A Multicenter Clinical Diagnostic Accuracy Study of SureStatus, an Affordable, WHO Emergency Use-Listed, Rapid, Point-Of-Care Antigen-Detecting Diagnostic Test for SARS-CoV-2-Reference-Cited by-同舟云学术

A Multicenter Clinical Diagnostic Accuracy Study of SureStatus, an Affordable, WHO Emergency Use-Listed, Rapid, Point-Of-Care Antigen-Detecting Diagnostic Test for SARS-CoV-2

Published:2022-10-26 Issue:5 Volume:10 Page:
ISSN:2165-0497
Container-title:Microbiology Spectrum
language:en
Short-container-title:Microbiol Spectr

Author:

Krüger Lisa J.¹,Lindner Andreas K.²^ORCID,Gaeddert Mary¹,Tobian Frank¹,Klein Julian¹,Steinke Salome¹,Lainati Federica¹,Schnitzler Paul³,Nikolai Olga²,Mockenhaupt Frank P.²,Seybold Joachim⁴,Corman Victor M.⁵⁶^ORCID,Jones Terry C.⁵⁶⁷,Pollock Nira R.⁸^ORCID,Knorr Britta⁹,Welker Andreas⁹,Weber Stephan¹⁰,Sethurarnan Nandini¹¹,Swaminathan Jayanthi¹¹,Solomon Hilda¹¹,Padmanaban Ajay¹¹,Thirunarayan Ma¹¹,L Prabakaran¹²,de Vos Margaretha¹³^ORCID,Ongarello Stefano¹³,Sacks Jilian A.¹³,Escadafal Camille¹³,Denkinger Claudia M.¹¹⁴^ORCID,Assaad Kholoud,Fuhs Andrea,Harter Christopher,Schulze Cristopher,Schmitt Gunter,Fink Martina,Schirmer Maximilian,Small Annika,Meinlschmidt Matthias,Dürr Valerie,Schuckert Alina,Steinke Salome,Ellinghaus Henrik,Penning Alexander,Abutaima Loai,Kollatzsch Mandy,Wintel Mia,Kausch Franka,Hommes Franziska,Bölke Alisa,Bernhard Julian,Hülso Claudia,Linzbach Elisabeth,Rössig Heike,Gertler Maximilian,Burock Susen,von dem Busche Katja,Stephanie Stephanie

Affiliation:

1. Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany

2. Charité—Universitätsmedizin Berlin, Institute of Tropical Medicine and International Health, Berlin, Germany

3. Virology, Heidelberg University Hospital, Heidelberg, Germany

4. Charité—Universitätsmedizin Berlin, Medical Directorate, Berlin, Germany

5. Charité—Universitätsmedizin Berlin, Institute of Virology, Berlin, Germany

6. German Center for Infection Research (DZIF), Charité Partner Site, Berlin, Germany

7. Center for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge, United Kingdom

8. Department of Laboratory Medicine, Boston Children’s Hospital, Boston, Massachusetts, USA

9. Department of Public Health Rhein Neckar Region, Heidelberg, Germany

10. Acomed Statistik, Leipzig, Germany

11. Apollo Hospitals, Chennai, India

12. Foundation of Innovative New Diagnostics (FIND), New Delhi, India

13. Foundation of Innovative New Diagnostics (FIND), Campus Biotech, Geneva, Switzerland

14. German Center for Infection Research (DZIF), Heidelberg University Hospital Partner Site, Heidelberg, Germany

Abstract

Our manufacturer-independent, prospective diagnostic accuracy study assessed clinical performance in participants presumed to have a SARS-CoV-2 infection at three study sites in two countries. We assessed the accuracy overall and in predefined subgroups ( C T values and symptom duration).

Funder

Foundation of Innovative New Diagnostics

Ministry of Science, Research and Culture of the State BW

Unitaid

Government of the Netherlands

UK Foreign, Commonwealth and Development Office

HHS | NIH | National Institute of Allergy and Infectious Diseases

World Health Organization

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Cell Biology,Microbiology (medical),Genetics,General Immunology and Microbiology,Ecology,Physiology

Link

https://journals.asm.org/doi/pdf/10.1128/spectrum.01229-22

Reference23 articles.

1. World Health Organization. 6 October 2021. Antigen-detection in the diagnosis of SARS-CoV-2 infection. World Health Organization Geneva Switzerland. https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays. Accessed 30 March 2022.

2. Denkinger CM Brümmer LE Katzenschlager S Schmitz S. 31 August 2021. Diagnostics global health: rapid antigen tests for the diagnosis of a SARS-CoV-2 infection. Heidelberg Germany. https://diagnosticsglobalhealth.org/. Accessed 30 March 2022.

3. Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis

4. Foundation of Innovative New Diagnostics. 2022. About the ACT-Accelerator. Foundation of Innovative New Diagnostics Geneva Switzerland. https://www.finddx.org/covid-19/act-accelerator/. Accessed 30 March 2022.

5. World Health Organization. 30 April 2021. WHO emergency use listing for in vitro diagnostics (IVDs) detecting SARS-CoV-2. World Health Organization Geneva Switzerland. https://extranet.who.int/pqweb/sites/default/files/documents/210430_EUL_SARS-CoV-2_product_list.pdf. Accessed 30 March 2022.

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