Abstract
Abstract Objectives We performed a verification study of the Sysmex 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 control 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 analysis, all parameters, except for MCHC, monocytes and basophils were within the systematic error limits of desirable biological variability criterion (SeDBV). The carryover was less than 0.4% for all parameters. The flagging performance 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 displayed a comparable analytical sensitivity, and increased specificity, which may result in an improved turnaround time and throughpu.
Highlights
Automated hematology analyzers (AHA) are used to perform complete blood counts (CBC) and to identify blood cells and their characteristics
We performed a verification study of the Sysmex 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)
All parameters, except for mean corpuscular hemoglobin concentration (MCHC), monocytes and basophils were within the systematic error limits of desirable biological variability criterion (SeDBV)
Summary
Automated hematology analyzers (AHA) are used to perform complete blood counts (CBC) and to identify blood cells and their characteristics. The CBC covers all parameters with regard to blood cells, including white blood cell (WBC), red blood cell (RBC), hemoglobin (HGB), hematocrit (HCT), mean cell volume (MCV), mean corpuscular hemoglobin concentration (MCHC), platelet (PLT), mean corpuscular hemoglobin (MCH), erythroblast (NRBC), reticulocyte (RET) and differential leukocyte counts [neutrophil (NEU%), lymphocyte (LYMP%), monocyte (MONO%), eosinophil (EO%), basophil (BASO%) and immature granulocyte (IG%)] [1]. The ISO 15189 [6] recommends a verification process for clinical laboratories prior to installation. These guidelines define neither the limits of acceptability for diverse parameters nor a minimal range interval for the reliability of parameters.
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