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

medrxiv(2020)

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摘要
We evaluated the Panbio™ COVID-19 AG Rapid Test Device (RAD) for the diagnosis of COVID-19 in symptomatic patients attended in primary healthcare centers (n=412). Overall specificity and sensitivity of RAD was 100% and 79.6%, respectively, taking RT-PCR as the reference. SARS-CoV-2 could not be cultured from specimens yielding RT-PCR+/RAD- results. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work received no public or private funds. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The current study was approved by the Research Ethics Committee of Hospital Clinico Universitario INCLIVA (March 2020). All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes The authors confirm that the data supporting the findings of this study are available within the article [and/or] its supplementary materials.
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rapid antigen test,panbio™,diagnosis
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