{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T14:39:20Z","timestamp":1788878360513,"version":"build-2803163510"},"reference-count":29,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,2,13]],"date-time":"2026-02-13T00:00:00Z","timestamp":1770940800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Cell. Infect. Microbiol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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 (&amp;lt;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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      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%), identifying 264 organisms not detected by standard culture. These additional detections predominantly comprised anaerobic organisms (150\/264, 56.8%) and fastidious species (54\/264, 20.5%); however, the clinical significance of these detections (infection vs. colonization vs. contamination) could not be determined without clinical correlation. For AMR prediction, genotype-phenotype concordance rates were 94.1% for fluoroquinolone resistance in\n                      <jats:italic>E. coli<\/jats:italic>\n                      (96\/102 resistant isolates correctly predicted), 91.4% for beta-lactams (106\/116), 91.3% for aminoglycosides (21\/23), and 81.5% for sulfamethoxazole\/trimethoprim (75\/92). Specificity and positive predictive value could not be calculated because organisms detected by BIOTIA-DX but not by culture could not be definitively classified as true positives or false positives without independent confirmation.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The BIOTIA-DX platform demonstrates robust analytical concordance with urine culture in a Thai patient population. Prospective clinical validation studies are needed to assess clinical utility and impact on patient outcomes, particularly in culture-negative and polymicrobial cases. This study represents the first analytical validation of this platform using Oxford Nanopore Technology and the first validation in Southeast Asia.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fcimb.2026.1751074","type":"journal-article","created":{"date-parts":[[2026,2,13]],"date-time":"2026-02-13T13:06:11Z","timestamp":1770987971000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":2,"title":["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"],"prefix":"10.3389","volume":"16","author":[{"given":"Panupong","family":"Wangprapa","sequence":"first","affiliation":[{"name":"Bumrungrad International Hospital","place":["Bangkok, Thailand"]},{"name":"Inter-Department Program of Biomedical Sciences, Faculty of Graduate School, Chulalongkorn University","place":["Bangkok, Thailand"]},{"name":"Center of 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