Abstract
Objectives
Cellular analysis of body fluids (BF) has clinical relevance in several medical conditions. The objective of this study is twofold: (1) evaluate the analytical performance of the BF mode of Mindray BC-6800 Plus compared to manual counts under microscopy and (2) analyse if the high-fluorescent cell counts provided by the analyser (HF-BF) are useful to detect malignancy.
Methods
A total of 285 BF was analysed: 250 corresponding to patients without neoplasia and 35 to patients with malignant diseases. Manual differential counts were performed in BF with ≥250 cells/μL. Percentages and absolute counts were obtained on the BC-6800Plus for total nucleated cells (TC-BF), mononuclear, polymorphonuclear and HF-BF. Statistical analysis was performed using Mann-Whitney U-test, Spearman’s correlation, Passing-Bablok regression, Bland-Altman graph and ROC curve.
Results
To compare manual and automatic total cell counts, samples were divided in three groups: <250, 250–1,000 and >1,000 cells/μL. Correlation was good in all cases (r=0.72, 0.73 and 0.92, respectively) without significant differences between both methods (p=0.65, 0.39 and 0.30, respectively). The concordance between methods showed values of 90%. Considering malignant samples, median HF-BF values showed significant higher values (102 cells/μL) with respect to non-malignant (4 cells/μL) (p<0.001). The cut-off value of 8.5 HF-BF/μL was able to discriminate samples containing malignant cells showing sensitivity and specificity values of 89 and 71%, respectively. Considering both, HF-BF and TC-BF values, sensitivity and specificity values were 100 and 53%, respectively.
Conclusions
This study reveals that the Mindray BC-6800Plus offers an accurate and acceptable performance, showing results consistent with the manual method. It is recommended to consider both HF-BF and TC-BF values for the screening of the microscopic evaluation to ensure the detection of all malignant samples.
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Research funding: None declared.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Not applicable.
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Ethical approval: Not applicable.
References
1. García de Guadiana Romualdo, L, Oliver Sáez, P, Merino González, A, Valcárcel Piedra, G, Guillén Campuzano, E, Arellano Rodrigo, E, et al.. Magnitudes biológicas que tiene interés medir de modo urgente. Rev Lab Clin 2017;10:31–43. https://doi.org/10.1016/j.labcli.2016.12.001.Search in Google Scholar
2. Sandhaus, LM. Body fluid cell counts by automated methods. Clin Lab Med 2015;35:93–103. https://doi.org/10.1016/j.cll.2014.10.003.Search in Google Scholar PubMed
3. Clinical Laboratory Standards Institute (CLSI). Body fluid analysis for cellular composition. Wayne, PA: Approved Guideline: CLSI Document H56-A; 2006.Search in Google Scholar
4. Bignardi, GE. Flow cytometry for the microscopy of body fluids in patients with suspected infection. J Clin Pathol 2015;68:870–8. https://doi.org/10.1136/jclinpath-2015-203088.Search in Google Scholar PubMed
5. Fuster, O, Andino, B, Pardo, A, Laiz, B. Continuous ambulatory peritoneal dialysis, ascitic and pleural body fluids evaluation with the Mindray BC-6800 hematology analyzer. J Clin Lab Anal 2018;32:1–6. https://doi.org/10.1002/jcla.22240.Search in Google Scholar PubMed PubMed Central
6. Buoro, S, Seghezzi, M, Mecca, T, Vavassori, M, Crippa, A, La Gioia, A. Evaluation of Mindray BC-6800 body fluid mode for automated cerebrospinal fluid cell counting. Clin Chem Lab Med 2016;54:1799–810. https://doi.org/10.1515/cclm-2015-1092.Search in Google Scholar PubMed
7. Buoro, S, Seghezzi, M, Manenti, B, Mecca, T, Candiago, E, Vidali, M, et al.. Reliability of automated synovial fluid cell counting with Mindray BC-6800 body fluid mode. Int J Lab Hematol 2017;39:337–46. https://doi.org/10.1111/ijlh.12632.Search in Google Scholar PubMed
8. Buoro, S, Mecca, T, Azzarà, G, Seghezzi, M, Candiago, E, Gianatti, A, et al.. Mindray BC-6800 body fluid mode, performance of nucleated cells, and differential count in ascitic and pleural fluids. Int J Lab Hematol 2016;38:90–101. https://doi.org/10.1111/ijlh.12446.Search in Google Scholar PubMed
9. De Jonge, R, Brouwer, R, Van Rijn, M, Van Acker, BAC, Otten, HJAM, Lindemans, J. Automated analysis of pleural fluid total and differential leukocyte counts with the sysmex XE-2100. Clin Chem Lab Med 2006;44:1367–71. https://doi.org/10.1515/cclm.2006.242.Search in Google Scholar
10. Fleming, C, Brouwer, R, Lindemans, J, De Jonge, R. Validation of the body fluid module on the new sysmex XN-1000 for counting blood cells in cerebrospinal fluid and other body fluids. Clin Chem Lab Med 2012;50:1791–8. https://doi.org/10.1515/cclm-2011-0927.Search in Google Scholar PubMed
11. Fleming, C, Brouwer, R, Van Alphen, A, Lindemans, J, De Jonge, R. UF-1000i: validation of the body fluid mode for counting cells in body fluids. Clin Chem Lab Med 2014;52:1781–90. https://doi.org/10.1515/cclm-2014-0512.Search in Google Scholar PubMed
12. Cho, YU, Chi, HS, Park, SH, Jang, S, Kim, YJ, Park, CJ. Body fluid cellular analysis using the Sysmex XN-2000 automatic hematology analyzer: focusing on malignant samples. Int J Lab Hematol 2015;37:346–56. https://doi.org/10.1111/ijlh.12292.Search in Google Scholar PubMed
13. Labaere, D, Boeckx, N, Geerts, I, Moens, M, Van den Driessche, M. Detection of malignant cells in serous body fluids by counting high-fluorescent cells on the Sysmex XN-2000 hematology analyzer. Int J Lab Hematol 2015;37:715–22. https://doi.org/10.1111/ijlh.12393.Search in Google Scholar PubMed
14. Wong-Arteta, J, Merino, A, Torrente, S, Banales, JM, Bujanda, L. High fluorescence cell count in ascitic body fluids for carcinomatosis screening. Clin Chem Lab Med 2018;56:e272–4. https://doi.org/10.1515/cclm-2018-0359.Search in Google Scholar PubMed
15. Larruzea, A, Aguadero, V, Orellana, R, Berlanga, E. High-fluorescent cells: a marker of malignancy in the analysis of body fluid samples. Int J Lab Hematol 2018;40:e43–5. https://doi.org/10.1111/ijlh.12793.Search in Google Scholar PubMed
16. Favresse, J, Boland, L, Schellen, M, Fervaille, C, Wuestenberghs, F, Camboni, A, et al.. Two-site evaluation of a new workflow for the detection of malignant cells on the Sysmex XN-1000 body fluid analyzer. Int J Lab Hematol 2020;42:544–51. https://doi.org/10.1111/ijlh.13187.Search in Google Scholar PubMed
17. Wu, W, Zhao, C, Shen, T, Tong, X, Chen, W. The diagnostic ability of high-fluorescent cells combined with carcinoembryonic antigen for malignant pleural effusion. Int J Lab Hematol 2019;41:509–12. https://doi.org/10.1111/ijlh.13034.Search in Google Scholar PubMed
18. Bourner, G, De la Salle, B, George, T, Tabe, Y, Baum, H, Culp, N, et al.. ICSH guidelines for the verification and performance of automated cell counters for body fluids. Int J Lab Hematol 2014;36:598–612. https://doi.org/10.1111/ijlh.12196.Search in Google Scholar PubMed
19. Noguera Bennaser, A, Galán Ortega, A, Guillén Campuzano, E, Hortas Nieto, ML, Marín Soria, JL, Padrós Soler, G. Recomendaciones para el estudio de líquidos biológicos serosos en el laboratorio de urgencias. Quím Clín 2004;23:141–5.Search in Google Scholar
20. Bar-Meir, S, Lerner, E, Conn, HO. Analysis of ascitic fluid in cirrhosis. Dig Dis Sci 1979;24:136–44. https://doi.org/10.1007/bf01324741.Search in Google Scholar PubMed
21. Merino, A. Cytology of biological fluids (serous and cerebrospinal) and its diagnostic utility. In: Manual of cytology of peripheral blood and biological fluids, 2nd ed. Madrid: Panamericana Editorial; 2020:213–52 pp. [Spanish].Search in Google Scholar
22. Clinical Laboratory Standards Institute (CLSI). Evaluation of detection capability for clinical laboratory measurement procedures. Wayne, PA: Approved Guideline: CLSI Document EP17-A2; 2012.Search in Google Scholar
23. Clinical Laboratory Standards Institute (CLSI). Evaluation of precision of quantitative measurement procedures. Wayne, PA: Approved Guideline: CLSI Document EP05-A3; 2014.Search in Google Scholar
24. Clinical Laboratory Standards Institute (CLSI). Evaluation of the linearity of quantitative measurement procedures: a statistical approach. Wayne, PA: Approved Guideline. CLSI Document EP06-A; 2003.Search in Google Scholar
25. The R Foundation. The R project for statistical computing. Available from: https://www.r-project.org/ [Accessed 14 Dec 2021].Search in Google Scholar
26. Bilic-Zulle, L. Comparison of methods: passing and bablok regression. Biochem Med 2011;21:49–52. https://doi.org/10.11613/bm.2011.010.Search in Google Scholar PubMed
27. Giavarina, D. Understanding bland altman analysis. Biochem Med 2015;25:141–51. https://doi.org/10.11613/bm.2015.015.Search in Google Scholar PubMed PubMed Central
28. Kallner, A. Bayes’ theorem, the ROC diagram and reference values: definition and use in clinical diagnosis. Biochem Med 2018;28:1–10. https://doi.org/10.11613/bm.2018.010101.Search in Google Scholar PubMed PubMed Central
29. Hooper, C, Lee, YCG, Maskell, N. Investigation of a unilateral pleural effusion in adults: British thoracic society pleural disease guideline 2010. Thorax 2010;65(2 Suppl):ii4–17. https://doi.org/10.1136/thx.2010.136978.Search in Google Scholar PubMed
30. Fleming, C, Russcher, H, Lindemans, J, De Jonge, R. Clinical relevance and contemporary methods for counting blood cells in body fluids suspected of inflammatory disease. Clin Chem Lab Med 2015;53:1689–706. https://doi.org/10.1515/cclm-2014-1247.Search in Google Scholar PubMed
31. The European Association for the Study of the Liver. EASL clinical practice guidelines for the management of patients with decompensated cirrhosis. J Hepatol 2018;69:406–60. https://doi.org/10.1016/j.jhep.2018.03.024.Search in Google Scholar PubMed
32. Runyon, BA. Management of adult patients with ascites due to cirrhosis: an update. Hepatol 2009;49:2087–107. https://doi.org/10.1002/hep.23261.Search in Google Scholar
33. Alcaide Martín, MJ, Altimira Queral, L, Sahuquillo Frías, L, Valiña Amado, L, Merino, A, García de Guadiana-Romualdo, L. Automated cell count in body fluids: a review. Adv Lab Med 2021;2:149–61. https://doi.org/10.1515/almed-2021-0011.Search in Google Scholar
34. Buoro, S, Seghezzi, M, Dominoni, P, Moioli, V, Manenti, B, Previtali, G, et al.. Lack of harmonization in high fluorescent cell automated counts with body fluids mode in ascitic, pleural, synovial, and cerebrospinal fluids. Int J Lab Hematol 2019;41:277–86. https://doi.org/10.1111/ijlh.12968.Search in Google Scholar PubMed
Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0447).
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