Analytical performance of the digital morphology analyzer Sysmex DI-60 for body fluid cell differential counts.

Abstract

Sysmex DI-60 (Sysmex, Kobe, Japan) is a digital morphology (DM) analyzer widely used in clinical laboratories and supports body fluid (BF) applications. We evaluated analytical performance of DI-60 compared with XN-350 (Sysmex) and manual counting for BF cell differential counts. A total of 213 BF samples were collected (47 cerebrospinal fluid [CSF], 80 pleural fluid, and 86 ascites samples). The analytical performance of DI-60 for BF cell differential counts was evaluated based on sensitivity, specificity, accuracy, and agreement. BF cell differential counts obtained by DI-60 were compared with those obtained by XN-350 and manual counting. The overall sensitivity was high for neutrophils, lymphocytes, and macrophages (range, 83.1-99.4%). The overall specificity and overall accuracy were high for all cell types (range, 95.3-99.7% and 94.3-99.3%, respectively). The agreement between DI-60 pre-classification and verification was strong (κ = 0.89). The absolute mean differences between DI-60 verification and XN-350 ranged from 0.26 to 11.05, and differences between DI-60 verification and manual counting ranged from 0.01 to 4.76. This is the first study to evaluate the performance of DI-60 compared with XN-350 and manual counting for BF cell differential counts. DI-60 showed reliable performance with CSF, pleural fluid, and ascites samples. For BF cell differential counts, DI-60 may be a better option than XN-350 and could be used for screening purposes in understaffed laboratories. To improve the hematology workflow for BF cell differential counting, the DM analyzer needs to be optimized by taking into account the laboratory situation and unmet needs, and the clinical laboratory needs to establish criteria for verification and manual slide review.