Ct values as a diagnostic tool for monitoring SARS-CoV-2 viral load using the QIAstat-Dx® Respiratory SARS-CoV-2 Panel

Objectives: Qualitative real-time polymerase chain reaction tests are not designed to provide quantitative or semiquantitative results because cycle threshold (Ct) values are not normalized to standardized controls of known concentration. The aim of this study was to characterize SARS-CoV-2 viral lo...

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Main Authors: Martí Juanola-Falgarona, Luis Peñarrubia, Sara Jiménez-Guzmán, Roberto Porco, Clàudia Congost-Teixidor, Marta Varo-Velázquez, Sonia N Rao, Gemma Pueyo, Davide Manissero, Josep Pareja
Format: Article
Language:English
Published: Elsevier 2022-09-01
Series:International Journal of Infectious Diseases
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S1201971222004192
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author Martí Juanola-Falgarona
Luis Peñarrubia
Sara Jiménez-Guzmán
Roberto Porco
Clàudia Congost-Teixidor
Marta Varo-Velázquez
Sonia N Rao
Gemma Pueyo
Davide Manissero
Josep Pareja
author_facet Martí Juanola-Falgarona
Luis Peñarrubia
Sara Jiménez-Guzmán
Roberto Porco
Clàudia Congost-Teixidor
Marta Varo-Velázquez
Sonia N Rao
Gemma Pueyo
Davide Manissero
Josep Pareja
author_sort Martí Juanola-Falgarona
collection DOAJ
description Objectives: Qualitative real-time polymerase chain reaction tests are not designed to provide quantitative or semiquantitative results because cycle threshold (Ct) values are not normalized to standardized controls of known concentration. The aim of this study was to characterize SARS-CoV-2 viral loads based on Ct values, using the QIAstat-Dx® Respiratory SARS-CoV-2 Panel. Methods: Different lineages of SARS-CoV-2 clinical samples and the World Health Organization international standard were used to assess the linearity of the QIAstat-Dx Respiratory SARS-CoV-2 Panel. Limit of detection for the different lineages was characterized. Results: Comparable efficiencies and linearity for all samples resulted in R2 ≥0.99, covering a dynamic range of 1,000,000-100 copies/mL for the SARS-CoV-2 assay, showing linear correlation between Ct values and viral load down to 300 copies/mL. Conclusion: The SARS-CoV-2 Ct values provided by the QIAstat-Dx® Respiratory SARS-CoV-2 Panel could be used as a surrogate for viral load given the linear correlation between Ct values and viral concentration down to limit of detection. This panel allows to obtain reproducible Ct values for SARS-CoV-2 ribonucleic acid downstream of the sample collection, reducing the sample-to-Ct workflow variability. Ct values can help provide a reliable assessment and comparison of viral loads in patients when tested with the QIAstat-Dx Respiratory SARS-CoV-2 Panel.
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spelling doaj.art-8cc7636c2c714b7c8d68833bb40622d42022-12-22T04:05:15ZengElsevierInternational Journal of Infectious Diseases1201-97122022-09-01122930935Ct values as a diagnostic tool for monitoring SARS-CoV-2 viral load using the QIAstat-Dx® Respiratory SARS-CoV-2 PanelMartí Juanola-Falgarona0Luis Peñarrubia1Sara Jiménez-Guzmán2Roberto Porco3Clàudia Congost-Teixidor4Marta Varo-Velázquez5Sonia N Rao6Gemma Pueyo7Davide Manissero8Josep Pareja9STAT-Dx Life S.L. (A QIAGEN company), Carrer de Baldiri Reixac, 4–8, 08028 Barcelona, Spain; Corresponding author.STAT-Dx Life S.L. (A QIAGEN company), Carrer de Baldiri Reixac, 4–8, 08028 Barcelona, SpainSTAT-Dx Life S.L. (A QIAGEN company), Carrer de Baldiri Reixac, 4–8, 08028 Barcelona, SpainSTAT-Dx Life S.L. (A QIAGEN company), Carrer de Baldiri Reixac, 4–8, 08028 Barcelona, SpainSTAT-Dx Life S.L. (A QIAGEN company), Carrer de Baldiri Reixac, 4–8, 08028 Barcelona, SpainSTAT-Dx Life S.L. (A QIAGEN company), Carrer de Baldiri Reixac, 4–8, 08028 Barcelona, SpainQIAGEN Inc., 19300 Germantown Road, Germantown, MD, 20874, USASTAT-Dx Life S.L. (A QIAGEN company), Carrer de Baldiri Reixac, 4–8, 08028 Barcelona, SpainQIAGEN Manchester Ltd, Citylabs 2.0. Hathersage Road, Manchester, M13 0BH, UKSTAT-Dx Life S.L. (A QIAGEN company), Carrer de Baldiri Reixac, 4–8, 08028 Barcelona, SpainObjectives: Qualitative real-time polymerase chain reaction tests are not designed to provide quantitative or semiquantitative results because cycle threshold (Ct) values are not normalized to standardized controls of known concentration. The aim of this study was to characterize SARS-CoV-2 viral loads based on Ct values, using the QIAstat-Dx® Respiratory SARS-CoV-2 Panel. Methods: Different lineages of SARS-CoV-2 clinical samples and the World Health Organization international standard were used to assess the linearity of the QIAstat-Dx Respiratory SARS-CoV-2 Panel. Limit of detection for the different lineages was characterized. Results: Comparable efficiencies and linearity for all samples resulted in R2 ≥0.99, covering a dynamic range of 1,000,000-100 copies/mL for the SARS-CoV-2 assay, showing linear correlation between Ct values and viral load down to 300 copies/mL. Conclusion: The SARS-CoV-2 Ct values provided by the QIAstat-Dx® Respiratory SARS-CoV-2 Panel could be used as a surrogate for viral load given the linear correlation between Ct values and viral concentration down to limit of detection. This panel allows to obtain reproducible Ct values for SARS-CoV-2 ribonucleic acid downstream of the sample collection, reducing the sample-to-Ct workflow variability. Ct values can help provide a reliable assessment and comparison of viral loads in patients when tested with the QIAstat-Dx Respiratory SARS-CoV-2 Panel.http://www.sciencedirect.com/science/article/pii/S1201971222004192SARS-CoV-2COVID-19Cycle threshold valueViral loadQIAstat-DxDisease severity
spellingShingle Martí Juanola-Falgarona
Luis Peñarrubia
Sara Jiménez-Guzmán
Roberto Porco
Clàudia Congost-Teixidor
Marta Varo-Velázquez
Sonia N Rao
Gemma Pueyo
Davide Manissero
Josep Pareja
Ct values as a diagnostic tool for monitoring SARS-CoV-2 viral load using the QIAstat-Dx® Respiratory SARS-CoV-2 Panel
International Journal of Infectious Diseases
SARS-CoV-2
COVID-19
Cycle threshold value
Viral load
QIAstat-Dx
Disease severity
title Ct values as a diagnostic tool for monitoring SARS-CoV-2 viral load using the QIAstat-Dx® Respiratory SARS-CoV-2 Panel
title_full Ct values as a diagnostic tool for monitoring SARS-CoV-2 viral load using the QIAstat-Dx® Respiratory SARS-CoV-2 Panel
title_fullStr Ct values as a diagnostic tool for monitoring SARS-CoV-2 viral load using the QIAstat-Dx® Respiratory SARS-CoV-2 Panel
title_full_unstemmed Ct values as a diagnostic tool for monitoring SARS-CoV-2 viral load using the QIAstat-Dx® Respiratory SARS-CoV-2 Panel
title_short Ct values as a diagnostic tool for monitoring SARS-CoV-2 viral load using the QIAstat-Dx® Respiratory SARS-CoV-2 Panel
title_sort ct values as a diagnostic tool for monitoring sars cov 2 viral load using the qiastat dx r respiratory sars cov 2 panel
topic SARS-CoV-2
COVID-19
Cycle threshold value
Viral load
QIAstat-Dx
Disease severity
url http://www.sciencedirect.com/science/article/pii/S1201971222004192
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