Quantifying the potential value of antigen-detection rapid diagnostic tests for COVID-19: a modelling analysis
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Published version
Author(s)
Type
Journal Article
Abstract
Background
Testing plays a critical role in treatment and prevention responses to the COVID-19 pandemic. Compared to nucleic acid tests (NATs), antigen-detection rapid diagnostic tests (Ag-RDTs) can be more accessible, but typically have lower sensitivity and specificity. By quantifying these trade-offs, we aimed to inform decisions about when an Ag-RDT would offer greater public health value than reliance on NAT.
Methods
Following an expert consultation, we selected two use cases for analysis: rapid identification of people with COVID-19 amongst patients admitted with respiratory symptoms in a ‘hospital’ setting; and early identification and isolation of people with mildly symptomatic COVID-19 in a ‘community’ setting. Using decision analysis, we evaluated the health system cost and health impact (deaths averted and infectious days isolated) of an Ag-RDT-led strategy, compared to a strategy based on NAT and clinical judgment. We adopted a broad range of values for ‘contextual’ parameters relevant to a range of settings, including the availability of NAT, the performance of clinical judgement, etc. We performed a multivariate sensitivity analysis to all of these parameters.
Results
In a hospital setting, an Ag-RDT-led strategy would avert more deaths than a NAT-based strategy, and at lower cost per death averted, when the sensitivity of clinical judgement is less than 85%, and when NAT results are available in time to inform clinical decision-making for less than 90% of patients. The use of an Ag-RDT is robustly supported in community settings, where it would avert more transmission at lower cost than relying on NAT alone, under a wide range of assumptions.
Conclusions
Despite their imperfect sensitivity and specificity, Ag-RDTs have the potential to be simultaneously more impactful, and have a lower cost per death and infectious person-days averted, than current approaches to COVID-19 diagnostic testing.
Testing plays a critical role in treatment and prevention responses to the COVID-19 pandemic. Compared to nucleic acid tests (NATs), antigen-detection rapid diagnostic tests (Ag-RDTs) can be more accessible, but typically have lower sensitivity and specificity. By quantifying these trade-offs, we aimed to inform decisions about when an Ag-RDT would offer greater public health value than reliance on NAT.
Methods
Following an expert consultation, we selected two use cases for analysis: rapid identification of people with COVID-19 amongst patients admitted with respiratory symptoms in a ‘hospital’ setting; and early identification and isolation of people with mildly symptomatic COVID-19 in a ‘community’ setting. Using decision analysis, we evaluated the health system cost and health impact (deaths averted and infectious days isolated) of an Ag-RDT-led strategy, compared to a strategy based on NAT and clinical judgment. We adopted a broad range of values for ‘contextual’ parameters relevant to a range of settings, including the availability of NAT, the performance of clinical judgement, etc. We performed a multivariate sensitivity analysis to all of these parameters.
Results
In a hospital setting, an Ag-RDT-led strategy would avert more deaths than a NAT-based strategy, and at lower cost per death averted, when the sensitivity of clinical judgement is less than 85%, and when NAT results are available in time to inform clinical decision-making for less than 90% of patients. The use of an Ag-RDT is robustly supported in community settings, where it would avert more transmission at lower cost than relying on NAT alone, under a wide range of assumptions.
Conclusions
Despite their imperfect sensitivity and specificity, Ag-RDTs have the potential to be simultaneously more impactful, and have a lower cost per death and infectious person-days averted, than current approaches to COVID-19 diagnostic testing.
Date Issued
2021-03-09
Date Acceptance
2021-02-22
Citation
BMC Medicine, 2021, 19 (75), pp.1-13
ISSN
1741-7015
Publisher
BioMed Central
Start Page
1
End Page
13
Journal / Book Title
BMC Medicine
Volume
19
Issue
75
Copyright Statement
© The Author(s). 2021 Open Access This 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/.
The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the
data made available in this article, unless otherwise stated in a credit line to the data.
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/.
The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the
data made available in this article, unless otherwise stated in a credit line to the data.
Sponsor
Wellcome Trust
Medical Research Council (MRC)
Identifier
https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-021-01948-z
Grant Number
203839/A/16/Z
MR/R015600/1
Subjects
Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
Antigen
Rapid diagnostic tests
COVID-19
Antigen
COVID-19
Rapid diagnostic tests
Antigens, Viral
COVID-19
COVID-19 Testing
Diagnostic Tests, Routine
Humans
Pandemics
SARS-CoV-2
Sensitivity and Specificity
Humans
Antigens, Viral
Diagnostic Tests, Routine
Sensitivity and Specificity
Pandemics
COVID-19
SARS-CoV-2
COVID-19 Testing
General & Internal Medicine
11 Medical and Health Sciences
Publication Status
Published
Date Publish Online
2021-03-09