Comprehensive Evaluation of a Point-of-Care Testing Platform for Decentralized Primary Healthcare: Ensuring Analytical Quality Through Central Laboratory Oversight

Giacomo Moretti; Francesca Danila Alcaro; Luigi Colacicco; Andrea Urbani

doi:10.3390/diagnostics15232977

Comprehensive Evaluation of a Point-of-Care Testing Platform for Decentralized Primary Healthcare: Ensuring Analytical Quality Through Central Laboratory Oversight

Diagnostics (Basel). 2025 Nov 24;15(23):2977. doi: 10.3390/diagnostics15232977.

Authors

Giacomo Moretti¹, Francesca Danila Alcaro², Luigi Colacicco^{1

3}, Andrea Urbani^{1

3}

Affiliations

¹ Clinical Chemistry, Biochemistry and Molecular Biology Operations (UOC), Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy.
² Bio-Bank Facility, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy.
³ Department of Basic Biotechnological Sciences, Intensive Care and Perioperative Clinics Research, Catholic University of the Sacred Heart, 00168 Rome, Italy.

Abstract

Background/Objectives: Point-of-care testing (POCT) is increasingly adopted in primary healthcare to facilitate rapid screening and monitoring of chronic conditions. Ensuring that its analytical quality is comparable to central laboratory testing is crucial for safe and effective implementation. This study aims to rigorously evaluate the analytical performance of the Allegro POCT system against established central laboratory reference methods to determine its suitability for decentralized healthcare settings. Methods: We assessed the correlation, concordance, and bias of glycated hemoglobin (HbA1c), glucose (GLUC), total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), triglycerides (TRIG), creatinine (CREA), and C-reactive protein (CRP). Using a cohort of 100 residual patient samples, measurements from the Allegro POCT system were compared against reference methods on the Atellica CH 930 Analyzer and TOSOH G8 system. The statistical analysis was performed using Deming regression, Bland-Altman plots, and Pearson correlation. Results: HbA1c and GLUC demonstrated strong linearity and correlation (Pearson's r = 0.9863 and r = 0.9994, respectively). A slight positive bias was noted for HbA1c at higher concentrations. In the lipid panel, CHOL showed a significant positive bias (mean bias +14.2 mg/dL), while TRIG exhibited a substantial negative bias (mean bias -37.0 mg/dL) and wide limits of agreement. HDL and CREA showed good linearity but only moderate agreement. CRP demonstrated excellent concordance with the reference method (Pearson's r = 0.9955) and minimal bias. Conclusions: The Allegro system exhibits acceptable analytical performance for GLUC and CRP, rendering it suitable for decentralized use. HbA1c and CREA performance is adequate, though caution is advised due to observed biases. However, the significant biases for CHOL and TRIG underscore the indispensable role of central laboratory oversight in any POCT program. Rigorous initial validation and continuous quality monitoring under a robust governance framework are essential to ensure the reliability and clinical utility of POCT.

Keywords: analytical quality; clinical governance; decentralized testing; laboratory oversight; method comparison; method validation; point-of-care testing (POCT); primary healthcare.