DIAGNOS TICS


impact of implementation, such as direct clinical benefits for patients, but also the longer term, indirect benefits to healthcare and society.26


It has been suggested that the


NHS needs to consider the introduction of POC testing in terms of value proposition.28


Implementation A carefully planned, meticulously executed strategy for implementation is needed if the full benefits of POCT for rapid detection of infection are to be achieved while avoiding harm.31


References 1. Lisby JG, Schneider UV. Point of care testing for infectious disease: ownership and quality. J Antimicrob Chemother. 2021;76(Supplement _ 3):iii28–32.


2. Gnanadurai R, Webb C, Zambon M. Point of care tests for influenza and other respiratory viruses - Winter 2019 to 2020. Public Heal Engl. 2018;28.


3.


ISO 22870:2016(en), Point-of-care testing (POCT) – Requirements for quality and competence. Available from: https://www.iso.org/obp/ ui/#iso:std:iso:22870:ed-2:v1:en


Failure to do this and the risks could


outweigh the benefits.1 There is a wealth of information available


to inform POCT strategy development: l Official Medicines and Healthcare Products Regulatory Agency (MHRA)32 and National Institute for Health and Care Excellence (NICE) Medtech Innovation Briefings,33–35


l Various checklists and frameworks,2,36,37 l Expertise in NIHR diagnostic centres.38


In summary, POC testing is a decision-making tool for real-time patient management, it is not a replacement for a thorough clinical examination or full complement of laboratory tests. Rather, POC testing can act as a screening tool to identify those patients who require further investigations and interventions and those who do not. In the wake of the COVID-19 pandemic, opportunities have emerged for POC testing for rapid detection of infection. It is not a lack of demand for POCT that is limiting progress with implementation, rather financial constraints, such as appropriate funding/reimbursement models, and a reluctance to change existing workflows when time is already stretched and pressure on services is high. Due to the complex, interacting nature of


the many facets of UK healthcare, a one-size POCT implementation approach is unlikely to be realistic; however, by investing in POCT for rapid detection of infection, the benefits and long-term savings to the NHS have the potential to be phenomenal.


CSJ


4. TDR | Rapid diagnostic tests for sexually transmitted infections. Available from: https:// www.who.int/tdr/publications/journal- supplements/sti-way-forward/en/


5. Martínez-González NA, Keizer E, Plate A, Coenen S, Valeri F, Verbakel JYJ, et al. Point-of-care C-reactive protein testing to reduce antibiotic prescribing for respiratory tract infections in primary care: Systematic review and meta- analysis of randomised controlled trials. Antibiotics. 2020;9(9):1–31.


6. Mantzourani E, Evans A, Cannings-John R, Ahmed H, Hood K, Reid N, et al. Impact of a pilot NHS-funded sore throat test and treat service in community pharmacies on provision and quality of patient care. BMJ open Qual. 2020;9(1).


7. Micocci M, Gordon AL, Seo MK, Allen AJ, Davies K, Lasserson D, et al. Is point-of-care testing feasible and safe in care homes in England? An exploratory usability and accuracy evaluation of a point-of-care polymerase chain reaction test for SARS-CoV-2. Age Ageing. 2021;50(5):1464–72.


8. Turner P, Bruel A Van den, Jones C. Point-of-care testing in UK primary care: a survey to establish clinical needs. Fam Pr. 2016 Aug 1;33(4):388–94.


9. Heaney K, Whiting K, Peteley L, Fry I, Newton A. Point-of-care testing by paramedics using a portable laboratory: an evaluation. https:// doi.org/1012968/jpar2020123100. 2020 Mar 12;12(3):100–8.


10. Kapur N. The NHS Long Term Plan. J Heal Policy Opin. 2020;12(1):10–1.


11. El-Osta A, Woringer M, Pizzo E, Verhoef T, Dickie C, Ni MZ, et al. Does use of point-of-care testing improve cost-effectiveness of the NHS Health Check programme in the primary care setting? A


cost-minimisation analysis. BMJ Open. 2017;7(8).


12. Clark TW, Brendish NJ, Poole S, Naidu V V., Mansbridge C, Norton N, et al. Diagnostic accuracy of the FebriDx host response point-of- care test in patients hospitalised with suspected COVID-19. J Infect. 2020;81(4):607–13.


13. Brendish NJ, Malachira AK, Armstrong L, Houghton R, Aitken S, Nyimbili E, et al. Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open- label, randomised controlled trial. Lancet Respir Med. 2017;5(5):401–11.


14. O’Connell S, Conlan C, Reidy M, Stack C, Mulgrew A, Baruah J. The impact of point-of-care testing for influenza A and B on patient flow and management in a medical assessment unit of a general hospital. BMC Res Notes. 2020;13(1):1–5.


15. Dewar S, Vass D, MacKenzie FM, Parcell BJ. Point-of-care testing by healthcare workers for detection of meticillin-resistant Staphylococcus aureus, Clostridioides difficile, and norovirus. J Hosp Infect. 2019 Dec 1;103(4):447–53.


16. Test directory - FIND. Available from: https:// www.finddx.org/test-directory/


17. Medicines and Healthcare products Regulatory Agency (MHRA). Target Product Profile Point of Care SARS-CoV-2 Detection Tests. Available from: https://www.gov.uk/government/publications/ how-tests-and-testing-kits-for-coronavirus- covid-19-work/target-product-profile-point-of- care-sars-cov-2-detection-tests


18. Protocol for evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices) - GOV.UK. Available from: https://www. gov.uk/government/publications/assessment- and-procurement-of-coronavirus-covid-19-tests/ protocol-for-evaluation-of-rapid-diagnostic- assays-for-specific-sars-cov-2-antigens-lateral- flow-devices


19. Outcome of the evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices) - GOV.UK. Available from: https://www.gov.uk/government/publications/ assessment-and-procurement-of-coronavirus- covid-19-tests/outcome-of-the-evaluation-of- rapid-diagnostic-assays-for-specific-sars-cov-2- antigens-lateral-flow-devices


20. Validation of COVID-19 tests: laboratory validation - GOV.UK. Available from: https://www.gov.uk/ government/consultations/validation-of-covid- 19-tests-laboratory-validation/validation-of- covid-19-tests-laboratory-validation


21. Royal Statistical Society Working Group. Royal Statistical Society Diagnostic Tests Working Group Report. 2021. Available from: https:// www.rss.org.uk/policy-campaigns/policy-groups/ working-group-on-diagnostic-tests/


22. Korevaar DA, Gopalakrishna G, Cohen JF, Bossuyt PM. Targeted test evaluation: a framework for designing diagnostic accuracy studies with clear study hypotheses. Diagnostic Progn Res. 2019;3(1):1–10.


23. Huddy JR, Ni MZ, Barlow J, Hanna GB. Qualitative analysis of stakeholder interviews to identify the barriers and facilitators to the adoption of point-


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