Rapid antigen-based and rapid molecular tests for the detection of SARS-CoV-2: a rapid review with network meta-analysis of diagnostic test accuracy studies.

Humans SARS-CoV-2 / genetics COVID-19 / diagnosis Network Meta-Analysis Bias Diagnostic Tests, Routine Sensitivity and Specificity COVID-19 Testing
COVID-19 Diagnostic test accuracy Network meta-analysis Rapid review Rapid tests SARS-CoV-2

Journal

BMC medicine
ISSN: 1741-7015
Titre abrégé: BMC Med
Pays: England
ID NLM: 101190723

Informations de publication

Date de publication:
29 03 2023
Historique:
received: 12 08 2022
accepted: 27 02 2023
medline: 30 3 2023
entrez: 28 3 2023
pubmed: 29 3 2023
Statut: epublish

Résumé

The global spread of COVID-19 created an explosion in rapid tests with results in < 1 hour, but their relative performance characteristics are not fully understood yet. Our aim was to determine the most sensitive and specific rapid test for the diagnosis of SARS-CoV-2. Design: Rapid review and diagnostic test accuracy network meta-analysis (DTA-NMA). Randomized controlled trials (RCTs) and observational studies assessing rapid antigen and/or rapid molecular test(s) to detect SARS-CoV-2 in participants of any age, suspected or not with SARS-CoV-2 infection. Embase, MEDLINE, and Cochrane Central Register of Controlled Trials, up to September 12, 2021. Sensitivity and specificity of rapid antigen and molecular tests suitable for detecting SARS-CoV-2. Data extraction and risk of bias assessment: Screening of literature search results was conducted by one reviewer; data abstraction was completed by one reviewer and independently verified by a second reviewer. Risk of bias was not assessed in the included studies. Random-effects meta-analysis and DTA-NMA. We included 93 studies (reported in 88 articles) relating to 36 rapid antigen tests in 104,961 participants and 23 rapid molecular tests in 10,449 participants. Overall, rapid antigen tests had a sensitivity of 0.75 (95% confidence interval 0.70-0.79) and specificity of 0.99 (0.98-0.99). Rapid antigen test sensitivity was higher when nasal or combined samples (e.g., combinations of nose, throat, mouth, or saliva samples) were used, but lower when nasopharyngeal samples were used, and in those classified as asymptomatic at the time of testing. Rapid molecular tests may result in fewer false negatives than rapid antigen tests (sensitivity: 0.93, 0.88-0.96; specificity: 0.98, 0.97-0.99). The tests with the highest sensitivity and specificity estimates were the Xpert Xpress rapid molecular test by Cepheid (sensitivity: 0.99, 0.83-1.00; specificity: 0.97, 0.69-1.00) among the 23 commercial rapid molecular tests and the COVID-VIRO test by AAZ-LMB (sensitivity: 0.93, 0.48-0.99; specificity: 0.98, 0.44-1.00) among the 36 rapid antigen tests we examined. Rapid molecular tests were associated with both high sensitivity and specificity, while rapid antigen tests were mainly associated with high specificity, according to the minimum performance requirements by WHO and Health Canada. Our rapid review was limited to English, peer-reviewed published results of commercial tests, and study risk of bias was not assessed. A full systematic review is required. PROSPERO CRD42021289712.

Sections du résumé

BACKGROUND
The global spread of COVID-19 created an explosion in rapid tests with results in < 1 hour, but their relative performance characteristics are not fully understood yet. Our aim was to determine the most sensitive and specific rapid test for the diagnosis of SARS-CoV-2.
METHODS
Design: Rapid review and diagnostic test accuracy network meta-analysis (DTA-NMA).
ELIGIBILITY CRITERIA
Randomized controlled trials (RCTs) and observational studies assessing rapid antigen and/or rapid molecular test(s) to detect SARS-CoV-2 in participants of any age, suspected or not with SARS-CoV-2 infection.
INFORMATION SOURCES
Embase, MEDLINE, and Cochrane Central Register of Controlled Trials, up to September 12, 2021.
OUTCOME MEASURES
Sensitivity and specificity of rapid antigen and molecular tests suitable for detecting SARS-CoV-2. Data extraction and risk of bias assessment: Screening of literature search results was conducted by one reviewer; data abstraction was completed by one reviewer and independently verified by a second reviewer. Risk of bias was not assessed in the included studies.
DATA SYNTHESIS
Random-effects meta-analysis and DTA-NMA.
RESULTS
We included 93 studies (reported in 88 articles) relating to 36 rapid antigen tests in 104,961 participants and 23 rapid molecular tests in 10,449 participants. Overall, rapid antigen tests had a sensitivity of 0.75 (95% confidence interval 0.70-0.79) and specificity of 0.99 (0.98-0.99). Rapid antigen test sensitivity was higher when nasal or combined samples (e.g., combinations of nose, throat, mouth, or saliva samples) were used, but lower when nasopharyngeal samples were used, and in those classified as asymptomatic at the time of testing. Rapid molecular tests may result in fewer false negatives than rapid antigen tests (sensitivity: 0.93, 0.88-0.96; specificity: 0.98, 0.97-0.99). The tests with the highest sensitivity and specificity estimates were the Xpert Xpress rapid molecular test by Cepheid (sensitivity: 0.99, 0.83-1.00; specificity: 0.97, 0.69-1.00) among the 23 commercial rapid molecular tests and the COVID-VIRO test by AAZ-LMB (sensitivity: 0.93, 0.48-0.99; specificity: 0.98, 0.44-1.00) among the 36 rapid antigen tests we examined.
CONCLUSIONS
Rapid molecular tests were associated with both high sensitivity and specificity, while rapid antigen tests were mainly associated with high specificity, according to the minimum performance requirements by WHO and Health Canada. Our rapid review was limited to English, peer-reviewed published results of commercial tests, and study risk of bias was not assessed. A full systematic review is required.
REVIEW REGISTRATION
PROSPERO CRD42021289712.

Identifiants

DOI: 10.1186/s12916-023-02810-0 PMID: 36978074 PMC: PMC10049780
pubmed: 36978074
doi: 10.1186/s12916-023-02810-0
pii: 10.1186/s12916-023-02810-0
pmc: PMC10049780
doi:

Types de publication

Meta-Analysis Journal Article Review Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

110

Informations de copyright

© 2023. The Author(s).

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Auteurs

Areti Angeliki Veroniki (AA)

Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, 209 Victoria Street, East Building, Toronto, ON, M5B 1T8, Canada. areti-angeliki.veroniki@unityhealth.to.
Institute for Health Policy, Management, and Evaluation, University of Toronto, Toronto, ON, Canada. areti-angeliki.veroniki@unityhealth.to.

Andrea C Tricco (AC)

Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, 209 Victoria Street, East Building, Toronto, ON, M5B 1T8, Canada.
Epidemiology Division & Institute of Health Policy, Management, and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
Queen's Collaboration for Health Care Quality: A JBI Centre of Excellence, Kingston, Canada.

Jennifer Watt (J)

Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, 209 Victoria Street, East Building, Toronto, ON, M5B 1T8, Canada.

Sofia Tsokani (S)

School of Education, University of Ioannina, Ioannina, Greece.

Paul A Khan (PA)

Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, 209 Victoria Street, East Building, Toronto, ON, M5B 1T8, Canada.

Charlene Soobiah (C)

Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, 209 Victoria Street, East Building, Toronto, ON, M5B 1T8, Canada.
Institute for Health Policy, Management, and Evaluation, University of Toronto, Toronto, ON, Canada.

Ahmed Negm (A)

University of Alberta, Edmonton, AB, Canada.

Amanda Doherty-Kirby (A)

Patient Partner, Strategy for Patient Oriented-Research Evidence Alliance (SPOR EA), Toronto, Canada.

Paul Taylor (P)

Patient Partner, Strategy for Patient Oriented-Research Evidence Alliance (SPOR EA), Toronto, Canada.

Carole Lunny (C)

Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, 209 Victoria Street, East Building, Toronto, ON, M5B 1T8, Canada.

Jessie McGowan (J)

University of Ottawa/Université d'Ottawa, Ottawa, ON, Canada.

Julian Little (J)

University of Ottawa/Université d'Ottawa, Ottawa, ON, Canada.

Patrick Mallon (P)

University College Dublin, Dublin, Ireland.

David Moher (D)

Ottawa Hospital Research Institute/Institut de Recherche de L'Hôpital d'Ottawa, Ottawa, ON, Canada.

Sabrina Wong (S)

University of British Columbia, Vancouver, BC, Canada.

Jacqueline Dinnes (J)

University of Birmingham, Birmingham, UK.

Yemisi Takwoingi (Y)

University of Birmingham, Birmingham, UK.

Lynora Saxinger (L)

University of Alberta, Edmonton, AB, Canada.

Adrienne Chan (A)

Sunnybrook Research Institute, Toronto, ON, Canada.

Wanrudee Isaranuwatchai (W)

Ministry of Public Health, Nonthaburi, Thailand.

Bryn Lander (B)

Health Canada (Ottawa)/Santé Canada (Ottawa), Ottawa, ON, Canada.

Adrienne Meyers (A)

Public Health Agency of Canada/Agence de La Santé Publique du Canada, Ottawa, ON, Canada.

Guillaume Poliquin (G)

Public Health Agency of Canada/Agence de La Santé Publique du Canada, Ottawa, ON, Canada.

Sharon E Straus (SE)

Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, 209 Victoria Street, East Building, Toronto, ON, M5B 1T8, Canada.
Institute for Health Policy, Management, and Evaluation, University of Toronto, Toronto, ON, Canada.
Department of Geriatric Medicine, University of Toronto, Toronto, ON, Canada.

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Classifications MeSH

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