Performance evaluation of new Abbott Alinity hq hematology analyzer

摘要

Abstract Introduction Abbott Alinity hq is a next‐generation automated hematology analyzer providing complete blood count (CBC) with 6‐part white blood cells (WBC) differential counts. The purpose of this study was to evaluate the performance of the analyzer to verify the diagnostic and clinical utility of the Abbott Alinity hq automated system. Methods We evaluated specimen stability, precision, linearity, carry‐over, and method comparison to assess the performance of Alinity hq. For comparison of the Alinity hq with Sysmex XN‐9000, totally 314 samples from adult and pediatric patients including both normal and abnormal hematology profiles were analyzed in parallel. The Alinity hq was also compared with the manual differential counts for the same 314 samples. Results At 4°C, the Alinity hq analyzer showed no significant changes in CBC and WBC differential count up to 48?hours. When stored at room temperature (18‐25°C), all parameters except the mean platelet volume (MPV) were stable up to 36?hours. The Abbott Alinity hq analyzer demonstrated excellent reproducibility and between‐batch precision for all CBC and WBC differential parameters. WBC, red blood cells (RBC), hemoglobin (HGB), and platelets showed good linearity and acceptable carry‐over. Comparison with a Sysmex XN‐9000 analyzer and manual 400‐cell differential showed excellent correlation for CBC and WBC differential count parameters (correlation coefficient?=?0.815‐0.999) except for mean corpuscular hemoglobin concentration (MCHC) and basophils. Conclusion We performed initial validation?studies and confirmed performance specifications on specimen stability, precision, linearity, carry‐over, and method comparison. The Abbott Alinity hq analyzer showed good analytical performance for all standard CBC parameters.