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Real-life validation of the Panbio™ COVID-19 antigen rapid test (Abbott) in community-dwelling subjects with symptoms of potential SARS-CoV-2 infection.

作者信息

Gremmels Hendrik, Winkel Beatrice M F, Schuurman Rob, Rosingh Andert, Rigter Nicolette A M, Rodriguez Olga, Ubijaan Johan, Wensing Annemarie M J, Bonten Marc J M, Hofstra L Marije

机构信息

Department of Medical Microbiology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands.

LABHOH, Fundacion Servicio Medico Laboratorio Aruba, Dr. Horacio E. Oduber Hospital, Boulevard 1, Oranjestad, Aruba.

出版信息

EClinicalMedicine. 2021 Jan;31:100677. doi: 10.1016/j.eclinm.2020.100677. Epub 2020 Dec 5.


DOI:10.1016/j.eclinm.2020.100677
PMID:33521610
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7832943/
Abstract

BACKGROUND: RT-qPCR is the reference test for identification of active SARS-CoV-2 infection, but is associated with diagnostic delay. Antigen detection assays can generate results within 20 min and outside of laboratory settings. Yet, their diagnostic test performance in real life settings has not been determined. METHODS: The diagnostic value of the Panbio™ COVID-19 Ag Rapid Test (Abbott), was determined in  comparison to RT-qPCR (Seegene Allplex) in community-dwelling mildly symptomatic subjects in a medium (Utrecht, the Netherlands) and high endemic area (Aruba), using two concurrently obtained nasopharyngeal swabs.Findings: 1367 and 208 subjects were enrolled in Utrecht and Aruba, respectively. SARS-CoV-2 prevalence, based on RT-qPCR, was 10.2% ( = 139) and 30.3% ( = 63) in Utrecht and Aruba respectively. Specificity of the Panbio™ COVID-19 Ag Rapid Test was 100% (95%CI: 99.7-100%) in both settings. Test sensitivity was 72.6% (95%CI: 64.5-79.9%) in the Netherlands and 81.0% (95% CI: 69.0-89.8%) in Aruba. Probability of false negative results was associated with RT-qPCR Ct-values, but not with duration of symptoms. Restricting RT-qPCR test positivity to Ct-values <32 yielded test sensitivities of 95.2% (95%CI: 89.3-98.5%) in Utrecht and 98.0% (95%CI: 89.2-99.95%) in Aruba. INTERPRETATION: In community-dwelling subjects with mild respiratory symptoms the Panbio™ COVID-19 Ag Rapid Test had 100% specificity, and a sensitivity above 95% for nasopharyngeal samples when using Ct-values <32 cycles as cut-off for RT-qPCR test positivity. Considering short turnaround times, user friendliness, low costs and opportunities for decentralized testing, this test can improve our efforts to control transmission of SARS-CoV-2.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a020/7846663/28520cab8a79/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a020/7846663/ad592d0dc3f6/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a020/7846663/2a8074f79fe0/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a020/7846663/28520cab8a79/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a020/7846663/ad592d0dc3f6/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a020/7846663/2a8074f79fe0/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a020/7846663/28520cab8a79/gr3.jpg

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[1]
Real-life validation of the Panbio™ COVID-19 antigen rapid test (Abbott) in community-dwelling subjects with symptoms of potential SARS-CoV-2 infection.

EClinicalMedicine. 2021-1

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[3]
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[4]
The diagnostic performance evaluation of Panbio and STANDARD Q coronavirus disease 2019 antigen tests against real-time polymerase chain reaction in southern Ethiopia.

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[5]
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[6]
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[7]
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[8]
Association Between Rapid Antigen Detection Tests and Real-Time Reverse Transcription-Polymerase Chain Reaction Assay for SARS-CoV-2: A Systematic Review and Meta-Analyses.

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[9]
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[10]
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本文引用的文献

[1]
Duration and key determinants of infectious virus shedding in hospitalized patients with coronavirus disease-2019 (COVID-19).

Nat Commun. 2021-1-11

[2]
Panbio antigen rapid test is reliable to diagnose SARS-CoV-2 infection in the first 7 days after the onset of symptoms.

J Clin Virol. 2020-10-16

[3]
Rethinking Covid-19 Test Sensitivity - A Strategy for Containment.

N Engl J Med. 2020-11-26

[4]
Fast coronavirus tests: what they can and can't do.

Nature. 2020-9

[5]
Seasonal coronavirus protective immunity is short-lasting.

Nat Med. 2020-9-14

[6]
Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection.

Cochrane Database Syst Rev. 2020-8-26

[7]
Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients.

Int J Infect Dis. 2020-8-12

[8]
Impact of delays on effectiveness of contact tracing strategies for COVID-19: a modelling study.

Lancet Public Health. 2020-7-16

[9]
SARS-CoV-2 Coronavirus Nucleocapsid Antigen-Detecting Half-Strip Lateral Flow Assay Toward the Development of Point of Care Tests Using Commercially Available Reagents.

Anal Chem. 2020-8-5

[10]
Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis.

J Clin Virol. 2020-5-21

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