J Hematol

Journal of Hematology, ISSN 1927-1212 print, 1927-1220 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Hematol and Elmer Press Inc

Journal website https://www.thejh.org

Original Article

Volume 12, Number 5, October 2023, pages 208-214

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

Figures

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. 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.

Tables

**Table 1.** Intra-Run, Inter-Run, and Inter-Instrument Precision Analysis With Quality Control ESR Control Cube
	Level 1 control		Level 2 control
	Evaluated	Declared	Evaluated	Declared
Level 1 control: normal. Level 2 control: pathologic. ESR: erythrocyte sedimentation rate; SD: standard deviation; CV: coefficient of variation.
Intra-run (mm/h)
Mean	5.83	13.00	73.33	94.00
SD	0.29	0.96	0.58	10.49
%CV	4.9%	7.4%	0.8%	11.2%
Variance	0.08		0.33
Inter-run (mm/h)
Mean	4.8	14.00	73.33	89.00
SD	1.01	0.83	2.32	9.46
%CV	21.1%	5.9%	3.2%	11.0%
Variance	1.02		5.65
Inter-instruments (mm/h)
Mean	4.8	13	72.53	89.00
SD	1.30	1.08	4.04	12.54
%CV	27.1%	8.03%	5.6%	14.1%
Variance	1.71		16.39

**Table 2.** Precision Analysis With Leftover Samples, Through the Measure of Mean, Repeatability, and Reproducibility
	RC (%)	RDC (%)	Mean
RC: repeatability coefficient; RDC: reproducibility coefficient.
Sample 1	2.26	2.86	3.00
Sample 2	2.10	2.70	5.50
Sample 3	3.84	4.85	5.50
Sample 4	2.07	2.61	10.67
Sample 5	1.03	1.31	11.83
Sample 6	1.90	2.41	15.17
Sample 7	1.31	1.65	17.33
Sample 8	5.00	6.32	45.50
Sample 9	5.86	7.41	48.17
Sample 10	5.20	6.53	64.83
Sample 11	1.31	1.65	109.70
Sample 12	0.00	0.00	140.00

**Table 3.** Results of Hemolysis Icterus, and Lipemia Interference on ESR Results
	Passing and Bablok regression			Bland-Altman
	Correlation coefficient	Significance level	95% CI	Mean bias	95% CI
ESR: erythrocyte sedimentation rate; CI: confidence interval.
Icterus, n = 13	0.753	P = 0.0029	0.346 - 0.922	0.3	-24.4 - 25
Lipemia, n = 9	0.921	P = 0.0002	0.693 - 0.981	6.1	-20.7 - 32.9
Hemolysis, n = 13	0.750	P = 0.0126	0.226 - 0.937	0.8	-6.3 - 7.9