Parallel Validation of Three Molecular Devices for Simultaneous Detection and Identification of Influenza A and B and Respiratory Syncytial Viruses

Abstract

Rapid identification of respiratory pathogens, such as influenza virus A (FluA), influenza virus B (FluB), and respiratory syncytial virus (RSV), reduces unnecessary antimicrobial use and enhances infection control practice. We performed a comparative evaluation of three molecular methods: (i) the Aries Flu A/B & RSV, (ii) the Xpert Xpress Flu/RSV, and (iii) the Cobas Flu A/B & RSV assays. The clinical performances of the three methods were evaluated using 200 remnant nasopharyngeal swab (NPS) specimens against a combined reference standard. The limits of detection (LODs) were determined using FluA, FluB, and RSV control strains with known titers. The 95% LODs were between 1.702 and 0.0003 50% tissue culture infective dose (TCID), with no significant differences revealed among the three assays. Perfect qualitative detection agreement was obtained in the reproducibility study. The Cobas assay failed at the first run on 13 clinical specimens, resulting in an invalid rate of 6.5%. The sensitivities and specificities for all assays were 96.0 to 100.0% and 99.3 to 100% for all three viruses. For on-demand single-specimen and batched 12-specimen workflows, the test turnaround times were 115.5 and 128.8 min for the Aries assay (12 sample capacity), 34.2 and 44.2 min for the Xpress assay (16 sample capacity), and 21.0 and 254.4 min for the Cobas assay (one instrument), respectively. In summary, the Aries, Xpress, and Cobas Liat assays demonstrated excellent sensitivities and specificities for simultaneous detection and identification of FluA, FluB, and RSV from NPS specimens in cancer patients. Test turnaround time was significantly shorter on the Xpress when instrument scalability is unlimited.

Laboratory diagnosis of emerging human coronavirus infections – the state of the art

“…The ID NOW™ (previously Alere i) Influenza A & B assay (Abbott, San Diego, CA) was cleared by the US FDA for direct use on NP swabs as the first-ever Clinical Laboratory Improvement Amendments (CLIA)-waived nucleic acid-based test in January 2016 [64,65]. Similarly, the Xpert® Xpress Flu/RSV (Cepheid, Sunnyvale, CA) and cobas® Liat® Flu A/B & RSV (Roche Molecular Systems, Pleasanton, CA) assays are integrated nucleic acid extraction-independent devices that have recently received FDA clearance and CLIA-waiver for simultaneous detection and identification of FluA, FluB, and RSV in nasopharyngeal swabs [66]. The FilmArray® Respiratory EZ Panel (BioFire, Salt Lake City, UT) so far so far is the only CLIA-waived syndromic panel that covers a set of 14 respiratory viral and bacterial pathogens including classical coronavirus species [67].…”

Implementation of the cobas Liat influenza point-of-care test into an emergency department during a high-incidence season: a retrospective evaluation following real-world implementation

“…Newer, point-of-care test (POCT) polymerase chain reaction (PCR)-based commercial tests are now available. One such test is the cobas Liat influenza A/B and respiratory syncytial virus (RSV) assay (Roche, Basel, Switzerland) (Liat), an automated multiplex PCR system with time to result of 20 min [4]. Previous studies have found its performance to be excellent, with sensitivity/specificity in the region of 100%/97.1e100% for influenza A and 97.8%e100/99.5e99.7% for influenza B when fresh prospectively collected samples are tested [3,5].…”

Comparison of the Cepheid Xpert Xpress Flu/RSV assay and commercial real-time PCR for the detection of influenza A and influenza B in a prospective cohort from China

“…The Xpert Flu/RSV assay demonstrated high sensitivity and specificity compared with other molecular methods or traditional diagnosis tests (Chen et al, 2018;Cohen et al, 2018;Ling et al, 2018). Therefore, this assay has been approved for in vitro diagnosis of FluA, FluB and RSV infection in the USA and Europe, but not in China currently.…”