Lab Med Online.  2022 Oct;12(4):269-277. 10.47429/lmo.2022.12.4.269.

Performance Evaluation of the Mindray BC-6200 Hematology Analyzer; Comparison with Sysmex XE-2100 and Manual Microscopy

• Lee TH
• Kim H
• Park M
• Hur M
• Lee CH

• KMID: 2538614
• DOI: http://doi.org/10.47429/lmo.2022.12.4.269

Abstract

Background
Complete blood count (CBC) and white blood cell (WBC) differential are essential tests for various diseases. Related to this, the Mindray BC-6200 automated hematology analyzer (BC-6200, Mindray Bio-Medical Electronics Co., Ltd, China) was recently launched in clinical laboratories. This study aimed to evaluate the analytical and flagging performance of BC-6200.
Methods
Using 688 whole blood samples, the precision and carryover of 12 CBC parameters were evaluated with BC-6200 according to the Clinical and Laboratory Standards Institute (CLSI) guidelines EP15-A3 and H26-A2, respectively. 11 CBC parameters of BC-6200 were compared with Sysmex XE-2100 (XE-2100, Sysmex Corporation, Japan) according to the CLSI guideline EP09c. To evaluate the flagging performance for blasts, immature granulocytes (IG), atypical lymphocytes (AL), and nucleated red blood cells (NRBC) of BC-6200, sensitivity, specificity, and efficiency to manual counts were estimated according to the CLSI guideline H20-A2.
Results
Precisions of WBC, red blood cells (RBC), hemoglobin (Hb), hematocrit (Hct), and platelets (PLT) were acceptable. Carryover was less than 1% in WBC, RBC, Hb, Hct, and PLT. In WBC differentials, BC-6200 and XE-2100 showed very high correlations, except for basophils. Flagging performances of BC-6200 showed excellent results in efficiency; 91.4% for blasts, 79.4% for IG, 75.5% for AL, and 98.6% for NRBC.
Conclusions
The analytical performances of BC-6200 were acceptable and comparable with those of XE-2100. The flagging performance was also comparable with that of manual counts. BC-6200 would be a competent instrument in clinical laboratories.

Keyword

Performance evaluation; Hematology analyzer; Mindray BC-6200

Figure

• 

  Fig. 1 Diagram showing the flow of participants’ samples in the current study. Disease characteristics of the 92 patient samples from KUMC are noted. In the comparison study, 35 samples had partial missing data. In the flagging performance study, 21 samples were excluded due to improper operation of the instrument. Abbreviations: AML, acute myeloid leukemia; CML, chronic myeloid leukemia; KUCH, Konkuk University Chungju Hospital; KUMC, Konkuk University Medical Center; MDS, myelodysplastic syndrome; PV, polycythemia vera.

• 

  Fig. 2 Comparison results for 11 CBC parameters between BC-6200 and XE-2100 using Bland-Altman plot (N=270). Solid lines represent the mean differences, and the dashed lines represent the mean difference±1.96 standard deviations (95% limits of agreements). Abbreviations: CBC, complete blood count; Hb, hemoglobin; Hct, hematocrit; PLT, platelets; RBC, red blood cells; RDW-CV, red blood cell distribu­tion width-coefficient of variation; WBC, white blood cells.

Reference

1. Libby P, Sidlow R, Lin AE, Gupta D, Jones LW, Moslehi J, et al. 2019; Clonal hematopoiesis: crossroads of aging, cardiovascular disease, and cancer: JACC review topic of the week. J Am Coll Cardiol. 74:567–77. DOI: 10.1016/j.jacc.2019.06.007. PMID: 31345432. PMCID: PMC6681657.

2. Orwoll ES, Orwoll RL. 1987; Hematologic abnormalities in patients with endocrine and metabolic disorders. Hematol Oncol Clin North Am. 1:261–79. DOI: 10.1016/S0889-8588(18)30675-0.

3. Briggs C, Culp N, Davis B, d'Onofrio G, Zini G, Machin SJ. 2014; ICSH guidelines for the evaluation of blood cell analysers including those used for differential leucocyte and reticulocyte counting. Int J Lab Hematol. 36:613–27. DOI: 10.1111/ijlh.12201. PMID: 24666725.

4. Sullivan E. 2006; Hematology analyzer: from workhorse to thoroughbred. LABMEDICINE. 37:273–8. DOI: 10.1309/TMQ6T4CBCG408141.

5. Park S, Huh J, Jeong TD. 2020; False-positive flag of WBC and change of mean platelet volume (MPV) caused by K3-EDTA on the DxH 900 hematology analyzer. Scand J Clin Lab Invest. 80:644–8. DOI: 10.1080/00365513.2020.1824298. PMID: 32975447.

6. Kulik K, Kwiecień I, Chełstowska B, Rutkowska E, Rzepecki P. 2021; Evaluation and comparison of the new Mindray BC-6200 hematology analyzer with ADVIA 2120i. Int J Lab Hematol. 43:395–402. DOI: 10.1111/ijlh.13418. PMID: 33270987.

7. Delsol G, Guiu-Godfrin B, Guiu M, Pris J, Corberand J, Fabre J. 1979; Leukoerythroblastosis and cancer frequency, prognosis, and physiopathologic significance. Cancer. 44:1009–13. DOI: 10.1002/1097-0142(197909)44:3<1009::AID-CNCR2820440331>3.0.CO;2-J.

8. Stachon A, Segbers E, Holland-Letz T, Kempf R, Hering S, Krieg M. 2007; Nucleated red blood cells in the blood of medical intensive care patients indicate increased mortality risk: a prospective cohort study. Crit Care. 11:R62. DOI: 10.1186/cc5932. PMID: 17550592. PMCID: PMC2206423.

9. Kim H, Hur M, Kim SW, Moon HW, Yun YM. 2020; Reference intervals for clinically reportable platelet parameters on the Mindray BC-6800Plus hematology analyzer. Clin Chem Lab Med. 58:e213–5. DOI: 10.1515/cclm-2020-0020. PMID: 32069230.

10. Deng J, Chen Y, Zhang S, Li L, Shi Q, Liu M, et al. 2020; Mindray SF-Cube technology: an effective way for correcting platelet count in individuals with EDTA dependent pseudothrombocytopenia. Clin Chim Acta. 502:99–101. DOI: 10.1016/j.cca.2019.12.012. PMID: 31863740.

11. Jo YA, Kim M, Kim HS, Kang HJ, Lee YK. 2013; Evaluation of the Mindray BC-6800 complete blood counts analyzer. Lab Med Online. 3:131–7. DOI: 10.3343/lmo.2013.3.3.131.

12. Briggs C, Harrison P, Grant D, Staves J, MacHin SJ. 2000; New quantitative parameters on a recently introduced automated blood cell counter - the XE 2100. Clin Lab Hematol. 22:345–50. DOI: 10.1046/j.1365-2257.2000.00330.x. PMID: 11318800.

13. Clinical, Laboratory Standards Institute. 2014. User verification of precision and estimation of bias; Approved guideline-Third edition. CLSI document EP15-A3. Wayne, PA: Clinical and Laboratory Standards Institute.

14. Clinical, Laboratory Standards Institute. 2010. Validation, verification, and quality assurance of automated hematology analyzers; Approved standard-Second edition. CLSI document H26-A2. Wayne, PA: Clinical and Laboratory Standards Institute.

15. Clinical, Laboratory Standards Institute. 2018. Measurement procedure comparison and bias estimation using patient samples, Third edition. CLSI guideline EP09c. Wayne, PA: Clinical and Laboratory Standards Institute.

16. Clinical, Laboratory Standards Institute. 2007. Reference leukocyte (WBC) differential count (proportional) and evaluation of instrumental method; Approved standard-Second edition. CLSI document H20-A2. Wayne, PA: Clinical and Laboratory Standards Institute.

17. Vis JY, Huisman A. 2016; Verification and quality control of routine hematology analyzers. Int J Lab Hematol. 38(S1):100–9. DOI: 10.1111/ijlh.12503. PMID: 27161194.

18. Mukaka MM. 2012; Statistics corner: a guide to appropriate use of correlation coefficient in medical research. Malawi Med J. 24:69–71.

19. Nakul-Aquaronne D, Sudaka-Sammarcelli I, Ferro-Vacher C, Starck B, Bayle J. 2003; Evaluation of the Sysmex Xe-2100 hematology analyzer in hospital use. J Clin Lab Anal. 17:113–23. DOI: 10.1002/jcla.10083. PMID: 12784259. PMCID: PMC6807756.

20. Takemura H, Ai T, Kimura K, Nagasaka K, Takahashi T, Tsuchiya K, et al. 2018; Evaluation of cell count and classification capabilities in body fluids using a fully automated Sysmex XN equipped with high-sensitive Analysis (hsA) mode and DI-60 hematology analyzer system. PLoS One. 13:e0195923. DOI: 10.1371/journal.pone.0195923. PMID: 29698492. PMCID: PMC5919509.

21. Lesesve JF, Benbih M, Lecompte T. 2005; Accurate basophils counting: not an easy goal! Clin Lab Hematol. 27:143–4. DOI: 10.1111/j.1365-2257.2005.00667.x. PMID: 15784131.

22. Amundsen EK, Henriksson CE, Holthe MR, Urdal P. 2012; Is the blood basophil count sufficiently precise, accurate, and specific?: three automated hematology instruments and flow cytometry compared. Am J Clin Pathol. 137:86–92. DOI: 10.1309/AJCP19BFTHYTMORO. PMID: 22180481.

23. Kim H, Hur M, Choi SG, Moon HW, Yun YM, Hwang HS, et al. 2013; Evaluation of ABX Pentra DX 120 and Sysmex XE-2100 in umbilical cord blood. Int J Lab Hematol. 35:658–65. DOI: 10.1111/ijlh.12110. PMID: 23738834.

24. Shen Y, Cao J, Zhou Z, Wang Y, Shen Y, He J. 2019; Clinical performance evaluation of the new hematology analyzer Mindray BC-6000. Int J Lab Hematol. 41:622–34. DOI: 10.1111/ijlh.13075. PMID: 31286670.