Analytical comparison of the portable ENNOLIFE HCA-TC-200 analyser and the Beckman UniCel DXC 880I for hepatorenal and urinary biomarkers: Implications for future point-of-care use

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Background: Accurate and efficient chemical analysers play a critical role in modern healthcare, particularly in community medicine, where early diagnosis and intervention can significantly improve patient outcomes. This study evaluated the analytical performance of the novel portable ENNOLIFE HCA-TC-200 analyser compared to the established Beckman UniCel DxC 880i analyser. Methods: A total of 600 individuals were recruited from Shuang Ho Hospital, Taiwan. The analytical performance of ENNOLIFE HCA-TC-200 was validated using clinical chemistry assays, specifically assessing hepatic, renal, and urinary biomarkers. The analysers were compared based on method comparison, accuracy, and inter-method agreement. Results: The ENNOLIFE HCA-TC-200 analyser demonstrated strong agreement with the Beckman UniCel DxC 880i. Passing-Bablok regression showed good agreement for albumin (ALB), microalbumin (mALB), and urine protein (UP), while proportional or constant biases were observed in other analytes. Bland-Altman analysis revealed minimal bias, with blood urea nitrogen (BUN) showing the smallest mean difference (-0.18 mg/dL) and alanine transaminase (ALT) the largest (5.99 U/L). Accuracy exceeded 97% for all parameters after excluding extreme outliers, with 100% agreement for hepatic and renal markers. High linear correlations (R>0.97) were found for most markers, with minor deviations observed for ALB (R=0.92) and urine creatinine (R=0.80), which remained within clinically acceptable diagnostic ranges. Conclusions: The ENNOLIFE HCA-TC-200 analyser demonstrated strong analytical performance and high concordance with the reference laboratory analyser, the Beckman UniCel DxC 880i, across hepatic, renal, and urinary parameters. These findings, combined with its portability, support its potential use as a reliable tool for biochemical analysis in outpatient and community-based settings.