罗氏cobas e801免疫分析仪检测血清抗缪勒管激素的性能验证  

Verification of the Performance of Roche Cobas e801 Immune Analyzer for Detecting Serum AMH

作　　者：孙嘉峰[1] 王建伟[1] 范艳佳 Sun Jiafeng;Wang Jianwei;Fan Yanjia(Laboratory Department,Fujian Provincial Hospital South Branch,Fuzhou,Fujian,350008,China)

机构地区：[1]福建省立医院南院检验科,福建福州350008

出　　处：《黑龙江医学》2024年第13期1582-1584,1588,共4页Heilongjiang Medical Journal

摘　　要：目的:对罗氏cobas e801免疫分析仪检测血清抗缪勒管激素(AMH)进行性能验证,评估其是否能够满足临床需求。方法:参照美国临床和实验室标准协会文件,对罗氏cobas e801免疫分析仪检测血清AMH的精密度、准确度、线性范围、携带污染率进行性能验证。结果:罗氏cobas e801免疫分析仪检测低值、高值AMH的批内精密度变异系数分别为4.8%、3.7%,批间精密度变异系数分别为3.5%、5.1%,符合厂家要求临床应用批内精密度、批间精密度<10%的标准。室间质评5个样品检测结果与靶值进行比对,相对偏倚分别为0.81%、-0.22%、0.85%、-2.73%、1.77%,符合厂家准确性相对偏倚的要求范围±10%。AMH的携带污染率为0.39%,符合厂家≤2.0%的要求。AMH的线性回归方程为Y=0.980 9X+0.658 8,斜率a为0.980 9,R2为0.996,结果符合厂家要求,a值1±0.05,R2值≥0.95。结论:罗氏cobas e801免疫分析仪检测AMH的精密度、准确度、携带污染率、线性范围均通过验证,检测结果准确可靠,可以满足临床的需求。Objective:To verify the performance of Roche cobas e801 immune analyzer for detecting serum antimullerian hormone(AMH),and to evaluate whether it can meet the clinical needs.Methods:According to the documents of American Institute of Clinical and Laboratory Standards,the precision,accuracy,linear range and contamination rate of serum AMH were verified by Roche cobas e801 immune analyzer.Results:The coefficients of variation of in-batch precision and inter-batch precision of Roche cobas e801 immune analyzer for detecting low and high AMH were 4.8%and 3.7%,respectively,and 3.5%and 5.1%,respectively,which met the requirements of the manufacturers for in-batch precision and inter-batch precision<10%.The results of the 5 samples from the room quality assessment were compared with the target values,and the relative bias was 0.81%,-0.22%,0.85%,-2.73%and 1.77%,respectively,which met the manufacturer’s requirements for relative bias of accuracy within±10%.The contamination rate of AMH was 0.39%,which met the manufacturer’s requirement of≤2.0%.The linear regression equation of AMH was Y=0.9809X+0.6588,the slope a was 0.9809,R2 was 0.996,and the results met the requirements of the manufacturer,a value was 1±0.05,and R2≥0.95.Conclusion:The precision,accuracy,linear range and contamination rate of AMH detected by Roche cobas e801 immune analyzer have been verified.The detection results are accurate and reliable,which can meet the clinical needs.

关 键 词：抗缪勒管激素 电化学发光免疫分析 性能验证 

分 类 号：R44[医药卫生—诊断学]