Multicenter Clinical Evaluation of the Luminex Aries Flu A/B & RSV Assay for Pediatric and Adult Respiratory Tract Specimens

Abstract

Influenza A and B viruses and respiratory syncytial virus (RSV) are three common viruses implicated in seasonal respiratory tract infections and are a major cause of morbidity and mortality in adults and children worldwide. In recent years, an increasing number of commercial molecular tests have become available to diagnose respiratory viral infections. The Luminex Aries Flu A/B & RSV assay is a fully automated sample-to-answer molecular diagnostic assay for the detection of influenza A, influenza B, and RSV. The clinical performance of the Aries Flu A/B & RSV assay was prospectively evaluated in comparison to that of the Luminex xTAG respiratory viral panel (RVP) at four North American clinical institutions over a 2-year period. Of the 2,479 eligible nasopharyngeal swab specimens included in the prospective study, 2,371 gave concordant results between the assays. One hundred eight specimens generated results that were discordant with those from the xTAG RVP and were further analyzed by bidirectional sequencing. Final clinical sensitivity values of the Aries Flu A/B & RSV assay were 98.1% for influenza A virus, 98.0% for influenza B virus, and 97.7% for RSV. Final clinical specificities for all three pathogens ranged from 98.6% to 99.8%. Due to the low prevalence of influenza B, an additional 40 banked influenza B-positive specimens were tested at the participating clinical laboratories and were all accurately detected by the Aries Flu A/B & RSV assay. This study demonstrates that the Aries Flu A/B & RSV assay is a suitable method for rapid and accurate identification of these causative pathogens in respiratory infections.

Comparison of Six Sample-to-Answer Influenza A/B and Respiratory Syncytial Virus Nucleic Acid Amplification Assays Using Respiratory Specimens from Children

“…Our study showed similar sensitivities and specificities for FluA (98.6% and 99.3%, respectively), FluB (97.9% and 99.4%, respectively), and RSV (99.1% and 98.4%, respectively) by Xpert. A multicenter clinical evaluation of the Aries system reported 95.8%, 93.8%, and 97.1% PPA for FluA, FluB, and RSV, respectively, a 98.4% NPA for FluA and RSV, and a 99.4% NPA for FluB (20). We report a higher specificity for all three targets with Aries and comparable sensitivities in our study.…”

“…Traditional reverse transcription-PCRs (RT-PCRs) require nucleic acid extraction prior to the amplification process, a low-to moderate-complexity (MC) instrument, trained personnel to perform both extraction and PCR, and manual interpretation of results, necessitating a TAT of approximately 3 to 4 h. The recently introduced automated sample-to-answer (STA) NAAT systems have improved the ease of use and provide moderate to highly accurate test results with a faster TAT. At present, a number of STA FluA/B and RSV molecular assays are approved by the Food and Drug Administration (FDA) and available for clinical use: GeneXpert Xpress Flu/RSV (Xpert; Cepheid, Sunnyvale, CA) (15,16), Diasorin Simplexa Flu A/B & RSV (Simplexa; Diasorin Molecular, Cypress, CA) (17), Alere (Abbott Rapid Diagnostics, IL) (18,19), Aries Flu A/B & RSV (Aries; Luminex Corporation, Austin, TX) (20), Cobas influenza A/B & RSV (Liat; Roche Diagnostics, Indianapolis, IN) (21), BioFire FilmArray respiratory panel (RP; BioFire Diagnostics, Salt Lake City, UT), and Panther Fusion Flu A/B/RSV (Fusion; Hologic Inc., San Diego, CA), among others (https:// www.cdc.gov/flu/professionals/diagnosis/table-nucleic-acid-detection.html). Of these STA assays, Alere, Liat, and Xpert offer Clinical Laboratory Improvement Amendments (CLIA)-waived (CW) assays suitable for point-of-care (POC) testing by nonlaboratory personnel to provide test results within 15 to 30 min in outpatient settings (21,22).…”

Evaluation of the Aries Bordetella Assay for Detection and Identification of Bordetella pertussis in Nasopharyngeal Swab Specimens

“…Technologists performing the Aries BA testing were blinded to the results of the FilmArray RP testing. Aries BA testing was performed on 200 l of each residual sample according to the manufacturer's instructions and as previously described (11). Residual samples were stored at Ϫ80°C for discordant testing when applicable.…”

Northwell Health Laboratories: The 10-Year Outcomes After Deciding to Keep the Lab

“…Among innumerable examples during the 10 years are national and international leadership in responding to the novel H1N1 influenza virus pandemic in 2009 18 ; demonstrating how in-system consolidation of anatomic pathology services can help drive subspecialization to support high-acuity patient care 14 ; and improvement in diagnostics for respiratory virus infections. 19 The consistent year-to-year effort to advance the delivery of health care is an essential element of being an effective insystem laboratory. Patient care is also served through leadership and volunteerism provided by pathology medical and managerial personnel at all levels of the institution and throughout its extensive geography.…”