游离甲状腺素化学发光免疫分析方法的建立  

Establishment of Chemiluminescence Immunoassay for Free Thyroxine

作　　者：陈春晓[1] 

机构地区：[1]北京北方生物技术研究所有限公司,北京100076

出　　处：《标记免疫分析与临床》2017年第5期576-580,共5页Labeled Immunoassays and Clinical Medicine

摘　　要：目的采用二抗-甲状腺素抗体固相两步包被法,使用鲁米诺-双氧水-辣根过氧化物酶化学发光体系作为检测体系,建立测定血清中游离甲状腺素的化学发光免疫分析方法。方法利用竞争法建立游离甲状腺素的检测体系,分别对该体系进行分析性能评估、2016年度内分泌室间质评,并与进口全自动发光试剂盒检测结果进行一致性检验。结果在4~64pmol/L的校准曲线范围内相关系数0.9995,最低检出限为0.54pmol/L,批内和批间精密度均小于7.0%,稳定性结果良好,不影响检测结果。2016年全国室间质评测定结果均在允许范围内,与进口西门子发光试剂盒有很好的临床符合性,两种试剂盒的样本测值差异不具有统计学意义。结论本方法利用二抗-甲状腺素抗体固相两步包被法,在节约包被原料的同时改善了精密度且提高了灵敏度,最后通过临床血样的一致性评价,与参比试剂盒具有同等的临床使用价值。Objective Chemiluminescence immunoassay for the determination of free thyroxine in serum was established by using a goat anti-mouse IgG and thyroxine antibody coated solid phase two-step method, which is using a luminol-hydrogen peroxide-horseradish peroxidase chemiluminescence system as a detection system. Methods The detection system is established by using the competition law on both the system of performance evaluation, and the 2016 annual endocrine EQA Theimported automatic light detection kit was also used to test the consistency of results. Results The correlation coefficient was 0. 9995, the lowest detection limit was 0.54pmol/L, and the intra- and inter batch precision was less than 7 % which was in the range of calibration curve from 4 to 64pmol/L. The stability of the test was good. In the period of 2016, the results of endocrine EQA were within the allowable range, and there was a very good clinical compliance with the imported SIEMENS luminescence kit. The sample values of the two kits were not statistically different. Conclusion Our study utilizes a goat anti-mouse IgG and thyroxine antibody coated solid phase two-step method to improve the precision and the sensitivity with less coated raw material. Base on that, by testing the consistency of clinical blood samples, we showed that it has the same clinical value with the reference kit.

关 键 词：游离甲状腺素 羊抗鼠IgG 甲状腺素抗体 固相两步包被法 化学发光免疫分析法 

分 类 号：R446.6[医药卫生—诊断学]