Performance Evaluation of Automated Erythrocyte Sedimentation Rate (ESR) Analyzers in a Multicentric Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Specimen Collection
2.3. ESR Analyzers Description
2.3.1. VES-MATIC 5
2.3.2. CUBE 30 TOUCH
2.3.3. MINI-CUBE
2.3.4. Westergren Method
2.4. Statistics
3. Results
3.1. Correlation Analysis
3.2. Precision Study
3.3. Repeatability
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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CUBE 30 TOUCH vs. Westergren Method | MINI-CUBE vs. Westergren Method | VES-MATIC 5 vs. Westergren Method | ||
---|---|---|---|---|
Tor Vergata Hospital | Sample size (n) | 230 | 230 | 230 |
Regression equation | y = −0.076 + 1.039x | y = 2.000 + 1.000x | y = −0.816 + 1.072x | |
Spearman correlation coefficient (R2) and [95% CI] | 0.970 [0.961 to 0.977] | 0.958 [0.946 to 0.968] | 0.972 [0.964 to 0.979] | |
Significance level | p < 0.0001 | p < 0.0001 | p < 0.0001 | |
Bland–Altman mean [min.–max] | 0.5 [min. −15.9; max −14.8] | −2.1 [min. −16.2; max 12.1] | −2.0 [min. −15.3; max 11.2] | |
Arezzo Hospital | Sample size (n) | 174 | 174 | 174 |
Regression equation | y = −0.104 + 1.042x | y = 3.000 + 1.000x | y = −1.353 + 1.068x | |
Spearman correlation coefficient (R2) and [95% CI] | 0.976 [0.967 to 0.982] | 0.971 [0.961 to 0.978] | 0.974 [0.965 to 0.981] | |
Significance level | p < 0.0001 | p < 0.0001 | p < 0.0001 | |
Bland–Altman mean [min.–max] | 1.5 [min. −10.2; max 13.2] | 2.5 [min. −10.5; max 15.6] | 0.4 [min. −13.0; max 13.7] | |
Siena Hospital | Sample size (n) | 191 | 191 | 191 |
Regression equation | y = −0.055 + 1.027x | y = 1.000x | y = −0.104 + 1.001x | |
Spearman correlation coefficient (R2) and [95% CI] | 0.989 [0.985 to 0.991] | 0.988 [0.984 to 0.991] | 0.988 [0.984 to 0.991] | |
Significance level | p < 0.0001 | p < 0.0001 | p < 0.0001 | |
Bland–Altman mean [min.–max] | 1.9 [min. −11.4; max 15.1] | 2.5 [min. −10.5; max 15.6] | −0.1 [min. −15.2; max 14.9] | |
Como Hospital | Sample size (n) | 192 | 192 | 192 |
Regression equation | y = −0.903 + 1.041x | y = 0.472 + 0.973x | y = 0.125 + 1.050x | |
Spearman correlation coefficient (R2) and [95% CI] | 0.986 [0.981 to 0.989] | 0.980 [0.973 to 0.985] | 0.965 [0.954 to 0.973] | |
Significance level | p < 0.0001 | p < 0.0001 | p < 0.0001 | |
Bland–Altman mean [min.–max] | 1.9 [min. −11.4; max 15.1] | 0.2 [min. −12.8; max 13.2] | 2.3 [min. −12.8; max 17.3] |
Tor Vergata Hospital | ||||
QC Level | CV % Within Run | CV % Between Run | Total Precision | |
VES-MATIC 5 | High | 2.8 | 2.8 | 3.6 |
VES-MATIC 5 | Low | 6.5 | 7.7 | 9.4 |
CUBE 30 TOUCH | High | 3.3 | 2.9 | 3.9 |
CUBE 30 TOUCH | Low | 9.1 | 4.7 | 9.0 |
MINI-CUBE | High | 3.2 | 0.8 | 2.7 |
MINI-CUBE | Low | 9.1 | 4.4 | 8.5 |
Arezzo Hospital | ||||
QC Level | CV% Within Run | CV% Between Run | Total Precision | |
VES-MATIC 5 | High | 2.7 | 0.7 | 2.3 |
VES-MATIC 5 | Low | 8.9 | 7.1 | 10.6 |
CUBE 30 TOUCH | High | 4.2 | 2.4 | 4.2 |
CUBE 30 TOUCH | Low | 10.3 | 4.3 | 9.7 |
MINI-CUBE | High | 2.3 | 2.1 | 2.8 |
MINI-CUBE | Low | 9.1 | 7.1 | 10.0 |
Siena Hospital | ||||
QC Level | CV % Within Run | CV % Between Run | Total Precision | |
VES-MATIC 5 | High | 2.0 | 1.4 | 2.2 |
VES-MATIC 5 | Low | 8.6 | 4.9 | 8.4 |
CUBE 30 TOUCH | High | 1.7 | 1.4 | 2.0 |
CUBE 30 TOUCH | Low | 8.6 | 5.1 | 8.8 |
MINI-CUBE | High | 1.8 | 0.8 | 1.7 |
MINI-CUBE | Low | 6.5 | 3.8 | 6.6 |
Como Hospital | ||||
QC Level | CV % Within Run | CV % Between Run | Total Precision | |
VES-MATIC 5 | High | 3.0 | 4.1 | 4.7 |
VES-MATIC 5 | Low | 11.1 | 3.1 | 9.4 |
CUBE 30 TOUCH | High | 1.7 | 1.0 | 1.7 |
CUBE 30 TOUCH | Low | 9.1 | 4.7 | 9.0 |
MINI-CUBE | High | 1.5 | 2.3 | 2.6 |
MINI-CUBE | Low | 9.1 | 4.7 | 9.0 |
CUBE 30 TOUCH | VES-MATIC 5 | MINI-CUBE | ||||
DIESSE | Evaluated | DIESSE | Evaluated | DIESSE | Evaluated | |
QC High | 3.5 | 3.70 | 7.7 | 4.90 | 14.1 | 4.90 |
QC Low | 9.8 | 1.30 | 13.3 | 2.02 | 8.3 | 1.50 |
Accepted | Accepted | Accepted | Accepted | Accepted | Accepted |
Tor Vergata Hospital | |||||
Analytic Interval | n | MEAN | SD | CV (%) | |
VES-MATIC 5 | Low | 68 | 7.64 | 0.49 | 6 |
Middle | 31 | 29.57 | 2.9 | 9 | |
High | 54 | 102.68 | 4.99 | 6 | |
CUBE 30 TOUCH | Low | 76 | 7.39 | 0.56 | 8 |
Middle | 51 | 1.74 | 1.74 | 6 | |
High | 39 | 3.04 | 3.04 | 3 | |
MINI-CUBE | Low | 36 | 10.58 | 0.80 | 6 |
Middle | 22 | 39.41 | 2.96 | 6 | |
Up | 30 | 100.45 | 3.22 | 4 | |
Arezzo Hospital | |||||
Analytic Interval | n | MEAN | SD | CV (%) | |
VES-MATIC 5 | Low | 66 | 9.25 | 0.49 | 5 |
Middle | 32 | 29.01 | 2.22 | 8 | |
High | 43 | 94.07 | 2.39 | 3 | |
CUBE 30 TOUCH | Low | 44 | 8.14 | 0.55 | 7 |
Middle | 42 | 30.36 | 1.16 | 4 | |
High | 43 | 92.12 | 1.88 | 2 | |
MINI-CUBE | Low | 36 | 11.14 | 0.54 | 5 |
Middle | 25 | 32.63 | 1.19 | 4 | |
High | 50 | 94.19 | 1.87 | 2 | |
Siena Hospital | |||||
Analytic Interval | n | MEAN | SD | CV (%) | |
VES-MATIC 5 | Low | 75 | 7.80 | 0.56 | 7 |
Middle | 34 | 31.60 | 1.3 | 4 | |
High | 53 | 91.75 | 2.25 | 2 | |
CUBE 30 TOUCH | Low | 81 | 8.0 | 0.5 | 6 |
Middle | 49 | 30.37 | 1.18 | 4 | |
High | 40 | 88.41 | 2.00 | 2 | |
MINI-CUBE | Low | 37 | 10.75 | 0.51 | 5 |
Middle | 27 | 37.15 | 0.98 | 3 | |
High | 32 | 95.14 | 1.67 | 2 | |
Como Hospital | |||||
Analytic Interval | n | MEAN | SD | CV (%) | |
VES-MATIC 5 | Low | 17 | 8.75 | 0.82 | 9.4 |
Middle | 16 | 25.69 | 2.30 | 8.9 | |
High | 79 | 86.02 | 6.13 | 7.9 | |
CUBE 30 TOUCH | Low | 34 | 10.63 | 0.74 | 7 |
Middle | 12 | 29.14 | 2.80 | 9.9 | |
High | 20 | 88.62 | 3.22 | 4.3 | |
MINI-CUBE | Low | 37 | 10.64 | 0.61 | 5.7 |
Middle | 46 | 37.34 | 2.97 | 8.6 | |
High | 30 | 77.49 | 3.02 | 4.2 |
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Tomassetti, F.; Calabrese, C.; Bertani, F.; Cennamo, M.; Diamanti, D.; Giovannelli, A.; Guerranti, R.; Leoncini, R.; Lorubbio, M.; Ognibene, A.; et al. Performance Evaluation of Automated Erythrocyte Sedimentation Rate (ESR) Analyzers in a Multicentric Study. Diagnostics 2024, 14, 2011. https://doi.org/10.3390/diagnostics14182011
Tomassetti F, Calabrese C, Bertani F, Cennamo M, Diamanti D, Giovannelli A, Guerranti R, Leoncini R, Lorubbio M, Ognibene A, et al. Performance Evaluation of Automated Erythrocyte Sedimentation Rate (ESR) Analyzers in a Multicentric Study. Diagnostics. 2024; 14(18):2011. https://doi.org/10.3390/diagnostics14182011
Chicago/Turabian StyleTomassetti, Flaminia, Cinzia Calabrese, Fabio Bertani, Michele Cennamo, Daniela Diamanti, Alfredo Giovannelli, Roberto Guerranti, Roberto Leoncini, Maria Lorubbio, Agostino Ognibene, and et al. 2024. "Performance Evaluation of Automated Erythrocyte Sedimentation Rate (ESR) Analyzers in a Multicentric Study" Diagnostics 14, no. 18: 2011. https://doi.org/10.3390/diagnostics14182011