Detection of antibodies against pre-S1 proteins in sera of patients with hepatitis B virus infection by ELISA using a pre-S fusion protein expressed in E. coli.

To evaluate the importance of antibodies directed against pre-S1 proteins (anti-pre-S1) of hepatitis B virus (HBV) in human sera, an enzyme-linked immunosorbent assay (ELISA) for their detection in human sera was established, using a bacterially synthesized pre-S1 fusion protein. Using this ELISA, it was found that anti-pre-S1 was present in sera from 10 of 11 patients with acute HBV infection who recovered completely, but only present in 1 of 8 patients where the infection was prolonged. In chronic HBV carriers anti-pre-S1 was present in only 3 out of 8 patients and titers were low. In addition, in 5 out of 17 individuals who had recovered from previous HBV infection, anti-pre-S1 was also detected. Individuals immunized with recombinant HBsAg-vaccine and healthy controls were all negative for anti-pre-S1. It is suggested that presence of anti-pre-S1 in sera of patients with acute HBV infection correlates with rapid recovery.