Performance Evaluation of the Mindray BC 6800 Hematology Analyzer and Flag Comparison with the XE-2100 and Manual Microscopy.

Abstract

The Mindray BC-6800 automated hematology analyzer is an automated hematology analyzer and 5-part leukocyte differential counter for in vitro diagnostic use in clinical laboratories. It is necessary to undergo an evaluation before the instrument is used to test patient samples. The performance was evaluated with regards to precision, linearity, carry-over, and method comparison. The flag performances were evaluated and compared with the Sysmex XE-2100 hematology analyzer and manual microscope in the hematology laboratory of a tertiary hospital in China. There was minimal carryover (< 0.05%) and excellent linearity for white blood cells and platelet (PLT) counts (r > 0.999). The BC-6800 displayed very good correlation (r > 0.97) with the XE-2100 for blood cell count and cell differential parameters. In a comparison of 295 leukocyte differential count results analyzed in parallel with manual microscopy, the main flags (immature granulocytes, blasts, abnormal lymphocytes) showed approxi-mately the same sensitivity and specificity on both analyzers (sensitivity > 90%, specificity > 78%). The BC-6800 showed excellent performance and supplied confidence in flag information for abnormal samples in the routine hematology laboratory.