Document Type

Article

Publication Date

11-21-2023

Identifier

DOI: 10.1128/jcm.00827-23; PMCID: PMC10662375

Abstract

The symptomology is overlapping for respiratory infections due to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), influenza A/B viruses, and respiratory syncytial virus (RSV). Accurate detection is essential for proper medical management decisions. This study evaluated the clinical performance of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay in nasopharyngeal swab (NPS) specimens from individuals of all ages with signs and symptoms of respiratory infection consistent with COVID-19, influenza, or RSV. Retrospective known-positive and prospectively obtained residual NPS specimens were collected during two respiratory seasons in the USA. Clinical performance was established by comparing Panther Fusion SARS-CoV-2/Flu assay results to a three-molecular assay composite comparator interpretation for SARS-CoV-2 and to the FDA-cleared Panther Fusion Flu A/B/RSV assay results for all non-SARS-CoV-2 targets. A total of 1,900 prospective and 95 retrospective NPS specimens were included in the analyses. The overall prevalence in prospectively obtained specimens was 20.7% for SARS-CoV-2, 6.7% for influenza A, and 0.7% for RSV; all influenza B-positive specimens were retrospective specimens. The positive percent agreement of the Panther Fusion assay was 96.9% (378/390) for SARS-CoV-2, 98.0% (121/123) for influenza A virus, 95.2% (20/21) for influenza B virus, and 96.6% (57/59) for RSV. The negative percent agreement was ≥98.5% for all target viruses. Specimens with discordant Panther Fusion SARS/Flu/RSV assay results all had cycle threshold values of ≥32.4 (by comparator or by Panther Fusion SARS/Flu/RSV assay). Only five co-infections were detected in the study specimens. The Panther Fusion SARS-CoV-2/Flu/RSV assay provides highly sensitive and specific detection of SARS-CoV-2, influenza A virus, influenza B virus, and RSV in NPS specimens.

Journal Title

Journal of clinical microbiology

Volume

61

Issue

11

First Page

0082723

Last Page

0082723

MeSH Keywords

Humans; Influenza, Human; SARS-CoV-2; Retrospective Studies; Prospective Studies; Respiratory Syncytial Virus Infections; Nasopharynx; COVID-19; Sensitivity and Specificity; Respiratory Syncytial Virus, Human; Influenza B virus; Respiratory Tract Infections; Influenza A virus

Keywords

Panther Fusion; SARS-CoV-2; clinical agreement; influenza; molecular respiratory assay; multiplex assay; respiratory syncytial virus

Comments

Grants and funding

This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license.

Publisher's Link: https://doi.org/10.1128/jcm.00827-23

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