Validated Devices for Easy Self-Collection and Stabilization of Vaginal Microbiome Samples: Recent News and Advances
Recent advances focus on the development of validated devices that enable easy self-collection and stabilization of vaginal microbiome samples, crucial for enhanced access and data reproducibility in women's health research34.
Variability in microbiome data across studies has been a major hurdle, largely due to inconsistent sampling and preservation techniques; the move toward standardized devices and vaginal microbiome-specific reference reagents aims to improve comparability and reproducibility in diagnostics globally3.
Novel methods such as metagenomic next-generation sequencing (mNGS) and third-generation sequencing (TGS) have significantly improved both sensitivity and specificity in analyzing collected vaginal samples4.
Recent clinical studies demonstrated validated workflows where participants self-collected vaginal swabs and placed them into protein-stabilizing buffers, maintaining sample integrity for up to 7 days—enabling both remote and home-based participation in trials2.
Regulatory agencies like the MHRA and WHO have initiated development of vaginal microbiome-specific international reference reagents, supporting harmonization of sampling protocols and clinical study designs worldwide3.
Key challenges for device implementation include ensuring the avoidance of contamination, robust metadata collection during sampling, and establishing clinically meaningful diagnostic endpoints based on standardized sampling and metagenomic analysis43.
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2. https://pmc.ncbi.nlm.nih.gov/articles/PMC12335476/