Accre 8 emerging point of care CLIA system for vitamin B12 assessment compared with three established assays

Abstract

Abstract Accurate Vitamin B12 (Vit B12) quantification is essential for diagnosing deficiencies linked to neurological and hematological disorders. The Accre 8 Point-of-Care (POC) Chemiluminescent Immunoassay (CLIA) system offers a compact design, rapid single-step operation, and minimal calibration requirements. This study evaluates Accre 8’s performance against established CLIA immunoassays (Abbott and Roche) and LC-MS/MS, the gold standard for Vit B12 quantification. A total of 297 serum samples, spanning deficient to sufficient Vit B12 levels, were analyzed. Accre 8 demonstrated a strong correlation with LC-MS/MS (r = 0.94, p < 0.001), with median Vit B12 levels closely aligning with LC-MS/MS (256.0 pmol/L). Accre 8 exhibited high sensitivity (96.9%) and specificity (86.7%), with Cohen’s Kappa agreement (0.76). Bland-Altman analysis showed a mean bias of - 18.5%, while Passing-Bablok regression indicated proportional bias at higher concentrations (slope = 1.44). ROC analysis confirmed excellent diagnostic accuracy (AUC = 0.98). Accre 8’s strong diagnostic performance, minimal calibration needs, and low sample volume requirements position it as a practical alternative to conventional CLIA systems for Vit B12 assessment, particularly in clinical and resource-limited settings. These findings support its potential integration into routine diagnostic workflows for Vit B12 deficiency screening and monitoring.