External quality assurance scheme for Bordetella pertussis serology 2013

This report presents the results of an external quality assurance (EQA) scheme for Bordetella pertussis serology which was carried out during the summer of 2013. The aim of the EQA was to assess the ability of national reference laboratories from EU/EEA Member States to correctly perform laboratory serodiagnostic tests for pertussis and to identify any laboratories producing results which differed significantly from the values obtained by the majority of participants. Furthermore, the results of the EQA should enable a set of recommendations to be drawn up to improve methodologies and identify areas for training.
 
A panel of five freeze-dried sera containing different concentrations of anti-PT IgG was prepared with concentrations ranging from undetectable to clinically associated with infection. The panel was blinded and sent to participants who used their own routine diagnostic ELISA assays to determine the anti-PT IgG concentrations. Raw data were then returned for analysis. Twenty-one laboratories from twenty countries agreed to take part in the study and a total of 76 data sets were collected. The results for the data sets indicated that the assays carried out by most of the participants were accurate.