Background In the United States, an estimated 13% of women between the ages of 15 and 49 years, experience impaired reproductive potential (fecundity). Assessment of fecundity typically requires an in-person physician visit and venous blood collection to evaluate hormone levels and identify potential reproductive health conditions. Exploring less invasive, at-home sampling options could offer couples insights into their personal reproductive abilities, providing peace of mind and aiding in family planning. Methods Capillary blood, obtained using the Tasso®+ capillary blood collection device coupled with a BD Microtainer® serum tube, was utilized for measurements of analytes associated with female fecundity (follicle stimulating hormone, luteinizing hormone, estradiol, progesterone, anti-Müllerian hormone, and prolactin). These are all FDA-approved assays measured on Roche cobas® e801, assay parameters remained unchanged. Professional and self-collected capillary serum samples were acquired in parallel with the standard venous serum samples, to compare clinical equivalency of the capillary sampling option. In addition to isothermal stability studies at room temperature (20-25°C) and refrigerated (2-8°C) conditions, shipping excursion studies based on ISTA 7D recommendations were performed using a novel packaging solution to control sample temperature and thus, specimen integrity. Studies to assess matrix equivalency, linearity, and imprecision of this alternate sample type were also performed to demonstrate analytical performance. Results Method comparison of venous and professional collection of capillary samples demonstrated correlations (R) ≥ 0.9720 with slopes ranging from 0.919 to 0.971 and mean biases within ±8.2% for all analytes (n = 19-79). Self-collected capillary serum samples demonstrated correlations (R) ≥ 0.9827 with slopes that ranged from 0.841 to 0.985 and mean biases within ±10.7% (n = 16-26). Isothermal stability was demonstrated for each analyte up to 7 days at room temperature and refrigerated conditions. Simulated shipping excursion results were found to be acceptable for both winter and summer conditions with mean biases for each analyte within ±10.2% and ±19.2%, respectively. Matrix equivalency, linearity, and imprecision results adhered to current CLIA acceptance limits for each respective measurement. Conclusions The analytical and stability results affirm the feasibility of collecting capillary serum in a patient-centric manner, providing women with relevant information about their reproductive health.

中文翻译：

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A-319 毛细血管血采集，获取卵细胞生殖见解


背景 在美国，年龄在 15 岁至 49 岁之间的女性中，估计有 13% 的生殖潜力（生育能力）受损。生育力评估通常需要亲自就诊并采集静脉血，以评估激素水平并确定潜在的生殖健康状况。探索侵入性较小的家庭采样方案可以让夫妇了解他们的个人生殖能力，让他们安心并帮助计划生育。方法 使用 Tasso®+ 毛细血管采血装置和 BD Microtainer® 血清管获得毛细血管血，用于测量与女性生育力相关的分析物（促卵泡激素、黄体生成素、雌二醇、黄体酮、抗苗勒氏管激素、和催乳素）。这些都是 FDA 批准的在 Roche cobas® e801 上测量的测定，测定参数保持不变。专业和自行采集的毛细血管血清样本与标准静脉血清样本同时采集，以比较毛细血管取样选项的临床等效性。除了在室温 (20-25°C) 和冷藏 (2-8°C) 条件下进行等温稳定性研究外，还使用新型包装解决方案进行了基于 ISTA 7D 建议的运输偏移研究，以控制样品温度，从而控制样品温度。正直。还进行了评估这种替代样品类型的基质等效性、线性和不精确性的研究，以证明分析性能。结果 静脉和专业毛细管样本采集的方法比较表明，所有分析物 (n = 19-79) 的相关性 (R) ≥ 0.9720，斜率范围为 0.919 至 0.971，平均偏差在 ±8.2% 以内。 自行采集的毛细血管血清样本显示相关性 (R) ≥ 0.9827，斜率范围为 0.841 至 0.985，平均偏差在 ±10.7% 范围内 (n = 16-26)。每种分析物在室温和冷藏条件下的等温稳定性长达 7 天。模拟运输偏移结果在冬季和夏季条件下均可接受，每种分析物的平均偏差分别在 ±10.2% 和 ±19.2% 以内。矩阵等效性、线性度和不精确度结果均符合当前 CLIA 各个测量的接受限值。结论 分析和稳定性结果证实了以患者为中心收集毛细血管血清的可行性，为女性提供生殖健康的相关信息。