摘要
目的:生化分析仪开展免疫五项检测的性能评价分析.方法:随机选取2019年2月~2019年8月于本院进行健康体检的40例健康体检人员作为观察对象,均无重大疾病史,身体健康.采集40例研究对象空腹状态下6mL静脉血,予以血清分离处理,把每位受检者的血清标本分别装在两个试管内,备用;采用生化分析仪(日立7600)检测血清五项免疫指标,按照检测结果对仪器的参考范围进行验证,选择传统方法对仪器开展免疫五项检验的精准度进行检验,根据国家卫生部室间质评结果评定免疫五项检测结果的正确度.结果:生化分析仪对IgA、IgG、IgM、补体C3以及补体C4进行检验,结果发现检验精准度都达到标准水平;检验正确度都达到标准;参考范围与厂家提供参考范围相符合.结论:生化分析仪(日立7600)开展免疫五项检测具有较好的精准度、正确度,性能较好.
Objective:To explore the performance evaluation of biochemical analyzer for five immunoassays.Methods:During the period from February 2019 to August 2019,randomly selected 40 health check-up personnel from our hospital for health check-ups were selected as the subjects of this study.All subjects had no significant medical history and were healthy.6 mL of venous blood in 40 fasting subjects were collected and treated with serum separation.The serum samples of each subject were placed in two test tubes for backup;a biochemical analyzer(Hitachi 7600)was used to detect five serum immune indicators.According to the test results,the reference range of the instrument was verified,and the traditional method was used to test the accuracy of the five immunity-free tests,and the accuracy of the five immune test results was evaluated according to the results of the inter-house quality assessment by the Ministry of Health.Results:The biochemical analyzer tested IgA,IgG,IgM,complement C3 and complement C4,and found that the accuracy of the tests reached the standard level;the accuracy of the tests reached the standard;the reference range was consistent with the reference range provided by the manufacturer.Conclusion:The biochemical analyzer(Hitachi 7600)has better accuracy,accuracy and better performance for the five immunoassays.
作者
胡斯文
HU Si-wen(Department of Clinical Laboratory,Panjin Central Hospital,Liaoning Panjin 124010)
出处
《中国医疗器械信息》
2020年第5期151-152,共2页
China Medical Device Information
关键词
生化分析仪
免疫五项检测
性能评价
biochemical analyzer
five immunoassays
performance evaluation
