不同免疫比浊系统检测血清淀粉样蛋白A的性能验证分析  

Performance evaluation of the serum amyloid A assay on different immunoturbidimetric system*

作　　者：李有强 张云燕 刘杨 黄霜 王蕴端 王晶晶 周锐 LI Youqiang;ZHANG Yunyan;LIU Yang;HUANG Shuang;WANG Yunduan;WANG Jingjing;ZHOU Rui(Department of Laboratory Medicine,He Xian Memorial Hospital,Southern Medical University,Guangzhou,Guangdong 511400,China;Department of Stomatology,Guangzhou Women and Children Medical Center,Guangzhou Medical University,Guangzhou,Guangdong 501180,China;The Second Clinical Medical College of Guangzhou University of Traditional Chinese Medicine,Guangzhou,Guangdong 510006,China)

机构地区：[1]南方医科大学附属何贤纪念医院检验科,广东广州511400 [2]广州医科大学附属广州市妇女儿童医疗中心口腔科,广东广州501180 [3]广州中医药大学第二临床医学院,广东广州510006

出　　处：《现代医药卫生》2020年第16期2494-2497,共4页Journal of Modern Medicine & Health

基　　金：国家自然科学基金项目(81601736)。

摘　　要：目的评价奥普、锦瑞、希莱恒和赛斯鹏芯检测系统的血清淀粉样蛋白A(SSA)分析性能,为临床应用提供依据。方法依据美国临床和实验室标准协会(CLSI)的EP-15A2文件,对上述4种系统进行精密度验证。每天分析1个批次,每批2个浓度水平,分别测定3次,连续测定5 d。依据CLSI的EP-9A2文件进行正确度验证,参比系统为西门子BNPRO配套检测系统。每批不少于8个样本,重复测定2次,连续测定5 d。依据CLSI的EP-6A文件进行分析线性范围验证和临床可报告范围验证,配制5个不同梯度临床样本分别测定。依据CLSI的C28-A2文件进行参考范围验证,收集20个健康体检者检测结果进行统计分析。结果奥普、锦瑞、希莱恒和赛斯鹏芯检测系统在高、低2个水平的不精密度分别为2.39%、3.25%,5.30%、4.97%,5.81%、4.18%和1.94%、0.59%。奥普、锦瑞、希莱恒和赛斯鹏芯检测系统与参比系统相比,奥普检测系统在10 mg/L时相对偏差为22.51%,其他检测系统在医学决定水平处的相对偏差均少于15%。奥普、锦瑞、希莱恒和赛斯鹏芯检测系统SAA验证的线性范围分别为4.58~186.35 mg/L、8.25~298.58 mg/L、6.10~279.10 mg/L和9.8~278.1 mg/L,临床可报告范围分别为2043.0 mg/L、2400.0 mg/L、1127.9 mg/L和1200.0 mg/L。奥普,锦瑞,希莱恒和赛斯鹏芯检测系统SAA参考范围均与厂家声称相符。结论奥普、锦瑞、希莱恒和赛斯鹏芯检测系统的SAA检测性能均满足行业标准要求。Objective Evaluate the performance of serum amyloid A(SSA)analysis of Upper,Genrui,Xilaiheng and Xpenarray detection systems to provide a basis for clinical application.Methods According to CLSI′s EP-15A2 document,the accuracy of the above four systems was verified.One batch was analyzed every day,and each batch had two concentration levels,which were measured three times and measured continuously for 5 days.The accuracy was verified according to CLSI′s EP-9A2 file,and the reference system was a matching detection system for Siemens BNPRO.Each batch was no less than 8 samples,repeated measurement 2 times,continuous measurement for 5 days.According to CLSI′s EP-6A file,the analysis of linear range verification and clinical reportable range verification was conducted,and 5 clinical samples with different gradients were prepared and tested separately.Based on CLSI C28-A2 file,the reference range was verified,and the results of 20 healthy examinees were collected for statistical analysis.Results The imprecision of the Upper,Genrui,Xilaiheng and Xpenarray detection systems at high and low levels were 2.39%,3.25%,5.30%,4.97%,5.81%,4.18%and 1.94%,0.59%respectively.Compared with the reference system,the relative deviations of the Genrui,Xilaiheng and Xpenarray detection systems at the medical decision level were all less than 15%,the Upper was 22.51%on the concention of 10 mg/L.The linear ranges of SAA verification for Upper,Genrui,Xilaiheng and Xpenarray detection systems were 4.58-186.35 mg/L,8.25-298.58 mg/L,6.10-279.10 mg/L and 9.8-278.1 mg/L,respectively.The SAA clinical reportable ranges of Upper,Genrui,Xilaiheng and Xpenarray detection systems were 2043.0 mg/L,2400.0 mg/L,1127.9 mg/L and 1200.0 mg/L,respectively.The SAA reference range of Upper,Genrui,Xilaiheng and Xpenarray detection systems were in accordance with the manufacturer′s claims.Conclusion The SAA inspection performance of Upper,Genrui,Xilaiheng and Xpenarray inspection systems all meet the requirements of industry standards.

关 键 词：血清淀粉样蛋白A 精密度 正确度 分析测量范围 临床可报告范围 参考范围 

分 类 号：R446.1[医药卫生—诊断学]