Hypothesis / aims of study
Lower urinary tract symptoms (LUTS), incontinence, and non specific clinical deterioration are common in older care home residents and frequently raise suspicion of urinary tract infection (UTI). In this population, diagnostic uncertainty often contributes to over diagnosis of UTI and inappropriate antibiotic use1. This clinical challenge is exacerbated by a reliance on standard urine dipstick testing, which demonstrates poor diagnostic accuracy in this cohort, notably exhibiting a negative predictive value (NPV) of less than 45%.
Rapid, highly accurate point-of-care diagnostic decision support is required to assist in distinguishing true UTIs from alternative causes of urinary symptoms and incontinence. The Lodestar DX UTI is a rapid, molecular-based test that utilises LAMP (loop-mediated isothermal amplification) technology to detect the top six uropathogens in just 35 minutes. This feasibility evaluation aimed to assess the practicality, acceptability, and perceived clinical utility of the Lodestar when deployed in a care home setting, with a specific focus on supporting urological decision-making and continence-related symptom assessment.
Study design, materials and methods
A prospective feasibility evaluation was conducted across three care home sites during a defined pilot period. Care staff were trained to use Lodestar DX UTI as part of routine assessment for residents presenting with suspected UTI or urinary symptoms, including changes in continence status. Data collected included number of tests performed, evaluable results, causes of test exclusion, and user reported outcomes. Staff feedback was captured via structured questionnaires assessing usability, confidence in urinary symptom assessment, and perceived impact on patient care. Time from urine sample collection to actionable result was recorded. No patient identifiable data were collected.
Results
Eighty six test results were recorded, of which 72 (84%) were evaluable. Fourteen results were excluded due to failed positive controls (n=6), missing outcome data (n=6), or user error (n=2).
Of the 72 evaluable tests, 28 (39%) were negative for UTI, enabling rapid exclusion of infection as a cause of urinary symptoms and avoided antibiotic treatment. Forty two (58%) were positive, providing timely evidence to support escalation of care and targeted treatment. Two tests (3%) were inconclusive; despite negative findings, persistent symptoms prompted further clinical review due to suspicion of atypical pathogens outside of the 6 pathogens within the Lodestar panel.
User questionnaires indicated that 97% of tests resulted in a positive outcome for the resident, and in 99% of cases staff believed point of care testing improved patient care and the management of urinary symptoms. Across all three sites, the mean time from sample collection to actionable result was approximately 117 minutes.
Interpretation of results
This evaluation demonstrates that Lodestar DX UTI can be feasibly implemented in care homes and integrated into routine assessment of urinary symptoms and incontinence. Rapid rule out of UTI in a substantial proportion of cases may reduce misdiagnosis of UTI as the cause of LUTS or continence deterioration, while positive results support timely intervention. Findings suggest potential benefits for antimicrobial stewardship and improved urological decision making in frail populations. Limitations include the small sample size and lack of comparator data.