Clinical Performance of the Allplex^TM Respiratory Panel 1 Test Compared to Simplexa^TM Flu A/B and RSV for Detection of Influenza Virus and Respiratory Syncytial Virus Infection Including Their Subtyping

Abstract

Objective: TheAllplex^TM Respiratory Panel 1 (ARP) is a new assay based on a real-time polymerase chain reaction (RT-PCR) for the detection of influenza A (Flu A), influenza B virus (Flu B), and respiratory syncytial virus (RSV), including subtyping by multiple detection temperature (MuDT) technology. We evaluated the performance of the Allplex Respiratory Panel compared to the Simplexa^TM Flu A/B & RSV assay (SP) and other diagnostic tools. Materials and Methods: A total of 372 samples were collected from patients at the Korea University Guro Hospital in Seoul, Korea. All samples were tested for influenza virus and RSV by ARP, SP, and an in-house RT-PCR. Results: The sensitivity of ARP was 95.56, 100, and 95.24% for Flu A, Flu B, and RSV, respectively. The specificity of ARP was 100, 100, and 100% for Flu A, Flu B, and RSV, respectively. SP had sensitivities and specificities of 98.89 and 100% for Flu A, 100 and 100% for Flu B, and 100 and 100% for RSV. Conclusion: The Allplex panelshowed high sensitivity, specificity, positive predictive, and negative predictive values for the detection of Flu A, Flu B, and RSV. This assay is fast and easy to perform because it takes only about 150 min and there is no need for post-PCR electrophoresis. The ARP can be used as a reliable and convenient assay in clinical laboratories.

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

“…In general, our findings are consistent with the PPA/sensitivity values reported in previous studies for influenza A and B 7,9,15‐20 . For RSV, however, although the NPA values are within the ranges of the previous reports, 7,9,15‐20 Xpert ® Flu/RSV detected less RSV cases than Allplex ™ RP1 (42 vs 54 positive cases) and the PPA was 77.8% in our study. This PPA value was lower than the findings of Gimferrer et al 15 and other studies which reported PPA/sensitivity values of 91%‐100% for RSV 9,18‐20 .…”

“…It is an important measure to rule‐out a disease when the test result is negative 25 . In general, our findings are consistent with the PPA/sensitivity values reported in previous studies for influenza A and B 7,9,15‐20 . For RSV, however, although the NPA values are within the ranges of the previous reports, 7,9,15‐20 Xpert ® Flu/RSV detected less RSV cases than Allplex ™ RP1 (42 vs 54 positive cases) and the PPA was 77.8% in our study.…”

“…Xpert ® Flu/RSV has been compared to quality control samples, 15 single‐plex real‐time RT‐PCR, 19 a laboratory‐developed assay, 18 BioFire FilmArray (USA), 20 and GenMark Diagnostics eSensor RVP (USA), 9 and reported to have the following measures: (a) 91%‐100% PPA/sensitivity and 99%‐100% NPA/specificity for influenza A; (b) 80%‐100% PPA/sensitivity and 99%‐100% NPA/specificity for influenza B; and (iii) 91%‐100% PPA/sensitivity and 99%‐100% NPA/specificity for RSV 9,15,18‐20 . Allplex ™ RP has been compared to AdvanSure (Korea), 7 Anyplex II RV16 (Korea), 17 Simplexa ™ Flu A/B & RSV (USA), 16 and quality control samples 15 and reported to have 90%‐98% PPA/sensitivity and 100% NPA/specificity for influenza A, 89%‐100% PPA/sensitivity and 100% NPA/specificity for influenza B, and 95%‐100% PPA/sensitivity and 100% NPA/specificity for RSV 7,15‐17 …”

“…All molecular assays based on RT‐PCR provide reliable results for the detection of respiratory viruses but are not always in diagnostic agreement. Previous studies reported the performance of Xpert ® Flu/RSV and Allplex ™ RP1 against other reference assays 7,9,15‐20 . However, to the best of our knowledge, no prior published studies have compared the Xpert ® Flu/RSV and Allplex ™ RP1 in clinical practice.…”