Abstract:

Objective To verify the performance of automated hematology analyzers in clinical laboratories, and provide the reference for choosing the referred analyzer of a clinical laboratory. Methods A total of 15 fresh whole blood specimens assigned values and being provided by the National Center for Clinical Laboratory were used to evaluate trueness, 3 levels of quality control materials were used to evaluate intra-day and inter-day precisions, 5 dilutions were assayed to verify linearity, and the score of each analyzer was adopted to determine the referred analyzer. Results Correalation coefficient R values of white blood cell (WBC), red blood cell (RBC), hemoglobin (Hb), hematocrit (HCT) and platelet(PLT) of each analyzer were 0.953-0.998. However,R values of RBC mean corpuscular volume (MCV) of each analyzer were 0.751-0.821. Except PLT of XE-2100,the other parameters of each analyzer showed that the 95% confidence intervals of slope included the value 1, and the 95% confidence intervals of Y-intercepts included the value 0. Except PLT inter-day precision of BC-5800, the intra-day and inter-day precisions of the other analyzers were complied with the specification of each analyzer. Analytical measuring intervals of WBC and PLT of LH750 and BC-5800 were wider than those of XE-2100. Sorted from high to low,the rates of general performance of each analyzer were LH750,BC-5800 and XE-2100 in sequence. Conclusions The performance verification of XE-2100, LH750 and BC-5800 shows roughly satisfactory results. Meanwhile,LH750 is the most qualified as the referred hematology analyzer in the clinical laboratory.

Key words: Performance verification, Hematology analyzer, Trueness, Precision, Linearity