From the Department of Obstetrics, Gynecology, and Reproductive Sciences, UC San Diego School of Medicine, University of California San Diego, La Jolla, CA.
Department of Urology, University of Minnesota, Minneapolis, MN.
Urogynecology (Phila). 2024 Nov 1;30(11):896-905. doi: 10.1097/SPV.0000000000001544. Epub 2024 Jul 3.
Feasibility of home urogenital microbiome specimen collection is unknown.
This study aimed to evaluate successful sample collection rates from home and clinical research centers.
Adult women participants enrolled in a multicentered cohort study were recruited to an in-person research center evaluation, including self-collected urogenital samples. A nested feasibility substudy evaluated home biospecimen collection prior to the scheduled in-person evaluation using a home collection kit with written instructions, sample collection supplies, and a Peezy™ urine collection device. Participants self-collected samples at home and shipped them to a central laboratory 1 day prior to and the day of the in-person evaluation. We defined successful collection as receipt of at least one urine specimen that was visibly viable for sequencing.
Of 156 participants invited to the feasibility substudy, 134 were enrolled and sent collection kits with 89% (119/134) returning at least 1 home urine specimen; the laboratory determined that 79% (106/134) of these urine samples were visually viable for analysis. The laboratory received self-collected urine from the research center visit in 97% (115/119); 76% (91/119) were visually viable for sequencing. Among 401 women who did not participate in the feasibility home collection substudy, 98% (394/401) self-collected urine at the research center with 80% (321/401) returned and visibly viable for sequencing.
Home collection of urogenital microbiome samples for research is feasible, with comparable success to clinical research center collection. Sample size adjustment should plan for technical and logistical difficulties, regardless of specimen collection site.
家庭尿生殖微生物组标本采集的可行性尚不清楚。
本研究旨在评估家庭和临床研究中心采集标本的成功率。
参加多中心队列研究的成年女性参与者被招募到一个现场研究中心进行评估，包括自我采集的尿生殖标本。一项嵌套可行性子研究使用带有书面说明、标本采集用品和 Peezy™尿液采集装置的家庭采集套件，在预定的现场评估前评估家庭生物标本采集。参与者在家中自行采集标本，并在现场评估前一天和当天将标本寄送至一个中心实验室。我们将成功采集定义为至少收到一份可见可用于测序的尿液标本。
在受邀参加可行性子研究的 156 名参与者中，有 134 名参与者入组并收到了采集套件，其中 89%（119/134）至少寄回了 1 份家庭尿液标本；实验室确定其中 79%（106/134）的尿液标本在视觉上可用于分析。实验室收到了 97%（115/119）来自研究中心访问的自我采集尿液；其中 76%（91/119）在视觉上可用于测序。在未参加可行性家庭采集子研究的 401 名女性中，98%（394/401）在研究中心自行采集了尿液，其中 80%（321/401）返回并在视觉上可用于测序。
家庭采集尿生殖微生物组标本进行研究是可行的，与临床研究中心采集的成功率相当。无论标本采集地点如何，都应根据技术和后勤困难调整样本量。
