Shine i2900全自动化学发光免疫分析仪检测血栓分子标志物的性能评价

Performance evaluation of thrombus molecular markers tested by Shine i2900 fully automated chemiluminescence immunoassay analyzer

目的:对Shine i2900全自动化学发光免疫分析仪检测血栓分子标志物即血栓调节蛋白(TM)、凝血酶-抗凝血酶Ⅲ复合物(TAT)、纤溶酶-α2纤溶酶抑制物复合物(PIC)、组织型纤溶酶原激活物-纤溶酶原激活抑制物-1复合物(t-PAIC)的性能进行评价。方法:参考CNAS-GL037:2019、WS/T 492—2016、WS/T 408—2012、WS/T 402—2012等相关标准,采用Shine i2900全自动化学发光免疫分析仪对经影像学诊断有血栓形成的临床患者的血浆、体检中心体检合格的健康人群的血浆及厂家提供的质控品和校准品进行检测,从精密度、正确度、线性范围、临床可报告范围、参考区间、稳定性6个方面评价该仪器检测血栓分子标志物的性能。结果:Shine i2900全自动化学发光免疫分析仪检测TM、TAT、PIC、t-PAIC的实验室内变异系数(coefficient of variation,CV)均小于2%;检测TM、TAT、PIC、t-PAIC 4个项目的结果与厂商宣称值的偏倚范围为-7.04%~-2.07%;检测TM、TAT、PIC、t-PAIC的线性范围分别为1.02~200.03 TU/mL、0.50~120.00 ng/mL、0.06~40.43μg/mL、0.50~100.00 ng/mL;检测TM、TAT、t-PAIC及PIC的最大稀释倍数均为40倍,临床可报告范围分别为1.02~8001.20 TU/mL、0.50~4800.00 ng/mL、0.50~4000.00 ng/mL、0.06~1617.20μg/mL;检测TM、TAT、PIC、t-PAIC 4个项目的参考区间验证均符合要求;在常温放置8 h及2~4℃静止24 h条件下检测TM、TAT、PIC、t-PAIC 4个项目的结果与即刻检测结果的偏差均在10%以内。结论:Shine i2900全自动化学发光免疫分析仪检测血栓分子标志物的各项性能均与厂家宣称的一致,可满足临床使用要求。

Objective To evaluate the performances of Shine i2900 fully automated chemiluminescence immunoassay analy-zer when detecting molecular markers of thrombosis such as thrombomodulin(TM),thrombin-antithrombinⅢcomplex(TAT),α2-plasmin-inhibitor-plasmin complex(PIC)and tissue plasminogen activator-inhibitor 1 complex(t-PAIC).Methods Shine i2900 fully automated chemiluminescence immunoassay analyzer was used to test the plasma of clinical patients with thrombosis diagnosed by imaging,plasma of healthy people qualified by physical examination in medical examination centers and quality control and calibration products provided by the manufacturer with references to CNAS-GL037:2019,WS/T 492—2016,WS/T 408—2012,WS/T 402—2012 and other relevant standards,whose performances were assessed in precision,correctness,linear range,clinically reportable range,reference interval and stability for the detection of molecular markers of thrombosis.Results The intra-laboratory coefficients of variation(CV)of Shine i2900 fully automated chemiluminescence immunoassay analyzer for TM,TAT,PIC,and t-PAIC were all lower than 2%;the range of bias between the results of the four assays for TM,TAT,PIC and t-PAIC and the manufacturer's declared values was-7.04%to-2.07%;the linear ranges for the assays for TM,TAT,PIC and t-PAIC were 1.02 to 200.03 TU/mL,0.50 to 120.00 ng/mL,0.06 to 40.43μg/mL,0.50 to 100.00 ng/mL,respectively;the maximum dilutions of TM,TAT,t-PAIC and PIC were all 40 times,and the clinically reportable ranges were 1.02 to 8001.20 TU/mL,0.50 to 4800.00 ng/mL,0.50 to 4000.00 ng/mL,0.06 to 1617.20μg/mL,respectively.The reference intervals of the four assays for TM,TAT,PIC and t-PAIC all met the requirements;the deviations of the four assays for TM,TAT,PIC and t-PAIC from the immediate detection was less than 10%under the conditions of 8 h standing at room temperature and 24 h standing at 2 to 4℃.Conclusion The performances of Shine i2900 fully automated chemiluminescent immunoassay analyzer for the detection of molecular markers of thrombosis prove to be consistent with the manufacturer's claims and can meet the requirements of clinical use.