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Bulletin references July 2025

You can read the July 2025 Bulletin here.

Point-of-care testing

Quality assurance principles in point-of-care testing – a pragmatic perspective

  1. Institute of Biomedical Science. Point of care testing: National strategic guidance for at point of need testing. Available at: https://www.ibms.org/resources/documents/point-of-care-testing-national-strategic-guidance-for-at-point/
  2. Nichols JH, Christenson RH, Clarke W, Gronowski A, Hammett-Stabler CA, Jacobs E et al. The National Academy of Clinical Biochemistry Laboratory Medicine Practice Guideline: evidence-based practice for point-of-care testing. Clin Chim Acta 2007;379:14–28.
  3. Medicines and Healthcare Products Regulatory Agency. Management and use of IVD point of care test devices 2021. Available at: https://www.gov.uk/government/publications/in-vitro-diagnostic-point-of-care-test-devices/management-and-use-of-ivd-point-of-care-test-devices
  4. International Organization for Standardization. ISO 15189:2022, Medical laboratories — Requirements for quality and competence. Available at https://www.iso.org/standard/76677.html
  5. NHS England. Point of care testing in community pharmacies Guidance for commissioners and community pharmacies delivering NHS services. Available at: https://www.england.nhs.uk/wp-content/uploads/2022/01/B0722-Point-of-Care-Testing-in-Community-Pharmacies-Guide_January-2022.pdf
  6. Khan AI, Pratumvinit B, Jacobs E, Kost GJ, Kary H, Balla J et al. Point-of-care testing performed by healthcare professionals outside the hospital setting: consensus-based recommendations from the IFCC Committee on Point-of-Care Testing (IFCC C-POCT). Clin Chem Lab Med 2023;61(9):1572–157
  7. Welsh Scientific Advisory Committee. Point of care testing governance pathology: Why, when and how? A user guide. 2017. Available at: https://www.gov.wales/policy-management-point-care-testing-whc2017034
  8. Welsh Government. Health and Social Care (Quality and Engagement) (Wales) 2020 Act. Available at: https://www.legislation.gov.uk/asc/2020/1/contents
  9. Welsh Government. The duty of quality statutory guidance 2023 and health and care quality standards 2023 WG23-12. Available at: https://www.gov.wales/duty-quality-healthcare
  10. Thomas A. Quality assurance and accreditation in point-of-care testing. Point Care J Near-Patient Test Tech 2008;7(4):227–232.
  11. Gidske G, Sandberg S, Fossum AL, Binder S, Langsjøen EC, Solsvik AE et al. Point-of-care testing in primary healthcare: a scoring system to determine the frequency of performing internal quality control. Clin Chem Lab Med 2022;60:740–747.
  12. Holt J, Freedman D. Internal quality control in point of care testing: Where’s the evidence? Ann Clin Biochem 2015;52:233–239
  13. Stavelin A, Sandberg S. Analytical performance specifications and quality assurance of point-of-care testing in primary healthcare. Crit Rev Clin Lab Sci 2024;61:164–177.
  14. Thomas A. External quality assessment in laboratory medicine: is there a rationale to determine frequency of surveys? Accred Qual Assur 2009;14:439–444.

Self-sampling at the point-of-care – enhancing access, improving care

  1. Hügle T.  Blood self-sampling: a missing link for remote patient care. RMD Open 2022;8(2):e002728.
  2. Mohammed T, Brewer JV, Pyatt M, Whitbourne S, Gaziano J, Edson C et al. Evaluation of independent self-collected blood specimens for COVID-19 antibody detection among the US veteran population. Diagn Microbiol Infect Dis 2022;104:115770.  
  3. Boum Y, Eyangoh S, Okomo M-C. Beyond COVID-19—will self-sampling and testing become the norm? Lancet Infect Dis 2021;21:1194–1195.
  4. James CA, Barfield MD, Maass, KF, Patel, SR, Anderson MD. Will patient-centric sampling become the norm for clinical trials after COVID-19? Nat Med 2020;26:1810.
  5. Poland DCW, Cobbaert CM. Blood self-sampling devices: innovation, interpretation and implementation in total lab automation. Clin Chem Lab Med 2024;63:3–13.
  6. Verougstraete N, Stove V, Stove CP. Remote HbA1c testing via microsampling: fit for purpose? Clin Chem Lab Med 2024;62:3–17.
  7. Ansari S, Abdel-Malek K, Kenkre J,  Choudhury SM,  Barnes S et al. The use of whole blood capillary samples to measure 15 analytes for a home-collect biochemistry service during the SARS-CoV-2 pandemic: A proposed model from North West London Pathology. Ann Clin Biochem 2021;58:411–421.
  8. Voigt KR, Wullaert L, Verhoef C, Grunhagen DJ, Ramakers C. Reliable capillary sampling of carcinoembryonic antigen at home: the CASA feasibility study. Colorectal Dis 2023;25;1163–1168.
  9. Sodi R, Young N, Tetucci A, Woolley T, Shah V, Maund I. Total PSA testing in capillary samples: proof-of principle and feasibility study for home self-testing for prostate cancer. J App Lab Med 2024;10(2):250–258.
  10. Doeleman M, Esseveld A, Huisman A, Roock S, Groenestege W. Stability and comparison of complete blood count parameters between capillary and venous blood samples. Int J Lab Hematol 2023;45:659–667.
  11. Zarbl J , Eimer K, Bendzuck C, Korinth M, Elling-Audersch C, Kleyer A et al. Remote self-collection of capillary blood using upper arm devices for autoantibody analysis in patients with immune-mediated inflammatory rheumatic diseases. RMD Open 2022;8:e002641.
  12. Marshall DJ, Kim JJ, Brand S, Bryne C, Keevil BG. Assessment of tacrolimus and creatinine concentration collected using Mitra microsampling devices. Ann Clin Biochem 2020;57;389–396.
  13. UKAS. ISO 15189 Medical Laboratory Accreditation. Available at: www.ukas.com/accreditation/standards/medical-laboratory-accreditation/
  14. Lim AWW, Deats K, Gambell J, Lawrence A, Lei J, Lyons M et al. Opportunistic offering of self-sampling to non-attenders within the English cervical screening programme: a pragmatic, multicentre, implementation feasibility trial with randomly allocated cluster intervention start dates (YouScreen). eClinicalMedicine 2024;73:102672.
  15. Public Health England. National HIV self-sampling service. Available at: assets.publishing.service.gov.uk/media/5fb3ee0ae90e0720929a0396/national_HIV_self_sampling_service_november_2018_to_october_2019.pdf
  16. Lingervelder D, Kip MMA, Wiese ED, Koffijberg H, Ijzerman MJ, Kusters R. The societal impact of implementing an at-home blood sampling device for chronic care patients: patient preferences and cost impact. BMC Health Serv Res 2022;22:1529.

Point-of-care testing in veterinary medicine

  1. Potockova H, Dohnal J, Thome-Kromer B. Regulation of veterinary point-of-care testing in the European Union, the United States of America and Japan. Revue Scientifique et Technique (International Office of Epizootics) 2020;39(3):699–709.
  2. Velayudhan BT, Naikare HK. 2022. Point-of-care testing in companion and food animal disease diagnostics. Front Vet Sci 25;9:1056440.
  3. Hassan MM, Grist LF, Poirier AC, La Ragione RM. JMM profile: Loop-mediated isothermal amplification (LAMP): for the rapid detection of nucleic acid targets in resource-limited settings. J Med Microbiol 2022;71;001522.
  4. Pirolo M, Menezes M, Poulsen M, Søndergaard V, Damborg P, Poirier AC et al. A LAMP point-of-care test to guide antimicrobial choice for treatment of Staphylococcus pseudintermedius pyoderma in dogs. Vet J 2024:304;106105.