Performance Analysis of the Beckman Coulter GEN-S Automated Hematology Analyzer

Song, Sean Mi; Lee, Seong Kyu; Park, Qu Ehn; Kim, Sun Hee; Oh, Won IL

Abstract

BACKGROUND: The complete blood cell count (CBC) and leukocyte differential counts are useful tools for making a diagnosis, treating and monitoring a disease. This study evaluated the perfor-mance of Beckman-Coulter's new model, the Coulter GEN-S system (Beckman Coulter Corpora-tion, Miami, USA; GEN-S), and compared it with the Sysmex NE-8000 (Sysmex Corporation, Kobe, Japan; NE-8000) and Sysmex R-3000 (Sysmex Corporation, Kobe, Japan; R-3000).
METHODS
One hundred and four blood samples and 120 blood samples were randomly chosen for a comparison analysis from various in-patients and healthy persons, who visited Samsung med-ical center, respectively. The GEN-S system was evaluated according to the linearity and how well it compared with the NE-8000 in terms of the CBC, and the efficiency of the leukocyte suspect flags.
RESULTS
The GEN-S showed that the determination coefficients (R(2)) of the WBC, RBC, platelet count and hemoglobin level were more than 0.94 (P < 0.05) and the correlation coefficients (r) of the WBC, RBC, platelet count, reticulocyte count, hemoglobin and MCV were > 0.95 (P < 0.001) when compared with the NE-8000. In addition, the correlations of the leukocyte differential counts for neutrophils, eosinophils, and lymphocytes were good, but those for monocytes and basophils were poor. The sensitivity, specificity and positive predictive value of the leukocyte suspect flags of the GEN-S system were 89%, 73%, and 43%, respectively.
CONCLUSIONS
These results demonstrate the comparable performance of the GEN-S system in clinical laboratories. However, a separate microscopic differential count is required due to the low positive predictive value for the leukocyte suspect flags.