Development and Implementation of a Single Radial Diffusion Technique for Quality Control of Acellular Pertussis Vaccines.

Background/objectives: An assay for protein content is essential but insufficient for quality control of acellular pertussis vaccines, which might consist of up to five components, each needing individual quantification. Generally, purified pertussis antigens such as pertussis toxin (PTx), filamentous haemagglutinin (FHA), and pertactin (PRN) should be detoxified or stabilized chemically before being formulated into vaccine bulk. The use of chemical agents like formaldehyde and glutaraldehyde can alter the immunological reactivity of these antigens, rendering direct assays by methods such as ELISA ineffective.