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. 2023 Oct;12(5):208-214.
doi: 10.14740/jh1165. Epub 2023 Oct 25.

Validation of the New MINI-CUBE for Clinic Determination of Erythrocyte Sedimentation Rate

Flaminia Tomassetti  1   2 , Martina Pelagalli  1   2 , Eleonora Nicolai  1   2 , Serena Sarubbi  1   2 , Cinzia Calabrese  1   2 , Alfredo Giovannelli  1   2 , Silvia Codella  1   2 , Gemma Viola  2 , Daniela Diamanti  3 , Renato Massoud  1   2 , Sergio Bernardini  1   2 , Massimo Pieri  1   2
Affiliations

Validation of the New MINI-CUBE for Clinic Determination of Erythrocyte Sedimentation Rate

Flaminia Tomassetti et al. J Hematol. 2023 Oct.

Abstract

Background: Erythrocyte sedimentation rate (ESR) indirectly measures blood fibrinogen, and it is altered by all those pathological conditions that modify the aggregation of red blood cells. The international guidelines by the International Council for Standardization in Hematology (ICSH) define the Westergren method as the gold standard for ESR, although it is completely operator-dependent, time-consuming, and requires a patient's blood consumption. Therefore, the validation of new ESR analyzers is needed. The aim of this study is the validation of a new automated ESR analyzer, MINI-CUBE (DIESSE, Diagnostica Senese, Italy).

Methods: The samples (n = 270) were collected at the University Hospital of the University of Rome Tor Vergata. A comparison between the automated instrument and the gold standard was performed. Statistical analyses were processed by MedCalc software.

Results: The comparison analysis performed on the overall samples reported a good agreement, showing a Spearman rank correlation coefficient of 0.94 (P < 0.001), compared to the Westergren test. The Bland-Altman analysis showed a mean bias of 1.5 (maximum (max.):19.6; minimum (min.): -16.6). Inter-run (level 1 coefficient of variation (CV): 4.9%; level 2 CV: 0.8%), intra-run (level 1 CV: 21.1%; level 2 CV: 3.2%), and inter-instrument (level 1 CV: 27.1%; level 2 CV: 5.6%) precision were also assessed. The hematocrit value did not interfere with the analysis: Spearman rank correlation coefficient of 0.929 (P < 0.001); mean bias of 1.3 (max.:18.3; min.: -15.6).

Conclusions: Overall results from MINI-CUBE asserted a good correlation rate with the gold standard, and it could be considered an accurate, and objective alternative for the Westergren test.

Keywords: Blood sedimentation; Erythrocyte sedimentation rate; Method validation.

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Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as a potential competing interest: DIESSE Diagnostica Senese S.p.A. Societa Benefit provided the MINI-PET® ESR instrument. Dr. Daniela Diamanti is a DIESSE Diagnostica Senese S.p.A. Societa Benefit member. None of the other authors has any other financial or personal relationship that could inappropriately influence or bias the content of the paper.

Figures

Figure 1
Figure 1
Linear regression and bias plots for the methods comparison (n = 261). (a) Passing-Bablok regression analysis between MINI-CUBE vs. Westergren test, defined by the equation y = 1.00 + 1.00x, intercept A 1.00 (95% CI: 0.00 - 2.00), slope B 1.00 (95% CI: 0.98 - 1.04). It was evaluated R2 of 0.94 (95% CI: 0.928 - 0.955; P < 0.001). (b) Bland-Altman test defined by the Westergren test and MINI-CUBE results (y-axis) and the mean of the two methods. The dotted lines denote the limits of the agreement (max.:19.6; min.: -16.6), and the continued line denotes the bias of 1.5. CI: confidence interval; max.: maximum; min.: minimum; SD: standard deviation.
Figure 2
Figure 2
Linear regression and bias plots for the methods comparison for all the samples with normal hematocrit (Hct) (36% - 44%) (n = 109). (a) Passing-Bablok regression analysis between MINI-CUBE vs. Westergren test, defined by the equation y = 3.778 + 0.889x, intercept 3.778 (95% CI: 0.00 - 5.143), slope 0.889 (95% CI: 0.777 - 5.954). It was evaluated R2 of 0.929 (95% CI: 0.898 - 0.951; P < 0.001). (b) Bland-Altman test defined by the Westergren test and MINI-CUBE results (y-axis) and the mean of the two methods. The dotted lines denote the limits of the agreement (max.:18.3; min.: -15.6), and the continued line denotes the bias of 1.3. CI: confidence interval; max.: maximum; min.: minimum; SD: standard deviation.
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