Cepheid Xpert^® Flu/RSV and Seegene Allplex^™ RP1 show high diagnostic agreement for the detection of influenza A/B and respiratory syncytial viruses in clinical practice

Abstract

Background Molecular assays based on reverse transcription‐polymerase chain reaction (RT‐PCR) provide reliable results for the detection of respiratory pathogens, although diagnostic agreement varies. This study determined the agreement between the RT‐PCR assays (Xpert ® Flu/RSV vs Allplex ™ RP1) in detecting influenza A, influenza B, and respiratory syncytial viruses (RSVs) in clinical practice. Methods We retrospectively identified 914 patient encounters where testing with both Xpert ® Flu/RSV and Allplex ™ RP1 was undertaken between October 2015 and September 2019 in seven hospitals across New South Wales, Australia. The diagnostic agreement of the two assays was evaluated using positive percent agreement, negative percent agreement, and prevalence and bias‐adjusted kappa. Results The positive percent agreement was 95.1% for influenza A, 87.5% for influenza B, and 77.8% for RSV. The negative percent agreement was 99.4% for influenza A, 99.9% for influenza B, and 100% for RSV. The prevalence and bias‐adjusted kappa was 0.98 for influenza A, 0.99 for influenza B, and 0.97 for RSV. In a sensitivity analysis, the positive percent agreement values were significantly higher during the non‐influenza season than the influenza season for influenza B and RSV. Conclusions The Xpert ® Flu/RSV and Allplex ™ RP1 demonstrated a high diagnostic agreement for all three viruses assessed. The seasonal variation in the positive percent agreement of the two assays for influenza B and RSV may have been due to lower numbers assessed, variability in the virology of infections outside the peak season, or changes in the physiology of the infected host in different seasons.

Estimating RSV seasonality from pandemic disruptions: a modelling study

“…However, emergency department visits for bronchiolitis remained roughly the same between 2010-2019 with around 350 cases per week at peak seasonal activity (Figure S1b) suggesting an increase in sensitivity of the sentinel surveillance rather than an increasing burden of disease. The increase in testing was in part due to the introduction of new multiplex PCR assays in some hospitals in 2015 [29]. Secondly, we used annual RSV infection attack rates estimates from a longitudinal, prospective study in Kenyan households, which collected biweekly samples of all participants regardless of symptoms [4].…”

Diagnostic Accuracy of Commercially Available Tests for Respiratory Syncytial Virus: A Scoping Literature Review in the COVID-19 Era

“…A systematic review and meta-analysis of the sensitivity and specificity of RSV rapid antigen-based tests by Chartrand et al reported a pooled sensitivity and specificity of 80% (95% CI 76-83) and 97% (95% CI 96-98), respectively (37). In addition, there was a large disparity observed in sensitivity of RSV tests between studies in pediatric patients (81% [95% CI [78][79][80][81][82][83][84]) and in adults (29% [95% CI ). In contrast, a systematic review by Bruning et al reported that age did not affect diagnostic accuracy of RSV tests; however, this analysis only focused on three rapid RSV tests (BD Veritor System RSV, Sofia RSV FIA, and Alere BinaxNOW RSV) (38).…”

Comparative Evaluation of Allplex Respiratory Panels 1, 2, 3, and BioFire FilmArray Respiratory Panel for the Detection of Respiratory Infections

“…In summary, Allplex RP 1, 2, and 3 showed higher sensitivity than the BioFire FilmArray RP in detecting the most common viruses associated with a respiratory infection. The performance of Allplex RP and the BioFire FilmArray RP assays for the detection of respiratory infections has been assessed in previous studies [ 13 , 22 , 23 , 24 , 25 ].…”