Reference Intervals in Malaysia: A Performance Evaluation and Comparison of Haematological Parameters between Sysmex Xe-5000 and Xn-3000

Abstract

The Sysmex XN-3000 is a new automated haematology analyser designed to improve the accuracy of cell counts and the specificity of the flagging events of unusual parameters. By comparing the previous full blood count (FBC) reference intervals in Malaysia for Sysmex XE5000, we determined a reference interval for all parameters measured by the Sysmex XN-3000 for the Malaysian population. Through the voluntary recruitment of 397 adults ages 18-45 years, both genders, and the three main ethnic groups, FBC was performed on the two analysers. Qualified healthy participants were screened using a health questionnaire. This was followed by reference intervals, probability distribution measurements, and dispersion with point estimate determination. Complete data were available in 390 subjects comprising 222 females and 168 males, which were included in the reference interval calculation. Parameters such as haemoglobin, red blood cell count, platelet count including immature platelet fraction (IPF) showed significant differences in Malaysians. XN-3000 showed excellent precision and linearity results. Withinand between-run precisions were met for all parameters tested, except for IPF. For all parameters tested, ≤ 0.5% carry-over was seen. An acceptable correlation with both XN-3000 and XE-5000 was achieved in comparison studies performed. XN-3000 showed good analytical performance and could provide a solution for laboratories with medium-to-high workloads and evolving clinical needs. Local guidelines are required for the establishment of reference intervals.