Objectives: (a) To develop, standardize, and evaluate sensitive and specific assays for antibodies to Bordetella pertussis antigens. (b) To serve as a refer-ence laboratory for pertussis serology by writing reference methods, procuring reference reagents, training visiting personnel, and performing comparative testing with outside laboratories. For all assays listed below, protocols have been distributed, visitors were trained, and comparative testing with outside laboratories has been performed. (1) Assays for which standardized protocols and reference reagents are available are the microagglutination assay, the CHO--cell pertussis toxin neutralization assay, and ELISA assays for IgG antibodies to pertussis toxin and filamentous hemagglutinin. Protocols and reagents have been distributed to more than 20 laboratories. The Laboratory continued to evaluate capsulation programs for ELISA. (2) Quality Control: Laboratory continues its ongoing program to assess the intra- and inter-assay reproducibility of serologic assays and to receive and qualify new reagents. Assisted Stockholm laboratory in testing and validating the anti-human IgG conjugate that will be used in the acellular pertussis vaccine efficacy trial in Sweden. (3) Assessment of inter-laboratory reproducibility: Laboratory has demonstrated inter-laboratory reproducibility of testing methods by performing collaborative studies with testing laboratories at Universities, manufacturers and national control agencies. Problems with demonstrating inter-laboratory reproducibility of the anti-pertactin ELISA has led to a multi-laboratory collaborations. (4) Development of new assays: (a) continued work to develop new ELISA-based assays usin capture systems and polyclonal and monoclonal antibodies. (b) Methods are being established to measure the opsonic potential of specific antibodies and to assess the effect of opsmins on phagocyte bactercidal activity.
