Molecular based diagnostic testing for urinary tract infections: the results remain unclear

Recent advances have led to a rise in metagenomic and molecular-based testing for more rapid diagnosis of urinary tract infections (UTI). We conducted a contemporary systematic review to understand how these molecular tests affect clinical outcomes.

A systematic review was conducted for articles in adults from January 2023 to October 2025 as an update to previous scoping reviews. Cochrane and PRISMA standards were utilized with the following databases: PubMed, OVID, and Embase (PROSPERO number: CRD420251070022). Data was extracted from the selected full-text papers including the type of study (microbiology versus clinical), patient demographics, key findings, and funding source. Excluded studies were abstracts, non-English manuscripts, and those involving only men or children.

The search resulted in 12 full-text articles. Among those, 7 were published in clinical-based journals and 5 were in Microbiology. Two clinical studies were randomized controlled trials (RCTs) which included a total of 773 patients, mostly female and above the age of 65. Compared to a standard urine culture, molecular based testing, specifically with polymerase chain reaction (PCR) testing yielded superior sensitivity despite lack of specificity and guided antibiotic therapy to reduce UTI baseline symptomatology in the short term (i.e. 28 days) in both RCT analyses. Of note, the RCT analyses and several of the prospective studies (5/10) were funded by the companies that developed the molecular tests.

Based on the increase in publications over the last three years, new industry-funded RCTs, and the limited clinical outcome data reported, this systematic review indicates the urgent need for prospective and multicentric studies to better understand the role of these molecular tests in UTI management.