Performance evaluation of the Panther Fusion® respiratory tract panel

•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®...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Journal of clinical virology 2020-02, Vol.123, p.104232-104232, Article 104232
Hauptverfasser: Voermans, Jolanda J.C., Mulders, Daphne G.J.C., Pas, Suzan D., Koopmans, Marion P.G., van der Eijk, Annemiek A., Molenkamp, Richard
Format: Artikel
Sprache:eng
Schlagworte:
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
Beschreibung
Zusammenfassung:•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. 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. 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). 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. 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
ISSN:1386-6532
1873-5967
DOI:10.1016/j.jcv.2019.104232