Authors' objectives: Urinary tract infections are diagnosed by general practitioners based on symptoms, dipstick tests in some and laboratory urine culture. Patients may be given inappropriate antibiotics. Point-of-care tests can diagnose urinary tract infection in near-patient settings quicker than standard culture. Some can identify the causative pathogen or antimicrobial sensitivity. To assess whether point-of-care tests for people with suspected urinary tract infection have the potential to be clinically effective and cost-effective to the NHS. Urinary tract infections (UTIs) are one of the most common causes of infection worldwide. The accurate and timely diagnosis of UTIs is crucial to ensure that appropriate treatment is started to help resolve symptoms, improve quality of life and reduce the risk of complications such as pyelonephritis, kidney failure and sepsis. In the ongoing public health challenge of antibiotic resistance, it is important that antibiotics are prescribed only when necessary and that they target the causative organism of the infection. However, UTIs can be difficult to diagnose. Currently they are diagnosed by a general practitioner (GP) based on symptoms and laboratory-based urine culture. Dipstick tests can be used to help make a quicker diagnosis in some people, for example children or women aged

Authors' results and conclusions: Two randomised controlled trials evaluated Flexicult Human (one against standard care; one against ID Flexicult). One trial found no evidence of a difference between groups in concordant antibiotic use (odds ratio 0.84, 95% confidence interval 0.58 to 1.20), and the other found no difference in appropriate antibiotic prescribing (odds ratio 1.44, 95% confidence interval 1.03 to 1.99). Compared with standard care, Flexicult was associated with reduced antibiotic prescribing at initial consultation (odds ratio 0.56, 95% confidence interval 0.35 to 0.88). No difference was found for other outcomes. Sixteen studies reported test accuracy data. Most were rated as being at unclear or high risk of bias. We identified data on three rapid tests (results

Authors' recommendations: Given the paucity of data on POCTs for diagnosing UTI, further studies are needed to determine whether POCTs for people with suspected UTI have the potential to be clinically effective and cost-effective to the NHS. Ideally, studies would be RCTs with embedded diagnostic test accuracy studies of POCTs and should be conducted in primary care; such studies would provide data on clinical impact and test accuracy. Studies should focus on tests with the greatest potential for clinical impact: the Astrego PA-100 system and Lodestar DX. Either the studies should enrol patients across multiple patient groups of interest (e.g. men, women, pregnant women, children) with results stratified according to patient subgroup, or separate studies should be carried out to determine whether results differ according to subgroups. Studies should also consider the feasibility of introducing rapid POCTs into pharmacy settings. In addition to further studies on clinical effectiveness, further research on potential cost-effectiveness and impact on antibiotic resistance is needed. This research could build on our conceptual economic model using systematic literature reviews to identify evidence on the efficacy of empiric versus targeted antibiotic treatment of UTI; the efficacy in preventing UTI complications; and both the cost and quality-of-life impacts of these complications.

Authors' methods: Systematic review and conceptual economic model. Clinical effectiveness review A systematic review was conducted in line with published guidance. Four databases and two trial registries were searched. Additional non-bibliographic search methods included searching trial registries, screening reference lists of reviews and study reports, hand-searching relevant websites and reviewing information submitted by test manufacturers. Study selection and review methods Studies were eligible for inclusion if they were published during or after the year 2000, enrolled patients with suspected UTI, and evaluated a POCT in scope: rapid tests giving results

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/NIHR135710

Year Published: 2024

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/PTMV8524

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/PTMV8524

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk