Point-of-Care Quantification of HbA1c and CRP using Finecare: Analytical Validation of a Fluorescence-Based System.

Background: This study evaluated the analytical performance and practicability of a novel point-of-care testing (POCT) device for measuring HbA1c and C-reactive protein (CRP) compared with central laboratory methods. Methods: Imprecision, bias, and analytical total error (TEa) were evaluated using quality control materials over five days (n=20 per level). Method comparison was performed on 120 patient venous samples per biomarker. Practicality was assessed using an operations scorecard. Results: CRP performance met EFLM biological variation specifications, with TEa values (25.95% and 18.57%) remaining below desirable limits (TEa < 38.14%). Method comparison showed a strong correlation (r = 0.98), despite proportional bias at low levels (< 20.0 mg/L), and high categorical agreement (κ = 0.92). For HbA1c, TEa exceeded EFLM minimum limits (TEa < 3.56%) and central laboratory goals (TEa < 6.0%). At Control Level 1, TEa (10.28%) aligned with CLIA POCT standards (TEa < 10%), but reached 14.75% at Control Level 2 due to elevated imprecision. Slight proportional bias was observed at low HbA1c levels (< 7.0%), though categorical agreement remained robust (κ = 0.90). Practicability evaluation indicated general user satisfaction, although HbA1c testing was perceived as more complex. Conclusion: The Finecare™ POCT device demonstrated acceptable analytical performance for CRP in acute care. However, due to elevated imprecision and workflow complexity for HbA1c, its use should be limited to settings prioritizing rapid decision-making over maximum precision.