본문 바로가기
KERD
논문KCI 등재

Performance Evaluation of Body Fluid Cellular Analysis Using the Beckman Coulter UniCel DxH 800, Sysmex XN-350, and UF-5000 Automated Cellular Analyzers

1

조회

0

다운로드

2

인용

0

참고문헌

키워드

주제분류병리학

초록

Background: Automated cellular analyzers are expected to improve the analytical performance in body fluid (BF) analysis. We evaluated the analytical performance of three automated cellular analyzers and established optimum reflex analysis guidelines. Methods: A total of 542 BF samples (88 cerebrospinal fluid [CSF] samples and 454 non-CSF samples) were examined using manual counting and three automated cellular analyzers: UniCel DxH 800 (Beckman Coulter), XN-350 (Sysmex), and UF-5000 (Sysmex). Additionally, 2,779 BF analysis results were retrospectively reviewed. For malignant cell analysis, the receiver operating characteristic (ROC) curve was used, and the detection of high fluorescence-BF cells (HF-BFs) using the XN-350 analyzer was compared with cytology results. Results: All three analyzers showed good agreement for total nucleated cell (TNC) and red blood cell (RBC) counts, except for the RBC count in CSF samples using the UniCel DxH 800. However, variable degrees of differences were observed during differential cell counting. For malignant cell analysis, the area under the curve was 0.63 for the XN-350 analyzer and 0.76 for manual counting. We established our own reflex analysis guidelines as follows: HF-BFs <0.7/100 white blood cells (WBCs) is the criterion for quick scans with 100× magnification microscopic examination as a rule-out cut-off, while HF-BFs >83.4/100 WBCs or eosinophils >3.8% are the criteria for mandatory double check confirmation with 1,000× magnification examination. Conclusions: The three automated analyzers showed good analytical performances. Application of reflex analysis guidelines is recommended for eosinophils and HF-BFs, and manual confirmation is warranted.

Abstract

Background: Automated cellular analyzers are expected to improve the analytical performance in body fluid (BF) analysis. We evaluated the analytical performance of three automated cellular analyzers and established optimum reflex analysis guidelines. Methods: A total of 542 BF samples (88 cerebrospinal fluid [CSF] samples and 454 non-CSF samples) were examined using manual counting and three automated cellular analyzers: UniCel DxH 800 (Beckman Coulter), XN-350 (Sysmex), and UF-5000 (Sysmex). Additionally, 2,779 BF analysis results were retrospectively reviewed. For malignant cell analysis, the receiver operating characteristic (ROC) curve was used, and the detection of high fluorescence-BF cells (HF-BFs) using the XN-350 analyzer was compared with cytology results. Results: All three analyzers showed good agreement for total nucleated cell (TNC) and red blood cell (RBC) counts, except for the RBC count in CSF samples using the UniCel DxH 800. However, variable degrees of differences were observed during differential cell counting. For malignant cell analysis, the area under the curve was 0.63 for the XN-350 analyzer and 0.76 for manual counting. We established our own reflex analysis guidelines as follows: HF-BFs <0.7/100 white blood cells (WBCs) is the criterion for quick scans with 100× magnification microscopic examination as a rule-out cut-off, while HF-BFs >83.4/100 WBCs or eosinophils >3.8% are the criteria for mandatory double check confirmation with 1,000× magnification examination. Conclusions: The three automated analyzers showed good analytical performances. Application of reflex analysis guidelines is recommended for eosinophils and HF-BFs, and manual confirmation is warranted.

참고문헌 (25)

  1. Sandhaus LM, "Body fluid cell counts by automated methods", Clin Lab Med, 35, pp.93~103 (2015)
  2. Fleming C, "Clinical relevance and contemporary methods for counting blood cells in body fluids suspected of inflammatory disease", Clin Chem Lab Med, 53, pp.1689~1706 (2015)
  3. Yang D, "Performance evaluation and result comparison of the automated hematology analyzers Abbott CD 3700, Sysmex XE 2100 and Coulter LH 750 for cell counts in serous fluids", Clin Chim Acta, 419, pp.113~118 (2013)
  4. CLSI, "Body fluid analysis for cellular composition; Approved guideline" (2006), Clinical and Laboratory Standards Institute
  5. Cho YU, "Validation of reflex testing rules and establishment of a new workflow for body fluid cell analysis using a Sysmex XN-550 automatic hematology analyzer", Int J Lab Hematol, 40, pp.258~267 (2018)
  6. Fleming C, "UF-1000i : validation of the body fluid mode for counting cells in body fluids", Clin Chem Lab Med, 52, pp.1781~1790 (2014)
  7. Nanos NE, "Evaluation of Sysmex UF-1000i for use in cerebrospinal fluid analysis", Clin Chim Acta, 392, pp.30~33 (2008)
  8. Cho YU, "Body fluid cellular analysis using the Sysmex XN-2000 automatic hematology analyzer : focusing on malignant samples", Int J Lab Hematol, 37, pp.346~356 (2015)
  9. Bourner G, "ICSH guidelines for the verification and performance of automated cell counters for body fluids", Int J Lab Hematol, 36, pp.598~612 (2014)
  10. Sandhaus LM, "A new automated technology for cerebrospinal fluid cell counts: comparison of accuracy and clinical impact of GloCyte, Sysmex XN, and manual methods", Am J Clin Pathol, 147, pp.507~514 (2017)
  11. Fleming C, "Evaluation of Sysmex XN-1000 high-sensitive analysis(hsA)research mode for counting and differentiating cells in cerebrospinal fluid", Am J Clin Pathol, 145, pp.299~307 (2016)
  12. Danise P, "Cell counting of body fluids: comparison between three automated haematology analysers and the manual microscope method", Int J Lab Hematol, 35, pp.608~613 (2013)
  13. Lehto TM, "Evaluation of the Sysmex XT-4000i for the automated body fluid analysis", Int J Lab Hematol, 36, pp.114~123 (2014)
  14. Fleming C, "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, 50, pp.1791~1798 (2012)
  15. Labaere D, "Detection of malignant cells in serous body fluids by counting high-fluorescent cells on the Sysmex XN-2000 hematology analyzer", Int J Lab Hematol, 37, pp.715~722 (2015)
  16. Beckman Coulter Inc, "Coulter cellular analysis system instructions cellular analysis system instructions for use: use: PN B26647AE", pp.127~ (2017), Beckman Coulter, Inc
  17. Previtali G, "Performance evaluation of the new fully automated urine particle analyser UF-5000 compared to the reference method of the Fuchs-Rosenthal chamber", Clin Chim Acta, 472, pp.123~130 (2017)
  18. Seghezzi M, "Preliminary evaluation of UF-5000 Body Fluid Mode for automated cerebrospinal fluid cell counting", Clin Chim Acta, 473, pp.133~138 (2017)
  19. Buoro S, "Automated cerebrospinal fluid cell counts using cerebrospinal fluid cell counts using the new body fluid mode of Sysmex UF-1000i", J Clin Lab Anal, 30, pp.381~391 (2016)
  20. CLSI, "User verification of performance for precision and trueness approved guideline" (2006), Clinical and Laboratory Standards Institute
  21. CLSI, "Evaluation of the linearity of quantitative measurement procedures: a statistical approach; approved guideline. CLSI approach approved guideline" (2003), Clinical and Laboratory Standards Institute
  22. CLSI, "CLSI measurement procedures approved guideline" (2012), Clinical and Laboratory Standards Institute
  23. "Desirable biological variation database specifications"[URL]
  24. CLSI, "Method comparison and bias estimation using patient samples; approved guideline" (2010), Clinical and Laboratory Standards Institute
  25. Buoro S, "Reflex testing rules for cell count and differentiation of nucleated elements in pleural and ascitic fluids on Sysmex XE-5000", J Lab Autom, 21, pp.297~304 (2016)

관련 논문AI추천

Comparison of IRIS Iq200, UF-1000i, and Cobas u701 Module Automated Urine Sediment Analyzers강푸름, 권선자, 김태윤, 박하성, 양다해, 최현지, 황현용대한진단검사의학회 · Laboratory Medicine Online2020 · 제10권 제4호체액세포분석 수기검사: 국내 실태조사 및 임상검사실 지침(2021)공선영, 김인숙, 김지명, 김현영, 방해인, 신명근, 신새암, 이자영, 이정녀, 조영욱, 황상미대한진단검사의학회 · Laboratory Medicine Online2022 · 제12권 제4호Validation of Hematology Rapid Reporting System for Complete Blood Cell Count with Differential김지용, 박지영, 윤수영, 이정민대한진단검사의학회 · Laboratory Medicine Online2022 · 제12권 제1호Reliable, Accurate Determination of the Leukocyte Differential of Leukopenic Samples by Using Hematoflow Method고광상, 김수화, 김용구, 박연준, 박종문, 심양보, 임지향, 조용준, 한경자대한진단검사의학회 · Annals of Laboratory Medicine2011 · 제31권 제3호Performance Evaluation of the Mindray BC-6200 Hematology Analyzer; Comparison with Sysmex XE-2100 and Manual Microscopy김한아, 박미경, 이창훈, 이태환, 허미나대한진단검사의학회 · Laboratory Medicine Online2022 · 제12권 제4호자동혈구분석기 Sysmex XN-2000의 성능 및 Low WBC Mode를 이용한 백혈구 감별계산 정확성 평가김혜란, 송새암, 신정환, 오승환, 이자영, 이정녀, 전경란대한진단검사의학회 · Laboratory Medicine Online2015 · 제5권 제4호

이 간행물의 다른 논문 (17건)