Cargando…

Impaired detection of omicron by SARS-CoV-2 rapid antigen tests

Since autumn 2020, rapid antigen tests (RATs) have been implemented in several countries as an important pillar of the national testing strategy to rapidly screen for infections on site during the SARS-CoV-2 pandemic. The current surge in infection rates around the globe is driven by the variant of...

Descripción completa

Detalles Bibliográficos
Autores principales: Osterman, Andreas, Badell, Irina, Basara, Elif, Stern, Marcel, Kriesel, Fabian, Eletreby, Marwa, Öztan, Gamze Naz, Huber, Melanie, Autenrieth, Hanna, Knabe, Ricarda, Späth, Patricia M., Muenchhoff, Maximilian, Graf, Alexander, Krebs, Stefan, Blum, Helmut, Durner, Jürgen, Czibere, Ludwig, Dächert, Christopher, Kaderali, Lars, Baldauf, Hanna-Mari, Keppler, Oliver T.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8858605/
https://www.ncbi.nlm.nih.gov/pubmed/35187580
http://dx.doi.org/10.1007/s00430-022-00730-z
_version_ 1784654275600711680
author Osterman, Andreas
Badell, Irina
Basara, Elif
Stern, Marcel
Kriesel, Fabian
Eletreby, Marwa
Öztan, Gamze Naz
Huber, Melanie
Autenrieth, Hanna
Knabe, Ricarda
Späth, Patricia M.
Muenchhoff, Maximilian
Graf, Alexander
Krebs, Stefan
Blum, Helmut
Durner, Jürgen
Czibere, Ludwig
Dächert, Christopher
Kaderali, Lars
Baldauf, Hanna-Mari
Keppler, Oliver T.
author_facet Osterman, Andreas
Badell, Irina
Basara, Elif
Stern, Marcel
Kriesel, Fabian
Eletreby, Marwa
Öztan, Gamze Naz
Huber, Melanie
Autenrieth, Hanna
Knabe, Ricarda
Späth, Patricia M.
Muenchhoff, Maximilian
Graf, Alexander
Krebs, Stefan
Blum, Helmut
Durner, Jürgen
Czibere, Ludwig
Dächert, Christopher
Kaderali, Lars
Baldauf, Hanna-Mari
Keppler, Oliver T.
author_sort Osterman, Andreas
collection PubMed
description Since autumn 2020, rapid antigen tests (RATs) have been implemented in several countries as an important pillar of the national testing strategy to rapidly screen for infections on site during the SARS-CoV-2 pandemic. The current surge in infection rates around the globe is driven by the variant of concern (VoC) omicron (B.1.1.529). Here, we evaluated the performance of nine SARS-CoV-2 RATs in a single-centre laboratory study. We examined a total of 115 SARS-CoV-2 PCR-negative and 166 SARS-CoV-2 PCR-positive respiratory swab samples (101 omicron, 65 delta (B.1.617.2)) collected from October 2021 until January 2022 as well as cell culture-expanded clinical isolates of both VoCs. In an assessment of the analytical sensitivity in clinical specimen, the 50% limit of detection (LoD50) ranged from 1.77 × 10(6) to 7.03 × 10(7) RNA copies subjected to the RAT for omicron compared to 1.32 × 10(5) to 2.05 × 10(6) for delta. To score positive in these point-of-care tests, up to 10-fold (LoD50) or 101-fold (LoD95) higher virus loads were required for omicron- compared to delta-containing samples. The rates of true positive test results for omicron samples in the highest virus load category (Ct values < 25) ranged between 31.4 and 77.8%, while they dropped to 0–8.3% for samples with intermediate Ct values (25–30). Of note, testing of expanded virus stocks suggested a comparable RAT sensitivity of both VoCs, questioning the predictive value of this type of in vitro-studies for clinical performance. Given their importance for national test strategies in the current omicron wave, awareness must be increased for the reduced detection rate of omicron infections by RATs and a short list of suitable RATs that fulfill the minimal requirements of performance should be rapidly disclosed. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00430-022-00730-z.
format Online
Article
Text
id pubmed-8858605
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Springer Berlin Heidelberg
record_format MEDLINE/PubMed
spelling pubmed-88586052022-02-22 Impaired detection of omicron by SARS-CoV-2 rapid antigen tests Osterman, Andreas Badell, Irina Basara, Elif Stern, Marcel Kriesel, Fabian Eletreby, Marwa Öztan, Gamze Naz Huber, Melanie Autenrieth, Hanna Knabe, Ricarda Späth, Patricia M. Muenchhoff, Maximilian Graf, Alexander Krebs, Stefan Blum, Helmut Durner, Jürgen Czibere, Ludwig Dächert, Christopher Kaderali, Lars Baldauf, Hanna-Mari Keppler, Oliver T. Med Microbiol Immunol Original Article Since autumn 2020, rapid antigen tests (RATs) have been implemented in several countries as an important pillar of the national testing strategy to rapidly screen for infections on site during the SARS-CoV-2 pandemic. The current surge in infection rates around the globe is driven by the variant of concern (VoC) omicron (B.1.1.529). Here, we evaluated the performance of nine SARS-CoV-2 RATs in a single-centre laboratory study. We examined a total of 115 SARS-CoV-2 PCR-negative and 166 SARS-CoV-2 PCR-positive respiratory swab samples (101 omicron, 65 delta (B.1.617.2)) collected from October 2021 until January 2022 as well as cell culture-expanded clinical isolates of both VoCs. In an assessment of the analytical sensitivity in clinical specimen, the 50% limit of detection (LoD50) ranged from 1.77 × 10(6) to 7.03 × 10(7) RNA copies subjected to the RAT for omicron compared to 1.32 × 10(5) to 2.05 × 10(6) for delta. To score positive in these point-of-care tests, up to 10-fold (LoD50) or 101-fold (LoD95) higher virus loads were required for omicron- compared to delta-containing samples. The rates of true positive test results for omicron samples in the highest virus load category (Ct values < 25) ranged between 31.4 and 77.8%, while they dropped to 0–8.3% for samples with intermediate Ct values (25–30). Of note, testing of expanded virus stocks suggested a comparable RAT sensitivity of both VoCs, questioning the predictive value of this type of in vitro-studies for clinical performance. Given their importance for national test strategies in the current omicron wave, awareness must be increased for the reduced detection rate of omicron infections by RATs and a short list of suitable RATs that fulfill the minimal requirements of performance should be rapidly disclosed. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00430-022-00730-z. Springer Berlin Heidelberg 2022-02-20 2022 /pmc/articles/PMC8858605/ /pubmed/35187580 http://dx.doi.org/10.1007/s00430-022-00730-z Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Article
Osterman, Andreas
Badell, Irina
Basara, Elif
Stern, Marcel
Kriesel, Fabian
Eletreby, Marwa
Öztan, Gamze Naz
Huber, Melanie
Autenrieth, Hanna
Knabe, Ricarda
Späth, Patricia M.
Muenchhoff, Maximilian
Graf, Alexander
Krebs, Stefan
Blum, Helmut
Durner, Jürgen
Czibere, Ludwig
Dächert, Christopher
Kaderali, Lars
Baldauf, Hanna-Mari
Keppler, Oliver T.
Impaired detection of omicron by SARS-CoV-2 rapid antigen tests
title Impaired detection of omicron by SARS-CoV-2 rapid antigen tests
title_full Impaired detection of omicron by SARS-CoV-2 rapid antigen tests
title_fullStr Impaired detection of omicron by SARS-CoV-2 rapid antigen tests
title_full_unstemmed Impaired detection of omicron by SARS-CoV-2 rapid antigen tests
title_short Impaired detection of omicron by SARS-CoV-2 rapid antigen tests
title_sort impaired detection of omicron by sars-cov-2 rapid antigen tests
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8858605/
https://www.ncbi.nlm.nih.gov/pubmed/35187580
http://dx.doi.org/10.1007/s00430-022-00730-z
work_keys_str_mv AT ostermanandreas impaireddetectionofomicronbysarscov2rapidantigentests
AT badellirina impaireddetectionofomicronbysarscov2rapidantigentests
AT basaraelif impaireddetectionofomicronbysarscov2rapidantigentests
AT sternmarcel impaireddetectionofomicronbysarscov2rapidantigentests
AT krieselfabian impaireddetectionofomicronbysarscov2rapidantigentests
AT eletrebymarwa impaireddetectionofomicronbysarscov2rapidantigentests
AT oztangamzenaz impaireddetectionofomicronbysarscov2rapidantigentests
AT hubermelanie impaireddetectionofomicronbysarscov2rapidantigentests
AT autenriethhanna impaireddetectionofomicronbysarscov2rapidantigentests
AT knabericarda impaireddetectionofomicronbysarscov2rapidantigentests
AT spathpatriciam impaireddetectionofomicronbysarscov2rapidantigentests
AT muenchhoffmaximilian impaireddetectionofomicronbysarscov2rapidantigentests
AT grafalexander impaireddetectionofomicronbysarscov2rapidantigentests
AT krebsstefan impaireddetectionofomicronbysarscov2rapidantigentests
AT blumhelmut impaireddetectionofomicronbysarscov2rapidantigentests
AT durnerjurgen impaireddetectionofomicronbysarscov2rapidantigentests
AT czibereludwig impaireddetectionofomicronbysarscov2rapidantigentests
AT dachertchristopher impaireddetectionofomicronbysarscov2rapidantigentests
AT kaderalilars impaireddetectionofomicronbysarscov2rapidantigentests
AT baldaufhannamari impaireddetectionofomicronbysarscov2rapidantigentests
AT kepplerolivert impaireddetectionofomicronbysarscov2rapidantigentests