The Diagnostic Accuracy of SARS-CoV-2 Nasal Rapid Antigen Self-Test: A Systematic Review and Meta-Analysis

Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of coronavirus disease 2019 (COVID-19), a disease that quickly spread into a pandemic. As such, management of the COVID-19 pandemic is deemed necessary, and it can be achieved by using reliable diagnostic tests f...

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Main Authors: Eleni Karlafti, Dimitrios Tsavdaris, Evangelia Kotzakioulafi, Georgia Kaiafa, Christos Savopoulos, Smaro Netta, Antonios Michalopoulos, Daniel Paramythiotis
Format: Article
Language:English
Published: MDPI AG 2023-01-01
Series:Life
Subjects:
Online Access:https://www.mdpi.com/2075-1729/13/2/281
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author Eleni Karlafti
Dimitrios Tsavdaris
Evangelia Kotzakioulafi
Georgia Kaiafa
Christos Savopoulos
Smaro Netta
Antonios Michalopoulos
Daniel Paramythiotis
author_facet Eleni Karlafti
Dimitrios Tsavdaris
Evangelia Kotzakioulafi
Georgia Kaiafa
Christos Savopoulos
Smaro Netta
Antonios Michalopoulos
Daniel Paramythiotis
author_sort Eleni Karlafti
collection DOAJ
description Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of coronavirus disease 2019 (COVID-19), a disease that quickly spread into a pandemic. As such, management of the COVID-19 pandemic is deemed necessary, and it can be achieved by using reliable diagnostic tests for SARS-CoV-2. The gold standard for the diagnosis of SARS-CoV-2 is a molecular detection test using the reverse transcription polymerase chain reaction technique (rt-PCR), which is characterized by various disadvantages in contrast with the self-taken nasal rapid antigen tests that produce results faster, have lower costs and do not require specialized personnel. Therefore, the usefulness of self-taken rapid antigen tests is indisputable in disease management, facilitating both the health system and the examinees. Our systematic review aims to access the diagnostic accuracy of the self-taken nasal rapid antigen tests. Methods: This systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool was used to assess the risk of bias in the included studies. All the studies included in this systematic review were found after searching the two databases, Scopus and PubΜed. All but original articles were excluded from this systematic review, while all the studies concerning self-taken rapid antigen tests with a nasal sample and using rt-PCR as a reference test were included. Meta-analysis results and plots were obtained using RevMan software and the MetaDTA website. Results: All 22 studies included in this meta-analysis demonstrated a specificity of self-taken rapid antigen tests greater than 98%, which exceeds the minimum required yield for the diagnosis of SARS-CoV-2, according to the WHO. Notwithstanding, the sensitivity varies (from 40% to 98.7%), which makes them in some cases unsuitable for the diagnosis of positive cases. In the majority of the studies, the minimum required performance set by the WHO was achieved, which is 80% compared with rt-PCR tests. The pooled sensitivity of self-taken nasal rapid antigen tests was calculated as 91.1% and the pooled specificity was 99.5%. Conclusions: In conclusion, self-taken nasal rapid antigen tests have many advantages over rt-PCR tests, such as those related to the rapid reading of the results and their low cost. They also have considerable specificity and some self-taken rapid antigen test kits also have remarkable sensitivity. Consequently, self-taken rapid antigen tests have a wide range of utility but are not able to completely replace rt-PCR tests.
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spelling doaj.art-39388e8a30bd4f5d9f4789647a1520e02023-11-16T21:39:06ZengMDPI AGLife2075-17292023-01-0113228110.3390/life13020281The Diagnostic Accuracy of SARS-CoV-2 Nasal Rapid Antigen Self-Test: A Systematic Review and Meta-AnalysisEleni Karlafti0Dimitrios Tsavdaris1Evangelia Kotzakioulafi2Georgia Kaiafa3Christos Savopoulos4Smaro Netta5Antonios Michalopoulos6Daniel Paramythiotis7Emergency Department, University General Hospital of Thessaloniki AHEPA, Aristotle University of Thessaloniki, 54636 Thessaloniki, GreeceFirst Propaedeutic Surgery Department, University General Hospital of Thessaloniki AHEPA, 54636 Thessaloniki, Greece1st Propaedeutic Department of Internal Medicine, AHEPA University General Hospital, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece1st Propaedeutic Department of Internal Medicine, AHEPA University General Hospital, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece1st Propaedeutic Department of Internal Medicine, AHEPA University General Hospital, Aristotle University of Thessaloniki, 54636 Thessaloniki, GreeceFirst Propaedeutic Surgery Department, University General Hospital of Thessaloniki AHEPA, 54636 Thessaloniki, GreeceFirst Propaedeutic Surgery Department, University General Hospital of Thessaloniki AHEPA, 54636 Thessaloniki, GreeceFirst Propaedeutic Surgery Department, University General Hospital of Thessaloniki AHEPA, 54636 Thessaloniki, GreeceIntroduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of coronavirus disease 2019 (COVID-19), a disease that quickly spread into a pandemic. As such, management of the COVID-19 pandemic is deemed necessary, and it can be achieved by using reliable diagnostic tests for SARS-CoV-2. The gold standard for the diagnosis of SARS-CoV-2 is a molecular detection test using the reverse transcription polymerase chain reaction technique (rt-PCR), which is characterized by various disadvantages in contrast with the self-taken nasal rapid antigen tests that produce results faster, have lower costs and do not require specialized personnel. Therefore, the usefulness of self-taken rapid antigen tests is indisputable in disease management, facilitating both the health system and the examinees. Our systematic review aims to access the diagnostic accuracy of the self-taken nasal rapid antigen tests. Methods: This systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool was used to assess the risk of bias in the included studies. All the studies included in this systematic review were found after searching the two databases, Scopus and PubΜed. All but original articles were excluded from this systematic review, while all the studies concerning self-taken rapid antigen tests with a nasal sample and using rt-PCR as a reference test were included. Meta-analysis results and plots were obtained using RevMan software and the MetaDTA website. Results: All 22 studies included in this meta-analysis demonstrated a specificity of self-taken rapid antigen tests greater than 98%, which exceeds the minimum required yield for the diagnosis of SARS-CoV-2, according to the WHO. Notwithstanding, the sensitivity varies (from 40% to 98.7%), which makes them in some cases unsuitable for the diagnosis of positive cases. In the majority of the studies, the minimum required performance set by the WHO was achieved, which is 80% compared with rt-PCR tests. The pooled sensitivity of self-taken nasal rapid antigen tests was calculated as 91.1% and the pooled specificity was 99.5%. Conclusions: In conclusion, self-taken nasal rapid antigen tests have many advantages over rt-PCR tests, such as those related to the rapid reading of the results and their low cost. They also have considerable specificity and some self-taken rapid antigen test kits also have remarkable sensitivity. Consequently, self-taken rapid antigen tests have a wide range of utility but are not able to completely replace rt-PCR tests.https://www.mdpi.com/2075-1729/13/2/281diagnostic accuracySARS-CoV-2antigen self-testrt-PCR
spellingShingle Eleni Karlafti
Dimitrios Tsavdaris
Evangelia Kotzakioulafi
Georgia Kaiafa
Christos Savopoulos
Smaro Netta
Antonios Michalopoulos
Daniel Paramythiotis
The Diagnostic Accuracy of SARS-CoV-2 Nasal Rapid Antigen Self-Test: A Systematic Review and Meta-Analysis
Life
diagnostic accuracy
SARS-CoV-2
antigen self-test
rt-PCR
title The Diagnostic Accuracy of SARS-CoV-2 Nasal Rapid Antigen Self-Test: A Systematic Review and Meta-Analysis
title_full The Diagnostic Accuracy of SARS-CoV-2 Nasal Rapid Antigen Self-Test: A Systematic Review and Meta-Analysis
title_fullStr The Diagnostic Accuracy of SARS-CoV-2 Nasal Rapid Antigen Self-Test: A Systematic Review and Meta-Analysis
title_full_unstemmed The Diagnostic Accuracy of SARS-CoV-2 Nasal Rapid Antigen Self-Test: A Systematic Review and Meta-Analysis
title_short The Diagnostic Accuracy of SARS-CoV-2 Nasal Rapid Antigen Self-Test: A Systematic Review and Meta-Analysis
title_sort diagnostic accuracy of sars cov 2 nasal rapid antigen self test a systematic review and meta analysis
topic diagnostic accuracy
SARS-CoV-2
antigen self-test
rt-PCR
url https://www.mdpi.com/2075-1729/13/2/281
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