磁微粒化学发光酶免疫分析法快速检测血栓4项性能评价
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摘要
目的探讨磁微粒化学发光酶免疫分析法检测血栓调节蛋白(TM)、凝血酶-抗凝血酶复合物(TAT)、纤溶酶-α2纤溶酶抑制剂复合物(PIC)和组织型纤溶酶原激活物-纤溶酶原激活物抑制剂-1复合物(t-PAIC)的临床价值。方法采用磁微粒化学发光酶免疫分析法分别检测TM、TAT、t-PAIC和PIC,分析其精密度、携带污染率、正确度、线性检测范围、临床可报告范围、生物参考区间,并按美国临床实验室标准化协会(CLSI)EP系列文件的要求,评价其检测结果。结果用磁微粒化学发光酶免疫分析法检测血栓4项时,批内、批间精密度[变异系数(CV)]均<10%,携带污染率均<1.0%,线性检测中a值均在1±0.05范围内,决定系数r2均≥0.950 0,临床可报告范围、正确度和生物参考区间均符合要求。结论用磁微粒化学发光酶免疫分析法检测血栓4项有较好的临床价值。
Objective To evaluate the role of magnetic particle chemiluminescence assay for thrombus 4 items,including thrombomodulin(TM),thrombin-antithrombin(TAT) complex,plasmin-α2 plasmin inhibitor complex(PIC) and tissue plasminogen activator-plasminogen activator inhibitor complex(t-PAIC). Methods TM,TAT,PIC and t-PAIC were determined. Precision,carry-over rate,accuracy,linear range,clinical reportable range and biological reference interval were analyzed. According to the EP guidelines of the Clinical and Laboratory Standards Institute(CLSI),the performance of magnetic particle chemiluminescence assay for determining thrombus 4 items was evaluated. Results The within-run and between-run precisions [coefficient of variation(CV)] were <10%.The carry-over rate was <1.0%. Linear range analysis showed that a value was 1.00±0.05,and r2 was ≥0.950 0. The clinical reportable range,accuracy and biological reference interval were all qualified. Conclusions Magnetic particle chemiluminescence assay can be used clinically to determine thrombus 4 items.
Objective To evaluate the role of magnetic particle chemiluminescence assay for thrombus 4 items,including thrombomodulin(TM),thrombin-antithrombin(TAT) complex,plasmin-α2 plasmin inhibitor complex(PIC) and tissue plasminogen activator-plasminogen activator inhibitor complex(t-PAIC). Methods TM,TAT,PIC and t-PAIC were determined. Precision,carry-over rate,accuracy,linear range,clinical reportable range and biological reference interval were analyzed. According to the EP guidelines of the Clinical and Laboratory Standards Institute(CLSI),the performance of magnetic particle chemiluminescence assay for determining thrombus 4 items was evaluated. Results The within-run and between-run precisions [coefficient of variation(CV)] were <10%.The carry-over rate was <1.0%. Linear range analysis showed that a value was 1.00±0.05,and r2 was ≥0.950 0. The clinical reportable range,accuracy and biological reference interval were all qualified. Conclusions Magnetic particle chemiluminescence assay can be used clinically to determine thrombus 4 items.
引文
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[8]Clinical and Laboratory Standards Institute.Measurement procedure comparison and bias estimation using patient samples[S].EP9-A3,CLSI,2013.
[2]NEGREVA M,GEORGIEV S,PRODANOVA K,et al.Early changes in the antithrombin and thrombin-antithrombin complex in patients with paroxysmal atrial fibrillation[J].Cardiol Res,2016,7(3):89-94.
[3]WADA T,GANDO S,MIZUGAKI A,et al.Coagulofibrinolytic changes in patients with disseminated intravascular coagulation associated with post-cardiac arrest syndrome-fibrinolytic shutdown and insufficient activation of fibrinolysis lead to organ dysfunction[J].Thromb Res,2013,132(1):e64-e69.
[4]CONWAY E M.Thrombomodulin and its role in inflammation[J].Semin Immunopathol,2012,34(1):107-125.
[5]陈文欣,李强,薛赢俊,等.恶性肿瘤患者凝血-纤溶系统标志物检测及其临床意义[J].检验医学,2018,33(8):722-726.
[6]付阳,金亚雄,刘玉梅,等.凝血标志物在危重症血栓性疾病患者诊断中的应用及与炎性因子的相关性研究[J].中国实验血液学杂志,2017,25(6):1776-1780.
[7]陈丹,徐婷,张洁心,等.实时荧光PCR用于CYP2C19基因多态性检测的性能验证[J].检验医学,2017,32(9):801-805.
[8]Clinical and Laboratory Standards Institute.Measurement procedure comparison and bias estimation using patient samples[S].EP9-A3,CLSI,2013.