ADVIA Centaur XP全自动化学发光免疫分析仪检测感染性血清标志物的性能评价

Performance test and evaluation of ADVIA Centaur XP automatic chemiluminescence immunoassay system

目的:验证和评价西门子ADVIA Centaur XP全自动化学发光免疫分析仪检测感染性血清标志物的性能。方法:以EP15-A2及CNAS-CL02-A004《医学实验室质量和能力认可准则在临床免疫学定性检验领域的应用说明》为依据,结合实际工作,对ADVIA Centaur XP全自动化学发光免疫分析仪的感染性标志物进行精密度、临界值附近精密度、最低检出限、方法学间比较、分析测量范围等性能验证。结果:4种感染性标志物批内精密度为1.30%~5.07%,批间精密度为0.35%~4.87%;临界值±20%浓度的样本检测阳性率及阴性率均通过验证;乙肝表面抗原(HBsAg)、人类免疫缺陷病毒抗体(Anti-HIV)、梅毒螺旋体抗体(Anti-TP)及丙型肝炎病毒抗体(Anti-HCV)的最低检出限分别为0.06 IU/ml、4.00 NCU/ml、0.50 NCU/ml、1.00 NCU/ml;2种检测方法的总一致率和符合率均>95%;HBsAg分析测量范围R2=0.998 2。结论:ADVIA Centaur XP全自动化学发光免疫分析仪符合预期的临床应用要求,可以应用到临床检验中。

Objective To verify and evaluate the performances of four infection serum markers in ADVIA Centaur XP automatic chemiluminescence immunoassay system. Methods The markers had the precision, cut-off precision, lowest detectable limit, method comparison, measuring range and etc verified according to the experimental schemes of Clinical and Laboratory Standards Institute (CLSI), EP15-A2 User Verification of Performance for Precision and Trueness CNAS-CL02-A004: 2018 Guidance on the Application of Accreditation Criteria for the Medical Laboratory Quality and Competence in the Field of Clinical Qualitative Immunology and other relevant documents. Results The within-run precisions of the four markers were between 1.30% and 5.07%, and the between-run precisions were between 0.35% and 4.87%;the samples with +20% and -20% critical concentrations had the positive and negative rates pass the verification;the lowest measuring limits of HBsAg, Anti-HIV, Anti-TP and Anti-HCV were 0.06 IU/ml, 4.00 NCU/ml, 0.50 NCU/ml and 1.00 NCU/ml, respectively;the total consistency and coincidence rates of the methods were higher than 95%;the measuring range R2 proved to be 0.998 2 (R2=0.998 2). Conclusion ADVIA Centaur XP automatic chemilumi-nescence immunoassay system meets the desired needs, and is worthy promoting clinically.