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

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(10(9)/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.