Evaluation of the performance of sysmex XN-3100 automated hematology analyzer regarding the sysmex XE-2100 and microscopic examination

Özet

Objectives: We performed a verification study of the Sys mex XN-3100 hematology analyzer in comparison with the XE-2100 according to the guidelines of the Clinical and Laboratory Standards Institute (CLSI) and the International Council for Standardization in Hematology (ICSH). Materials and methods: Blood samples and quality con trol materials were used for precision. For comparison, we used the current XE-2100 as the comparative method and analyzed 540 blood samples. The Passing-Bablok and Bland-Altman tests were performed according to the CLSI EP09-A3 and a carryover study was performed according to the CLSI H26-A2 guidelines. The flagging performance of the two analyzers was compared, using two experienced laboratory technicians as the reference method. Results: The Sysmex XN-3100 demonstrated high levels of precision for most parameters. For the comparison anal ysis, all parameters, except for MCHC, monocytes and ba sophils were within the systematic error limits of desirable biological variability criterion (SeDBV). The carryover was less than 0.4% for all parameters. The flagging perfor mance of the XN-3100 was satisfactory and the overall efficiency was high. Conclusions: The XN-3100 not only showed a strong correlation and agreement with the XE-2100 but also dis played a comparable analytical sensitivity, and increased specificity, which may result in an improved turnaround time and throughpu.