Performance evaluation of the Sysmex® XP-300 in an oncology setting: evaluation and comparison of hematological parameters with the Sysmex® XN-3000

Summary Introduction The Sysmex XP‐300® (XP‐300) is a new, fully automated hematology analyzer, designed to generate complete blood counts (CBC) with 3‐part differential. In our study, the XP‐300 was evaluated as a point‐of‐care (POC) analyzer in an oncology setting. In which blood samples from patients with different pathologies and treatments, affecting hematopoiesis, were analyzed. Methods Performance was evaluated according to the International Council for Standardization in Haematology (ICSH) guidelines and CLSI protocol H20‐A2 . Beside precision, linearity and carry‐over, a comparison study with the Sysmex® XN‐3000 (XN‐3000) and a manual reference leukocyte differential was performed. Flagging performance was also evaluated. Results XP‐300 showed excellent precision and linearity results. For within‐ and between‐run precision, the criteria, according to Ricos et al. , were met for all parameters tested, except for platelets in the low level. Less than or equal to 0.5% carry‐over was seen for all parameters tested. Comparison studies showed an acceptable correlation with both XN‐3000 and the manual reference leukocyte count. A suboptimal flagging performance was demonstrated. Conclusion In the context of diagnosing cytopenia due to myelosuppressing agents or leukocytosis due to infection, the XP‐300 showed good analytical performance. However, in the thrombocytopenic range, precision was suboptimal. In follow‐up of hematological malignancies with the occurrence of abnormal cells, we advise verification with a more advanced analyzer or with microscopic review, although further studies with a higher prevalence of abnormal cells are needed.