Analytical performances of the point-of-care SIENNA™ COVID-19 Antigen Rapid Test for the detection of SARS-CoV-2 nucleocapsid protein in nasopharyngeal swabs: A prospective evaluation during the COVID-19 second wave in France
Objectives: We herein assessed the analytical performances of the antigen-rapid diagnostic test (Ag-RDT) SIENNA™ COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) (Salofa Oy, Salo, Finland), targeting the SARS-CoV-2 N nucleocapsid protein, for the diagnosis of COVID-19 in hospitalized patie...
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| Format: | Article |
| Language: | English |
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Elsevier
2021-05-01
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| Series: | International Journal of Infectious Diseases |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971221002691 |
| _version_ | 1831750314216128512 |
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| author | Ralph-Sydney Mboumba Bouassa David Veyer Hélène Péré Laurent Bélec |
| author_facet | Ralph-Sydney Mboumba Bouassa David Veyer Hélène Péré Laurent Bélec |
| author_sort | Ralph-Sydney Mboumba Bouassa |
| collection | DOAJ |
| description | Objectives: We herein assessed the analytical performances of the antigen-rapid diagnostic test (Ag-RDT) SIENNA™ COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) (Salofa Oy, Salo, Finland), targeting the SARS-CoV-2 N nucleocapsid protein, for the diagnosis of COVID-19 in hospitalized patients with suspected SARS-CoV-2 infection, by reference to real-time RT-PCR (rRT-PCR). Methods: Nasopharyngeal swabs were collected from patients with COVID-19-like illness during the second epidemic wave in Paris, France, among which 100 and 50 were positive and negative for SARS-CoV-2 RNA, respectively. Results: Overall, the Ag-RDT showed high sensitivity, specificity, positive and negative predictive values of 90.0%, 100.0%, 100.0% and 98.1%, respectively, as well as high or almost perfect agreement (93.3%), reliability assessed by Cohen’s κ coefficient (0.86), and accuracy assessed by Youden’s J index (90%) to detect SARS-CoV-2. The analytical performances of the Ag-RDT remained high in the event of significant viral excretion (i.e., N gene Ct values ≤33 by reference rtRT-PCR), while the sensitivity of the Ag-RDT dropped to 69.6% with low or very low viral shedding (Ct > 33). Conclusions: The SIENNA™ Ag-RDT presents excellent analytical performances for viral loads ≤33 Ct, classically corresponding to situations of symptomatic COVID-19 and/or proven contagiousness. |
| first_indexed | 2024-12-21T22:25:30Z |
| format | Article |
| id | doaj.art-01dbad401ec941c69351bd11d5d4b088 |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-12-21T22:25:30Z |
| publishDate | 2021-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-01dbad401ec941c69351bd11d5d4b0882022-12-21T18:48:14ZengElsevierInternational Journal of Infectious Diseases1201-97122021-05-01106812Analytical performances of the point-of-care SIENNA™ COVID-19 Antigen Rapid Test for the detection of SARS-CoV-2 nucleocapsid protein in nasopharyngeal swabs: A prospective evaluation during the COVID-19 second wave in FranceRalph-Sydney Mboumba Bouassa0David Veyer1Hélène Péré2Laurent Bélec3Laboratoire de Virologie, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France; Université de Paris, and INSERM, Paris, FranceLaboratoire de Virologie, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France; Université de Paris, and INSERM, Paris, FranceLaboratoire de Virologie, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France; Université de Paris, and INSERM, Paris, FranceLaboratoire de Virologie, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France; Université de Paris, and INSERM, Paris, France; Corresponding author at: Laboratoire de Virologie, Hôpital Européen Georges Pompidou, 20 Rue Leblanc, 75015 Paris, France.Objectives: We herein assessed the analytical performances of the antigen-rapid diagnostic test (Ag-RDT) SIENNA™ COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) (Salofa Oy, Salo, Finland), targeting the SARS-CoV-2 N nucleocapsid protein, for the diagnosis of COVID-19 in hospitalized patients with suspected SARS-CoV-2 infection, by reference to real-time RT-PCR (rRT-PCR). Methods: Nasopharyngeal swabs were collected from patients with COVID-19-like illness during the second epidemic wave in Paris, France, among which 100 and 50 were positive and negative for SARS-CoV-2 RNA, respectively. Results: Overall, the Ag-RDT showed high sensitivity, specificity, positive and negative predictive values of 90.0%, 100.0%, 100.0% and 98.1%, respectively, as well as high or almost perfect agreement (93.3%), reliability assessed by Cohen’s κ coefficient (0.86), and accuracy assessed by Youden’s J index (90%) to detect SARS-CoV-2. The analytical performances of the Ag-RDT remained high in the event of significant viral excretion (i.e., N gene Ct values ≤33 by reference rtRT-PCR), while the sensitivity of the Ag-RDT dropped to 69.6% with low or very low viral shedding (Ct > 33). Conclusions: The SIENNA™ Ag-RDT presents excellent analytical performances for viral loads ≤33 Ct, classically corresponding to situations of symptomatic COVID-19 and/or proven contagiousness.http://www.sciencedirect.com/science/article/pii/S1201971221002691COVID-19Rapid diagnostic testAntigenProtein NFrance |
| spellingShingle | Ralph-Sydney Mboumba Bouassa David Veyer Hélène Péré Laurent Bélec Analytical performances of the point-of-care SIENNA™ COVID-19 Antigen Rapid Test for the detection of SARS-CoV-2 nucleocapsid protein in nasopharyngeal swabs: A prospective evaluation during the COVID-19 second wave in France International Journal of Infectious Diseases COVID-19 Rapid diagnostic test Antigen Protein N France |
| title | Analytical performances of the point-of-care SIENNA™ COVID-19 Antigen Rapid Test for the detection of SARS-CoV-2 nucleocapsid protein in nasopharyngeal swabs: A prospective evaluation during the COVID-19 second wave in France |
| title_full | Analytical performances of the point-of-care SIENNA™ COVID-19 Antigen Rapid Test for the detection of SARS-CoV-2 nucleocapsid protein in nasopharyngeal swabs: A prospective evaluation during the COVID-19 second wave in France |
| title_fullStr | Analytical performances of the point-of-care SIENNA™ COVID-19 Antigen Rapid Test for the detection of SARS-CoV-2 nucleocapsid protein in nasopharyngeal swabs: A prospective evaluation during the COVID-19 second wave in France |
| title_full_unstemmed | Analytical performances of the point-of-care SIENNA™ COVID-19 Antigen Rapid Test for the detection of SARS-CoV-2 nucleocapsid protein in nasopharyngeal swabs: A prospective evaluation during the COVID-19 second wave in France |
| title_short | Analytical performances of the point-of-care SIENNA™ COVID-19 Antigen Rapid Test for the detection of SARS-CoV-2 nucleocapsid protein in nasopharyngeal swabs: A prospective evaluation during the COVID-19 second wave in France |
| title_sort | analytical performances of the point of care sienna™ covid 19 antigen rapid test for the detection of sars cov 2 nucleocapsid protein in nasopharyngeal swabs a prospective evaluation during the covid 19 second wave in france |
| topic | COVID-19 Rapid diagnostic test Antigen Protein N France |
| url | http://www.sciencedirect.com/science/article/pii/S1201971221002691 |
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