Evaluation of the new 2.0 version of the Roche SARS-CoV-2 Rapid Antigen Test
Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved..
We evaluated the new 2.0 version of the Roche Diagnostics SARS-CoV-2 Rapid Antigen Test (RAT 2.0) for the detection of SARS-CoV-2. Our evaluation material comprised of nasopharyngeal samples of 140 persons positive for SARS-CoV-2 nucleic acid amplification test (NAAT) and of 100 persons negative for SARS-CoV-2 NAAT. The sensitivity limit of the RAT 2.0 was further estimated with the additional selected samples of 27 persons with high NAAT cycle threshold (Ct) value representing low viral load. For the detection of possible cross-reactions in the RAT 2.0, routine respiratory samples positive for influenza A (N = 5), respiratory syncytial virus (RSV) (N = 4), or combined RSV and human coronavirus OC43 (N = 1) were included in the study material. The overall sensitivity of the RAT 2.0 was 92.1% and specificity 100%. When evaluating the samples with NAAT Ct value ≤ 30, the sensitivity was 97.0%. All samples for cross-reactivity testing containing other viruses instead of SARS-CoV-2 remained negative in RAT 2.0. According to our findings, this RAT 2.0 offers a reliable tool for the diagnostics of acute COVID-19 in this pandemic environment.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:319 |
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| Enthalten in: |
Journal of virological methods - 319(2023) vom: 30. Sept., Seite 114758 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Flinck, Heini [VerfasserIn] |
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| Links: |
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| Themen: |
Journal Article |
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| Anmerkungen: |
Date Completed 24.07.2023 Date Revised 24.07.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jviromet.2023.114758 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM357654331 |
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| 520 | |a Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved. | ||
| 520 | |a We evaluated the new 2.0 version of the Roche Diagnostics SARS-CoV-2 Rapid Antigen Test (RAT 2.0) for the detection of SARS-CoV-2. Our evaluation material comprised of nasopharyngeal samples of 140 persons positive for SARS-CoV-2 nucleic acid amplification test (NAAT) and of 100 persons negative for SARS-CoV-2 NAAT. The sensitivity limit of the RAT 2.0 was further estimated with the additional selected samples of 27 persons with high NAAT cycle threshold (Ct) value representing low viral load. For the detection of possible cross-reactions in the RAT 2.0, routine respiratory samples positive for influenza A (N = 5), respiratory syncytial virus (RSV) (N = 4), or combined RSV and human coronavirus OC43 (N = 1) were included in the study material. The overall sensitivity of the RAT 2.0 was 92.1% and specificity 100%. When evaluating the samples with NAAT Ct value ≤ 30, the sensitivity was 97.0%. All samples for cross-reactivity testing containing other viruses instead of SARS-CoV-2 remained negative in RAT 2.0. According to our findings, this RAT 2.0 offers a reliable tool for the diagnostics of acute COVID-19 in this pandemic environment | ||
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