Long-term real-world performance of the Bayer Contour TS point-of-care testing glucose meters.

To assess the real-world analytical performance of Bayer Contour TS (Bayer) Point-of-Care Testing (POCT) glucose meters in long-term actual clinical settings. Based on the ISO 15197:2013, EN ISO 15197:2015, and CLSI POCT12-A3 standards, the analytical performance of 202 Bayer POCT glucose meters was evaluated using 2,931 paired glucose comparative results compared to the central laboratory biochemical analyzer over a continuous five-year period (2020-2024) in a tertiary teaching hospital. The coefficients of variation (CV) of Bayer POCT glucose meters were 2.0%, 2.1%, and 1.6% at the glucose concentration of 3.28 mmol/L, 5.84 mmol/L, and 11.20 mmol/L, respectively. The glucose results of Bayer POCT meters showed good correlation with the central laboratory results (r = 0.996, p < 0.001) with an overall mean bias of -5.20% (p < 0.001). Stratified analysis revealed good correlations in both low (1.71-3.28 mmol/L; r = 0.940, p < 0.001) and medium (3.29-6.59 mmol/L; r = 0.970, p < 0.001) glucose ranges, with corresponding measurement bias of -2.03% (p < 0.001) and - 4.79% (p < 0.001). Notably, 100% (2,931/2,931) of the results met the ISO 15197:2013 standards, 95.87% (2,810/2,931) met CLSI POCT12-A3:2013 standards. The Bayer POCT glucose meters exhibited stable and accurate performance in rapid glucose testing, rendering them suitable for clinical application. However, the minus bias measurements of Bayer POCT glucose meters compared with the central laboratory analyzer in the low glucose concentration range observed in this real-world context requires further investigation.