Abstract: Given the growing impact of antimicrobial resistance, improvements in diagnosis and treatment of the most common outpatient infection, urinary tract infection (UTI), are of great interest to stakeholders. Regulatory authorities have long accepted a microbial threshold of 10⁵ CFU/mL as the standard for diagnosing UTI based on standard urine cultures. However, microbial thresholds considered clinically relevant remain in dispute. The aim of this systematic scoping review is to assess the evidence supporting a threshold of 10⁵ CFU/mL, to review microbial threshold guidelines, and highlight knowledge gaps in the diagnosis of UTI. A total of 36 guidelines containing 144 recommendations were identified with 64% of guidelines (n = 23) and 58% of recommendations (n = 83) published in the last six years (2016– 2023). Recommendations have changed over time and across variables including the geographical location of the guideline, urine specimen collection method, patient sex, and category of UTI. Guidelines uniformly agreed with suprapubic needle specimen collection; however, there was no consensus for midstream collected urine samples. Guideline microbial thresholds for clinical UTI diagnosis were higher for women at average risk (10⁵ CFU/mL) than for men (10² to 10⁵ CFU/mL) and high-risk patients (10² to 10⁴ CFU/mL). Guidelines relied heavily on 48 research articles from 20 author teams published between 1956 and 2019 and recommendations frequently cited 23 research articles by 15 author teams published between 1956 and 2013. Evidence supporting 10⁵ CFU/mL threshold originated in the mid-1950s from 4 research articles, whereas 18 frequently cited peer-reviewed publications focused their research on the clinical relevance of lower thresholds (10¹ to < 10⁵ CFU/mL). This review demonstrates a lack of consensus for urine culture microbial threshold recommendations for the clinical diagnosis of UTI. Guidelines are primarily based upon sparse and dated evidence. Additional research is needed to inform clinically meaningful diagnostic microbial thresholds in the diagnosis of UTI.
Keywords: urinary tract infection, guideline, microbial, diagnostic threshold, uropathogen, scoping systematic review