Why carry out this study?

Commercially available enzyme immunoassay diagnostic kits are not validated for the evaluation of antibody responses to whole-cell pertussis vaccines in clinical trials.

We developed and validated a new multiplexed electrochemiluminescence-based assay for the detection of human IgG antibodies against four specific Bordetella pertussis antigens.

We used clinical trial sera and international standards to compare the performance of the new electrochemiluminescence assay to two commercially available Bordetella pertussis enzyme immunoassay kits and to historical in-house single-antigen enzyme-linked immunosorbent assays.

What was learned from this study?

The new electrochemiluminescence assay was validated in terms of precision, accuracy, dilutability, lower limit of quantification, and specificity.

The accuracy and linearity of the observed versus the expected response were better for the new electrochemiluminescence assay than the comparator kits.

The new electrochemiluminescence assay allows more precise, accurate, and specific analysis of antibodies to Bordetella pertussis antigens in clinical trials.