Performance Evaluation of Automated Erythrocyte Sedimentation Rate (ESR) Analyzers in a Multicentric Study

Area of Science:

• Clinical Chemistry
• Hematology
• Laboratory Medicine

Background:

• Erythrocyte Sedimentation Rate (ESR) is a key diagnostic marker for inflammatory and infectious diseases.
• Automated analyzers offer potential for improved efficiency and standardization in ESR testing.

Purpose of the Study:

• To evaluate the performance of three automated ESR analyzers: VES-MATIC 5, CUBE 30 TOUCH, and MINI-CUBE.
• To assess inter-site variability and identify device- or operator-dependent influences across four Italian polyclinics.

Main Methods:

• Comparative analysis against the gold standard Westergren method.
• Accuracy and precision assessed using quality control materials and fresh blood samples across low, intermediate, and high ESR ranges.
• Intra-run and inter-run precision evaluated, with repeatability estimated through multiple sample re-analyses.

Main Results:

• Strong correlations observed between automated analyzers and the Westergren method (R² > 0.974).
• Excellent accuracy demonstrated with coefficients of variation (CVs) below 10% for all instruments.
• High repeatability confirmed across all ESR ranges, with CVs consistently below 10%.

Conclusions:

• All three evaluated automated ESR instruments exhibit optimal performance characteristics.
• These analyzers are suitable for diverse laboratory settings, from large to small facilities.
• Device performance is robust and not significantly influenced by laboratory environmental factors or operator variability.