Diagnostic performance of commercial serological assays measuring Bordetella pertussis IgG antibodies

Giorgio Fedele, Pasqualina Leone, Stefania Bellino, Ilaria Schiavoni, Claudia Pavia, Tiziana Lazzarotto, Paola Stefanelli

Research output: Contribution to journalArticlepeer-review


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 cutoff of either ≥125 IU/mL anti-PT IgG or ≥62 IU/mL anti-PT IgG for the in-house ELISA and accordingly to package inserts for commercial assays. Using the in-house ELISA at a 62 IU/mL cutoff, as the gold standard for interpretation of results from the commercial kits, resulted in lower sensitivity and higher specificity as compared to 125 IU/mL, thus, it may be especially useful in outbreak situations when high specificity is required.

Original languageEnglish
Pages (from-to)157-162
Number of pages6
JournalDiagnostic Microbiology and Infectious Disease
Issue number3
Publication statusPublished - Mar 1 2018


  • B. pertussis
  • Diagnosis
  • IgG
  • Serology

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases


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