Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples
Objectives: In the context of the coronavirus disease 2019 (COVID-19) pandemic, the development and validation of rapid and easy-to-perform diagnostic methods are of high priority. This study was performed to evaluate a novel rapid antigen detection test (RDT) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in respiratory samples. Methods: The fluorescence immunochromatographic SARS-CoV-2 antigen test (Bioeasy Biotechnology Co., Shenzhen, China) was evaluated using universal transport medium with nasopharyngeal (NP) and oropharyngeal (OP) swabs from suspected COVID-19 cases. Diagnostic accuracy was determined in comparison to SARS-CoV-2 real-time (RT)-PCR. Results: A total of 127 samples were included; 82 were RT-PCR-positive. The median patient age was 38 years, 53.5% were male, and 93.7% were from the first week after symptom onset. Overall sensitivity and specificity were 93.9% (95% confidence interval 86.5–97.4%) and 100% (95% confidence interval 92.1–100%), respectively, with a diagnostic accuracy of 96.1% and Kappa coefficient of 0.9. Sensitivity was significantly higher in samples with high viral loads. Conclusions: The RDT evaluated in this study showed a high sensitivity and specificity in samples mainly obtained during the first week of symptoms and with high viral loads, despite the use of a non-validated sample material. The assay has the potential to become an important tool for early diagnosis of SARS-CoV-2, particularly in situations with limited access to molecular methods..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:99 |
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| Enthalten in: |
International Journal of Infectious Diseases - 99(2020), Seite 328-333 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lorena Porte [VerfasserIn] |
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| Links: |
doi.org [kostenfrei] |
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| Themen: |
Antigen |
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| doi: |
10.1016/j.ijid.2020.05.098 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
DOAJ008342644 |
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| 245 | 1 | 0 | |a Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples |
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| 520 | |a Objectives: In the context of the coronavirus disease 2019 (COVID-19) pandemic, the development and validation of rapid and easy-to-perform diagnostic methods are of high priority. This study was performed to evaluate a novel rapid antigen detection test (RDT) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in respiratory samples. Methods: The fluorescence immunochromatographic SARS-CoV-2 antigen test (Bioeasy Biotechnology Co., Shenzhen, China) was evaluated using universal transport medium with nasopharyngeal (NP) and oropharyngeal (OP) swabs from suspected COVID-19 cases. Diagnostic accuracy was determined in comparison to SARS-CoV-2 real-time (RT)-PCR. Results: A total of 127 samples were included; 82 were RT-PCR-positive. The median patient age was 38 years, 53.5% were male, and 93.7% were from the first week after symptom onset. Overall sensitivity and specificity were 93.9% (95% confidence interval 86.5–97.4%) and 100% (95% confidence interval 92.1–100%), respectively, with a diagnostic accuracy of 96.1% and Kappa coefficient of 0.9. Sensitivity was significantly higher in samples with high viral loads. Conclusions: The RDT evaluated in this study showed a high sensitivity and specificity in samples mainly obtained during the first week of symptoms and with high viral loads, despite the use of a non-validated sample material. The assay has the potential to become an important tool for early diagnosis of SARS-CoV-2, particularly in situations with limited access to molecular methods. | ||
| 650 | 4 | |a Coronavirus | |
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| 650 | 4 | |a COVID-19 | |
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| 650 | 4 | |a Antigen | |
| 653 | 0 | |a Infectious and parasitic diseases | |
| 700 | 0 | |a Paulette Legarraga |e verfasserin |4 aut | |
| 700 | 0 | |a Valeska Vollrath |e verfasserin |4 aut | |
| 700 | 0 | |a Ximena Aguilera |e verfasserin |4 aut | |
| 700 | 0 | |a José M Munita |e verfasserin |4 aut | |
| 700 | 0 | |a Rafael Araos |e verfasserin |4 aut | |
| 700 | 0 | |a Gabriel Pizarro |e verfasserin |4 aut | |
| 700 | 0 | |a Pablo Vial |e verfasserin |4 aut | |
| 700 | 0 | |a Mirentxu Iruretagoyena |e verfasserin |4 aut | |
| 700 | 0 | |a Sabine Dittrich |e verfasserin |4 aut | |
| 700 | 0 | |a Thomas Weitzel |e verfasserin |4 aut | |
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