Abstract
ABSTRACTInfluenza 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.
Highlights
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
The vast majority (90%) of these are viral in nature [2, 3], as many as 60% of patients are ineffectively treated with antibiotics for these viral infections [4]
Clinical sensitivity of the Aries Flu A/B & RSV assay was 95.8% for influenza A virus (299/312; 95% confidence interval [CI], 93.0% to 97.8%), 93.8% for influenza B virus (45/48; 95% CI, 82.8% to 98.7%), and 97.1% for RSV
Summary
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. Knowing whether a respiratory infection is viral or bacterial allows for more effective patient isolation and infection control [1] Respiratory viruses such as influenza virus and respiratory syncytial virus (RSV) are the most common cause of acute illness and physician visits in the United States [7]. The slow results from culture and the poor reliability of rapid immunoassay-based respiratory tests present challenges to clinicians and hospitals [1] Molecular diagnostic tests such as PCR methods offer high sensitivity, speed, and cost advantages over traditional methods, such as culture or direct immunofluorescence (DFA), and have been the focus of clinical laboratories for more than a decade. Rapid and early diagnosis of the causative pathogen in respiratory illness aids in patient diagnosis, treatment management, and the avoidance of overprescribing antibiotics
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