Authors' objectives: This review assessed the clinical- and cost-effectiveness of point-of-care tests to guide the initial management of people presenting with suspected acute respiratory infection. Acute respiratory infection (ARI) is a group of diseases caused by viruses or bacteria that affect the respiratory tract, such as the common cold and influenza. Rapid testing of biomarkers and microbial pathogens that can return results quickly at the point of care has emerged as potentially useful tools to aid the initial assessment of patients with suspected ARI. The primary objective of this rapid evidence synthesis was to evaluate the clinical effectiveness and cost-effectiveness of different near-patient, rapid point-of-care tests (POCTs) alone or in combination to guide initial assessment and management in people aged 16 and over with suspected ARI. This evidence review was conducted to help inform whether rapid tests should be made available for use at initial patient consultations in various settings to help inform referral of patients to NHS ARI hubs, virtual wards or hospitals.

Authors' results and conclusions: Clinical effectiveness Fourteen randomised controlled trials were included; all had a high risk of bias. Ten randomised controlled trials analysed point-of-care tests for C-reactive protein. Compared with usual care, the effects on hospital admissions and mortality were highly uncertain due to sparse data. Three randomised controlled trials had heterogeneous findings on the resolution of symptoms/time to full recovery. The risk of re-consultations increased in patients receiving C-reactive protein point-of-care tests (pooled risk ratio 1.61, 95% confidence interval 1.07 to 2.41; four studies). There was a reduction in antibiotics initially prescribed (C-reactive protein point-of-care tests vs. usual care: pooled risk ratio 0.75, 95% confidence interval 0.68 to 0.84; nine studies). The effects of procalcitonin point-of-care tests compared with usual care on hospital admission, escalation of care, and duration of symptoms were very uncertain as only one randomised controlled trial was included. The study found a large reduction in antibiotic prescriptions within 7 days. Two studies revealed a large reduction in initial antibiotic prescriptions for Group A streptococcus point-of-care tests versus usual care. Only one study compared an influenza point-of-care test with usual care. The effect of the antibiotics prescribed was very uncertain. No deaths occurred in either treatment group. C-reactive protein point-of-care test may reduce the number of patients given an antibiotic prescription but could increase the rate of re-consultations. C-reactive protein point-of-care test may potentially be cost-effective but existing estimates were based on very small and uncertain gains in quality-adjusted life-years and only accounted for short-term costs and consequences. There was very limited or an absence of evidence for other point-of-care tests. Clinical effectiveness Eligible trials were identified for C-reactive protein (CRP) POCTs, procalcitonin POCTs, group A streptococcus (GAS) POCTs and influenza POCTs only. No evidence was identified for other types of near-patient rapid POCTs. Outcomes assessed by the included studies varied. One recent systematic review was included as a source of data for eligible studies. Fourteen RCTs were included; all had a high risk of bias. The setting was mainly primary care; two studies involved outpatient clinics, and one study involved nursing homes. Ten RCTs analysed POCTs for CRP. In five of these studies, the test assessed is currently unavailable in the UK. The effects of CRP tests compared with usual care on hospital admissions, mortality and health-related quality of life were highly uncertain due to sparse data. Three RCTs had heterogeneous findings on resolution of symptoms/time to full recovery. The risk of re-consultations increased in patients receiving CRP POCTs (risk ratio 1.61, 95% CI 1.07 to 2.41; I2 56.6%; four studies). There was a reduction in antibiotics initially prescribed (CRP POCT vs. usual care: risk ratio 0.75, 95% CI 0.68 to 0.84; I2 54.7%; nine studies). Subgroup analysis of people with chronic obstructive pulmonary disease and sensitivity analyses excluding studies in a nursing home setting or tests unavailable in the UK did not change the conclusions inferred from the main analyses. The effects of procalcitonin POCTs compared with usual care on hospital admission, re-consultations, duration of symptoms and mortality were very uncertain as evidence was available from only one RCT with a high risk of bias. The study found a large reduction in initial antibiotic prescriptions within 7 days. Two RCTs found a large reduction in initial antibiotic prescriptions for GAS POCTs versus usual care. Only one RCT compared an influenza POCT with usual care. The effect on antibiotics prescribed was very uncertain. No deaths occurred in either treatment group. These trials had a high risk of bias. The rapid review of clinical effectiveness identified only a small number of eligible trials covering few relevant POCTs. There was limited evidence of the effectiveness of near-patient rapid POCTs in adults with suspected ARI. CRP POCT may reduce the number of patients given an antibiotic prescription at initial consultation but could increase the rate of re-consultations. The overall certainty of the evidence was very low according to the GRADE assessment. CRP POCT may potentially be cost-effective, but existing estimates were based on very small and uncertain gains in quality-adjusted life-years and only accounted for short-term costs and consequences. There was very limited or an absence of evidence for other POCTs. Further research is needed to explore the impact of POCTs, used alone or in combination, on triaging decisions across different clinical settings and to quantify the longer-term health and cost consequences of reducing antibiotic prescribing.

Authors' methods: Searches for systematic reviews, randomised controlled trials and cost–utility studies were conducted in May 2023. Sources included MEDLINE, Epistemonikos, EMBASE, Cochrane Central Register of Controlled Trials, the Cost-effectiveness Analysis Registry and reference checking. Eligible studies included people (≥ 16 years) making initial contact with the health system with symptoms suggestive of acute respiratory infection. Risk of bias in randomised controlled trials was assessed using the Cochrane risk-of-bias tool. The Drummond checklist was used for cost–utility studies. Meta-analyses of clinical outcomes were conducted to estimate summary risk ratios with 95% confidence intervals. Study characteristics and main results were summarised narratively and tabulated. Rapid synthesis methods were used, so relevant studies may have been missed. No evidence was identified for several review questions. This rapid synthesis consists of a review of clinical effectiveness studies with meta-analysis and a review of cost–utility studies. The reviews followed published methods, were registered on PROSPERO (CRD42023429515) and are reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance. Search strategies Searches were conducted in May 2023. MEDLINE and Epistemonikos databases were searched for systematic reviews with no date limit. Searches for randomised controlled trials (RCTs) were conducted in EMBASE, MEDLINE and Cochrane Central Register of Controlled Trials. Searches for cost–utility studies were conducted in EMBASE, MEDLINE and the Cost-effectiveness Analysis Registry with no date limit. Relevant study design filters were used. Searches combined the concepts of ARI with near-patient, rapid POCTs. For the RCT searches, terms for specific biomarkers and tests in combination with terms for guide or inform were added to capture the concept of biomarker test-guided management. All searches were restricted to English language and humans, and excluded grey literature and non-research articles. References of included studies and relevant reviews were checked.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/NIHR159946

Year Published: 2025

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/KHGP7129

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/KHGP7129

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