| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 3346968 | Diagnostic Microbiology and Infectious Disease | 2014 | 4 Pages |
•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.
