Performance evaluation of the prototype Abbott Alinity hq?hematology analyzer

摘要

Abstract Introduction The analytical and clinical performance as well as the workflow efficiency of the novel, prototype Alinity hq hematology analyzer was evaluated in the clinical laboratory of Universitair Ziekenhuis Brussel, Department of Hematology, Brussels, Belgium. Methods Within‐run and within‐laboratory imprecision, linearity, and carryover were assessed using clinical blood samples and commercial blood products. Four hundred and seventeen samples were selected for method comparison with Abbott CELL‐DYN Sapphire, and for flagging performance analysis in comparison with smear review and manual microscopic white blood cell (WBC) differential. Results Within‐run and within‐laboratory imprecision verification demonstrated low %CV for complete blood count and WBC differential results within the normal ranges (0.1%‐10.4%), except for basophil granulocytes. The linearity of the analytical measuring ranges was verified for WBCs, red blood cells, hemoglobin, and platelets. Alinity hq results showed strong agreement with those of CELL‐DYN Sapphire. Good correlation was demonstrated with manual WBC differential results, with negative bias for neutrophil (NEU) granulocytes, and positive bias for lymphocytes and monocytes. Blasts were detected with 75% sensitivity and 96% specificity at 1% blast threshold, and 100% sensitivity at 5% blast threshold. Immature granulocyte detection was more sensitive (81% vs 76%, P ?=?0.086) and specific (88% vs 78%, P ?=?0.0002) than with CELL‐DYN Sapphire. Nucleated red blood cell detection was more sensitive (89% vs 63%, P ??0.001) and just slightly less specific (96% vs 99%, P ?=?0.0067) than with CELL‐DYN Sapphire. Re‐run and reflex testing rates were lower with Alinity hq. Conclusion The Alinity hq hematology analyzer is suitable for clinical use.