Abstract:

Objective To compare the performance of peripheral blood lymphocyte subset determination by flow cytometry with domestic 6-color flow cytometry reagents（referred to as domestic reagents） and imported 6-color flow cytometry reagents（referred to as imported reagents）. Methods The whole blood samples from 200 patients from 3 clinical laboratories in different areas were determined by domestic reagents and imported reagents on the same flow cytometer to analyze the percentages and the absolute values of lymphocyte subsets（CD3⁺,CD4⁺,CD8⁺,CD19⁺,CD3^-CD16⁺CD56⁺ cell）. The staining indexes（SI） of lymphocyte subsets were calculated,and the deviation of the 2 reagents was evaluated. Results Compared with imported reagents,the percentages of CD3⁺ cells,CD8⁺ cells,CD19⁺ cells and the absolute values of CD3⁺ cells,CD19⁺ cells in domestic reagents had statistical significance（P<0.05）. The average deviations of the percentages and the absolute values of CD3⁺ cells,CD4⁺ cells,CD8⁺ cells,CD19⁺ cells and CD3^-CD16⁺CD56⁺ cells determined by the 2 reagents were <5%. The intraclass correlation coefficient（ICC） of the consistency was >0.95 for all the items（P<0.001）. The results of Spearman correlation analysis showed that the determination results of lymphocyte subsets of domestic reagents and imported reagents had a good correlation（r>0.9,P=0.000）. Conclusions Although the results of lymphocyte subsets with domestic reagents and imported reagents are somewhat different,the correlation and consistency are good. Each clinical laboratory can choose the appropriate antibody reagent according to its own needs.

Key words: Lymphocyte subset, Flow cytometry, Correlation, Consistency