Evaluation of a near-patient test for C-reactive protein used in daily routine in primary healthcare by use of difference plots

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Abstract
We have assessed the technical performance and robustness of NycoCard® CRP Whole Blood, a near-patient test for C-reactive protein (CRP), when used in realistic daily routine situations in general practice clinics (GPC). Thirteen GPCs participated, five of them with technician staff. From 898 patients, split-sample measurements for CRP were made. Results from GPCs were compared with results from a turbidimetric laboratory method, traceable to international reference preparations (IFCC CRM 470). Results were evaluated in difference plots where the expected distribution, due to an estimated analytical variation, was compared with measured differences. Of all difference points, 91.5% (n = 819) were within a 95% prediction interval based on the imprecision of both methods. Mean bias (95% confidence interval) was −0.3 mg/L (−0.9 to 0.3). No differences in analytic quality were found between GPCs with technician staffs and GPCs without, and between test results obtained within the first and second week, compared with the rest of the study period. We find the test as good when used in GPCs as could be expected from laboratory testing, and consequently robust, which is a necessity for use in routine situations in general practice. General application of difference plots in test evaluations are discussed in detail.