Clinical Validation of GenBody COVID-19 Ag, Nasal and Nasopharyngeal Rapid Antigen Tests for Detection of SARS-CoV-2 in European Adult Population
Accurate and rapid identification of COVID-19 is critical for effective patient treatment and disease outcomes, as well as the prevention of SARS-CoV-2 transmission. Rapid antigen tests (RATs) for identifying SARS-CoV-2 are simpler, faster and less expensive than molecular assays. Any new product to...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-02-01
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| Series: | Biomedicines |
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| Online Access: | https://www.mdpi.com/2227-9059/11/2/493 |
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| author | Karolina Wegrzynska Jaroslaw Walory Radoslaw Charkiewicz Marzena Anna Lewandowska Izabela Wasko Aleksandra Kozinska Piotr Majewski Anna Baraniak |
| author_facet | Karolina Wegrzynska Jaroslaw Walory Radoslaw Charkiewicz Marzena Anna Lewandowska Izabela Wasko Aleksandra Kozinska Piotr Majewski Anna Baraniak |
| author_sort | Karolina Wegrzynska |
| collection | DOAJ |
| description | Accurate and rapid identification of COVID-19 is critical for effective patient treatment and disease outcomes, as well as the prevention of SARS-CoV-2 transmission. Rapid antigen tests (RATs) for identifying SARS-CoV-2 are simpler, faster and less expensive than molecular assays. Any new product to be considered a medical device is subject to evaluation and data analysis to verify the in vitro diagnostic ability to achieve its intended purpose. Clinical validation of such a test is a prerequisite before clinical application. This study was a clinical validation on adult Europeans of GenBody COVID-19 Ag, nasal and nasopharyngeal RATs. A set of 103 positive and 301 negative from nose and nasopharynx samples confirmed by RT-qPCR were examined. The tests were safe to use and showed 100% specificity in both specimens, and high sensitivity of 94.17% (95%CI 87.75% to 97.83%) and 97.09% (95%CI 91.72% to 99.4%), respectively. The parameters were significantly better for samples with higher virus loads (the highest for CT ≤ 25). The GenBody COVID-19 Ag RATs are inexpensive (compared to RT-qPCR), reliable and rapid with high sensitivity and specificity, making them suitable for diagnosis and timely isolation and treatment of COVID-19 patients, contributing to the better control of virus spread. |
| first_indexed | 2024-03-11T09:06:52Z |
| format | Article |
| id | doaj.art-56dd37f1adb5414384dece58acb2ace3 |
| institution | Directory Open Access Journal |
| issn | 2227-9059 |
| language | English |
| last_indexed | 2024-03-11T09:06:52Z |
| publishDate | 2023-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Biomedicines |
| spelling | doaj.art-56dd37f1adb5414384dece58acb2ace32023-11-16T19:19:01ZengMDPI AGBiomedicines2227-90592023-02-0111249310.3390/biomedicines11020493Clinical Validation of GenBody COVID-19 Ag, Nasal and Nasopharyngeal Rapid Antigen Tests for Detection of SARS-CoV-2 in European Adult PopulationKarolina Wegrzynska0Jaroslaw Walory1Radoslaw Charkiewicz2Marzena Anna Lewandowska3Izabela Wasko4Aleksandra Kozinska5Piotr Majewski6Anna Baraniak7Department of Biomedical Research, National Medicines Institute, 00-725 Warsaw, PolandDepartment of Biomedical Research, National Medicines Institute, 00-725 Warsaw, PolandDepartment of Clinical Molecular Biology, Medical University of Bialystok, 15-269 Bialystok, PolandThe F. Lukaszczyk Oncology Center, Molecular Oncology and Genetics Department, Innovative Medical Forum, 85-796 Bydgoszcz, PolandDepartment of Biomedical Research, National Medicines Institute, 00-725 Warsaw, PolandDepartment of Biomedical Research, National Medicines Institute, 00-725 Warsaw, PolandDepartment of Microbiological Diagnostics and Infectious Immunology, Medical University of Bialystok, 15-369 Bialystok, PolandDepartment of Biomedical Research, National Medicines Institute, 00-725 Warsaw, PolandAccurate and rapid identification of COVID-19 is critical for effective patient treatment and disease outcomes, as well as the prevention of SARS-CoV-2 transmission. Rapid antigen tests (RATs) for identifying SARS-CoV-2 are simpler, faster and less expensive than molecular assays. Any new product to be considered a medical device is subject to evaluation and data analysis to verify the in vitro diagnostic ability to achieve its intended purpose. Clinical validation of such a test is a prerequisite before clinical application. This study was a clinical validation on adult Europeans of GenBody COVID-19 Ag, nasal and nasopharyngeal RATs. A set of 103 positive and 301 negative from nose and nasopharynx samples confirmed by RT-qPCR were examined. The tests were safe to use and showed 100% specificity in both specimens, and high sensitivity of 94.17% (95%CI 87.75% to 97.83%) and 97.09% (95%CI 91.72% to 99.4%), respectively. The parameters were significantly better for samples with higher virus loads (the highest for CT ≤ 25). The GenBody COVID-19 Ag RATs are inexpensive (compared to RT-qPCR), reliable and rapid with high sensitivity and specificity, making them suitable for diagnosis and timely isolation and treatment of COVID-19 patients, contributing to the better control of virus spread.https://www.mdpi.com/2227-9059/11/2/493clinical trialclinical validationGenBody COVID-19 Agrapid antigen test (RAT)RT-qPCR |
| spellingShingle | Karolina Wegrzynska Jaroslaw Walory Radoslaw Charkiewicz Marzena Anna Lewandowska Izabela Wasko Aleksandra Kozinska Piotr Majewski Anna Baraniak Clinical Validation of GenBody COVID-19 Ag, Nasal and Nasopharyngeal Rapid Antigen Tests for Detection of SARS-CoV-2 in European Adult Population Biomedicines clinical trial clinical validation GenBody COVID-19 Ag rapid antigen test (RAT) RT-qPCR |
| title | Clinical Validation of GenBody COVID-19 Ag, Nasal and Nasopharyngeal Rapid Antigen Tests for Detection of SARS-CoV-2 in European Adult Population |
| title_full | Clinical Validation of GenBody COVID-19 Ag, Nasal and Nasopharyngeal Rapid Antigen Tests for Detection of SARS-CoV-2 in European Adult Population |
| title_fullStr | Clinical Validation of GenBody COVID-19 Ag, Nasal and Nasopharyngeal Rapid Antigen Tests for Detection of SARS-CoV-2 in European Adult Population |
| title_full_unstemmed | Clinical Validation of GenBody COVID-19 Ag, Nasal and Nasopharyngeal Rapid Antigen Tests for Detection of SARS-CoV-2 in European Adult Population |
| title_short | Clinical Validation of GenBody COVID-19 Ag, Nasal and Nasopharyngeal Rapid Antigen Tests for Detection of SARS-CoV-2 in European Adult Population |
| title_sort | clinical validation of genbody covid 19 ag nasal and nasopharyngeal rapid antigen tests for detection of sars cov 2 in european adult population |
| topic | clinical trial clinical validation GenBody COVID-19 Ag rapid antigen test (RAT) RT-qPCR |
| url | https://www.mdpi.com/2227-9059/11/2/493 |
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