Screening for malignant tumor cells in serous effusions with an automatic hematology analyzer using a novel diagnostic algorithm.

Abstract

BackgroundDue to the high false-positive rate of the high-fluorescence body fluid (HF-BF) cell parameter of the hematology analyzer in BF mode, a novel algorithm based on the Mindray BC-6800 Plus hematology analyzer (BC-6800Plus), with higher diagnostic accuracy compared to that of the traditional HF-BF algorithm, was used to screen for malignant tumor cells in clinical BF samples. In this study, the body fluid mode of BC-6800Plus was applied to investigate the ability of its available parameters and characteristic regional particles in tumor cells screening.MethodsA total of 220 BF samples (including pleural effusion and ascites) were randomly classified into a training cohort (154 samples) and a validation cohort (66 samples), and detected on the BC-6800Plus in BF mode. Based on the scatter plot analysis of the instrument, a novel gating algorithm, malignant cell algorithm-body fluid (MA-BF), was designed to detect the aggregated cells expressing highest fluorescence (FL) signals and side-scatter (SS) signals than other cells. BF collection and analyses were performed in compliance with the CLSI H56-A guideline. tumor cell-positive samples were defined as greater than or equal to confirIIIb (Papanicolaou class system) by the pathological examination. The diagnostic accuracy of HF-BF and MA-BF were determined by the receiver operating characteristic (ROC) curve analysis.ResultsWhen the cutoff values of the absolute count (HF-BF#) and relative count (HF-BF%) were set as 0.022×109/L and 3.0%, respectively, the area under curve (AUC), sensitivity, and specificity were 0.76, 0.85 and 0.55 for HF-BF#, and were 0.70, 0.85, and 0.49 for HF-BF%, respectively. The new parameters, the absolute tumor cell count (MA-BF#) and relative count (MA-BF%), were established in the training cohort using the novel algorithm. We confirmed the cutoff values of MA-HF# and MA-HF% in BF were set as 0.006×109/L and 0.2% in the training cohort, respectively. In the validation cohort, the AUC, sensitivity, and specificity were 0.89, 0.93, and 0.78 for MA-BF#, and were 0.89, 0.87 and 0.75 for MA-BF%, respectively.ConclusionsThe MA-BF parameters of the novel algorithm output had better diagnostic accuracy for BF tumor cells than the traditional HF-BF parameters.