摘要
目的对4种国产化学发光免疫分析(CLIA)设备的配套定量检测试剂盒中的8项肿瘤标志物的检测结果进行性能验证。方法将4种国产CLIA设备厂家随机标为A、B、C、D,8项肿瘤标志包括糖类抗原(CA)125、CA15-3、CA19-9、铁蛋白(Fer)、甲胎蛋白(AFP)、癌胚抗原(CEA)、前列腺特异抗原(PSA)及游离前列腺特异抗原(fPSA)。参考美国临床实验室标准化协会(CLSI)文件要求,对4种国产设备配套的8项肿瘤标志物进行精密度验证、方法学比对、分析测量范围验证。样本来源于苏州医院就诊患者血清。其中方法学比对实验参考CLSIEP9-A3方案,参考系统为配套进口检测系统,评价国产设备与进口设备检测结果的可比性。拟合并计算医学决定水平处的偏移,采用Pearson相关与Spearman秩相关分析数据。结果A检测系统的CA125和PSA,B检测系统的CA125和AFP,C检测系统的CA125、CEA、AFP和PSA和D检测系统的8个项目的精密度验证结果符合本实验室质量要求;A^D系统与进口设备测定结果间明显相关,相关系数分别为0.79~0.99、0.47~0.99、0.90~0.98、0.78~1.00(均P<0.05),医学决定水平处百分偏移可接受项目数量分别为5、2、5、4项;所有项目分析测量范围验证结果均符合要求。结论4种国产CLIA设备对肿瘤标志物检测性能有所差异,实验室在选用国产CLIA设备时应进行验证,并选择满足实验室质量要求的设备和检测项目。
Objective To validate the performance of 4 domestic chemiluminescence immunoassay (CLIA) systems on 8 tumor markers quantitative assay kits. Methods Four domestic CLIA systems were randomly marked as A, B, C, D and 8 tumor markers, including carbohydrate antigen (CA)125, CA15-3, CA19-9, ferritin (Fer), alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), prostate-specific antigen (PSA) and free PSA (fPSA) were determined. According to the standard of Clinical and Laboratory Standards Institute (CLSI), the precision, methodological comparison and analytical measure range of 4 systems were validated. Clinical serum samples were obtained from patients in Suzhou Hospital. According to the CLSI EP9-A3 protocol, imported equipment was used as the reference system. The biases of medical decision points were assumed, and Pearson correlation analysis and Spearman correlation analysis were used to analyze the data. Results The precision verification of CA125 and PSA on A, CA125 and AFP on B, CA125, CEA, AFP and PSA on C, and all 8 tumor markers on D could meet the laboratory quality control requirements. The correlations of the test results between A-D and the imported equipment were significant (all P<0.05) with the correlation coefficients 0.79-0.99, 0.47-0.99, 0.90-0.98 and 0.78-1.00, respectively, and the number of acceptable tests at the level of medical decision was 5, 2, 5, 4. All tests were certified to meet the analytical measure range validation. Conclusions The detection performance of 4 domestic CLIA systems for all 8 tumor markers are different. The performance of domestic CLIA systems should be tested when choosing one that can meet laboratory quality control requirements.
作者
石燕
魏衍财
郑维玲
魏佳玲
宋妙丽
朱耿超
卢旬
杨辰
Shi Yan;Wei Yancai;Zheng Weiling;Wei Jialing;Song Miaoli;Zhu Gengchao;Lu Xun;Yang Chen(Department of Nuclear Medicine,Suzhou Hospital Affiliated to Nanjing Medical University,Suzhou 215002, China)
出处
《中华核医学与分子影像杂志》
CAS
北大核心
2018年第12期801-804,共4页
Chinese Journal of Nuclear Medicine and Molecular Imaging
关键词
化学发光测定法
免疫测定
肿瘤标记
生物学
Chemiluminescent measurements
Immunoassay
Tumor markers,biological
作者简介
通信作者:杨辰,Email:15950093311@139.com
