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

• Three analyte-specific reagents (ASR) were evaluated for detection of B. pertussis and B. parapertussis.
• A total of 104 samples obtained from pediatric patients and previously characterized by laboratory-developed PCR assay were included.
• All 3 ASRs were comparable in performance and can be used for accurate clinical testing for pertussis and parapertussis.
• This study provides important and timely information for the clinical laboratorians for detection of B. pertussis and B. parapertussis in single reaction.

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.