Multicenter Clinical Evaluation of the Automated Aries Assay.

Molecular methods offer superior sensitivity and specificity and reduce testing turnaround time from days to hours for detection of and In this study, we evaluated the performance of the automated PCR-based Aries Assay, which detects both and directly from nasopharyngeal swab specimens. The limits of detection (LoDs) were 1,800 CFU·ml for and 213 CFU·ml for The assay detected 16/18 unique / strains. Of 71 potentially cross-reacting organisms, 5 generated false positives in 1/6 replicates; none of 6 additional spp. were erroneously detected. Specimens were stable at 20 to 25°C for at least 10 h, at 4 to 8°C for 10 days, and at temperatures not exceeding -70°C for 6 months. Of 1,052 nasopharyngeal specimens from patients with suspected pertussis, 3.0% ( = 32) were positive and 0.2% ( = 2) were positive. Combining these data with Aries Assay data from 57 nasopharyngeal samples with previously confirmed or data and with data from 50 contrived samples, the proportions of positive and negative agreement of the respective Aries assays with the reference assays were 97.1% and 99.0% for and 100% and 99.7% for The Aries Assay provides accurate detection and distinction of and infections within 2 h. (This study has been registered at ClinicalTrials.gov under registration no. NCT02862262.).