Feasibility of Home Collection for Urogenital Microbiome Samples.

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.

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Emily S. Lukacz is a scientific advisory board member and consultant for Pathnostics (2021 to present), receives royalties from UpToDate (2015 to present), is an advisory board member for Emmi Solutions (patient education material, 2023 to present), and works for Tegus.com (2023 to present). Furthermore, she is a consultant (study section) for NIDDK and received research funding from NIDDK, NICHD, and PCORI. Cynthia S. Fok received author royalty from UptoDate and is a consultant for UroCure and Medtronic. Melanie R. Meister is an advisory board member for AbbVie Inc. Margaret G. Mueller provides expert testimony for Butler Snow and received educational honoraria from Axonics and NIH funding (NIDDK and NICHD). Ariana L. Smith received research funding from Convatec and PA Department of State, is an associate editor for NAU, and is on the board of directors and a treasurer for SUFU. Ann Stapleton is a consultant for GSK. Daniel McDonald is a consultant for, and has equity in, BiomeSense, Inc. The terms of these arrangements have been reviewed and approved by the University of California, San Diego, in accordance with its conflict of interest policies. Rob Knight is a scientific advisory board member and consultant for BiomeSense, Inc., has equity, and receives income. He is a scientific advisory board member and has equity in GenCirq. He is a consultant and scientific advisory board member for DayTwo and receives income. He has equity in and acts as a consultant for Cybele. He is a cofounder of Biota, Inc. and has equity. He is a cofounder of Micronoma, has equity, and is a scientific advisory board member. The terms of these arrangements have been reviewed and approved by the University of California, San Diego, in accordance with its conflict of interest policies. Linda Brubaker received editorial stipends from JAMA and UptoDate. The rest of the authors reported no disclosures.