Background: Manual microscopic examination is the gold standard of humoral cell count test. However, it has some limitations and cannot fully meet clinical needs. Compared with the manual method, the automatic blood cell analyzer has the advantages of a high degree of automation, minimal error, high speed, high precision, and easy standardization. This study intends to verify the detection performance of the body fluid model of the Mindray BC-6000PLUS automatic hematology analyzer.
Methods: This study was performed in accordance with the International Committee for Standardization in Haematology (ICSH) Hematology Analyzer Evaluation Guide (version 2014) and the requirements of WS/T662-2020 "Clinical humoral examination technique". The humoral white blood cell-body fluid (WBC-BF), humoral red blood cell-body fluid (RBC-BF), monocyte (MN), polymorphonuclear (PMN) were measured to verify the performance indicators of the instrument, including background counting, intra-batch precision, accuracy, carrying contamination rate, and linear range. Referring to the WS/T514-2017 (Establishment and verification of detection capability for clinical laboratory measurement procedures), the limit of blank (LoB) and limit of detection (LoD) values of WBC-BF and RBC-BF in the humoral mode of the instrument were established.
Results: The blank count of WBC-BF and RBC-BF, and contamination of Mindray BC-6000PLUS analyzer were zero; the coefficient of variation (CV) of intra-batch precision at different levels of each item was less than 10%. There was a high correlation between instrument test results and manual microscopic examination results (r>0.95). The linear range of the instrument was wide, and the linear verification parameters was good (R2>0.999). The LoB value and LoD value of WBC-BF established by the instrument were 0×109/L and 0.004×109/L, respectively. The LoB value and LoD value of the RBC-BF established by the instrument were 0×1012/L and 0.004×1012/L, respectively. The lower detection limits of WBC-BF and RBC-BF were set as 0.004×109/L and 0.004×1012/L, respectively.
Conclusions: All performance indicators of the Mindray BC-6000PLUS automatic blood analyzer met the requirements of the manufacturer's criteria. This instrument can fulfill the requirement of body fluid sample routine test in clinical practice.
Keywords: WS/T662-2020; humoral mode; performance evaluation (PE).