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...
Main Authors: | , , , , , , , , , |
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Format: | Article |
Language: | English |
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Elsevier
2022-09-01
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Series: | International Journal of Infectious Diseases |
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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. |
first_indexed | 2024-04-11T20:08:14Z |
format | Article |
id | doaj.art-8cc7636c2c714b7c8d68833bb40622d4 |
institution | Directory Open Access Journal |
issn | 1201-9712 |
language | English |
last_indexed | 2024-04-11T20:08:14Z |
publishDate | 2022-09-01 |
publisher | Elsevier |
record_format | Article |
series | International Journal of Infectious Diseases |
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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