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Evaluation of the analytical sensitivity of ACON and LumiraDx SARS-CoV-2 rapid antigen tests using samples with presumed Omicron variant
BACKGROUND: Analytical sensitivity of 2 rapid antigen tests was evaluated for detection of presumed SARS-CoV-2 Omicron variants and earlier variants of concern. METHODS: A total of 152 SARS-CoV-2 RNA positive samples (N and ORF1ab positive but S gene negative) were tested for SARS-CoV-2 antigen by A...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier Inc.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10154058/ https://www.ncbi.nlm.nih.gov/pubmed/37329875 http://dx.doi.org/10.1016/j.diagmicrobio.2023.115977 |
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author | Karon, Brad S. Donato, Leslie J. Moyer, Ann M. Wockenfus, Amy M. Kelley, Brandon R. Majumdar, Ramanath Kipp, Benjamin R. Yao, Joseph D. |
author_facet | Karon, Brad S. Donato, Leslie J. Moyer, Ann M. Wockenfus, Amy M. Kelley, Brandon R. Majumdar, Ramanath Kipp, Benjamin R. Yao, Joseph D. |
author_sort | Karon, Brad S. |
collection | PubMed |
description | BACKGROUND: Analytical sensitivity of 2 rapid antigen tests was evaluated for detection of presumed SARS-CoV-2 Omicron variants and earlier variants of concern. METHODS: A total of 152 SARS-CoV-2 RNA positive samples (N and ORF1ab positive but S gene negative) were tested for SARS-CoV-2 antigen by ACON lateral flow and LumiraDx fluorescence immunoassays. Sensitivity within 3 viral load ranges was compared among these 152 samples and 194 similarly characterized samples collected prior to the circulation of the Delta variant (pre-Delta). RESULTS: Antigen was detected in >95% of pre-Delta and presumed Omicron samples for both tests at viral loads >500,000 copies/mL, and 65 to 85% of samples with 50,000-500,000 copies/mL. At viral load <50,000 copies/mL, antigen tests showed better sensitivity in detecting pre-Delta compared to Omicron variants. LumiraDx was more sensitive than ACON at low viral load. CONCLUSIONS: Antigen tests had decreased sensitivity for detecting presumed Omicron compared to pre-Delta variants at low viral load. |
format | Online Article Text |
id | pubmed-10154058 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Elsevier Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-101540582023-05-03 Evaluation of the analytical sensitivity of ACON and LumiraDx SARS-CoV-2 rapid antigen tests using samples with presumed Omicron variant Karon, Brad S. Donato, Leslie J. Moyer, Ann M. Wockenfus, Amy M. Kelley, Brandon R. Majumdar, Ramanath Kipp, Benjamin R. Yao, Joseph D. Diagn Microbiol Infect Dis Original Article BACKGROUND: Analytical sensitivity of 2 rapid antigen tests was evaluated for detection of presumed SARS-CoV-2 Omicron variants and earlier variants of concern. METHODS: A total of 152 SARS-CoV-2 RNA positive samples (N and ORF1ab positive but S gene negative) were tested for SARS-CoV-2 antigen by ACON lateral flow and LumiraDx fluorescence immunoassays. Sensitivity within 3 viral load ranges was compared among these 152 samples and 194 similarly characterized samples collected prior to the circulation of the Delta variant (pre-Delta). RESULTS: Antigen was detected in >95% of pre-Delta and presumed Omicron samples for both tests at viral loads >500,000 copies/mL, and 65 to 85% of samples with 50,000-500,000 copies/mL. At viral load <50,000 copies/mL, antigen tests showed better sensitivity in detecting pre-Delta compared to Omicron variants. LumiraDx was more sensitive than ACON at low viral load. CONCLUSIONS: Antigen tests had decreased sensitivity for detecting presumed Omicron compared to pre-Delta variants at low viral load. Elsevier Inc. 2023-09 2023-05-03 /pmc/articles/PMC10154058/ /pubmed/37329875 http://dx.doi.org/10.1016/j.diagmicrobio.2023.115977 Text en © 2023 Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Original Article Karon, Brad S. Donato, Leslie J. Moyer, Ann M. Wockenfus, Amy M. Kelley, Brandon R. Majumdar, Ramanath Kipp, Benjamin R. Yao, Joseph D. Evaluation of the analytical sensitivity of ACON and LumiraDx SARS-CoV-2 rapid antigen tests using samples with presumed Omicron variant |
title | Evaluation of the analytical sensitivity of ACON and LumiraDx SARS-CoV-2 rapid antigen tests using samples with presumed Omicron variant |
title_full | Evaluation of the analytical sensitivity of ACON and LumiraDx SARS-CoV-2 rapid antigen tests using samples with presumed Omicron variant |
title_fullStr | Evaluation of the analytical sensitivity of ACON and LumiraDx SARS-CoV-2 rapid antigen tests using samples with presumed Omicron variant |
title_full_unstemmed | Evaluation of the analytical sensitivity of ACON and LumiraDx SARS-CoV-2 rapid antigen tests using samples with presumed Omicron variant |
title_short | Evaluation of the analytical sensitivity of ACON and LumiraDx SARS-CoV-2 rapid antigen tests using samples with presumed Omicron variant |
title_sort | evaluation of the analytical sensitivity of acon and lumiradx sars-cov-2 rapid antigen tests using samples with presumed omicron variant |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10154058/ https://www.ncbi.nlm.nih.gov/pubmed/37329875 http://dx.doi.org/10.1016/j.diagmicrobio.2023.115977 |
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