Evaluation of 3 analyte-specific reagents for detection of Bordetella pertussis and Bordetella parapertussis in clinical specimens

Diagn Microbiol Infect Dis. 2014 Nov;80(3):181-4. doi: 10.1016/j.diagmicrobio.2014.08.004. Epub 2014 Aug 29.


The performance of 3 analyte-specific reagents (ASRs), Elitech Biosciences, EraGen Biosciences, and Focus Diagnostic, was evaluated for detection of Bordetella pertussis (BP) and Bordetella parapertussis (BPP) in nasopharyngeal swab specimens. A total of 104 frozen, leftover clinical specimens obtained from pediatric patients during 2011-2012 were included in this study. Performance was compared to the Bordetella real-time polymerase chain reaction (PCR) laboratory-developed test (LDT). The positive percent agreement for detection of BP by Elitech was 96% (95% confidence interval [CI]: 85.14-99.30); EraGen and Focus was 98% (95% CI: 87.99-99.89) in comparison to LDT PCR assay. The negative percent agreement of Elitech, EraGen, and Focus in comparison to LDT was 96% (95% CI: 85.14-99.30), 92% (95% CI: 79.89-97.41), and 96% (95% CI: 85.14-99.30), respectively. Limit of detection (LOD) for BP was 0.1 CFU/reaction by both Focus and EraGen and 1.0 CFU/reaction by Elitech. However, LOD for BPP was lower by EraGen (0.1 CFU/reaction) compared to Focus (1.0 CFU/reaction) and Elitech (1.0 CFU/reaction). These results demonstrate that all 3 ASRs tested are comparable and reliable for routine clinical diagnosis of pertussis and parapertussis.

Keywords: Analyte specific reagents; Bordetella parapertussis; Bordetella pertussis; Real time-PCR.

Publication types

  • Comparative Study
  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bacteriological Techniques / methods*
  • Bordetella Infections / diagnosis*
  • Bordetella Infections / microbiology
  • Bordetella parapertussis / isolation & purification*
  • Bordetella pertussis / isolation & purification*
  • Humans
  • Molecular Diagnostic Techniques / methods*
  • Nasopharynx / microbiology
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity


  • Reagent Kits, Diagnostic