Evaluation of FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit for Detection of SARS-CoV-2 in Respiratory Samples from Mildly Symptomatic or Asymptomatic Patients
Molecular tests are the gold standard to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection but are associated with a diagnostic delay, while antigen detection tests can generate results within 20 min even outside a laboratory. In order to evaluate the accuracy and relia...
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| Format: | Article |
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MDPI AG
2022-03-01
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| Series: | Diagnostics |
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| Online Access: | https://www.mdpi.com/2075-4418/12/3/650 |
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| author | Immacolata Polvere Serena Voccola Silvia D'Andrea Lucrezia Zerillo Romualdo Varricchio Jessica Raffaella Madera Romania Stilo Pasquale Vito Tiziana Zotti |
| author_facet | Immacolata Polvere Serena Voccola Silvia D'Andrea Lucrezia Zerillo Romualdo Varricchio Jessica Raffaella Madera Romania Stilo Pasquale Vito Tiziana Zotti |
| author_sort | Immacolata Polvere |
| collection | DOAJ |
| description | Molecular tests are the gold standard to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection but are associated with a diagnostic delay, while antigen detection tests can generate results within 20 min even outside a laboratory. In order to evaluate the accuracy and reliability of the FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit (Ag-RDT), two respiratory swabs were collected simultaneously from 501 patients, with mild or no coronavirus disease 2019 (COVID-19)-related symptoms, and analyzed with both the Reverse Transcriptase-quantitative Polymerase Chain Reaction (RT-qPCR) and the FAST COVID-19 SARS-CoV-2 Antigen Rapid Test. Results were then compared to determine clinical performance in a screening setting. We measured a precision of 97.41% (95% CI 92.42–99.15%) and a recall of 98.26% (95% CI 93.88–99.25%), with a specificity of 99.22% (95% CI 97.74–99.74%), a negative predictive value of 99.48% (95% CI 97.98–99.87%), and an overall accuracy of 99.00% (95% CI 97.69–99.68%). Concordance was described by a Kappa coefficient of 0.971 (95% CI 0.947–0.996). Considering short lead times, low cost, and opportunities for decentralized testing, the Ag-RDT test can enhance the efforts to control SARS-CoV-2 spread in several settings. |
| first_indexed | 2024-03-09T13:46:38Z |
| format | Article |
| id | doaj.art-d8e5f6a4bfd1446a85c374c145b431ce |
| institution | Directory Open Access Journal |
| issn | 2075-4418 |
| language | English |
| last_indexed | 2024-03-09T13:46:38Z |
| publishDate | 2022-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj.art-d8e5f6a4bfd1446a85c374c145b431ce2023-11-30T20:59:02ZengMDPI AGDiagnostics2075-44182022-03-0112365010.3390/diagnostics12030650Evaluation of FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit for Detection of SARS-CoV-2 in Respiratory Samples from Mildly Symptomatic or Asymptomatic PatientsImmacolata Polvere0Serena Voccola1Silvia D'Andrea2Lucrezia Zerillo3Romualdo Varricchio4Jessica Raffaella Madera5Romania Stilo6Pasquale Vito7Tiziana Zotti8Department of Science and Technologies, University of Sannio, 82100 Benevento, ItalyGenus Biotech, University of Sannio, 82100 Benevento, ItalyGenus Biotech, University of Sannio, 82100 Benevento, ItalyDepartment of Science and Technologies, University of Sannio, 82100 Benevento, ItalyGenus Biotech, University of Sannio, 82100 Benevento, ItalyDepartment of Science and Technologies, University of Sannio, 82100 Benevento, ItalyDepartment of Science and Technologies, University of Sannio, 82100 Benevento, ItalyDepartment of Science and Technologies, University of Sannio, 82100 Benevento, ItalyDepartment of Science and Technologies, University of Sannio, 82100 Benevento, ItalyMolecular tests are the gold standard to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection but are associated with a diagnostic delay, while antigen detection tests can generate results within 20 min even outside a laboratory. In order to evaluate the accuracy and reliability of the FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit (Ag-RDT), two respiratory swabs were collected simultaneously from 501 patients, with mild or no coronavirus disease 2019 (COVID-19)-related symptoms, and analyzed with both the Reverse Transcriptase-quantitative Polymerase Chain Reaction (RT-qPCR) and the FAST COVID-19 SARS-CoV-2 Antigen Rapid Test. Results were then compared to determine clinical performance in a screening setting. We measured a precision of 97.41% (95% CI 92.42–99.15%) and a recall of 98.26% (95% CI 93.88–99.25%), with a specificity of 99.22% (95% CI 97.74–99.74%), a negative predictive value of 99.48% (95% CI 97.98–99.87%), and an overall accuracy of 99.00% (95% CI 97.69–99.68%). Concordance was described by a Kappa coefficient of 0.971 (95% CI 0.947–0.996). Considering short lead times, low cost, and opportunities for decentralized testing, the Ag-RDT test can enhance the efforts to control SARS-CoV-2 spread in several settings.https://www.mdpi.com/2075-4418/12/3/650SARS-CoV-2COVID-19antigenic testAg-RDTRT-qPCRdiagnosis |
| spellingShingle | Immacolata Polvere Serena Voccola Silvia D'Andrea Lucrezia Zerillo Romualdo Varricchio Jessica Raffaella Madera Romania Stilo Pasquale Vito Tiziana Zotti Evaluation of FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit for Detection of SARS-CoV-2 in Respiratory Samples from Mildly Symptomatic or Asymptomatic Patients Diagnostics SARS-CoV-2 COVID-19 antigenic test Ag-RDT RT-qPCR diagnosis |
| title | Evaluation of FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit for Detection of SARS-CoV-2 in Respiratory Samples from Mildly Symptomatic or Asymptomatic Patients |
| title_full | Evaluation of FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit for Detection of SARS-CoV-2 in Respiratory Samples from Mildly Symptomatic or Asymptomatic Patients |
| title_fullStr | Evaluation of FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit for Detection of SARS-CoV-2 in Respiratory Samples from Mildly Symptomatic or Asymptomatic Patients |
| title_full_unstemmed | Evaluation of FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit for Detection of SARS-CoV-2 in Respiratory Samples from Mildly Symptomatic or Asymptomatic Patients |
| title_short | Evaluation of FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit for Detection of SARS-CoV-2 in Respiratory Samples from Mildly Symptomatic or Asymptomatic Patients |
| title_sort | evaluation of fast covid 19 sars cov 2 antigen rapid test kit for detection of sars cov 2 in respiratory samples from mildly symptomatic or asymptomatic patients |
| topic | SARS-CoV-2 COVID-19 antigenic test Ag-RDT RT-qPCR diagnosis |
| url | https://www.mdpi.com/2075-4418/12/3/650 |
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