Evidence map›Paper›PMID 40801538›Full record

ArticleMicrobiology spectrum2025

Comparison of the analytical and clinical sensitivities of 34 rapid antigen tests with prevalent SARS-CoV-2 variants of concern during the COVID-19 pandemic in the UK.

Rachel L Byrne, Rachel S Owen, Ghaith Aljayyoussi, Caitlin Greenland-Bews, Konstantina Kontogianni, Anushri Somasundaran, Dominic Wooding, Christopher T Williams, LSTM Diagnostics Group, Falcon Steering Group and 6 more

Abstract readComparative Study
In one paragraph

Article in Microbiology spectrum, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Rachel L Byrne *Centre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.ORCID 0000-0001-5398-3125
Rachel S Owen *Centre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.ORCID 0000-0001-6441-2213
Ghaith AljayyoussiCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.ORCID 0000-0002-5288-4501
Caitlin Greenland-BewsCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.ORCID 0000-0003-3374-1385
Konstantina KontogianniCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.ORCID 0000-0002-5353-3682
Anushri SomasundaranCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.ORCID 0009-0008-4785-080X
Dominic WoodingCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.ORCID 0000-0002-9985-0413
Christopher T WilliamsCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.
LSTM Diagnostics Group
Falcon Steering Group
Margaretha de VosFIND, Foundation for Innovative New Diagnostics, Geneva, Switzerland.ORCID 0000-0003-3059-2986
Richard BodyManchester University NHS Foundation Trust, Manchester, United Kingdom.ORCID 0000-0001-9089-8130
Emily R AdamsCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.ORCID 0000-0002-0816-2835
Camille EscadafalFIND, Foundation for Innovative New Diagnostics, Geneva, Switzerland.ORCID 0000-0002-0268-750X
Thomas EdwardsCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.ORCID 0000-0003-4058-4461
Ana I Cubas-AtienzarCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.ORCID 0000-0002-9604-124X

Funding

Foundation for Innovative New DiagnosticsMedical Research Council MR/R015678/1National Institute for Health Research
6 · The paper itself

Abstract

Antigen-detection rapid diagnostic tests (Ag-RDTs) have become a central pillar for the management of coronavirus disease worldwide due to their speed and ease of use and are now being developed for use in other emerging outbreaks. Like other viruses, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is subject to rapid mutation as it spreads, and new variants of concern (VOCs) emerge frequently, posing a significant challenge for the detection of newer, highly mutated variants. It is, therefore, important that the performance of Ag-RDTs is regularly evaluated, particularly in outbreak scenarios where rapid diagnostics are key to limiting disease spread. Here, we present a comprehensive evaluation of the analytical and clinical sensitivities of 34 commercially available Ag-RDTs with five SARS-CoV-2 VOCs, all of which were highly prevalent in the UK at various times between 2019 and 2023. This study highlights the importance of regular evaluation of the Ag-RDT performance, with several Ag-RDTs demonstrating a reduced performance with some VOCs. We conclude that a regular performance evaluation through our proposed pipeline, combined with a broad consensus approval threshold across global organizations, is essential to maintaining the effectiveness of Ag-RDTs as a disease management tool during outbreaks.IMPORTANCEAntigen-detection rapid diagnostic tests (Ag-RDTs) came to global prominence during the coronavirus disease pandemic, where they offered a quick and simple at-home diagnostic, which could be used to manage disease spread. A major ongoing challenge for the broad use of Ag-RDTs is the speed at which new SARS-CoV-2 variants emerge, each of which has the potential to reduce the performance of available Ag-RDTs. As Ag-RDTs are explored for use in other viral disease outbreaks, pipelines for the regular evaluation of test performance are essential for ensuring that Ag-RDTs can be employed effectively. Here, we have developed a robust pipeline for the large-scale evaluation of commercially available Ag-RDTs against several major SARS-CoV-2 variants, which can be adapted and applied to other emerging outbreaks to ensure that test performance is maintained as a virus evolves.

Indexed as

Antigens, ViralCOVID-19COVID-19 Serological TestingSARS-CoV-2HumansPandemicsSensitivity and SpecificityUnited KingdomAntigens, Viralantigen detectionB.1.1.529COVID-19Deltalimit of detection (LOD)Omicronrapid diagnostic test (RDT)SARS-CoV-2 variant of concern (VOC), B.1.617.2

Identifiers

PMID40801538
PMCPMC12502672

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.