Analytical performance and user-friendliness of four commercially available point-of-care devices for C-reactive protein.
(2024) Clinica Chimica Acta — Vol. 560, p. 119737 [1-10] (2024)
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- 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. The analytical performance and user-friendliness of four POCT-CRP assays were evaluated: QuikRead go easy, LumiraDx, cobas b 101 and Afinion 2. 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. 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. 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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Van Hoovels, L., Massa, B., Stavelin, A., De Meyer, H., De Schrijver, P., Van Laethem, V., Barglazan, D., Gruson, D., Hopstaken, R., Peeters, B., Van Hoof, V., Verdonck, A., & Verbakel, J. Y. (2024). Analytical performance and user-friendliness of four commercially available point-of-care devices for C-reactive protein. Clinica Chimica Acta, 560, 119737 [1-10]. https://doi.org/10.1016/j.cca.2024.119737 (Original work published 2024)