Evaluation of Performance Characteristics of Panther Fusion Assays for Detection of Respiratory Viruses from Nasopharyngeal and Lower Respiratory Tract Specimens

Abstract

Accurate and rapid diagnosis is needed for timely intervention and clinical management of acute respiratory infections. This study evaluated performance characteristics of the Panther Fusion assay for the detection of influenza A virus (Flu A), influenza B virus (Flu B), respiratory syncytial virus (RSV), parainfluenza viruses 1 to 3 (Para 1 to 3), human metapneumovirus (hMPV), rhinovirus (RV), and adenovirus (Adeno) targets in comparison to those of the eSensor and Lyra assays using 395 nasopharyngeal (NP) and 104 lower respiratory tract (LRT) specimens. Based on the consensus positive result established (positive result in 2 of the 3 assays), the NP specimens for the Fusion and eSensor assays had 100% positive percent agreement (PPA) for all the analytes and the Lyra assays had 100% PPA for Flu A and Adeno analytes. A 100% negative percent agreement (NPA) was observed for all the Lyra analytes, whereas those for the Fusion targets ranged from 98.4 to 100% and those for the eSensor ranged from 99.4 to 100% for all the analytes except RV. For the LRT specimens, Fusion had 100% PPA and 100% NPA for all the targets except hMPV. There was a 100% PPA for eSensor analytes; the NPA ranged from 98 to 100%, except for RV. For the Lyra assays, the PPA ranged between 50 and 100%, while the NPA was 100% for all the targets except Adeno. The Fusion assay performed similarly to the eSensor assay for majority of the targets tested and provides laboratories with a fully automated random-access system to test for a broad array of viral respiratory pathogens.

Recent advances in the detection of respiratory virus infection in humans

“…The Panther Fusion respiratory assay has been developed to detect multiple respiratory viruses, and it consists of three multiplex real‐time PCR panels: Flu A/B/RSV, Paraflu (Parainfluenza), and hAdV/hMPV/RV 75 . The performance characteristics of this assay for the detection of Flu A/B, RSV, Paraflu 1 to 3, hMPV, RV, and hAdV have been evaluated using 395 nasopharyngeal (NP) and 104 lower respiratory tract (LRT) samples 75 . The Wilson‐126 Score method was used to calculate the 95% CI for positive percent agreement (PPA) and negative percent agreement (NPA).…”

“…For the NP samples, the Panther Fusion Assay has 100% PPA and 98.4% to 100% NPA for all targets. For the LRT samples, it had 100% PPA for all targets and 100% NPA for all targets, except hMPV (96.1%) 75 …”

Panther Fusion® Respiratory Virus Assays for the detection of influenza and other respiratory viruses

“…There were 12 additional Fusion positive samples, which were confirmed true positive by analysis on Pro using higher sample input volumes. Indeed, the need for more sensitive methods for discrepancy analysis for Fusion has been demonstrated by others [20]. This leaves 21 samples not confirmed by a different method.…”

Lower Respiratory Multiplex Panels for the Detection of Bacterial and Viral Infections

“…While the Fusion and eSensor had 100% positive agreement for all targets tested (influenza A virus, influenza B virus, respiratory syncytial virus, parainfluenza virus types 1 to -3, human metapneumovirus, adenovirus, and rhinovirus), the Lyra had a variable positive agreement ranging from 50 to 100%. The negative agreement ranged between 96.1 and 100%, 79.4 and 100%, and 98.9 and 100% for the Fusion, eSensor, and Lyra respectively [6]. Other studies have included LRT samples in larger evaluations of commercially approved viral panels, noting similar performance regardless of specimen type [7][8][9].…”

“…The FA detected two coinfections, while the eSensor detected four [5]. In another study, the eSensor, Quidel (San Diego, CA) Lyra, and Panther (San Diego, CA) Fusion were compared using 105 LRT specimens, where a positive result in two of the three assays was considered a "true positive" [6]. While the Fusion and eSensor had 100% positive agreement for all targets tested (influenza A virus, influenza B virus, respiratory syncytial virus, parainfluenza virus types 1 to -3, human metapneumovirus, adenovirus, and rhinovirus), the Lyra had a variable positive agreement ranging from 50 to 100%.…”