摘要
目的:探讨电化学发光法检测抗甲状腺过氧化物酶抗体(TPOAb)的性能验证及其在甲状腺疾病诊断中的应用价值。方法:使用罗氏Cobas e602电化学发光免疫分析仪对TPOAb进行检测,观察精密度实验结果、准确度实验结果与线性范围情况;同时选取2018年4月~2019年12月本院收治的120例甲状腺疾病患者与40名健康人员,对不同类型患者及健康人员的TPOAb、血清促甲状腺激素(TSH)、血清游离三碘甲状腺素原氨酸(FT3)、血清游离甲状腺素(FT4)水平进行观察。结果:TPOAb的批内与批间不精密度符合厂家所提供的性能标准;检测厂商的4份定值校准品,结果与靶值的相对偏倚-2.98%~3.82%之间;TPOAb在5.8IU/mL~588.5IU/mL之间线性良好。甲亢组患者与甲减组患者的TPOAb水平明显高于甲肿组患者与健康人员,差异显著(P<0.05);但甲肿组患者与健康人员的TPOAb水平则无显著差异(P>0.05)。结论:电化学发光法检测抗甲状腺过氧化物酶抗体的分析性能符合质量目标要求,通过检测甲状腺过氧化物酶抗体水平对于不同类型的甲状腺疾病具有良好的鉴别作用。
Objective:To evaluate the performance of electrochemiluminescence(ECL)in the detection of anti thyroid peroxidase antibody(TPOAb)and its application value in the diagnosis of thyroid diseases.Methods:Roche Cobas was used E602 electrochemiluminescence immunoassay was used to detect TPOAb,and the precision test results,accuracy test results and linear range were observed;at the same time,120 cases of thyroid disease patients and 40 healthy people admitted to our hospital from April 2018 to December 2019 were selected,and the TPOAb,serum thyroid stimulating hormone(TSH)and serum free triiodothyroxine(triiodothyroxine)of different types of patients and health personnel were measured The levels of FT3 and FT4 were observed.Results:The intraassay and inter assay imprecision of TPOAb met the performance standards provided by the manufacturer;the relative bias between the results and the target value was-2.98%-3.82%when 4 calibration samples were detected;the linear range of TPOAb was 5.8iu/mL-588.5iu/mL.The level of TPOAb in hyperthyroidism group and hypothyroidism group was significantly higher than that in goiter group and healthy people(P<0.05),but there was no significant difference between hyperthyroidism group and healthy people(P>0.05).Conclusion:The analytical performance of the detection of anti thyroid peroxidase antibody by electrochemiluminescence method meets the requirements of quality objectives.The detection of thyroid peroxidase antibody level has a good differential effect for different types of thyroid diseases.
作者
刘孝文
LIU Xiao-wen(Department of laboratory medicine,Wenshan People’s Hospital of Yunnan Province,Yunnan Wenshan 663000)
出处
《中国医疗器械信息》
2021年第10期9-10,22,共3页
China Medical Device Information
关键词
电化学发光法
抗甲状腺过氧化物酶抗体
性能验证
甲状腺疾病
诊断价值
electrochemiluminescence
anti thyroid peroxidase antibody
performance verification
thyroid diseases
diagnostic value
