Analytical Performance Evaluation of a Newly Developed Miniaturized Disposable U-tube for Automated Blood Viscometer: Validation and Comparison to Conventional Methods
This study evaluates the analytical performance of a newly developed miniaturized disposable U-tube for an automated blood viscometer and compares it to conventional viscometers. Whole blood viscosity (WBV), essential for circulatory function, exhibits non-Newtonian behavior, posing challenges for measurement at low shear rates. The blood viscometer, based on a scanning capillary tube method, used disposable U-tubes to measure viscosities across a shear rate range of 1s⁻¹ to 1,000s⁻¹. Precision evaluation showed stable coefficients of variation (CV) across different viscosity levels. Repeatability assessment indicated consistent CV values, demonstrating the reliability of the device. The agreement with the LV-III Brookfield viscometer and MCR 92 Rheometer was analyzed using Bland-Altman plots, which revealed minor systematic biases and consistent differences across the measurement range. Correlation analysis using Passing-Bablok regression showed high correlation coefficients (R > 0.96) with regression slopes close to 1. The newly developed miniaturized disposable U-tube exhibits excellent precision, reliable repeatability, and high correlation with established methods, enhancing laboratory productivity and offering potential for clinical applications. Further studies with human blood samples are recommended to confirm its clinical applicability.