Analytical performance evaluation of Hematology analyzers using Sigma metrics

Abstract

Abstract Introduction: In clinical laboratory, the performance of the hematology analyzers should be checked routinely to ensure that the desired quality is achieved. Therefore, the aim of the study was to assess the performance of hematology analyzers using sigma metrics. Method The study included all daily internal quality control data of hematology analyzer prospectively from August to October 2022. Data was collected by trained laboratory professionals using record formats. The sigma values of each CBC parameter were calculated using the formula: Sigma = (TEa – Bias) / CV. The data of TEa were adopted from five different guidelines. The bias of all complete blood count parameters was calculated from the laboratory mean of the daily IQC data and the target value of the manufacturer in the insert kit. A coefficient of variation was also calculated using IQC data. Results The current study found an inconsistent sigma value, based on sources TEa. Except HCT out 5 parameters included based on CLIA guideline, except MCV, MCHC, RDW, MPV and Basophil out of 15 parameters included based on EFLM 2022 minimum guideline, except Hb and PLT out of 9 parameters included based on SOTA guideline other parameters meets minimum specification. On the other hand, all parameters included in Rilibak and Standards of Spanish guideline achieved minimum specification. Conclusion Sigma values of the CBC parameters have significantly varied depends on the TEa sources. So, the source of TEa needs harmonization. Additionally, suggested that the laboratory to optimize local Westgard rules for each parameter.