Performance evaluation of leukocyte differential on the hematology analyzer Celltac G compared with two hematology analyzers, reference flow cytometry method, and two manual methods

J Clin Lab Anal. 2021 Aug;35(8):e23827. doi: 10.1002/jcla.23827. Epub 2021 Jun 12.

Abstract

Background: The automated hematology analyzer Celltac G (Nihon Kohden) was designed to improve leukocyte differential performance. Comparison with analyzers using different leukocyte detection principles and differential leukocyte count on wedge film (Wedge-Diff) shows its clinical utility, and comparison with immunophenotypic leukocyte differential reference method (FCM-Ref) shows its accuracy performance.

Methods: For method comparison, 598 clinical samples and 46 healthy volunteer samples were selected. The two comparative hematology analyzers (CAAs) used were XN-9000 (Sysmex) and CELL-DYN Sapphire (Abbott). The FCM-Ref provided by the Japanese Society for Laboratory Hematology was selected, and a flow cytometer Navios (Beckman-Coulter) was used. In manual differential, two kinds of automated slide makers were used: SP-10 (Sysmex) for wedge technique and SPINNER-2000 (Lion-Power) for spinner technique. The spinner technique avoids the issue of Wedge-Diff smudge cells by removing the risk of breaking cells and non-uniformity of blood cell distribution on films (Spinner-Diff).

Results: The Celltac G showed sufficient comparability (r = 0.67-1.00) with the CAAs for each leukocyte differential counting value at 0.00-40.87(109 /L), and sufficient comparability (r = 0.73-0.97) with FCM-Ref for each leukocyte differential percentage at 0.4-78.5. The identification ratio of the FCM-Ref in CD45-positive cells was 99.7% (99.4% to 99.8%). Differences were found between FCM-Ref/Celltac G/XN-9000/Spinner-Diff and Wedge-Diff for monocytes and neutrophils. The appearance ratio of smudge cells on wedge and spinner film was 12.5% and 0.5%.

Conclusion: The Celltac G hematology analyzer's leukocyte differential showed adequate accuracy compared with the CAAs, FCM-Ref, and two manual methods and was considered suitable for clinical use.

Keywords: Celltac G; accuracy; hematology analyzer; leukocyte differential counting; smudge cell.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Antigens, CD
  • Flow Cytometry / instrumentation
  • Flow Cytometry / methods
  • Hematologic Tests / instrumentation*
  • Hematologic Tests / methods*
  • Humans
  • Leukocytes* / metabolism
  • Monocytes

Substances

  • Antigens, CD