文章摘要

生化分析仪检测胶乳免疫比浊法AFP的性能验证评价

作者: 1孔维菊, 2次平, 1林杰, 2仁增白玛, 2格桑克真, 2土旦卓玛, 1任传路
1 中国人民解放军联勤保障部队第九〇四医院检验科,江苏 无锡 214000
2 西藏林芝市米林县人民医院检验科,西藏 林芝 860500
通讯: 任传路 Email: CLU_REN@126.com
DOI: 10.3978/j.issn.2095-6959.2021.05.002
基金: 南京军区面上基金(15MS033)。

摘要

目的:对生化分析仪检测胶乳免疫比浊法AFP的分析性能进行验证和评价。方法:参照中国合格评定国家认可委员会(China National Accreditation Service,CNAS)最新的性能验证指南和美国临床和实验室标准协会(American Clinical and Laboratory Standards Institute,CLSI)的文件,并结合实际工作,设计验证方案,对贝克曼库尔特AU480生化分析仪检测北京九强金斯尔的胶乳免疫比浊法AFP试剂的正确度、精密度、线性范围、临床可报告范围、生物参考区间进行验证和评价。试验结果与厂家提供的分析性能或国家卫生健康委临床检验中心(National Center for Clinical Laboratories,NCCL)的质量指标进行比较。结果:2个水平的正确度偏倚分别为6.47%和2.22%;3个水平的批内及批间精密度的变异系数(coefficient of variation,CV)分别为5.79%,1.66%,2.16%及2.47%,2.23%,1.07%;线性范围验证回归系数a值为1.012,R2=0.9995;最大稀释倍数为30倍,临床可报告上限为24 000 ng/mL;生物参考区间的符合率R为100%。结论:生化分析仪AU480检测胶乳免疫比浊法AFP的各项分析性能均能够较好地满足临床应用需求。实验室可根据自身情况选择替代化学发光法使用。
关键词: 甲胎蛋白;胶乳免疫比浊法;生化分析仪;性能验证

Validation and evaluation of the performance of latex immunoturbidimetric assay for AFP detected by biochemical analyzer

Authors: 1KONG Weiju, 2CI Pi, 1LIN Jie, 2RENZENG Baima, 2GESANG Kezhen, 2TUDAN Zhuoma, 1REN Chuanlu
1 Department of Laboratory, PLA Joint Logistic Support Force 904 Hospital, Wuxi Jiangsu 214000, China
2 Laboratory of Milin County People’s Hospital, Linzhi Xizang 860500, China

CorrespondingAuthor: REN Chuanlu Email: CLU_REN@126.com

DOI: 10.3978/j.issn.2095-6959.2021.05.002

Foundation: This work was supported by the General Fund of Nanjing Military Area Command, China (15MS033).

Abstract

Objective: To verify and evaluate the analytical performance of latex immunoturbidimetric assay for AFP. detected by biochemical analyzer. Methods: The verification scheme was designed with a reference to the latest performance verification guidelines of China National Accreditation Service (CNAS), the documents of American Clinical and Laboratory Standards Institute (CLSI) and the actual work. The accuracy, precision, linear range, clinical reportable range, and biological reference range of the latex immunoturbidimetric AFP reagent of Beijing Jiuqiang Jisier with the BECKMAN COULTER AU480 biochemical analyzer were verified and evaluated. The results were compared with the analytical performance claimed by the manufacturer or the quality indicators of the National Center for Clinical Laboratories (NCCL). Results: The accuracy bias of the two levels was 6.47% and 2.22%, respectively. Coefficient of variation (CV) of precision within and between batches at three levels were 5.79%, 1.66%, 2.16%, and 2.47%, 2.23%, 1.07%, respectively. The value of the regression coefficient in the linear range was 1.012, with the R2 of 0.9995. The maximum dilution multiple is 30 times, and the detectable upper limit was 24 000 ng/mL. The coincidence rate R of biological reference range is 100%. Conclusion: The analytical performance of AU480 in detecting latex immunoturbidimetric AFP was able to meet the needs of clinical application. The laboratory can choose to replace chemiluminescence method according to its own situation.
Keywords: alpha fetoprotein; latex immunoturbidimetry; biochemical analyzer; performance verification