Abstract:

Objective To know the comparability and consistency of whole blood cell count determination in Shanghai. Methods Various clinical laboratories in Shanghai were enrolled. For the comparability and consistency of whole blood cell count determination,their coefficients of variation（CV）and the difference among different instruments were evaluated. Results A total of 612 clinical laboratories finished the determinations and uploaded their results,and there involves 12 brands and 56 types of hematology analyzers. For 2 batches of investigation products,the CV of white blood cell（WBC） count were 3.34% and 3.56%,those of red blood cell（RBC） count were 1.46% and 1.50%,those of hemoglobin（Hb） were 1.42% and 1.31%,those of hematocrit（HCT） were 2.89% and 2.79%,and those of platelet（PLT） count were 3.96% and 3.65%. The difference between the means （$\overline{x}$） of different instruments and total mean were 0.38%--2.25% and 0.00%--2.87% for WBC count,0.13%--3.47% and 0.05%-3.04% for RBC count,0.16%--1.48% and 0.16%--1.11% for Hb,0.16%--4.65% and 0.05%-4.10% for HCT,and 0.15%--5.43% and -0.27%-3.21% for PLT count. Conclusions The results of whole blood cell count determination has comparability and consistency. However,the difference still exists among different instruments.

Key words: Cell count, Whole blood, Comparability, Consistency