DIAGNOS TICS


Type Example Technology Time to result


Dipstick Roche Combur-Test


Lateral Flow Fortress COVID-19 Chromatogenic Immuno 1-2 mins


Analyser required No Cost*


£


WHO ASSURED Yes Pathogen-specific No


10 mins No £


Yes Yes


What is detected Molecules (e.g., Antigen or glucose, bilirubin) antibody or cells (e.g., WBC, RBC)


Clinical syndrome UTI aRTI Immuno


10 mins No £


Yes No


CRP and mXA


aRTI


Lateral Flow FebriDx


Immunoassay Immunoassay - Molecular – multiple targets single target


Aidian QuikRead go Immuno chromatogenic chromatogenic turbidometric


<5 mins Yes ££ No No


CRP


NK Yes ££ No No


≤20 mins Yes ££ No Yes


TRAIL, IP-10, Genes for CRP


specific pathogens


Bacterial/viral differentiation


Bacterial/viral differentiation


aRTI


RTI, GTI, sepsis, meningitis


KEY: *Cost (cost per test and associated analyser) has been arbitrarily categorised as follows: £, inexpensive; ££, moderate; £££, expensive; WHO ASSURED: World Health Organization criteria: Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free and Deliverable to end users; UTI, urinary tract infection, aRTI, acute respiratory tract infection; GTI, gastrointestinal.


Table 2. Characteristics of a selection of point-of-care tests used for the rapid detection of infection.


of-care diagnostic tests in the UK. BMJ Open. 2021;11(4).


24. Lingervelder D, Koffijberg H, Kusters R, IJzerman MJ. Point-of-care testing in primary care: A systematic review on implementation aspects addressed in test evaluations. Int J Clin Pract. 2019;73(10):1–12.


25. Khalid TY, Duncan LJ, Thornton H V., Lasseter G, Muir P, Toney ZA, et al. Novel multi-virus rapid respiratory microbiological point-of-care testing in primary care: a mixed-methods feasibility evaluation. Fam Pract. 2021;38(5):598–605.


26. Eley CV, Sharma A, Lecky DM, Lee H, McNulty CAM. Qualitative study to explore the views of general practice staff on the use of point-of-care C reactive protein testing for the management of lower respiratory tract infections in routine general practice in England. BMJ Open. 2018;8(10):1–12.


27. Johnson M, Cross L, Sandison N, Stevenson J, Monks T, Moore M. Funding and policy incentives to encourage implementation of point-of-care C-reactive protein testing for lower respiratory tract infection in NHS primary care: A mixed- methods evaluation. BMJ Open. 2018;8(10).


28. Price CP, St John A. Will COVID-19 be the coming of age for point-of-care testing? BMJ Innov. 2021;7(1):3–5.


29. Cooke J, Butler C, Hopstaken R, Dryden MS, McNulty C, Hurding S, et al. Narrative review of primary care point-of- care testing (POCT) and antibacterial use in respiratory tract infection (RTI). BMJ Open Respir Res. 2015;2(1):1–10.


30. Lingervelder D, Koffijberg H, Kusters R, IJzerman MJ. Health Economic Evidence of Point-of-Care Testing: A Systematic Review. PharmacoEconomics - Open. 2021;5(2):157–73. 31. Phin N, Poutanen SM. The cat is out of the bag


- point-of-care testing (POCT) is here to stay. Eurosurveillance. 2020;25(44):4–6.


32. Management and use of IVD point of care test devices - GOV.UK. Available from: https:// www.gov.uk/government/publications/in- vitro-diagnostic-point-of-care-test-devices/ management-and-use-of-ivd-point-of-care-test- devices


33. National Institute for Health and Care Excellence (NICE). QuikRead go for C-reactive protein testing in primary care [Internet]. Medtech Briefing. 2016. Available from: https://www.nice.org.uk/ advice/mib78


34. National Institute for Health and Care Excellence (NICE). FebriDx for C-reactive protein and myxovirus resistance protein A testing [Internet]. Medtech Briefing. 2019. Available from: https:// www.nice.org.uk/advice/mib224


35. National Institute for Health and Care Excellence (NICE). Alere Afinion CRP for C-reactive protein testing in primary care [Internet]. Medtech Briefing. 2016. Available from: https://www.nice. org.uk/advice/mib81


36. Graziadio S, Winter A, Lendrem BC, Suklan J, Jones WS, Urwin SG, et al. How to ease the pain of taking a diagnostic point of care test to the market: A framework for evidence development. Micromachines. 2020;11(3).


37. Huddy JR, Ni M, Misra S, Mavroveli S, Barlow J, Hanna GB. Development of the Point-of-Care Key Evidence Tool (POCKET): a checklist for multi- dimensional evidence generation in point-of-care tests. Clin Chem Lab Med. 2019 Jun 1;57(6):845– 55.


38. NIHR. How we support medical technology, device and diagnostic companies. Available from: https://www.nihr.ac.uk/partners-and-industry/ industry/access-to-expertise/medtech.htm


36 l WWW.CLINICALSERVICESJOURNAL.COM About the author


Carolyne Horner is the scientific lead at Una Health, a role in which she provides scientific and clinical expertise to the team. She has a Bachelor of Science (Biological Sciences) from the University of Leicester and a Ph.D from the University of Leeds. Carolyne trained as a clinical scientist (Microbiology) at Leeds Teaching Hospitals NHS Trust where she worked for over 15 years before moving to the British Society for Antimicrobial Chemotherapy to work as a clinical affairs officer. Carolyne’s areas of interest are antimicrobial resistance and surveillance, diagnostic stewardship and education of these subjects.


DECEMBER 2021


≤60 mins Yes


£££ No Yes


Genes for a wide panel of pathogens


MeMed BV


Abbott ID NOW


Immunoassay PCR


Molecular - syndromic


BioFire FilmArray Multiplex PCR


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56