Modern Fertility, San Francisco, and Universal Diagnostic Laboratories, Van Nuys, California; and Rutgers-New Jersey Medical School, Newark, New Jersey.
Obstet Gynecol. 2019 Feb;133(2):343-348. doi: 10.1097/AOG.0000000000003066.
Minimally invasive fingerstick sampling allows testing of reproductive hormone levels at home, providing women with increased access to tests that can screen for conditions such as polycystic ovarian syndrome, primary ovarian insufficiency, and pituitary and thyroid dysfunction.
We present a measurement procedure comparison study of matched venipuncture and fingerstick samples from 130 women aged 18-40 years, tested on menstrual cycle day 3. Samples were measured for anti-müllerian hormone, estradiol (E2), follicle-stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), testosterone, thyroid-stimulating hormone (TSH), and free thyroxine (T4) levels. Samples were tested using U.S. Food and Drug Administration-cleared immunoassays, with a modified reconstitution step for fingerstick samples.
Venipuncture and fingerstick hormone values were concordant and linear across all assay ranges. There was no evidence of systematic bias across the assay ranges, and bias measures were below recommended guidelines. The correlation between venipuncture and fingerstick was between 0.99 and 1.0 for each hormone. Each assay displayed a high degree of precision (less than 13% coefficient of variation) and a high level of accuracy (average recovery equaled 95.5-102.3%).
Venipuncture and fingerstick samples can be used interchangeably to measure anti-müllerian hormone, E2, FSH, LH, PRL, testosterone, TSH, and free T4 levels. Fingerstick sampling provides doctors and women more convenient testing options.
The study was sponsored by Modern Fertility.
微创指尖采血可在家中检测生殖激素水平，为女性提供更多机会接受检查，筛查多囊卵巢综合征、原发性卵巢功能不全、垂体和甲状腺功能障碍等疾病。
我们进行了一项对比研究，比较了 130 名年龄在 18-40 岁之间的女性在月经周期第 3 天的静脉血样和指尖血样的测量过程。对这些样本进行了抗苗勒氏管激素、雌二醇（E2）、卵泡刺激素（FSH）、黄体生成素（LH）、催乳素（PRL）、睾酮、促甲状腺激素（TSH）和游离甲状腺素（T4）水平的检测。这些样本使用获得美国食品药品监督管理局（FDA）批准的免疫检测法进行了检测，指尖血样的检测过程中有一个改良的复溶步骤。
在所有检测范围内，静脉血和指尖血的激素值均一致且呈线性关系。在整个检测范围内没有发现系统偏差，偏差测量值低于推荐标准。静脉血和指尖血的相关性在每个激素之间都在 0.99 到 1.0 之间。每个检测都表现出高度的精密度（变异系数小于 13%）和高度的准确性（平均回收率等于 95.5-102.3%）。
静脉血和指尖血样本可相互替换，用于检测抗苗勒氏管激素、E2、FSH、LH、PRL、睾酮、TSH 和游离 T4 水平。指尖采血为医生和女性提供了更便捷的检测选择。
该研究由 Modern Fertility 赞助。
