Performance Validation and Evaluation of the Mindray BC-7900 Automated Hematology Analyzer.

BACKGROUND

The performance of the Mindray BC-7900 automated hematology analyzer was evaluated to deter-mine whether the instrument fulfills clinical requirements.

METHODS

The BC-7900 hematology analyzer was evaluated based on the background count, carryover rate, precision, linear range, sample stability, comparability of results from different sample aspiration modes, comparability of results between instruments, erythrocyte sedimentation rate (ESR) for small blood volumes, and its ability to flag for abnormal leukocytes.

RESULTS

The background count was consistently 0, and the maximum carryover rate was 0.54%. The coefficients of variation for the repeatability and the within-laboratory precision were within the allowable ranges. Verification of the linear range yielded r2 ≥ 0.994. The sample stability met the deviation requirements at both ambient and cryogenic temperatures. The results obtained from the two sample aspiration modes were comparable. The routine blood parameter values were highly correlated with those obtained using the BC-6800Plus analyzer. Specifically, the correlation coefficients for white blood cell count (WBC), neutrophil percentage (Neu%), lymphocyte percentage (Lym%), nucleated red blood cell percentage (NRBC%), RBC, hemoglobin (HGB), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and impedance (PLT-I) and hybrid platelet counts (PLT-H) were all greater than 0.99. The correlation coefficients for monocyte percentage (Mon%), eosinophil percentage (Eos%), and basophil percentage (Baso%) were all greater than 0.91, while the coefficient for the mean corpuscular hemoglobin concentration (MCHC) was greater than 0.89. Compared with the Westergren method, the results of ESR for both standard and trace blood sample volumes were well correlated, with correlation coefficients of 0.943 and 0.952, respectively. Additionally, the analyzer demonstrated excellent sensitivity and specificity for flagging for immature granulocytes (95.4% and 93.8%, respectively) and abnormal lymphocytes (86.9% and 90.7%). Finally, the hematological malignant cell (HMC) channel showed high sensitivity (98.4%) and moderate specificity for detecting blasts (including abnormal promyelocytes).

CONCLUSIONS

The BC-7900 automated hematology analyzer demonstrated strong performance, providing accurate and reliable results that meet clinical application requirements. This instrument provides excellent ESR detection methods for trace and standard blood sample volumes and an effective method for flagging blast cells.