Diagnostic performance of commercial serological assays measuring Bordetella pertussis IgG antibodies

Publication date: Available online 13 November 2017
Source:Diagnostic Microbiology and Infectious Disease
Author(s): Giorgio Fedele, Pasqualina Leone, Stefania Bellino, Ilaria Schiavoni, Claudia Pavia, Tiziana Lazzarotto, Paola Stefanelli
Due to their specificity to B. pertussis antigens, immunoglobulin G (IgG) antibodies should be measured primarily for diagnosing pertussis. We compared the diagnostic performance of commercially available enzyme-linked immunosorbent assays (ELISAs) and chemiluminescent immunoassays (CLIAs) measuring IgG to B. pertussis antigens. An in-house ELISA with purified pertussis toxin (PT) was used as reference system. Commercial assays using PT only as coating antigen showed better performance as compared to those using a mixture of different antigens. The best diagnostic performances were achieved by CLIAs. Results were analyzed using a dual cut-off of either ≥125IU/ml anti-PT IgG or ≥62IU/ml anti-PT IgG for the in-house ELISA and accordingly to package inserts for commercial assays. Using the in-house ELISA at a 62IU/ml cut-off, as the gold standard for interpretation of results from the commercial kits, resulted in lower sensitivity and higher specificity as compared to 125IU/ml value, thus it may be especially useful in outbreak situations when high specificity is required.



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