Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2025
Clinical evaluation of nasal swab specimens in VTM/UTM and RespDirect eSTM using the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Shakir Salika M, McCall Robert K, Selvarangan Rangaraj, Banerjee Dithi, Goldstein Yitz, Lansang Christine, Bogh Rachel, Remillard Carmelle V, RespDirect Clinical Study Group
Аннотация
BACKGROUND: Respiratory viral infections by SARS-CoV-2, influenza A and B viruses, and RSV overlap in disease signs and symptomology, but differ in treatment modality. Nasal swab specimens have been shown to be an effective alternative specimen type for SARS-CoV-2 detection.
OBJECTIVES: This study evaluated the performance of the Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay in anterior nasal swab specimens (self- or healthcare professional [HCP]-) collected in either viral/universal (VTM/UTM) transport media or the Hologic® RespDirect® collection kit (RespDirect swab in enhanced specimen transport media [eSTM]).
STUDY DESIGN: A multicenter study was conducted from October 2022 to March 2024. A total of 2686 nasal swab specimens collected in VTM/UTM or in eSTM were tested with the investigational assay and comparator molecular assays. Positive and negative agreement were calculated for each viral target.
RESULTS: Overall, the results of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay in nasal swab specimens demonstrated high concordance with the nasal swab-based molecular comparator methods with positive and negative percent agreement of 96.6 % and 98.9 % for SARS-CoV-2, 96.1 % and 99.3 % for influenza A virus, 96.0 % and 99.8 % for influenza B virus, and 97.7 % and 99.6 % for RSV, respectively. There were no statistically significant differences between specimens in VTM/UTM and eSTM and between self- or HCP-collected swabs in either transport medium for any of the viral pathogens.
CONCLUSION: The results of this study indicate that both self- and HCP- collected anterior nasal swabs in VTM or eSTM matrix are suitable options for detecting SARS-CoV-2, influenza A/B, and RSV using the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.
OBJECTIVES: This study evaluated the performance of the Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay in anterior nasal swab specimens (self- or healthcare professional [HCP]-) collected in either viral/universal (VTM/UTM) transport media or the Hologic® RespDirect® collection kit (RespDirect swab in enhanced specimen transport media [eSTM]).
STUDY DESIGN: A multicenter study was conducted from October 2022 to March 2024. A total of 2686 nasal swab specimens collected in VTM/UTM or in eSTM were tested with the investigational assay and comparator molecular assays. Positive and negative agreement were calculated for each viral target.
RESULTS: Overall, the results of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay in nasal swab specimens demonstrated high concordance with the nasal swab-based molecular comparator methods with positive and negative percent agreement of 96.6 % and 98.9 % for SARS-CoV-2, 96.1 % and 99.3 % for influenza A virus, 96.0 % and 99.8 % for influenza B virus, and 97.7 % and 99.6 % for RSV, respectively. There were no statistically significant differences between specimens in VTM/UTM and eSTM and between self- or HCP-collected swabs in either transport medium for any of the viral pathogens.
CONCLUSION: The results of this study indicate that both self- and HCP- collected anterior nasal swabs in VTM or eSTM matrix are suitable options for detecting SARS-CoV-2, influenza A/B, and RSV using the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.