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Tytuł pozycji:

Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres.

Tytuł:
Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres.
Autorzy:
Albert E; Microbiology Service, Hospital Clínico Universitario, INCLIVA Research Institute, Valencia, Spain.
Torres I; Microbiology Service, Hospital Clínico Universitario, INCLIVA Research Institute, Valencia, Spain.
Bueno F; Microbiology Service, Hospital Clínico Universitario, INCLIVA Research Institute, Valencia, Spain.
Huntley D; Microbiology Service, Hospital Clínico Universitario, INCLIVA Research Institute, Valencia, Spain.
Molla E; Instituto Valenciano de Microbiología, Bétera, Valencia, Spain.
Fernández-Fuentes MÁ; Instituto Valenciano de Microbiología, Bétera, Valencia, Spain.
Martínez M; Microbiology Service, Hospital Clínico Universitario, INCLIVA Research Institute, Valencia, Spain.
Poujois S; Microbiology Service, Hospital Clínico Universitario, INCLIVA Research Institute, Valencia, Spain.
Forqué L; Microbiology Service, Hospital Clínico Universitario, INCLIVA Research Institute, Valencia, Spain.
Valdivia A; Microbiology Service, Hospital Clínico Universitario, INCLIVA Research Institute, Valencia, Spain.
Solano de la Asunción C; Microbiology Service, Hospital Clínico Universitario, INCLIVA Research Institute, Valencia, Spain.
Ferrer J; Microbiology Service, Hospital Clínico Universitario, INCLIVA Research Institute, Valencia, Spain.
Colomina J; Instituto Valenciano de Microbiología, Bétera, Valencia, Spain.
Navarro D; Microbiology Service, Hospital Clínico Universitario, INCLIVA Research Institute, Valencia, Spain; Department of Microbiology, School of Medicine, University of Valencia, Valencia, Spain. Electronic address: .
Źródło:
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases [Clin Microbiol Infect] 2021 Mar; Vol. 27 (3), pp. 472.e7-472.e10. Date of Electronic Publication: 2020 Nov 13.
Typ publikacji:
Evaluation Study; Journal Article
Język:
English
Imprint Name(s):
Publication: 2015- : London : Elsevier
Original Publication: Paris : Decker Europe, c1995-
MeSH Terms:
Point-of-Care Testing*
COVID-19/*diagnosis
COVID-19 Serological Testing/*methods
SARS-CoV-2/*isolation & purification
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Ambulatory Care Facilities ; Antigens, Viral/analysis ; COVID-19 Nucleic Acid Testing ; Child ; Child, Preschool ; Early Diagnosis ; Female ; Humans ; Immunoassay ; Infant ; Male ; Middle Aged ; Nasopharynx/virology ; Reagent Kits, Diagnostic ; SARS-CoV-2/genetics ; SARS-CoV-2/immunology ; Sensitivity and Specificity ; Young Adult
Contributed Indexing:
Keywords: COVID-19; Early diagnosis; Primary healthcare centre; Rapid antigen detection test (RAD); SARS-CoV-2
Substance Nomenclature:
0 (Antigens, Viral)
0 (Reagent Kits, Diagnostic)
Entry Date(s):
Date Created: 20201115 Date Completed: 20210311 Latest Revision: 20210311
Update Code:
20240105
PubMed Central ID:
PMC7662075
DOI:
10.1016/j.cmi.2020.11.004
PMID:
33189872
Czasopismo naukowe
Objectives: To our knowledge no previous study has assessed the performance of a rapid antigen diagnostic immunoassay (RAD) conducted at the point of care (POC). We evaluated the Panbio™ COVID-19 Ag Rapid Test Device for diagnosis of coronavirus 2019 disease (COVID-19) in symptomatic patients (n = 412) attending primary healthcare centres.
Methods: RAD was performed immediately after sampling following the manufacturer's instructions (reading at 15 min). RT-PCRs were carried out within 24 h of specimen collection. Samples displaying discordant results were processed for culture in Vero E6 cells. Presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in cell cultures was confirmed by RT-PCR.
Results: Out of 412 patients, 43 (10.4%) tested positive by RT-PCR and RAD, and 358 (86.9%) tested negative by both methods; discordant results (RT-PCR+/RAD-) were obtained in 11 patients (2.7%). Overall specificity and sensitivity of rapid antigen detection (RAD) was 100% (95%CI 98.7-100%) and 79.6% (95%CI 67.0-88.8%), respectively, taking RT-PCR as the reference. Overall RAD negative predictive value for an estimated prevalence of 5% and 10% was 99% (95%CI 97.4-99.6%) and 97.9% (95%CI 95.9-98.9), respectively. SARS-CoV-2 could not be cultured from specimens yielding RT-PCR+/RAD- results (n = 11).
Conclusion: The Panbio™ COVID-19 Ag Rapid Test Device performed well as a POC test for early diagnosis of COVID-19 in primary healthcare centres. More crucially, the data suggested that patients with RT-PCR-proven COVID-19 testing negative by RAD are unlikely to be infectious.
(Copyright © 2020 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

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