Multicenter Clinical Evaluation of the Automated ARIES® Bordetella Assay.

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Multicenter Clinical Evaluation of the Automated ARIES® Bordetella Assay.

J Clin Microbiol. 2018 Dec 05;:

Authors: Relich RF, Leber A, Young S, Schutzbank T, Dunn R, Farhang J, Uphoff TS

Abstract
Molecular methods offer superior sensitivity and specificity, and reduce testing turnaround time from days to hours for detection of Bordetella pertussis and Bordetella parapertussis In this study, we evaluated the performance of the automated PCR-based ARIES Bordetella Assay, which detects both B. pertussis and B. parapertussis directly from nasopharyngeal swab specimens. Limits of detection were 1,800 colony-forming units/mL (CFU·mL-1) for B. pertussis and 213 CFU·mL-1 for B. parapertussis The assay detected 16/18 unique B. pertussis/B. parapertussis strains. Of 71 potential cross-reacting organisms, 5 generated false-positives in 1/6 replicates; none of 6 additional Bordetella spp. were erroneously detected. Specimens were stable at 20-25°C for at least 10 h, 4-8°C for 10 days, and at ≤ -70°C for 6 months. Of 1,052 nasopharyngeal specimens from patients with suspected pertussis, 3.0% (n=32) were B. pertussis-positive, and 0.2% (n=2) were B. parapertussis-positive. After combining these data with ARIES Bordetella Assay data from 57 nasopharyngeal samples with previously confirmed B. pertussis or B. parapertussis, and from 50 contrived B. parapertussis samples, ARIES assay respective positive and negative percent agreements with the reference assays were 97.1% and 99.0% for B. pertussis, and 100% and 99.7% for B. parapertussis The ARIES Bordetella Assay provides accurate detection and distinction of B. pertussis and B. parapertussis infection within 2 hours.

PMID: 30518543 [PubMed - as supplied by publisher]

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