Work

Shear-Dependent Agreement and Clinical Reclassification of Whole-Blood Viscosity Measurements: A Paired Comparison of Rheovis 2000A and Hemovister

Year: 2026

Type: article

Abstract: Background/Objectives: Whole-blood viscosity (WBV) is increasingly used in cardiovascular risk assessment; however, inter-device comparability may depend on shear-rate definition. We performed a paired comparison of two scanning capillary viscometers to evaluate shear-dependent analytical agreement and its impact on clinical classification. Methods: In 300 identical blood samples, WBV was measured using Rheovis 2000A and Hemovister. Systolic WBV was defined at 300 s−1 for both devices (shear-matched), whereas clinically defined diastolic WBV corresponded to 1 s−1 for Rheovis 2000A and 5 s−1 for Hemovister. Agreement was assessed using linear regression and Bland–Altman analysis. Hematocrit tertiles were examined as effect modifiers. Clinical agreement was evaluated using quadratic weighted Cohen’s κ. Results: Across matched shear rates (1000 to 1 s−1), Hemovister yielded consistently higher WBV values than Rheovis 2000A, with statistically significant inter-device differences at all shear levels except 1000 s−1. The magnitude of bias increased progressively as shear rate decreased, reaching −8.34 mPa·s at 1 s−1. Under shear-matched systolic conditions (300 s−1), the mean difference was −0.25 mPa·s (limits of agreement −1.72 to 1.22). In contrast, under clinically defined diastolic conditions (1 vs. 5 s−1), the mean difference was 14.54 mPa·s (3.93 to 25.15), increasing across hematocrit tertiles. Clinical agreement was fair for systolic (κ = 0.31; 95% CI 0.24 to 0.39) and moderate for diastolic WBV (κ = 0.44; 95% CI 0.37 to 0.51). Notably, among samples classified as high by Hemovister, 72.8% (systolic) and 54.0% (diastolic) were reclassified as normal by Rheovis 2000A. Conclusions: Inter-device agreement in WBV measurement is strongly shear-dependent. Although numerical divergence increases at low shear, categorical concordance may remain moderate when device-specific reference thresholds are applied. Harmonization of shear definitions and reference frameworks may therefore be essential for consistent cross-platform interpretation.

Source: Diagnostics

DOI: 10.3390/diagnostics16081232