title: Evaluation of 3 analyte-specific reagents for detection of Bordetella pertussis and Bordetella parapertussis in clinical specimens.
abstract: 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.
authors.affiliation: Department of Pathology and Laboratory Medicine, Children's Mercy Hospitals and Clinics, Kansas City, MO 64108, USA; Department of Pediatrics, School of Medicine, University of Missouri, Kansas City, MO 64108, USA.
authors.forename: Ferdaus
authors.initials: F
authors.lastname: Hassan
authors.affiliation: Department of Pathology and Laboratory Medicine, Children's Mercy Hospitals and Clinics, Kansas City, MO 64108, USA.
authors.forename: Lindsay
authors.initials: L
authors.lastname: Hays
authors.affiliation: Department of Pathology and Laboratory Medicine, Children's Mercy Hospitals and Clinics, Kansas City, MO 64108, USA; Department of Pediatrics, School of Medicine, University of Missouri, Kansas City, MO 64108, USA.
authors.forename: Jeremiah
authors.initials: J
authors.lastname: Bell
authors.affiliation: Department of Pathology and Laboratory Medicine, Children's Mercy Hospitals and Clinics, Kansas City, MO 64108, USA; Department of Pediatrics, School of Medicine, University of Missouri, Kansas City, MO 64108, USA. Electronic address: rselvarangan@cmh.edu.
authors.forename: Rangaraj
authors.initials: R
authors.lastname: Selvarangan
mesh_terms: D001431:Bacteriological Techniques / Q000379:methods*; D001885:Bordetella Infections / Q000175:diagnosis* / Q000382:microbiology; D042483:Bordetella parapertussis / Q000302:isolation & purification*; D001886:Bordetella pertussis / Q000302:isolation & purification*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009305:Nasopharynx / Q000382:microbiology; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: Analyte specific reagents; Bordetella parapertussis; Bordetella pertussis; Real time-PCR