Comparative analysis of antigen and molecular tests for the detection of Sars-CoV-2 and related variants : A study on 4266 samples
Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved..
OBJECTIVES: The present study compared the performance of the Lumipulse G Sars-CoV-2 Ag kit with the TaqPath COVID-19 RT-PCR CE IVD kit.
METHODS: The study was conducted on 4266 naso-oropharyngeal swabs. Samples were subjected to antigen RT-PCR tests for the detection of Sars-CoV-2 and related variants. Statistical analyses were conducted in R software.
RESULTS: We found 503 positives (including 138 H69-V70 deletion carriers) and 3763 negatives by RT-PCR, whereas 538 positives and 3728 negatives were obtained by antigen testing. We achieved empirical and binormal AU-ROCs of 0.920 and 0.990, accuracy of 0.960, sensitivity of 0.866, specificity of 0.973, positive and negative predictive values of 0.810 and 0.980. We obtained a positive correlation between viral loads and antigen levels (R2 = 0.81), finding a complete concordance for high viral loads (log10 copies/mL > 5.4). Antigen levels > 222 pg/mL were found to be reliable in assigning positive samples (p < 0.01). Concerning variant carriers, antigen test detected them with the same accuracy as other positive samples.
CONCLUSIONS: Molecular and antigen tests should be evaluated regarding the prevalence of the area. In case of low prevalence, antigen testing can be employed as a first-line screening for the timely identification of affected individuals with high viral load, also if carriers of Sars-CoV-2 variants.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:108 |
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| Enthalten in: |
International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases - 108(2021) vom: 09. Juli, Seite 187-189 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Caputo, Valerio [VerfasserIn] |
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| Links: |
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| Themen: |
Antigen test |
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| Anmerkungen: |
Date Completed 19.08.2021 Date Revised 29.11.2021 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.ijid.2021.04.048 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM324328591 |
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| 245 | 1 | 0 | |a Comparative analysis of antigen and molecular tests for the detection of Sars-CoV-2 and related variants |b A study on 4266 samples |
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| 500 | |a Date Revised 29.11.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved. | ||
| 520 | |a OBJECTIVES: The present study compared the performance of the Lumipulse G Sars-CoV-2 Ag kit with the TaqPath COVID-19 RT-PCR CE IVD kit | ||
| 520 | |a METHODS: The study was conducted on 4266 naso-oropharyngeal swabs. Samples were subjected to antigen RT-PCR tests for the detection of Sars-CoV-2 and related variants. Statistical analyses were conducted in R software | ||
| 520 | |a RESULTS: We found 503 positives (including 138 H69-V70 deletion carriers) and 3763 negatives by RT-PCR, whereas 538 positives and 3728 negatives were obtained by antigen testing. We achieved empirical and binormal AU-ROCs of 0.920 and 0.990, accuracy of 0.960, sensitivity of 0.866, specificity of 0.973, positive and negative predictive values of 0.810 and 0.980. We obtained a positive correlation between viral loads and antigen levels (R2 = 0.81), finding a complete concordance for high viral loads (log10 copies/mL > 5.4). Antigen levels > 222 pg/mL were found to be reliable in assigning positive samples (p < 0.01). Concerning variant carriers, antigen test detected them with the same accuracy as other positive samples | ||
| 520 | |a CONCLUSIONS: Molecular and antigen tests should be evaluated regarding the prevalence of the area. In case of low prevalence, antigen testing can be employed as a first-line screening for the timely identification of affected individuals with high viral load, also if carriers of Sars-CoV-2 variants | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Antigen test | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Naso-oropharyngeal swabs | |
| 650 | 4 | |a Sars-CoV-2 variants | |
| 650 | 4 | |a Screening | |
| 650 | 4 | |a Viral load | |
| 700 | 1 | |a Bax, Cristina |e verfasserin |4 aut | |
| 700 | 1 | |a Colantoni, Luca |e verfasserin |4 aut | |
| 700 | 1 | |a Peconi, Cristina |e verfasserin |4 aut | |
| 700 | 1 | |a Termine, Andrea |e verfasserin |4 aut | |
| 700 | 1 | |a Fabrizio, Carlo |e verfasserin |4 aut | |
| 700 | 1 | |a Calvino, Giulia |e verfasserin |4 aut | |
| 700 | 1 | |a Luzzi, Laura |e verfasserin |4 aut | |
| 700 | 1 | |a Panunzi, Giorgia Gaia |e verfasserin |4 aut | |
| 700 | 1 | |a Fusco, Claudia |e verfasserin |4 aut | |
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| 700 | 1 | |a Sancesario, Giulia |e verfasserin |4 aut | |
| 700 | 1 | |a Giardina, Emiliano |e verfasserin |4 aut | |
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