Development of HBsAg Colloidal Gold Strip

Objective To develop the HBsAg colloidal gold strip.Methods Anti-HBs monoclonal antibodies were obtained through immunizatgion of BALB/c mice with the plasma derived hepatitis B vaccine,and then purified,and labeled with the colloidal gold.The stability and clinical evaluation,as well as quality control of the HBsAg colloidal gold strip were conducted.The strip was evaluated and approved by the State Drug Administration,China.Conclusion The HBsAg colloidal gold strip can be used for HBsAg screening of blood donors and general populations,and for epidemiological studies and diagnosis of hepatitis B virus infection.