Performance evaluation of the Panther Fusion® respiratory tract panel

Abstract

A B S T R A C TBackground: 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.

Analytical Performances of the Panther Fusion System for the Detection of Respiratory Viruses in the French National Reference Centre of Lyon, France

“…The presented results demonstrate that both Panther Fusion and comparator technologies produced comparable results for detection of the viruses responsible for most of the viral respiratory infections, with slightly higher performances for the Panther Fusion respiratory assays [ 2 , 3 , 4 ]. Similar results have been described when comparing Panther Fusion system to seasonal panels (i.e., Cobas Influenza A/B test (cIAB, Roche Diagnostics, Indianapolis, IN, USA), Xpt (Cepheid, Carlsbad, CA, USA), wide-range panels (i.e., Filmarray respiratory panels 1.7 (RP, BioFire, Salt Lake City, UT, USA), Allplex respiratory panels (Seegene, Seoul, Korea), eSensor RVP (eSensor; Genmark Dx, Carlsbad, CA, USA), Lyra (Quidel, San Diego, CA, USA)) and by laboratory designed tests or sequencing [ 21 , 22 , 23 , 24 ]. It is important to note that in this study, similarly to others, false results for both the methods are associated with higher Ct values (corresponding to the lowest viral load in the tested samples).…”

Standardization of SARS-CoV-2 Nucleic Acid Amplification Techniques by Calibration and Quantification to the First WHO International Standard for SARS-CoV-2 RNA

“…Pretreatment of sputa (SP) was performed as described before [9,10]. Troat and nasal swabs were not pretreated.…”

Analytical validation of quantitative SARS-CoV-2 subgenomic and viral load laboratory developed tests conducted on the Panther Fusion® (Hologic) with preliminary application to clinical samples

“…Coronavirus Disease 2019 (COVID- 19) is an ongoing global pandemic caused by infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Fast genome mapping of SARS-CoV-2 has accelerated the development of multiple real-time reverse transcription polymerase chain reaction (RT-PCR) assays that have become the gold standard for detection of viral ribonucleic acid (RNA) and the identification of patients with COVID-19 as well as asymptomatic carriers [1].…”

“…The potential utility of sgRNA to identify intermediates of replication (potentially indicative of actively replicating virus) prompted development of high throughput automated specimen-to-answer quantitative sgRNA and Viral Load (VL) assays (based on the E target) on the Hologic Panther Fusion ® platform using its Open Access Functionality. Several Laboratory Developed Tests (LDTs) targeting different pathogens including SARS-CoV-2 [ 16 ] were developed on the Panther Fusion ® to allow for simultaneous detection of norovirus and rotavirus [ 17 ], subtyping of Influenza A Virus (FluA) [ 18 ], characterization of respiratory tract infection with Influenza A virus (Flu) A, FluB, and Respiratory Syncytial Virus (RSV) [ 19 ], and detection/differentiation of pandemic and endemic coronaviruses (Human Coronaviruses (HCoV) NL63, 229E, HKU1, OC43 and SARS-CoV-2) [ 20 ]. Panther Fusion ® SARS-CoV-2 LDTs targets included ORF1a (Hologic Food and Drug Administration Emergency Use Authorization), the RNA-dependent polymerase gene [ 21 ] and E + N1 [ 22 ].…”