FDA, namely, the FilmArray RP ( respiratory panel) (BioFire Diagnostics, Salt Lake City, UT), the eSensor RVP ( respiratory viral panel) (GenMark Dx, Carlsbad, CA), the Luminex xTAG RVPv1, and the Luminex xTAG RVP fast (Luminex Molecular Diagnostics, Austin, TX). Currently, four molecular multiplex respiratory virus panels for the simultaneous detection of more than three respiratory viruses have been cleared by the U.S.
Other assays offer limited multiplex testing, such as for influenza viruses and RSV (Focus Diagnostics, Cypress, CA Nanosphere, Northbrook, IL and Hologic Gen-Probe) and for RSV and metapneumovirus (Quidel). Some assays only detect a single viral type, such as adenovirus (AdV) (Hologic Gen-Probe, San Diego, CA), parainfluenza viruses (PIV) (Hologic Gen-Probe), metapneumovirus (MPV) (Hologic Gen-Probe and Quidel, San Diego, CA), and influenza viruses (Cepheid, Sunnyvale, CA IQuum, Marlborough, MA and Qiagen, Gaithersburg, MD). Several nucleic acid amplification tests are available as in vitro diagnostics for respiratory virus detection. To close the gap between sensitivity and time to result, amplification-based technologies have been developed. Direct fluorescent antibody testing and viral culture have a greater degree of sensitivity and have the advantage of detecting several viruses simultaneously however, both are time consuming and demand significant experience to perform the testing and correctly interpret the results. The sensitivities of two rapid influenza virus tests for the detection of influenza virus A/H1N1/2009 averaged 21% ( 6), and respiratory syncytial virus (RSV) rapid antigen sensitivity as low as 59% has been reported ( 7). Although rapid antigen testing offers quick results, the sensitivity and specificity of rapid antigen testing vary greatly ( 4, 5). Additional benefits of respiratory viral identification include epidemiologic tracking of local outbreaks or epidemics, applying appropriate infection control measures to admitted patients (e.g., droplet and/or contact precautions and considerations in creating cohorts), and decreasing the use of unnecessary antimicrobial therapy, when appropriate ( 2, 3).Ĭurrent diagnostic techniques for the detection and identification of respiratory viruses are somewhat limited. Accurate and timely identification of respiratory viruses benefits the patient, particularly when the pathogen is one for which therapy exists, such as influenza viruses ( 1). Most respiratory viruses present with similar symptoms, making a diagnosis difficult without laboratory testing. Respiratory viral infections remain a leading cause of medical visits and can contribute significantly to morbidity and mortality. Hands-on time and time to result were recorded and ease of use was assessed to generate a complete profile of each assay. The sensitivity of each assay fluctuated by viral target, with the greatest discrepancies noted for adenovirus and influenza virus B detection. Three hundred specimens (200 retrospective and 100 consecutive) were tested using all four platforms to determine performance characteristics. This study compares four multiplex panels, the BioFire Diagnostics FilmArray RP ( respiratory panel), the GenMark Dx eSensor RVP ( respiratory viral panel), the Luminex xTAG RVPv1, and the Luminex xTAG RVP fast. FDA-cleared molecular respiratory virus panels available today, each with advantages and disadvantages.