Abstract: Objective To try to use fetal calf serum (FCS) to prepare hepatitis B virus (HBV) marker external quality assessment material instead of human serum. Methods FCS was used as matrix, and human serum high-level HBV marker external quality assessment material was diluted. The matrix efficiency, interchangeability, homogeneity, stability and clinical application significance were evaluated. Resutls For the interchangeability of the 2 determination methods, the results were within 95% confidence interval, and the correlation was good. F values were all <cut-off value of F (3.02) by Abbott i1000 for 5 HBV parameters [hepatitis B surface antigen (HBsAg), anti-hepatitis B surface antigen antibody (HBsAb), hepatitis B e antigen (HBeAg), anti-hepatitis B e antigen antibody (HBeAb) and anti-hepatitis B core antigen antibody (HBcAb)]. The stability was good above 1 month when storing under -20℃ and 4 ℃. The coefficients of variation (CV) for HBsAg, HBsAb, HBeAg, HBeAb and HBcAb were 7.60%, 7.79%, 6.37%, 13.30% and 3.61% by 20 laboratories using Abbott i2000, and were 11.67%, 14.72%, 9.11%, 12.30% and 9.75% by 20 laboratories using KHB reagents. Conclusions When using FCS as matrix, the interchangeability, homogeneity and stability meet the requirements of external quality assessment, and FCS can be used as matrix for the preparation of HBV marker external quality assessment material primarily.

Key words: Hepatitis B virus, Marker, External quality assessment material, Animal serum, Matrix efficiency, Homogeneity and stability