抗苗勒管激素(AMH)是评估卵巢储备的理想生物标志物。然而,由于现有AMH检测的敏感性较低,其在确定卵巢储备减少方面的应用受到限制.在这里,基于单分子阵列(SiMoA,HD-X平台),系统评价了UD-AMH的分析性能。UD-AMH的检测限(LoD)和定量限(LoQ)分别为0.13和0.14pg/mL,分别,比目前报道的一般临床AMH检测高约100倍。一项比较研究显示了高度的相关性,对于BeckmanAccessAMH测定,r=0.988,对于KangrunAMH测定,r=0.945。此外,我们发现,早熟卵巢功能不全(POI)患者的AMH浓度非常低(2.59(0.86,31.79)pg/mL),与围绝经期妇女的AMH浓度相似(2.37(0.65,35.88)pg/mL),但显著高于围绝经期妇女的AMH浓度(0.43(0.28,1.17)pg/mL).此外,我们观察到大多数激素疗法(HT)治疗的POI患者的AMH浓度急剧下降,表明POI患者的卵巢储备随着时间的推移甚至在HT治疗下也会下降。
Anti-Müllerian hormone (AMH) is an ideal biomarker for the assessment of ovarian reserve. However, its application in determining ovarian reserve reduction is restricted due to the low sensitivity of existing AMH assays. Herein, a homebrew ultrasensitive digital AMH assay (UD-AMH) was established based on a single-molecule array (SiMoA, HD-X platform), and the analytical performance of UD-AMH was evaluated systematically. The limit of detection (LoD) and limit of quantitation (LoQ) of UD-AMH were 0.13 and 0.14 pg/mL, respectively, which is approximately 100-fold higher than that of the current reported general clinical AMH assay. A comparison study showed a high correlation, with r = 0.988 for the Beckman Access AMH assay and r = 0.945 for the Kangrun AMH assay. In addition, we found that the AMH concentrations of premature ovarian insufficiency (POI) patients were very low (2.59 (0.86, 31.79) pg/mL) and similar to those of perimenopausal women (2.37 (0.65, 35.88) pg/mL) but significantly higher than those of menopausal women (0.43 (0.28, 1.17) pg/mL). Furthermore, we observed that the AMH concentration of most hormone therapy (HT) treated POI patients decreased sharply, suggesting that the ovarian reserve of POI patients declines over time even under HT-treatment.