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      Performance evaluation of the Panther Fusion® respiratory tract panel

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          Highlights

          • •

            Clinical specificity of Panther Fusion® is between 96 %–100 %, compared to LDT.

          • •

            Clinical sensitivity Panther Fusion® is between 71.9 %–100 %, compared to LDT.

          • •

            Overall linear regression showed good correlations between LDT and Panther Fusion® for all viruses, except RV and PIV-4.

          • •

            The Panther Fusion® provides a random-access system with continuous loading and shorter sample-to-answer times compared to LDT.

          Abstract

          Background

          Respiratory tract infections are among the most common infections during winter season. Rapid diagnostics is required for clinical decision making regarding isolation of patients and appropriate therapy.

          Objectives

          The aim of this study was to evaluate the analytical and clinical performance characteristics of the Panther Fusion® respiratory panel using published laboratory-developed real-time PCR assays (LDT).

          Study design

          Analytical sensitivity of Panther Fusion® Flu A/B/RSV was assessed by testing dilutions of cell culture isolates. Clinical performance assessment included the complete Panther Fusion® respiratory panel (Flu-A/B/RSV, PIV 1-4 and AdV/hMPV/RV) and consisted of a retrospective and a prospective study-arm. The retrospective evaluation included 201, stored (−80 °C) samples collected between February 2006 and January 2017. Prospective evaluation was performed on 1045 unselected pretreated respiratory tract samples from patients presented to our hospital between November 2017 and May 2018.

          Results

          Analytical sensitivity was generally slightly lower for the Panther Fusion® assays. Clinical specificity and sensitivity was between 96 %–100 % and 71.9 %–100 %, respectively. Discrepant results were found in 146 samples of which 88 samples tested LDT positive / Panther Fusion® negative and 58 samples were LDT negative / Panther Fusion® positive. A total of ten discrepant samples with Ct-values <30 were sequenced to confirm the presence of 7 RV-C not-detected by LDT and 1 RV-A and 2 ADV-2 not detected by Panther Fusion®.

          Conclusions

          The Panther Fusion® provides a random-access system with continuous loading and much shorter sample-to-answer times compared to LDT, albeit with a slightly less clinical sensitivity compared to the LDT.

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          Most cited references15

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          Rapid and sensitive method using multiplex real-time PCR for diagnosis of infections by influenza a and influenza B viruses, respiratory syncytial virus, and parainfluenza viruses 1, 2, 3, and 4.

          Kate E. Templeton, Sitha Scheltinga, Matthias Beersma … (2004)
          Laboratory diagnosis of viral respiratory infections is generally performed by virus isolation in cell culture and immunofluorescent assays. Reverse transcriptase PCR is now recognized as a sensitive and specific alternative for detection of respiratory RNA viruses. A rapid real-time multiplex PCR assay was developed for the detection of influenza A and influenza B viruses, human respiratory syncytial virus (RSV), parainfluenza virus 1 (PIV1), PIV2, PIV3, and PIV4 in a two-tube multiplex reaction which used molecular beacons to discriminate the pathogens. A total of 358 respiratory samples taken over a 1-year period were analyzed by the multiplex assay. The incidence of respiratory viruses detected in these samples was 67 of 358 (19%) and 87 of 358 (24%) by culture and real-time PCR, respectively. Culture detected 3 influenza A virus, 2 influenza B virus, 57 RSV, 2 PIV1, and 2 PIV3 infections. All of these culture-positive samples and an additional 5 influenza A virus, 6 RSV, 2 PIV1, 1 PIV2, 1 PIV3, and 3 PIV4 infections were detected by the multiplex real-time PCR. The application of real-time PCR to clinical samples increases the sensitivity for respiratory viral diagnosis. In addition, results can be obtained within 6 h, which increases clinical relevance. Therefore, use of this real-time PCR assay would improve patient management and infection control.
          Article 0 comments Cited 179 times – based on 0 reviews     Review now
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            Comparison of the Biofire FilmArray RP, Genmark eSensor RVP, Luminex xTAG RVPv1, and Luminex xTAG RVP fast multiplex assays for detection of respiratory viruses.

            Elena B Popowitch, Stacey S O'Neill, Melissa B. Miller (2013)
            There are several U.S. FDA-cleared molecular respiratory virus panels available today, each with advantages and disadvantages. 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. Three hundred specimens (200 retrospective and 100 consecutive) were tested using all four platforms to determine performance characteristics. The overall sensitivity and specificity, respectively, and 95% confidence interval (CI; in parentheses) for each panel were as follows: FilmArray RP, 84.5% (79.2, 88.6) and 100% (96.2, 100); eSensor RVP, 98.3% (95.5, 99.5) and 99.2% (95.4, 100); xTAG RVPv1, 92.7% (88.5, 95.4) and 99.8% (96.0, 100); and xTAG RVP fast, 84.4% (78.5, 88.9) and 99.9% (96.1, 100). The sensitivity of each assay fluctuated by viral target, with the greatest discrepancies noted for adenovirus and influenza virus B detection. Hands-on time and time to result were recorded and ease of use was assessed to generate a complete profile of each assay.
            Article 0 comments Cited 113 times – based on 0 reviews     Review now
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              Rapid Tests for Influenza, Respiratory Syncytial Virus, and Other Respiratory Viruses: A Systematic Review and Meta-analysis

              Andrea Bruning, Mariska M G Leeflang, Johanna Vos … (2017)
              Key Points This meta-analysis evaluates the diagnostic accuracy of rapid tests for the detection of respiratory viruses. Sensitivity of tests varied considerably, but specificity was high. Although newly developed tests seem more sensitive, high quality evaluations of these tests are lacking.
              Article 0 comments Cited 65 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Jolanda J.C. Voermans
                Journal
                Journal ID (nlm-ta): J Clin Virol
                Journal ID (iso-abbrev): J. Clin. Virol
                Title: Journal of Clinical Virology
                Publisher: The Authors. Published by Elsevier B.V.
                ISSN (Print): 1386-6532
                ISSN (Electronic): 1873-5967
                Publication date PMC-release: 10 December 2019
                Publication date (Print): February 2020
                Publication date (Electronic): 10 December 2019
                Volume: 123
                Page: 104232
                Affiliations
                [0005]Department of Viroscience, Erasmus Medical Center, Rotterdam, the Netherlands
                Author notes
                [* ]Corresponding author at: P.O. Box 2040, 3000CA Rotterdam, the Netherlands. j.voermans@ 123456erasmusmc.nl
                [1]

                Current affiliate: Microvida, Roosendaal, the Netherlands.

                Article
                Publisher ID: S1386-6532(19)30262-8 Publisher ID: 104232
                DOI: 10.1016/j.jcv.2019.104232
                PMC ID: 7172494
                PubMed ID: 31869661
                SO-VID: a694e646-a518-4f44-8723-3805e5c6d463
                Copyright © © 2020 The Authors
                License:

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                History
                Date received : 13 August 2019
                Date revision received : 29 November 2019
                Date accepted : 9 December 2019
                Categories
                Subject: Article

                ScienceOpen disciplines: Microbiology & Virology
                Keywords: panther fusion®,respiratory viruses,real-time pcr,rapid diagnostics,sample-to-answer
                Data availability:
                ScienceOpen disciplines: Microbiology & Virology
                Keywords: panther fusion®, respiratory viruses, real-time pcr, rapid diagnostics, sample-to-answer

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