Abstract:A novel cell analyzer and a component biochip, based on microfluidic technology and Coulter principle, was developed to count leukocyte cells for point-of-care testing. The microfluidic chip was composed of multi-layer structure, and the liquid flowed between the upper and lower layers of the chip, not in contact with the cell analyzer. The cell analyzer and chips were used to test standard particles and leukocyte cells to characterize the performance. The results showed that the variation coefficients of the standard particle counting results are 4.95%, 3.56% and 2.13% with different diameters, respectively. The total leukocyte count results by the microfluidic cell analyzer and hematology analyzer Sysmex XN20 were compared. The linear regression coefficient R2 is 0.999 7. Bland-Altman plots showed that more than 95% of points fluctuate within the 95% consistency bound. The expected bias percentages at the three medical decision levels of 3.00×109/L, 11.00×109/L and 30.00×109/L were 2.12%, 0.54%, and 0.17%, respectively. Thus, the cell analyzer has good repeatability for standard particle test, and the results of leukocyte test are comparable with those of XN20. It can be used to detect leukocyte in clinical blood sample, especially suitable for village clinics and other basic medical units.