Performance Evaluation of Automated Erythrocyte Sedimentation Rate (ESR) Analyzers in a Multicentric Study
Flaminia Tomassetti,
Cinzia Calabrese,
Fabio Bertani,
Michele Cennamo,
Daniela Diamanti,
Alfredo Giovannelli,
Roberto Guerranti,
Roberto Leoncini,
Maria Lorubbio,
Agostino Ognibene,
Eleonora Nicolai,
Martina Pelagalli,
Carolina Pieroni,
Sergio Bernardini,
Massimo Pieri
Affiliations
Flaminia Tomassetti
Department of Experimental Medicine, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy
Cinzia Calabrese
Department of Experimental Medicine, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy
Fabio Bertani
Clinical Pathology and Microbiology Unit, Laboratory Analysis, ASST Lariana, Hospital Sant’Anna, 22100 Como, Italy
Michele Cennamo
Clinical Pathology and Microbiology Unit, Laboratory Analysis, ASST Lariana, Hospital Sant’Anna, 22100 Como, Italy
Daniela Diamanti
Research and Development Department, DIESSE Diagnostica Senese S.p.A., Monteriggioni, 53035 Siena, Italy
Alfredo Giovannelli
Department of Experimental Medicine, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy
Roberto Guerranti
Clinical Pathology Unit, Innovation, Experimentation and Clinical and Translational Research Department, University Hospital of S. Maria alle Scotte of Siena, Viale Mario Bracci 16, 53100 Siena, Italy
Roberto Leoncini
Clinical Pathology Unit, Innovation, Experimentation and Clinical and Translational Research Department, University Hospital of S. Maria alle Scotte of Siena, Viale Mario Bracci 16, 53100 Siena, Italy
Maria Lorubbio
Chemical-Clinical Analysis Laboratory, Department of Laboratory Medicine and Transfusion, San Donato Hospital, 52100 Arezzo, Italy
Agostino Ognibene
Chemical-Clinical Analysis Laboratory, Department of Laboratory Medicine and Transfusion, San Donato Hospital, 52100 Arezzo, Italy
Eleonora Nicolai
Department of Experimental Medicine, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy
Martina Pelagalli
Department of Experimental Medicine, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy
Carolina Pieroni
Research and Development Department, DIESSE Diagnostica Senese S.p.A., Monteriggioni, 53035 Siena, Italy
Sergio Bernardini
Department of Experimental Medicine, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy
Massimo Pieri
Department of Experimental Medicine, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy
Background: Erythrocyte Sedimentation Rate (ESR) is an easy test used to diagnose and monitor inflammatory and infectious diseases. The aim of this study was the evaluation of the performance of three ESR automated analyzers, VES-MATIC 5, CUBE 30 TOUCH, and MINI-CUBE, involving four Italian polyclinics in Rome, Siena, Como, and Arezzo, as well as inter-site variability assessment to detect possible device-dependent and operator-dependent influences. Methods: Accuracy analysis was carried out by analyzing the same samples with all three instruments and comparing them with the Westergren method. Precision was assessed with quality control material through intra-run and inter-run precision. Repeatability was estimated by reanalyzing fresh blood samples belonging to three ESR ranges (low, intermediate, and high) six times. Results: The results showed a strong correlation (Spearman coefficients R2) between the manual method and VES-MATIC 5 (0.978), CUBE 30 TOUCH (0.981), and MINI-CUBE (0.974). The accuracy of all clinics was excellent, with coefficients of variation (CVs) of less than 10% for all instruments. Repeatability confirmed an excellent level for all ESR ranges, with CVs below 10%. Conclusions: The study proved that all three automated instruments offer optimal performance for accuracy and precision and are suitable for both large and small facilities without influences of the laboratory environment.
