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161“…Early reports indicate that immune suppressed or immune compromised populations have reduced immune responses to US emergency use authorized (EUA) vaccines. Patients with autoimmune disorders are at risk for severe COVID-19, and are frequently immune suppressed related to therapy, the underlying disease, or both. …”
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162“…Several countries have approved a few vaccine candidates for emergency use authorization (EUA), showing significant effectiveness and inducing a robust immune response. …”
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164Publicado 2007Electrónico Software eBook
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166por Bulterys, Philip L., Garamani, Natasha, Stevens, Bryan, Sahoo, Malaya K., Huang, ChunHong, Hogan, Catherine A., Zehnder, James, Pinsky, Benjamin A.“…BACKGROUND: Numerous nucleic acid amplification tests, including real-time, reverse transcription PCR (rRT-PCR) and isothermal amplification methods, have been developed to detect SARS-CoV-2 RNA, including many that have received emergency use authorization (EUA). There is a need to assess their test performance relative to one another. …”
Publicado 2020
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167por Banerji, Aleena, Wickner, Paige G., Saff, Rebecca, Stone, Cosby A., Robinson, Lacey B., Long, Aidan A., Wolfson, Anna R., Williams, Paul, Khan, David A., Phillips, Elizabeth, Blumenthal, Kimberly G.“…Food and Drug Administration (FDA) has recently issued an Emergency Use Authorization (EUA) for 2 highly effective coronavirus disease 2019 (COVID-19) vaccines from Pfizer-BioNTech and Moderna. …”
Publicado 2021
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168“…All patients (100%) had at least 1 documented EUA defined risk factor for severe COVID-19 (Table 1). …”
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169“…RESULTS: The results are analyzed for the 6 weeks after bamlanivimab EUA. In PALTC, there was a median of 3 days between positive test and infusion. …”
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170por Zhen, Wei, Manji, Ryhana, Smith, Elizabeth, Wuitschick, Jeffrey, Lucic, Danijela, Berry, Gregory J.“…To evaluate the analytical performance of the FDA emergency use authorization (EUA)-approved Abbott Alinity m resp-4-plex assay (Alinity m) in testing for SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV), we compared its performance to those of both the EUA-approved Cepheid Xpert Xpress SARS-CoV-2, influenza A/B virus, and RSV assay (Xpert Xpress) and the EUA-approved Roche Cobas SARS-CoV-2 and influenza A/B virus assay (Cobas) in a single-center retrospective analysis. …”
Publicado 2022
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171por Rodriguez-Watson, Carla V., Louder, Anthony M., Kabelac, Carly, Frederick, Christopher M., Sheils, Natalie E., Eldridge, Elizabeth H., Lin, Nancy D., Pollock, Benjamin D., Gatz, Jennifer L., Grannis, Shaun J., Vashisht, Rohit, Ghauri, Kanwal, Knepper, Camille, Leonard, Sandy, Embi, Peter J., Jenkinson, Garrett, Klesh, Reyna, Garner, Omai B., Patel, Ayan, Dahm, Lisa, Barin, Aiden, Cooper, Dan M., Andriola, Tom, Byington, Carrie L., Crews, Bridgit O., Butte, Atul J., Allen, Jeff“…BACKGROUND: Real-world performance of COVID-19 diagnostic tests under Emergency Use Authorization (EUA) must be assessed. We describe overall trends in the performance of serology tests in the context of real-world implementation. …”
Publicado 2023
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175por Singh, Preet Mohinder, Trikha, Anjan, Sinha, Renu, Ramachandran, Rashmi, Rewari, Vimi, Borle, Anuradha“…The sevoflurane consumption was also not influenced by the gender. The total cost of EUA correlated most strongly with duration of maintenance phase, followed by induction duration.…”
Publicado 2013
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176por Lopez, Denise, Roberts, Jill, Bourgeois, Marie, Kootstra, Joshua, Minnick, Sharon, Black, Allison, Mauss, Joshua, Flores, Nick“…It also reinforces the need for diligent reporting of abnormal test results by clinical laboratories, especially during Emergency Use Authorization (EUA) periods, as additional information is gathered about the target organism and the performance of EUA-authorized tests over time.…”
Publicado 2022
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177“…These recommendations have potential application for home use tests being developed for other viral respiratory infections, such as COVID-19, as guidance moves from EUA designation into 510(k) requirements.…”
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179por Sibio, S., Di Giorgio, A., Campanelli, M., Di Carlo, S., Divizia, A., Fiorani, C., Scaramuzzo, R., Arcudi, C., Del Vecchio Blanco, G., Biancone, L., Sica, G.“…All clinical information, including previous EUA and/or records from MRI and endoscopic ultrasound, was included. …”
Publicado 2018
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180“…BACKGROUND: Monoclonal antibodies were given emergency use authorization (EUA) by the Food and Drug Administration for the treatment of high-risk, outpatient COVID-19 infection. …”
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