【摘要】 抗缪勒氏管激素(AMH)是由卵巢窦前卵泡和小窦卵泡的颗粒细胞所分泌的一种糖蛋白,对于卵泡发育具有重要的调节作用,其血清水平直接受发育中窦卵泡的数量的影响,因此能够直接反映卵巢储备功能。对抗缪勒氏管激素(Anti-Muellerian hormone,AMH)量子点荧光免疫法床旁快速检测试剂进行性能评价,判断其是否可以满足临床需求,并评估该试剂是否可以准确检测女性的卵巢功能。基于量子点荧光免疫层析技术制备AMH全血检测试剂盒,建立AMH全血检测体系,评估该检测试剂的日间和日内精密度、定量限和线性范围,验证了该试剂与Beckman化学发光法AMH检测试剂的量值一致性以及该试剂诊断卵巢相关疾病的准确性。该试剂盒日内和日间精密度均小于15%;定量限<0. 1 ng/m L,线性范围为0. 11~16. 1 ng/m L。该试剂与Beckman化学发光法AMH检测试剂的相关系数为0. 96。对表面健康人群、卵巢早衰(Premature ovarian failure,POF)患者和多囊卵巢综合征(Polycystic ovary syndrome,PCOS)患者的血清AMH浓度的结果表明该方法诊断卵巢早衰的准确度为100%,诊断PCOS的特异性和灵敏度分别为91. 1和95. 2%。AMH量子点荧光免疫法床旁快速检测试剂具有良好的性能,且能够准确评估患者卵巢功能,对于不孕患者的病因筛查、快速诊断及医生制定治疗方案的指导具有重要价值。更多还原

【Abstract】 Anti-mullerian hormone(AMH) is a kind of glycoprotein secreted by the granulocytes of preovarian follicles and small sinus follicles,which plays an important role in the regulation of follicular development. Its serum level is directly affected by the number of developing sinus follicles,and thus can directly reflect the ovarian reserve function. To evaluate the performances Anti-Mullerian hormone quantum dots fluorescence immunoassay reagent,determine whether its performance meets clinical needs and evaluate whether the reagent can accurately detect female ovarian function. AMH whole blood detection kit was prepared based on the quantum dot fluorescence immunochromatography and a whole blood detection system for AMH was established. The intra-day and inter-day precisions,quantitative limit,linear range of the reagent,and the consistency of this reagent with Beckman chemiluminescence were evaluated,as well as the accuracy of diagnosing ovarian related diseases was also investigated. The inter-day and intra-day precisions of the reagent were less than 15%,meeting the requirement of rapid detection. Quantitative limit is less than 0. 1 ng/m L,the linear range of the reagent is between 0. 11 ~ 16 ng/m L,and the correlation coefficient between the reagent and Beckman chemiluminescence is 0. 96.AMH concentrations in serum of healthy people indicated that patients with premature ovarian failure and patients with polycystic ovary syndrome(PCOS) were detected and the results showed that this reagent diagnosed premature ovarian failure with 100% accuracy and diagnosed PCOS with specificity and sensitivity 91. 1% and 95. 2%,respectively. Anti-Mullerian hormone quantum dot fluorescence immunoassay reagent had good performance and could accurately evaluate the ovarian function of patients,which was of great value to the etiology screening,fast diagnosis of infertility patients,providing guidance for doctor to develop a treatment plan.更多还原