探讨一种基于临床意义的不同化学发光免疫分析仪的区间比对方法  

To Explore a Method of Interval Comparison of Different Chemiluminescence Immunoanalyzers Based on Clinical Significance

作　　者：孙洪珍[1] 董军[1] SUN Hong-zhen;DONG Jun(Zibo Central Hospital,Shandong Zibo 255036)

机构地区：[1]淄博市中心医院,山东淄博255036

出　　处：《中国医疗器械信息》2024年第14期39-42,82,共5页China Medical Device Information

摘　　要：探讨一种不同化学发光免疫分析仪间的比对方法即区间比对方法,是一种基于临床意义的仪器间比对方法。采用患者测试的实测数据进行比对,是仅针对临床化学发光免疫法测试的抗原类项目进行比对,因为抗原类物质的量与疾病的严重程度密切相关,对符合正态分布的项目结果用参考区间(X-3S,X+3S)区间跨度为标准区间跨度划分区间,对不符合正态分布的测定数值以95%正常参考区间的区间跨度划分区间。不同品牌的仪器根据各自项目测定范围内数据是否符合正态分布以上述规则进行自身不同项目的区间划分,不同品牌的仪器比对结果区间编号相同,仪器间比对成功,为临床所接受,比对结果区间编号不同,则比对失败,比对结果解释结合同期正常参考区间比对结果、同期病理区间比对结果、逻辑关联项目结果及临床诊断为依据,如果仪器出现偏差是由仪器的系统误差引起的,为临床所不接受,就要从仪器系统误差方面查找失控原因;如果项目结果偏差为临床可接受,则比对通过。项目结果区间比对是对质控品室内质量控制的有效补充,并利用品牌仪器之间的互补,出具准确的检验报告。We discuss a method of comparison between different chemiluminescence immunoanalyzers,that is,interval comparison method,it is a method of interinstrument comparison based on clinical significance.The comparison using the measured data of patient tests is only for the antigenic items tested by clinical chemiluminescence,because the amount of antigenic substances is closely related to the severity of the disease.For the project results conforming to normal distribution were divided into standard interval spans by reference interval spans(X-3S,X+3S),and for the measured values not conforming to normal distribution,the interval span of 95%normal reference interval was used to divide the interval.Instruments of different brands are divided into different items according to the above rules according to whether the data in the measured range of their respective items conforms to the normal distribution.The results of comparison between instruments of different brands have the same number,and the comparison between instruments is successful,which is accepted by clinical practice.If the results of comparison are different,the comparison fails.The interpretation of comparison results is based on the comparison results of normal reference intervals,pathological intervals,logical association items and clinical diagnosis in the same period.If the deviation of the instrument is caused by the systematic error of the instrument and is not accepted by the clinic,the out-of-control cause should be found from the aspect of the systematic error of the instrument.If the deviation of the project results is clinically acceptable,the comparison is approved.The interval comparison of project results is an effective supplement to the indoor quality control of quality control products,and the complementary use of brand instruments to issue accurate inspection reports.

关 键 词：化学发光免疫分析仪 质量控制 仪器间比对 区间比对 

分 类 号：R446.1[医药卫生—诊断学]