六点定标化学发光微粒子免疫法检测TT_(3)、FT_(3)性能评价及其在乙肝患者中应用价值  

The Performance Evaluation of Six-Point Calibration ChemiluminescenceMicroparticle Immunoassay for the Detection of TT_(3)and FT_(3)andIts Application Value in Patients with Hepatitis B

作　　者：韩莹 孙继云[1] 殷商启 郑梅 孟欢 何超男 陈瑾 韩金育 王雅杰 HAN Ying;SUN Jiyun;YIN Shangqi;ZHENG Mei;MENG Huan;HE Chaonan;CHEN Jin;HAN Jinyu;WANG Yajie(Department of Clinical Laboratory,Beijing Ditan Hospital,Capital Medical University,Beijing 100015,China)

机构地区：[1]首都医科大学附属北京地坛医院检验科,北京100015

出　　处：《标记免疫分析与临床》2022年第7期1209-1214,共6页Labeled Immunoassays and Clinical Medicine

基　　金：吴阶平医学基金会临床科研专项资助基金(HBV pgRNA和拉曼光谱技术在慢乙肝及相关疾病中诊断价值探讨)(编号:320.6750.19019)。

摘　　要：目的进行化学发光微粒子免疫法总三碘甲状腺原氨酸(TT_(3))、游离三碘甲状腺原氨酸(FT_(3))检测性能评估并探讨其在慢性乙型肝炎相关疾病中实验室应用价值。方法参照美国临床实验室标准协会(CLSI)有关文件,对TT_(3)、FT_(3)精密度、正确度、线性范围、参考区间及新旧试剂对比结果进行验证分析。选取我院2020年10月至12月共78例慢性乙型肝炎患者、78例乙型肝炎肝硬化患者及57例健康体检者纳入本研究,分析其TT_(3)及FT_(3)结果特点。结果TT_(3)、FT_(3)的精密度分别为2.77%~3.55%、2.35%~5.61%。检测偏倚均小于12.5%,正确度符合验证标准。线性范围与试剂盒线性范围相符,且线性回归方程中R^(2)>0.95、0.97<b<1.03、a接近于0,线性良好。参考区间符合率分别为97.5%、100%。新旧试剂结果对比中TT_(3)检测偏倚均<12.5%,FT_(3)的一个结果超出12.5%。慢性乙型肝炎患者TT_(3)值高于健康体检人群,FT_(3)值低于健康体检人群。乙型肝炎肝硬化患者TT_(3)及FT_(3)值均低于慢性乙型肝炎患者及健康体检人群。结论利用六点定标化学发光微粒子免疫法检测TT_(3)、FT_(3)的精密度、正确度、线性范围、参考区间验证及新旧试剂对比结果均达到相关标准要求,结果准确可靠,可应用于临床检测。TT_(3)及FT_(3)值与肝损伤程度相关,对于慢性乙型肝炎及乙型肝炎肝硬化患者病情预估、监测可起到一定辅助作用。Objective To evaluate the performance of the chemiluminescent microparticle immunoassay for total triiodothyronine(TT_(3))and free triiodothyronine(FT_(3))and to investigate its laboratory characteristics in diseases associated with chronic hepatitis B.Methods The precision,accuracy,linear range,results of old and new reagents,and reference intervals of TT_(3)and FT_(3)were validated with reference to the relevant documents of the Clinical and Laboratory Standards Institute.A total of 78 patients with chronic hepatitis B,78 patients with hepatitis B cirrhosis and 57 healthy people from October to December,2020 were included in this study,and their TT_(3)and FT_(3)results were analyzed.Results The precision of TT_(3)and FT_(3)were 2.77%-3.55%and 2.35%-5.61%,respectively.The detection bias was less than 12.5%,and the accuracy met the verification standard.The linear range was consistent with the linear range provided by the kit,and R^(2)>0.95,0.97<b<1.03 and a was close to 0 in the linear regression equation,showing a good linearity.The coincidence rates of reference interval were 97.5%and 100%,respectively.In the comparison of the results of new and old reagents,the detection bias of TT_(3)was all less than 12.5%,and one result of FT_(3)exceeded 12.5%,which met the requirements.TT_(3)value of patients with chronic hepatitis B was higher than healthy people,while FT_(3)value was lower.TT_(3)and FT_(3)values in patients with hepatitis B cirrhosis were lower than those in patients with chronic hepatitis B and healthy people.Conclusion The precision,accuracy,linear range,comparison of new and old reagents and reference interval verification of TT_(3)and FT_(3)detected by six-point calibration chemiluminescence microparticle immunoassay can meet the requirements of relevant standards.The obtained results are accurate and reliable,and could be applied to clinical detection.TT_(3)and FT_(3)values are related to the degree of liver injury,which could play an auxiliary role in the prediction and monitoring of the condition

关 键 词：总三碘甲状腺原氨酸 游离三碘甲状腺原氨酸 性能验证 慢性乙型肝炎 乙型肝炎肝硬化 

分 类 号：R512.62[医药卫生—内科学]