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Analytical performance and user-friendliness of four commercially available point-of-care devices for C-reactive protein. | LitMetric

Analytical performance and user-friendliness of four commercially available point-of-care devices for C-reactive protein.

Clin Chim Acta

EPI-Centre, Academisch Centrum Huisartsgeneeskunde, KU Leuven, Leuven, Belgium; NIHR Community Healthcare Medtech and IVD cooperative, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.

Published: June 2024

AI Article Synopsis

  • - Proper implementation of Point-of-Care testing (POCT) for C-reactive protein (CRP) in primary care can help reduce unnecessary antibiotic use, which is crucial for combating antimicrobial resistance.
  • - Four POCT-CRP assays (QuikRead go easy, LumiraDx, cobas b 101, and Afinion 2) were evaluated for performance and user-friendliness, with findings showing significant differences in precision and accuracy.
  • - Results indicated that cobas b 101 and Afinion had the best performance compared to laboratory standards, while LumiraDx and QuikRead fell short in terms of accuracy; Afinion was rated highest for user-friendliness.

Article Abstract

Introduction: Proper implementation of Point-of-Care testing (POCT) for C-reactive protein (CRP) in primary care can decrease the inappropriate use of antibiotics, thereby tackling the problem of growing antimicrobial resistance.

Objective: The analytical performance and user-friendliness of four POCT-CRP assays were evaluated: QuikRead go easy, LumiraDx, cobas b 101 and Afinion 2.

Materials And Methods: Imprecision was evaluated using plasma pools in addition to manufacturer-specific control material. Trueness was assessed by verification of traceability to ERM-DA474/IFCC in parallel to method comparison towards the central laboratory CRP method (cobas c 503) using i) retrospectively selected plasma samples (n = 100) and ii) prospectively collected capillary whole blood samples (n = 50). User-friendliness was examined using a questionnaire.

Results: Between-day imprecision on plasma pools varied from 4.5 % (LumiraDx) to 11.5 % (QuikRead). Traceability verification revealed no significant difference between cobas c 503 CRP results and the ERM-DA474/IFCC certified value. cobas b 101 and Afinion achieved the best agreement with the central laboratory method. LumiraDx and QuikRead revealed a negative mean difference, with LumiraDx violating the criterion of > 95 % of POCT-CRP-results within ± 20 % of the comparison method. Regarding user-friendliness, Afinion obtained the highest Likert-scores.

Conclusion: The analytical performance and user-friendliness of POCT-CRP devices varies among manufacturers, emphasizing the need for quality assurance supervised by a central laboratory.

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Source
http://dx.doi.org/10.1016/j.cca.2024.119737DOI Listing

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