Abstract: Objective　To evaluate primarily the detection of pepsinogen Ⅱ （PGⅡ） by latexenhanced immunoturbidimetry assay, and provide the reference for clinical application. Methods　According to the National Committee for Clinical Laboratory Standards (NCCLS) EP5A and EP10A2 documents, the detection of PGⅡ by latexenhanced immunoturbidimetry assay was evaluated primarily. Results　The withinrun, betweenrun，betweenday and total coefficients of variation （CV） of samples with low concentration of PGⅡ were 2.05%，1.60%，3.92% and 4.70% respectively. The withinrun, betweenrun，betweenday and total CV of samples with high concentration of PGⅡ were 1.70%，1.21%，3.79% and 4.32% respectively.When PGⅡ concentrations were 9.6， 24.7 and 39.8 μg/L，the relative biases were -0.18，-0.47 and -0.39 μg/L respectively. The total imprecisions were 4.98%， 2.39% and 2.71% respectively. There was no statistical significance in total carryover （P>0.05）. The equation of linear regression of PGⅡ was Y =0.975 7X －0.016 8，and the coefficient of determination(R2)= 0.998 7. Conclusions　The latexenhanced immunoturbidimetry assay for the PGⅡ detection with good repeatability meets the clinical application requirements of EP5A document for precision and the requirements of EP10A2 document for the linearity， bias， total imprecision and carryover. It is suitable for the clinical application.

Key words: Pepsinogen Ⅱ, Latexenhanced immunoturbidimetry assay, EP5-A document, EP10-A2 document, Methodology evaluation