI测定的回归方程为Y=1.02X-0.12,相关系数r2=0.9999;绝对偏差分别是-0.06μg/L、-0.09μg/L、0.18μg/L;总不精密度分别是7.22%、2.17%、1.62%。结论MINIVIDAS酶联荧光免疫定量测定cTnI方法的检测性能符合临床应用要求。更多还原

【Abstract】 Objective To evaluate the quantitative clinical laboratory ELISA method for cardiac troponin I (cTnI). Methods In accordance with the NCCLS Document EP10 A, Preliminary Evaluation of Quantitative Clinical Laboratory Methods. Approved Guideline, preliminary evaluation of the MINI VIDAS’s measurement for cTnI was made on controls at high, middle and low concentrations for a period of 5 days. Results When the control serum’s concentration of cTnI were 0.602μg/L, 7.911μg/L, 15.22μg/L, the return equation was Y=1.02X-0.12, with r2=0.9999. Bias were -0.06μg/L, -0.09μg/L, 0.18μg/L, with imprecisions at 7.22%, 2.17%, 1.62%. Conclusion The performance of VIDAS TNI was up to the clinical applicable requests.更多还原