Analytical Performance Evaluation of a Newly Developed Miniaturized Disposable U-tube for Automated Blood Viscometer: Validation and Comparison to Conventional Methods
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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.
Abstract
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.
참고문헌 (14)
- Lowe, GD, "Etiopathogenesis of cardiovascular disease: hemostasis, thrombosis, and vascular medicine", Annals of Periodontology, 3(1), pp.121~126 (1998)
- Lynch S, "Effects of non-Newtonian viscosity on arterial and venous flow and transport", Scientific Reports, 12, pp.1~12 (2022)
- Jung JM, "Reference intervals for whole blood viscosity using the analytical performance-evaluated scanning capillary tube viscometer", Clinical Biochemistry, 47(6), pp.489~493 (2014)
- Picart C, "Human blood shear yield stress and its hematocrit dependence", Journal of Rheology, 42, pp.1~12 (1998)
- Kim S, "A method of isolating surface tension and yield stress effects in a u-shaped scanning capillary-tube viscometer using a casson model", Journal of Non-Newtonian Fluid Mechanics, 103(2-3), pp.205~219 (2002)
- Kim H, "Analytical performance evaluation of the scanning capillary tube viscometer for measurement of whole blood viscosity", Clinical Biochemistry, 46(1-2), pp.139~142 (2013)
- Jung JM, "Non-Newtonian standard viscosity fluids", International Communications in Heat and Mass Transfer, 49, pp.1~4 (2013)
- Garber CC, "Clinical chemistry: theory, analysis, correlation", pp.410~411 (1996), Mosby
- Lee DH, "Comparison tests for plasma viscosity measurements", International Communications in Heat and Mass Transfer, 39, pp.1474~1477 (2012)
- de Simone G, "Relation of blood viscosity to demographic and physiologic variables and to cardiovascular risk factors in apparently normal adults", Circulation, 81, pp.107~117 (1990)
- Windberger U, "Whole blood viscosity, plasma viscosity and erythrocyte aggregation in nine mammalian species: reference values and comparison of data", Experimental Physiology, 88(3), pp.431~440 (2003)
- Rosencranz R, "Clinical laboratory measurement of serum, plasma, and blood viscosity", Pathology Patterns Reviews, 125(Suppl 1), pp.S78~S86 (2006)
- Passing H, "A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I", Journal of Clinical Chemistry and Clinical Biochemistry, 21, pp.709~720 (1983)
- Bland JM, "Statistical methods for assessing agreement between two methods of clinical measurement", The Lancet, 327(8476), pp.307~310 (1986)