目的 对美国贝克曼库尔特有限公司Access2免疫化学发光仪的主要分析性能进行验证。方法 对该仪器检测项目血清心肌钙蛋白I(Cardiac Troponin I, cTnI)进行性能验证。利用变异系数分别对质控及大鼠、犬和食蟹猴血清心肌钙蛋白I的精密度进行评估, 并根据质控精密度数据对质控的靶值范围进行计算。利用相对偏差及靶值范围对准确度进行评价;利用携带污染率对携带污染情况进行评价。利用线性方程对TropI的线性范围进行评价, 同时对Access 2免疫化学发光仪检测动物血清cTnI的功能灵敏度进行了评价。结果 Access2免疫化学发光仪检测cTnI低、中、高3个水平质控的批内RSD均<8%, 批间RSD均<63.75%, 大鼠、犬和食蟹猴血清cTnI批内RSD均<8%。Bio-Rad 3水平质控的靶值范围分别为:0.363 8～0.473 5、1.898 6～2.819 3、7.950 3～9.367 6 ng/mL。Access2免疫化学发光仪检测cTnI的RSD<16.32%, 且低、中、高3水平质控均在各自的靶值±30%范围内。携带污染率<10%, 线性验证高值动物血清按一定比例稀释后将所得理论值与实测值进行回归分析, a值介于0.95～1.05, R> 0.975, 线性范围为0.016 0～82.843 3 ng/mL, 功能灵敏度为0.007 6 ng/mL。结论 Access2免疫化学发光仪检测cTnI的精密度、准确度、携带污染率及线性范围均在可接受范围内, 且本研究获得了动物血清cTnI检测的线性范围及功能灵敏度。因此, Access2免疫化学发光仪可用于临床前不同动物种属cTnI的检测。

Objective To validate the main performance of Access 2 immunoassay system in detecting Cardiac Troponin I (cTnI) in animals' serum from rats, dogs, and monkeys. Methods The precision was evaluated by coefficient of variance of within-run (RSD_within%) and coefficient of variance of between-run (RSD_total%). The target values range of BIO-RAD immunoassay plus control samples at three levels were calculated by precision data. The accuracy was assessed by Relative Bias (Bias%) and target values. Carryover circumstance was evaluated by carryover rates. Linear was evaluated by regression equation, and the functional sensitivity (FS) was established. Results The RSD_within% of BIO-RAD immunoassay plus control samples at three levels were less than 8%, the RSD_total% of BIO-RAD immunoassay plus control samples were less than 63.75%; The RSD_within% of serum cTnI from rats, dogs, and monkeys were less than 8%, respectively. The target value range of BIO-RAD immunoassay plus control samples at three levels were at 0.363 8—0.473 5 ng/mL, 1.898 6—2.819 3 ng/mL and 7.950 3—9.367 6 ng/mL, respectively. The Bias% of cTnI was less than 16.32%, and the measured results were all within the respective target value range. The carryover rates of cTnI was less than 10%. The equation of linearity range (0.016 0—82.843 3 ng/mL) of the theoretical value and detected value was got after serial dilution, in which a value was within the range 0.95—1.05 (r > 0.975). The FS was 0.007 6 ng/mL. Conclusion The precision, accuracy, carryover rates, and the linearity have a good performance, and FS of serum cTnI from rats, dogs and monkeys were established. In conclusion, cTnI could be detected via Access 2 immunoassay system in non-clinical studies.

国家“十二五”重大专项基金(2012ZX09505-001-003);国家自然科学基金(81273603);上海市青年科技启明星计划(14QB1400400)