摘要
目的验证化学发光免疫分析法检测C肽的分析性能。方法参考美国临床和实验室标准化协会(CLSI)系列文件和相关文献,结合科室具体实际,验证深圳新产业MAGLUMI 4000 Plus检测系统检测C肽的基本分析性能。结果C肽低、高浓度批内不精密度、批间不精密度均在可接受范围内;无样本携带污染;C肽原装配套定值标准品检测值与靶值的偏倚小于12.5%,20例临床样本与MAGLUMI 4000检测结果差异无统计学意义(P>0.05),平均相对偏差为3.76%;C肽最大稀释倍数为8倍;功能灵敏度为0.10 ng/mL;C肽浓度范围在0.09~17.25ng/mL线性回归方程为Y=1.008X-0.2891,相关系数r=0.983;20名健康体检者检测C肽的结果为1.042~2.901ng/mL,100%的检测结果在厂家提供的参考区间内。结论深圳新产业MAGLUMI 4000 Plus化学发光免疫分析检测系统检测C肽的基本分析性能与厂家声明或相关文献基本一致,可以替换深圳新产业MAGLUMI 4000,用于临床常规工作的开展。
Objective To verify the analytical properties of chemiluminescence immunoassay for C-peptide.Methods The basic analytical performance of the new industry MAGLUMI 4000 Plus detection system from ShenZhen for c-peptide was verified by referring to CLSI series documents and related literatures and combining with the specific practice of the department.Results The results showed that low concentration of C-peptide,inaccuracy in batch and imprecision between batches were all in acceptable ranges.There was no sample contamination and the bias between the measured value of standard substance and the target value of C-peptide original package was less than 12.5%.Also,there was no statistical difference between the 20 clinical samples and the MAGLUMI 4000 test results(P>0.05),and the average relative deviation was 3.76%.The maximum dilution factor of C-peptide was 8 times.Functional sensitivity was 0.10 ng/mL and the linear regression equation of C-peptide concentration ranged from 0.09ng/mL to 17.25ng/mL was Y=1.008X-0.2891,with the correlation coefficient r=0.983.The test results of C-peptide from 20 healthy subjects were 1.042-2.901ng/mL,and 100%of the test results were within the reference range provided by the manufacturer.Conclusion The basic analytical performance of the new industry MAGLUMI 4000 Plus chemiluminescence immunoassay and detection system for C-peptide from Shenzhen is generally consistent with the manufacturer′s statement or relevant literature,which can replace the new industry MAGLUMI 4000 from Shenzhen and be used in routine clinical work.
作者
满霞
郑进
徐洋
MAN Xia;ZHENG Jin;XU Yang(Department of Clinical Laboratory,Huadong Sanatorium,Wuxi 214065,China;New Industry Biomedical Engineering Co.,Ltd.,Shenzhen 518000,China)
出处
《标记免疫分析与临床》
CAS
2020年第1期163-167,共5页
Labeled Immunoassays and Clinical Medicine
关键词
化学发光免疫分析法
C肽
性能验证
Chemiluminescence immunoassay
C-peptide
Performance verification
