目的 對美國貝克曼庫爾特有限公司Access2免疫化學發(fā)光儀的主要分析性能進行驗證。方法 對該儀器檢測項目血清心肌鈣蛋白I(Cardiac Troponin I, cTnI)進行性能驗證。利用變異系數(shù)分別對質(zhì)控及大鼠、犬和食蟹猴血清心肌鈣蛋白I的精密度進行評估, 并根據(jù)質(zhì)控精密度數(shù)據(jù)對質(zhì)控的靶值范圍進行計算。利用相對偏差及靶值范圍對準確度進行評價;利用攜帶污染率對攜帶污染情況進行評價。利用線性方程對TropI的線性范圍進行評價, 同時對Access 2免疫化學發(fā)光儀檢測動物血清cTnI的功能靈敏度進行了評價。結(jié)果 Access2免疫化學發(fā)光儀檢測cTnI低、中、高3個水平質(zhì)控的批內(nèi)RSD均<8%, 批間RSD均<63.75%, 大鼠、犬和食蟹猴血清cTnI批內(nèi)RSD均<8%。Bio-Rad 3水平質(zhì)控的靶值范圍分別為:0.363 8～0.473 5、1.898 6～2.819 3、7.950 3～9.367 6 ng/mL。Access2免疫化學發(fā)光儀檢測cTnI的RSD<16.32%, 且低、中、高3水平質(zhì)控均在各自的靶值±30%范圍內(nèi)。攜帶污染率<10%, 線性驗證高值動物血清按一定比例稀釋后將所得理論值與實測值進行回歸分析, a值介于0.95～1.05, R> 0.975, 線性范圍為0.016 0～82.843 3 ng/mL, 功能靈敏度為0.007 6 ng/mL。結(jié)論 Access2免疫化學發(fā)光儀檢測cTnI的精密度、準確度、攜帶污染率及線性范圍均在可接受范圍內(nèi), 且本研究獲得了動物血清cTnI檢測的線性范圍及功能靈敏度。因此, Access2免疫化學發(fā)光儀可用于臨床前不同動物種屬cTnI的檢測。

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.

國家“十二五”重大專項基金(2012ZX09505-001-003);國家自然科學基金(81273603);上海市青年科技啟明星計劃(14QB1400400)