首页|国产全自动化学发光免疫分析仪推广可行性分析及检验科对其发展的建议与期待研究

国产全自动化学发光免疫分析仪推广可行性分析及检验科对其发展的建议与期待研究

Feasibility Analysis of Domestic Automatic Chemiluminescence Immuno-analyzer and Suggestions for Its Development

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目的 探究国产全自动化学发光免疫分析仪推广的可行性.方法 选取2023年7-10月广西中医药大学第一附属医院的40份静脉血标本为研究对象,采用国产迈瑞CL-6000i全自动化学发光免疫分析仪和进口雅培i2000SR全自动化学发光免疫分析仪检测标本中的心肌肌钙蛋白I(Cardiac Troponin I,cTnI),使用变异系数(Coefficient of Variation,CV)计算仪器精密度,根据检测数据计算相关性回归方程.结果 cTnI高低两个水平的批内CV分别小于各自的1/4允许总误差(Total Error Allowed,TEa),批间CV也同样分别小于各自的1/3TEa.在cTnI测定的线性范围内,两种检测系统相关性回归分析方程为Y=0.9658X±0.1495,R2 为0.983.结论 两套检测系统cTnI检测结果具有较好的一致性,国产迈瑞全自动化学发光免疫分析仪检测cTnI能够满足临床需要,适于临床实验室使用.
Objective To explore the feasibility of promoting domestic automatic chemiluminescence immunoanalyzer.Methods The venous blood samples of 40 patients from the First Affiliated Hospital of Guangxi University of Tradi-tional Chinese Medicine from July to October 2023 were selected as the research objects.Cardiac troponin I(cTnI)was detected by domestic Mindray CL-6000i automatic chemiluminescence immunoanalyzer and imported Abbott i2000SR automatic chemiluminescence immunoanalyzer.Coefficient of variation(CV)was used to calculate the preci-sion of the instrument,and the correlation regression equation was calculated according to the test data.Results The in-batch CV of the high and low levels of cTnI was less than 1/4 of the total error allowed(TEa)respectively.The inter-batch CV was also less than 1/3 tea respectively.In the linear range measured by cTnI,the correlation regres-sion analysis equation of the two detection systems was Y=0.9658X±0.1495,and the R2 was 0.983.Conclusion The cTnI detection results of the two detection systems have a good consistency,and the domestic Mindray automatic che-miluminescence immunoanalyzer can meet the clinical needs and is suitable for clinical laboratory use.

Chemiluminescence immunoanalyzerFeasibility analysisCardiac troponin

李敏、梁锦贤、杜心蕊、傅苗、潘爱萍

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广西中医药大学第一附属医院检验科,广西 南宁 530023

化学发光免疫分析仪 可行性分析 发展建议

广西中医药大学创新创业训练计划重点项目

201908004

2024

中国卫生产业
全国卫生产业企业管理协会

中国卫生产业

影响因子:0.692
ISSN:1672-5654
年,卷(期):2024.21(5)