A retrospective evaluation of the EuroImmun Bordetella pertussis toxin ELISAs. (#68)
In Australia, pertussis whole cell IgA
has traditionally been used extensively for a single sample serological
diagnosis of pertussis. Due to specificity issues regarding whole cell and
filamentous haemagglutinin assays, the Public Health Laboratory Network suggests
that it is likely that pertussis toxin IgG assays will become the test of
choice for the serological diagnosis of pertussis. However, the actual cut-offs
are far from clear. The Virology Department at SA Pathology utilises real-time
PCR to detect IS481 for the molecular diagnosis of Bordetella pertussis. A retrospective data extract and sample
search resulted in 441 serum samples, collected from 372 IS481 PCR positive
patients, being analysed using the EuroImmun anti-pertussis toxin IgG, IgA and
IgM ELISAs. The serology sample collection dates ranged from up to 558 days
prior to and 525 days after the positive PCR result. In addition, 245 “pertussis
negative” samples, were also analysed. Both the pertussis toxin IgM and IgA assays
were deemed to be highly specific yet both exhibited poor sensitivity.
Therefore the pertussis toxin IgG assay was determined to be the most suitable
assay for the serological diagnosis of pertussis. Furthermore, for the IgG
assay, a dual cut-off of 40 IU/mL and 100 IU/ml was deemed to be the most
sensible approach to result interpretation.