Lab Med Qual Assur 2023; 45(4): 149-155
Published online December 31, 2023
https://doi.org/10.15263/jlmqa.2023.45.4.149
Copyright © Korean Association of External Quality Assessment Service.
Shinae Yu1,* , Ja Young Lee2,* , Eunkyoung You2 , Sae Am Song1 , Jeong Nyeo Lee1 , and Kyung Ran Jun1
1Department of Laboratory Medicine, Inje University Haeundae Paik Hospital, Inje University College of Medicine; 2Department of Laboratory Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea
Correspondence to:Kyung Ran Jun
Department of Laboratory Medicine, Inje University Haeundae Paik Hospital, Inje University College of Medicine, 875 Haeun-daero, Haeundae-gu, Busan 48108, Korea
Tel +82-51-797-3191
E-mail jun@paik.ac.kr
*These authors contributed equally to this study as first authors.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background: The Beckman Coulter DxH 900 hematology analyzer (Beckman Coulter Inc., USA) is based on the Coulter Principle and accurately counts and measures the size of cells by monitoring changes in the electrical resistance of cells in a conductive liquid. Monocyte distribution width (MDW) is a new parameter of the DxH 900 analyzer that assists in the early diagnosis of sepsis. We evaluated the analytical performance of the DxH 900 for all parameters, including MDW.
Methods: We evaluated the precision, linearity, and carryover-related performance of the DxH 900, and analyzed the correlation between the DxH 900 and XE-2100 (Sysmex Corp., Japan) analyzers for all parameters (except MDW).
Results: The DxH 900 demonstrated acceptable precision for measuring normal and abnormal high- and low-level quality controls. The MDW repeatability was good (coefficient of variation of 3.99%–6.68%). White blood cells, red blood cells, hemoglobin, and platelets exhibited excellent linearity at high and low ranges, and no carryover effect was seen. The results obtained from the DxH 900 and XE-2100 analyzers were highly correlated.
Conclusions: The parameters including MDW of the DxH 900 analyzer showed good analytical performance and reproducibility. The parameters correlated well with the existing model, XE-2100. Our study demonstrated that the DxH 900 is useful in routine laboratories.
Keywords: Hemoglobins, Monocyte distribution width, Performance evaluation, Automated hematology analyzer
Complete blood count (CBC) and leukocyte differential count (LDC) are the most basic and widely used tests for the diagnosis, treatment, and monitoring of various diseases, including hematological disorders. Various automated hematology analyzers capable of reporting quick and accurate results have been developed and used in clinical practice [1]. The DxH 900 (Beckman Coulter Inc., Brea, CA, USA) is the most recently developed quantitative, multiparameter automated hematology analyzer for
This study was approved by the Institutional Review Board of Inje University Haeundae Paik Hospital, Busan (approval number: HPIRB 2018-12-003), and was conducted in accordance with the Declaration of Helsinki. The requirement for informed consent was waived owing to the anonymity of the collected data and the use of residual samples. Residual samples from patients with both normal and abnormal hematological profiles referred to the central laboratory were used for comparison. Samples were collected in K2-EDTA tubes (Becton Dickinson, Plymouth, UK) from April to May 2019, stored at room temperature (20–26℃), and analyzed by a dedicated technologist within 2 hours of collection. Commercial controls (Beckman Coulter Inc.) were included in the samples to ensure precision, carryover, and linearity.
The DxH 900 analyzer uses photometric measurements to measure hemoglobin (Hb) levels. The mean cell volume, red cell distribution width and standard deviation (SD) are derived from the RBC histogram, and the mean platelet volume is derived from the platelet histogram. Other parameters such as hematocrit (Hct), mean corpuscular hemoglobin (MCH), MCH concentration (MCHC), immature reticulocyte fraction, mean reticulocyte volume, and absolute counts of neutrophils, lymphocytes, monocytes, eosinophils, basophils, NRBC, and reticulocytes are also calculated.
Within-run and between-run precision analyses for the DxH 900 analyzer were performed using normal and abnormal high- and low-level quality control (QC) materials (6C Plus Control level 1–3). Within-run precision was analyzed based on 20 measurements, and between-run precision analysis was performed once daily for 10 consecutive days. The coefficient of variation (CV) was expressed as a percentage and was calculated from the mean and SD for each level of the QC material, which was compared with the manufacturer’s protocol and current state-of-the-art precision limits [5].
Carryover was measured for WBC, RBC, Hb, and platelets using the Coulter LIN-X Linearity Control (Beckman Coulter) according to the Clinical and Laboratory Standards Institute (CLSI) H26-A2 guidelines [6]. Carryover was assessed by analyzing high-level samples 3 times (H1, H2, and H3), followed by three consecutive analyses of low-level samples (L1, L2, and L3). Carryover was calculated using the following formula:
Carryover (%)=(L1–L3)/(H3–L3)×100.
Linearity analysis for WBC, RBC, Hb, and platelets was performed using Coulter LIN-X Linearity Control in duplicate, according to the CLSI H26-A2 guidelines [6]. The Pearson’s correlation coefficients (
The correlation between the measurements obtained from the DxH 900 analyzer were evaluated with the measurements obtained from the XE-2100 (Sysmex Corp., Kobe, Japan), which was in use in the laboratory. Seventy samples for measurements within the analytical measurement range, according to the CLSI EP09C-ED3 guidelines [7]. The correlation coefficient (
The DxH 900 analyzer demonstrated good precision for the measurement of normal and abnormal high- and low-level QC materials for all parameters except basophils (Table 1). Despite the lack of current state-of-the-art limits for MDW, all the measured %CVs for MDW were <3%, which was much lower than the manufacturer’s limit of 10%.
Table 1 . Within-run and between-run precision analyses for normal and abnormal high-level and low-level quality control material
Variable | Normal control | Abnormal high-level control | Abnormal low-level control | Manufacturer’s limit, CV (%) | State-of-the-art, CV (%) | |||||
---|---|---|---|---|---|---|---|---|---|---|
Mean | CV (%) | Mean | CV (%) | Mean | CV (%) | |||||
Within-run | ||||||||||
WBC (×109/L) | 8.7 | 0.97 | 21.1 | 0.91 | 3.2 | 1.21 | 3 | 2.5/1.5/2.5 | ||
Neutrophils (×109/L) | 4.78 | 1.49 | 13.61 | 1.59 | 1.45 | 2.09 | 3.5 | 2.5 | ||
Eosinophils (×109/L) | 0.63 | 8.36 | 1.12 | 8.4 | 0.14 | 7.64 | 13.5 | 10 | ||
Basophils (×109/L) | 0.003 | 39.19 | 0.015 | 40.64 | 0.001 | 56.42 | - | 20 | ||
Lymphocytes (×109/L) | 2.49 | 2.48 | 3.15 | 3.46 | 1.37 | 1.1 | 5 | 3.5 | ||
Monocytes (×109/L) | 0.77 | 3.71 | 3.16 | 2.88 | 0.29 | 4.38 | 10 | 8.5 | ||
RBC (×1012/L) | 3.96 | 1.3 | 5.26 | 0.51 | 1.77 | 0.5 | 1.5 | 1.1 | ||
Hb (g/dL) | 11.7 | 0.29 | 15.4 | 0.35 | 4.7 | 0.37 | 1.5 | 0.9 | ||
MCV (fL) | 88.03 | 0.21 | 89.05 | 0.19 | 80.99 | 0.17 | 1 | 0.6 | ||
RDW (%) | 15.4 | 0.53 | 15.97 | 0.74 | 15.25 | 0.97 | 2.5 | 2.0 | ||
Platelets (×109/L) | 206 | 1.21 | 402 | 1.88 | 69 | 2.15 | 3.5 | 3.0 | ||
MPV (fL) | 9.76 | 0.82 | 10.08 | 0.57 | 9.46 | 0.55 | 2.5 | 2.5 | ||
MDW (units) | 37.97 | 2.3 | 37.44 | 2.44 | 36.73 | 2.58 | 10 | - | ||
Between-run | ||||||||||
WBC (×109/L) | 8.8 | 1.3 | 21.3 | 1.05 | 3.3 | 1.28 | 3 | 2.5/1.5/2.5 | ||
Neutrophils (×109/L) | 4.9 | 1.9 | 13.8 | 1.51 | 1.5 | 1.91 | 3.5 | 2.5 | ||
Eosinophils (×109/L) | 0.52 | 5.22 | 1.15 | 5.28 | 0.14 | 6.55 | 13.5 | 10 | ||
Basophils (×109/L) | 0.005 | 98.07 | 0.019 | 37.7 | 0.001 | 148.79 | - | 20 | ||
Lymphocytes (×109/L) | 2.5 | 2.53 | 3.1 | 3.49 | 1.4 | 2.28 | 5 | 3.5 | ||
Monocytes (×109/L) | 0.79 | 4.42 | 3.3 | 2.95 | 0.29 | 4.31 | 10 | 8.5 | ||
RBC (×1012/L) | 3.94 | 0.86 | 5.32 | 1.09 | 1.79 | 1 | 1.5 | 1.1 | ||
Hb (g/dL) | 11.8 | 0.67 | 15.6 | 0.51 | 4.8 | 0.35 | 1.5 | 1.0 | ||
MCV (fL) | 88.05 | 0.32 | 89.07 | 0.28 | 81.01 | 0.31 | 1 | 0.8 | ||
RDW (%) | 15.44 | 1.04 | 16.03 | 1.04 | 15.34 | 1.18 | 2.5 | 2.0 | ||
Platelets (×109/L) | 208 | 1.91 | 404 | 1.49 | 70 | 1.87 | 3.5 | 3.0 | ||
MPV (fL) | 9.79 | 0.56 | 10.07 | 0.59 | 9.47 | 0.66 | 2.5 | 2.5 | ||
MDW (units) | 37 | 2.76 | 38.3 | 2.45 | 36.7 | 2.41 | 10 | - |
Abbreviations: CV, coefficient of variation; WBC, white blood cells; RBC, red blood cells; Hb, hemoglobin; MCV, mean corpuscular volume; MDW, monocyte distribution width; MPV, mean platelet volume; RDW, red cell distribution width.
The percentage of carryover was –0.08% for WBC, 0.00% for RBC, 0.00% for Hb, and –0.04% for platelets. These carryover values were not clinically significant. However, the values were within the manufacturer provided limit of 0.05% for WBC and RBC, and 1.0% for Hb and platelets. The
Table 2 . Linearity of WBC, RBC, Hb, and platelet counts obtained using the DxH 900
Variable | Range | Correlation coefficient ( | Intercept | Slope |
---|---|---|---|---|
WBC (×109/L) | 0.25–372.90 | 0.9999 | –0.1453 | 0.9986 |
RBC (×1012/L) | 0.03–8.24 | 1 | –0.01 | 0.9973 |
Hb (g/dL) | 0.2–24.7 | 0.9999 | –0.0751 | 0.9946 |
Platelets (×109/L) | 3–2,655 | 0.9997 | 5.269 | 0.9902 |
Abbreviations: WBC, white blood cells; RBC, red blood cells; Hb, hemoglobin.
The results of the comparison between two hematology analyzers are shown in Table 3. Fig. 1 shows the correlations between the measurements performed using the DxH 900 and XE-2100 analyzers. The results obtained for WBC, RBC, Hb, Hct, platelet, and 5-part LDC measurements from the DxH 900 analyzer were comparable to measurements obtained from the XE-2100 analyzer. All parameters, except the percentage of basophils (
Table 3 . Comparison of major complete blood count parameters between DxH 900 and XE-2100 (N=70)
Variable | Range | Correlation coefficient ( | Slope | Intercept | |
---|---|---|---|---|---|
DxH 900 | XE-2100 | ||||
WBC (×109/L) | 2.7–20.1 | 2.76–20.34 | 0.998 | 0.9652 | –0.0301 |
RBC (×1012/L) | 1.7–5.85 | 1.81–5.99 | 0.998 | 0.9896 | –0.0843 |
Hb (g/dL) | 5.5–17.8 | 5.8–18.7 | 0.999 | 0.9443 | 0.3159 |
Hct (%) | 16.9–53.9 | 18.1–54.8 | 0.995 | 0.9968 | –0.7592 |
Platelets (×109/L) | 23–692 | 22–641 | 0.989 | 1.0264 | –6.7465 |
Neutrophils (%) | 25.1–88.5 | 24.5–87.9 | 0.995 | 0.9947 | 0.9373 |
Eosinophils (%) | 0–3.4 | 0–3.7 | 0.983 | 0.956 | 0.0227 |
Basophils (%) | 0.2–0.8 | 0–1.3 | 0.553 | 0.6317 | 0.4518 |
Lymphocytes (%) | 2.5–55.8 | 3.1–59.4 | 0.993 | 0.9808 | –0.682 |
Monocytes (%) | 2.5–23.9 | 3.4–25.9 | 0.932 | 0.9444 | 0.8861 |
Abbreviations: WBC, white blood cells; RBC, red blood cells; Hb, hemoglobin; Hct, hematocrit.
In this study, the analytical performance of the DxH 900 analyzer was evaluated. The precision (%CV) of all parameters, except for basophils, was less than the limits provided by the manufacturer and current state-of-the-art. The %CV for basophils was between 37.70%–148.79% with normal, high-level, and low-level QC material in within-run and between-run precision analyses, and exceeded the 20% limit considered as state-of-the-art currently. This could be due to the very low concentration of basophils in the QC material, which was cross-checked by reanalyzing using other automated hematology analyzers [8,9].
MDW is a relatively new laboratory parameter that has been studied as a potential early indicator of sepsis in emergency departments (ED) [2,4]. The DxH 900 can measure MDW as part of the standard CBC without requiring extra time. So MDW can provide quick results to aid prompt decision-making in the ED. In addition, all %CV values for MDW in this study were less than 3%, demonstrating good precision, which is similar to the values of 1.99%–3.54% reported by Martinez-Iribarren et al. [10]. Therefore, MDW can be a useful biomarker for the early detection of sepsis in the ED.
The DxH 900 analyzer showed no significant carryover effect or linearity bias in WBC, RBC, Hb, or platelet counts. Martinez-Iribarren et al. [10] reported that the DxH 900 displayed good linearity for low WBC and platelet counts. These results could be obtained in the absence of using specific modes for low WBC counts as required by other automated hematology analyzers.
The correlation between the DxH 900 and XE-2100 CBC, and 5-part LDC values was high, except for the percentage of basophils (
There are some limitations for this study. First, there were no specific exclusion criteria for specimens with an abnormal hematological profile. Second, we did not perform a microscopic blood film examination and 5-part LDC in our samples.
In conclusion, our findings show that the DxH 900 analyzer has good analytical performance and good agreement with Sysmex XE-2100 results. The DxH 900 analyzer also showed good analytical performance in measuring MDW, a novel parameter for the early diagnosis of sepsis.
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