Analytical validation of a metagenomic next-generation diagnostic platform for urinary tract infection in a Thai tertiary hospital setting: a BI-Biotia UTI cohort study
Abstract
Background The BIOTIA-DX platform (BDX), a commercially available clinical-grade mNGS-based test in the United States, has not been analytically validated for urinary tract infections (UTIs) in a Southeast Asian cohort, where microbial epidemiology and antimicrobial resistance (AMR) patterns differ significantly. Objective Our primary objective was to evaluate the analytical performance and concordance with standard urine culture of the BIOTIA-DX platform in a Thai tertiary hospital setting, thereby assessing its transportability to a Southeast Asian population with distinct microbial epidemiology. Methods We analyzed 398 retrospectively collected urine samples from patients with suspected UTI at a private hospital in Bangkok. Each sample was processed in parallel using standard-of-care urine culture and the BDX mNGS workflow. After excluding 30 samples with insufficient sequencing reads (<500 non-human reads), 368 samples (231 culture-positive, 137 culture-negative) were included. Diagnostic accuracy was assessed against culture, and genotypic AMR predictions were compared to phenotypic antimicrobial susceptibility testing (AST) N = 192. Results The BIOTIA-DX platform demonstrated high analytical sensitivity at the sample level (98.7% [95% CI: 0.95-0.99]; 228/231 culture-positive samples detected) and organism level (94.6%; 229/242 culture-identified organisms correctly detected). Among 137 culture-negative samples, BIOTIA-DX detected microbial DNA in 98 samples (71.5%),…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 192 participants or records.
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