不同化学发光免疫分析设备甲功五项检测结果比对观察  

Comparison and Observation of the Results of Five Different Chemiluminescence Immunoassay Devices for Detecting Thyroid Function

作　　者：赖河山 苏仁星 LAI He-shan;SU Ren-xing(Luoxi Health Center,Luojiang District,Quanzhou City,Fujian Quanzhou 362015;Luojiang District Center for Disease Control,Quanzhou City,Fujian Quanzhou 362011)

机构地区：[1]泉州市洛江区罗溪卫生院,福建泉州362015 [2]泉州市洛江区疾病控制中心,福建泉州362011

出　　处：《中国医疗器械信息》2024年第4期57-59,共3页China Medical Device Information

摘　　要：目的:研究不同化学发光免疫分析设备甲功五项检测结果比对差异。方法:选取2022年1月~2022年3月于本院收治的甲状腺功能减退患者、甲状腺功能亢进患者、正常体检人员各30例,三组受检者按照不同化学发光免疫分析设备进行分组,对照组采用进口西门子immulite 2000全自动化学发光免疫分析仪进行甲功五项检测,观察组采用国产某型号全自动化学发光免疫分析仪进行甲功五项检测。结果:两组甲状腺功能减退患者、甲状腺功能亢进患者、正常体检人员的甲功五项检测结果、检测结果符合率对比结果相近,差异不显著(P>0.05)。国产设备FT3、FT4、T3、T4诊断结果与甲状腺功能亢进、甲状腺功能减退高度正相关,与TSH高度负相关,对比结果差异显著(P<0.05)。结论:国产某型号全自动化学发光免疫分析仪的甲功五项检测结果比较准确,与西门子immulite 2000全自动化学发光免疫分析仪相近,准确性较高,因此甲功五项检测可以采用国内化学发光免疫分析设备取代国外化学发光免疫分析设备。Objective:To study the differences in the comparison of five test results of different chemiluminescent immunoassay devices for thyroid function.Methods:30 patients with hypothyroidism,hyperthyroidism,and normal physical examination were selected from our hospital from January 2022 to March 2022.The three groups of patients were grouped according to different chemiluminescence immunoassay equipment.The control group was tested for five thyroid function tests using an imported Siemens immulite 2000 fully automatic chemiluminescence immunoassay analyzer,the observation group used a domestic model of fully automatic chemiluminescence immunoassay analyzer for five tests of nail function.Results:The comparison of the five thyroid function test results and the compliance rate between the two groups of patients with hypothyroidism,hyperthyroidism,and normal physical examination personnel were similar,but the difference was not significant(P>0.05).The diagnostic results of domestically produced equipment FT3,FT4,T3,and T4 are highly positively correlated with hyperthyroidism and hypothyroidism,and highly negatively correlated with TSH,the difference in comparison results is significant(P<0.05).Conclusion:The results of the five test items of the domestically produced model of fully automatic chemiluminescence immunoassay analyzer are relatively accurate,similar to the Siemens Immunite 2000 fully automatic chemiluminescence immunoassay analyzer,with high accuracy.Therefore,domestic chemiluminescence immunoassay equipment can be used to replace foreign chemiluminescence immunoassay equipment for the five test items of thyroid function.

关 键 词：全自动化学发光免疫分析仪 甲功五项检测结果 符合率 

分 类 号：R446.1[医药卫生—诊断学]