Objective: To develop a time-resolved fluoroimmunoassay (TRFIA) for detection of pertussis toxin (PT) S1 subunit for quality control of human PT vaccine.
Methods: A double antibody sandwich one-step method was used to establish the TRFIA for detecting PT S1 subunit in the vaccine.
Results: The sensitivity of c peptide analysis reached 2.5 ng/ml without cross-reactions with other antigens. This assay could be used in detecting S1 subunit in the vaccine.
Conclusion: The TRFIA for detecting PT S1 subunit is simple, sensitive and rapid for quality control of the PT vaccine.