Diagnostic Accuracy and Variability in Positivity Criteria of Genomic Methods for Urinary Tract Infection: A Systematic Review and Meta-Analysis

Background: Urinary tract infections (UTIs) are a major global health burden that drives substantial antimicrobial use. Microbiological culture, the reference standard, can miss uropathogens and delay appropriate treatment, promoting interest in genomic approaches. Here, we systematically review the diagnostic accuracy of genomic methods and discuss their positivity criteria, turnaround time (TAT) and clinical impact. Methods: The Scopus and PubMed databases were searched for studies published between January 2020 and January 2026 that evaluated genomic methods for UTI diagnosis against microbiological culture and reported accuracy. Sensitivity and specificity were pooled separately using binomial-normal generalised linear mixed models (GLMM). Quality assessment was conducted using QUADAS-2. TAT and clinical impact were synthesised narratively. The review protocol was registered with PROSPERO (CRD420261294559). Results: Thirteen studies were included. Genomic methods showed high pooled sensitivity with moderate heterogeneity (0.94; 95% CI 0.87–0.98, τ2 = 1.43). However, pooled specificity was moderate and highly variable (0.61; 95% CI 0.23–0.89; τ2 = 5.92). The criteria used to define a positive genomic result varied widely, the shortest TAT was 4–6 h, and evidence on clinical outcomes was limited to two studies. Conclusions: Genomic methods are sensitive, potentially rapid, detect organisms missed by culture and characterise microbial diversity. However, their moderate, variable specificity likely reflects both limitations of culture as a reference standard and inconsistent genomic positivity criteria. As culture-negative, genomic-positive results may have explanations other than infection, they should be interpreted alongside symptoms and pre-test probability. Standardised positivity criteria and evidence of clinical benefit are needed before routine implementation.