Next Article in Journal
Adherence to Prescribed Acamprosate in Alcohol Dependence and 1-Year Morbidities and Mortality: Utilizing a Data Linkage Methodology
Previous Article in Journal
The Effect of Ageing on Clinical, Hormonal and Sonographic Features Associated with PCOS—A Long-Term Follow-Up Study
Article

Accuracy of a Novel SARS-CoV-2 Antigen-Detecting Rapid Diagnostic Test from Standardized Self-Collected Anterior Nasal Swabs

1
Department of Nephrology and Medical Intensive Care, Charité–Universitätsmedizin Berlin, 10117 Berlin, Germany
2
Berlin Institute of Health, 10117 Berlin, Germany
3
Institute of Virology, Charité–Universitätsmedizin Berlin, 13353 Berlin, Germany
4
Labor Berlin–Charité Vivantes GmbH, 13353 Berlin, Germany
5
Institute of Tropical Medicine and International Health, Charité–Universitätsmedizin Berlin, 13353 Berlin, Germany
6
Medical Directorate, Charité–Universitätsmedizin Berlin, 10117 Berlin, Germany
*
Author to whom correspondence should be addressed.
Academic Editor: Nicola Petrosillo
J. Clin. Med. 2021, 10(10), 2099; https://doi.org/10.3390/jcm10102099
Received: 20 April 2021 / Revised: 6 May 2021 / Accepted: 11 May 2021 / Published: 13 May 2021
(This article belongs to the Section Infectious Diseases)
Background Antigen-detecting rapid diagnostic tests (Ag-RDT) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) offer new opportunities for the quick and laboratory-independent identification of infected individuals for control of the SARS-CoV-2 pandemic. Despite the potential benefits, nasopharyngeal sample collection is frequently perceived as uncomfortable by patients and requires trained healthcare personnel with protective equipment. Therefore, anterior nasal self-sampling is increasingly recognized as a valuable alternative. Methods We performed a prospective, single-center, point of care validation of an Ag-RDT using a polypropylene absorbent collector for standardized self-collected anterior nasal swabs. Real-time polymerase chain reaction (RT-PCR) from combined oropharyngeal/nasopharyngeal swabs served as a comparator. Primary endpoint was sensitivity of the standardized Ag-RDT in symptomatic patients with medium or high viral concentration (≥1 million RNA copies on RT-PCR for SARS-CoV-2). Results Between 12 February and 22 March 2021, 388 participants were enrolled. After exclusion of 9 patients for which no PCR result could be obtained, the novel Ag-RDT was evaluated based on 379 participants, of whom 273 were symptomatic and 106 asymptomatic. In 61 samples from symptomatic patients with medium or high viral load (≥1 million RNA copies), the sensitivity of the standardized Ag-RDT was 96.7% (59/61; 95% confidence interval (CI): 88.7–99.6%) for the primary endpoint. In total, 62 positive Ag-RDT results were detected out of 70 RT-PCR positive individuals, yielding an overall sensitivity of 88.6% (95% CI: 78.7–94.9%). Specificity was 99.7% (95% CI: 98.2–100%) in 309 RT-PCR negative individuals. Conclusions Here, we present a validation of a novel Ag-RDT with a standardized sampling process for anterior nasal self-collection, which meets World Health Organisation (WHO) criteria of ≥80% sensitivity and ≥97% specificity. Although less sensitive than RT-PCR, this assay could be beneficial due to its rapid results, ease of use, and suitability for standardized self-testing. View Full-Text
Keywords: COVID-19; COVID-19 diagnostic testing; SARS-CoV-2; SARS-COV-2 antigen testing COVID-19; COVID-19 diagnostic testing; SARS-CoV-2; SARS-COV-2 antigen testing
Show Figures

Figure 1

MDPI and ACS Style

Osmanodja, B.; Budde, K.; Zickler, D.; Naik, M.G.; Hofmann, J.; Gertler, M.; Hülso, C.; Rössig, H.; Horn, P.; Seybold, J.; Lunow, S.; Bothmann, M.; Barrera-Pesek, A.; Mayrdorfer, M. Accuracy of a Novel SARS-CoV-2 Antigen-Detecting Rapid Diagnostic Test from Standardized Self-Collected Anterior Nasal Swabs. J. Clin. Med. 2021, 10, 2099. https://doi.org/10.3390/jcm10102099

AMA Style

Osmanodja B, Budde K, Zickler D, Naik MG, Hofmann J, Gertler M, Hülso C, Rössig H, Horn P, Seybold J, Lunow S, Bothmann M, Barrera-Pesek A, Mayrdorfer M. Accuracy of a Novel SARS-CoV-2 Antigen-Detecting Rapid Diagnostic Test from Standardized Self-Collected Anterior Nasal Swabs. Journal of Clinical Medicine. 2021; 10(10):2099. https://doi.org/10.3390/jcm10102099

Chicago/Turabian Style

Osmanodja, Bilgin, Klemens Budde, Daniel Zickler, Marcel G. Naik, Jörg Hofmann, Maximilian Gertler, Claudia Hülso, Heike Rössig, Philipp Horn, Joachim Seybold, Stephanie Lunow, Melanie Bothmann, Astrid Barrera-Pesek, and Manuel Mayrdorfer. 2021. "Accuracy of a Novel SARS-CoV-2 Antigen-Detecting Rapid Diagnostic Test from Standardized Self-Collected Anterior Nasal Swabs" Journal of Clinical Medicine 10, no. 10: 2099. https://doi.org/10.3390/jcm10102099

Find Other Styles
Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Article Access Map by Country/Region

1
Back to TopTop