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.
作者
孙嘉峰
王建伟
范艳佳
Sun Jiafeng;Wang Jianwei;Fan Yanjia(Laboratory Department,Fujian Provincial Hospital South Branch,Fuzhou,Fujian,350008,China)
出处
《黑龙江医学》
2024年第13期1582-1584,1588,共4页
Heilongjiang Medical Journal
关键词
抗缪勒管激素
电化学发光免疫分析
性能验证
Antimullerian hormone
Electro-chemiluminescence immunoassay
Performance verification
