Performance evaluation of the new Sysmex XR-Series haematology analyser

Pract Lab Med. 2024 Feb 15:39:e00370. doi: 10.1016/j.plabm.2024.e00370. eCollection 2024 Mar.

Abstract

Background: The new XR-Series haematology analyser from Sysmex provides increased throughput and automation, along with a new reagent in WDF channel for optimised WBC differential.

Methods: An analytical performance study for the XR analyser was conducted to evaluate the WDF channel parameters in comparison to the instrument specifications. Additionally, 7460 samples were measured on XR and XN analysers to compare selected parameters and flags, and 930 randomly selected samples were further evaluated with microscopy.

Results: All investigated aspects of the analytical performance study for the XR fell within the manufacturer specifications. The correlation coefficients between the two systems for the parameters tested were greater than 0.983 for the main CBC and DIFF parameters, greater than 0.909 for the Extended Inflammation Parameters, and greater than 0.932 for the parameters used in the workflow rulesets of the Extended IPU. Similarly high sensitivities for the detection of abnormal cells were observed for the 'Blasts/Abn Lympho?' flag (XN: 100%, XR: 99.0%) and WPC abnormal flags ('Blasts?' or 'Abn Lympho?') (XN: 97.0%, XR: 96.0%). XN with WPC channel had a 26% reduction of false positive smears compared to XR with 22% reduction, a statistically non-significant difference.

Conclusion: The XR analyser had very good analytical performance, and highly comparable results to the predecessor XN analyser in all investigated parameters, flags and workflow aspects.

Keywords: Analytical performance; Flagging performance; Method comparison; Sysmex XN-Series; Sysmex XR-Series; Whole blood analysis.