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481por Shapiro, Lauren C, Gali, Radhika, Thakkar, Astha, Gonzalez-Lugo, Jesus D, Bazarbachi, Abdul Hamid, Rahman, Shafia, Pradhan, Kith, Fehn, Karen, Abreu, Michelly, Kornblum, Noah, Gritsman, Kira, Goldfinger, Mendel, Shastri, Aditi, Mantzaris, Ioannis, Braunschweig, Ira, Halmos, Balazs, Verma, Amit, McCort, Margaret, Bachier-Rodriguez, Lizamarie, Sica, R. Alejandro“…Emerging data suggests that despite the 3 COVID-19 vaccines with emergency use authorization (EUA) by the FDA inducing high levels of immunity in the general population, pts with hematologic malignancies have lower rates of seroconversion for the SARS-CoV-2 Spike antibody (Spike IgG) and thus possibly lower protection against severe COVID-19. …”
Publicado 2021
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482por Guillen, G., Limonta, M., Muzio, V., Lemos, G., Hernández-Bernal, F., Chinea, G., Gonzalez-Roche, D., Martin, A., Bequet, M., Marques, G., Zamora, J., Brito, J., Enriquez-Puertas, J., Cruz-Sui, O., Noa, E., Gonzalez-Sosa, N., Dubed, M., Valdibia, I., Palenzuela, A., Valdes, J., Carlos-Pia, N., Rodriguez, M., Ayala, M., Pimentel, E., Martinez, E.“…Two vaccines based on RBD recombinant protein were developed, one for systemic administration “Abdala” and one mucosal vaccine “Mambisa”. Abdala received the EUA in July 2021 and "Mambisa" completed its clinical development as a booster dose for convalescent subjects. …”
Publicado 2023
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483por Mathur, Rajkumar, Joshi, Nitin, Aggarwal, Gaurav, Raikwar, Ramsharan, Shrivastava, Vaibhav, Mathur, Poonam, Raikwar, Poonam, Joshi, Rupali“…Cystoscopy along with examination under anaesthesia (EUA) were done to assess the actual extent of injury. …”
Publicado 2010
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484por Yang, He S., Racine-Brzostek, Sabrina E., Karbaschi, Mohsen, Yee, Jim, Dillard, Alicia, Steel, Peter A.D., Lee, William T., McDonough, Kathleen A., Qiu, Yuqing, Ketas, Thomas J., Francomano, Erik, Klasse, P.J., Hatem, Layla, Westblade, Lars, Wu, Heng, Chen, Haode, Zuk, Robert, Tan, Hong, Girardin, Roxanne C., Dupuis, Alan P., Payne, Anne F., Moore, John P., Cushing, Melissa M., Chadburn, Amy, Zhao, Zhen“…The TOP-TAb assay exhibited higher sensitivity in the 0–7 DAOS window than a widely used FDA-EUA assay. The rapid and automated TOP-SNAb correlated well with two well-established SARS-CoV-2 virus neutralization tests. …”
Publicado 2021
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485por Yadav, Meghna, Martinez, Tiffany, Regoli, Isabel, Hernandez, Osvaldo, Le, Phuong, Carolan, Heather, Brown, Brad, Menge, Karen“…Clinical performance was assessed with 48 positive and 50 negative frozen retrospective samples using the Direct Extraction protocol compared to an external Emergency Use Authorized (EUA) comparator assays (cobas® Liat® SARS-CoV-2 & Influenza A/B assay and the Hologic Panther Fusion® SARS-CoV-2 Assay respectively) on three PCR platforms. …”
Publicado 2021
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486por Nichols, Courtney, Lustberg, Mark, Sobhanie, Mohammad Mahdee, Lehman, Joy, Reed, Erica E, Kman, Nicholas E, Conroy, Mark, Dick, Michael, Allen, James N, Parsons, Jonathan, Malvestutto, Carlos“…Monoclonal antibody therapy (MAT) has been investigated as a therapeutic option for symptomatic COVID-19 patients in the outpatient setting at high-risk for progression to severe disease based on emergency use authorization (EUA) criteria. No published studies have compared outcomes for patients treated with different MAT for COVID-19. …”
Publicado 2021
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487por Achenbach, Chad J, Caputo, Matthew, Hawkins, Claudia, Balmert, Lauren C, Qi, Chao, Odorisio, Joseph, Dembele, Etienne, Jackson, Alema, Abbas, Hiba, Frediani, Jennifer K, Levy, Joshua M, Rebolledo, Paulina A., Kempker, Russell R., Esper, Annette M., Lam, Wilbur A., Martin, Greg S., Murphy, Robert L“…CONCLUSIONS: DASH POC SARS-CoV-2 PCR was accurate, easy to use, and provided fast results in real-life clinical settings with an overall performance similar to an EUA-approved laboratory-based PCR. Its compact design and ease of use are optimal for a variety of healthcare, and potentially community settings, including areas with lack of access to central laboratory-based PCR testing.…”
Publicado 2022
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488por Smith-Jeffcoat, Sarah E, Biddle, Jessica E, Talbot, H Keipp, Olivo, Vanessa, Sano, Ellen, Goodman, Sara H, Petrie, Joshua, Ledezma, Karla I, Bullock, Ayla, Rao, Suchitra, Mellis, Alexandra, Johnson, Sheroi, Kirking, Hannah L, Rolfes, Melissa A, Zhu, Yuwei, Schmitz, Jonathan, Hart, Kimberly W, Battan-Wraith, Steph, Merrill, Lori S, McLaren, Son H, Vargas, Celibell, Sarnquist, Clea, Govindaranjan, Prasanthi, Belongia, Edward, Pryor, Kathleen, Lutrick, Karen, Yang, Amy, Haehnel, Quenla, Asturias, Edwin J, Bowman, Natalie M, Ellingson, Katherine, McLean, Huong, Maldonado, Yvonne A, Stockwell, Melissa, Morrissey, Kerry Grace, Grijalva, Carlos G, Salvatore, Phillip P“…N/R=nirmatrelvir/ritonavir; SCV2=SARS-CoV-2; EUA=Emergency Use Agreement [Figure: see text] RESULTS: N/R treated (n=116) and untreated (n=232) participants had similar baseline characteristics (Table 1). …”
Publicado 2023
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489por Svoboda, Jakub, Ballard, Hatcher J, Ho, Carrie I, Hughes, Mitchell E., Chong, Elise A, Duca, Adam, Prischak, Sara, Dwivedy Nasta, Sunita, Ruella, Marco, Landsburg, Daniel J, Barta, Stefan K., Gerson, James N, Schuster, Stephen J.“…Although mRNA vaccines have been granted Food and Drug Administration emergency use authorization (EUA) for prevention of COVID-19, the pivotal trials largely excluded pts with active cancer. …”
Publicado 2021
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490“…All patients were risk stratified and managed according to EUA guidelines then followed by a surveillance regimen per 3 months for 6 months. …”
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491por Carmody, Ellie, Parameswaran, Lalitha, Wilson, Kesi K, Kottkamp, Angelica C, Frank, Olivia, Engelson, Celia, Davis, Tamia S, Noriega, Irma, Callahan, Jacqueline, Yip, Samantha, Youn, Heekoung, Rettig, Stephanie, Wagner, Julia, Nweke, Samuel, Suman, Pamela, Samanovic, Marie I, Duerr, Ralf, Haiken, Sarah, Mulligan, Mark J“…BACKGROUND: In the 2022 Mpox outbreak, the US FDA issued an EUA for a low-dose intradermal (ID) vaccination regimen to increase vaccine supply by five-fold. …”
Publicado 2023
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492por Sercy, Erica, Stewart, Laveta, Craig-Kuhn, Megan Clare, Stern, Caryn, Graham, Brock, Michel, Amber, Parmelee, Edward, Shackelford, Stacy, Pollett, Simon, Burgess, Timothy, Tribble, David R, Tribble, David R“…Timing of the first and second vaccine doses showed peaks in the months following the vaccine EUA, as well as after the DoD vaccine mandate. SM who had a COVID diagnosis between their two primary doses were more likely to receive a late second dose, although the diagnosis was likely not the cause for the late second dose, as were those who received their first dose during the pre-mandate period. …”
Publicado 2023
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493por Lacombe, Amanda Meneses Ferreira, Soares, Iberê Cauduro, Charchar, Helaine da Silva, Brondani, Vânia Balderrama, Neto, João Evangelista Bezerra, Tanno, Fabio, Srougi, Victor, Chambo, José Luiz, de Freitas, Ricardo Miguel Costa, Hoff, Ana Oliveira, Almeida, Madson Q, Zerbini, Maria Claudia Nogueira, Kroiss, Matthias, Fragoso, Maria Candida Barisson Villares“…Methods: We evaluated SOAT1 protein expression by immunohistochemistry (ab39327; 1:4000; Abcam, EUA) in a tissue microarray of 107 adrenocortical carcinomas (Weiss score ≥ 3) from adult patients treated in a single tertiary center in Brazil. …”
Publicado 2020
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494por Spaulding, Usha, Antosch, Jeremiah, stone, Jessica, Robinson, Tanner, Halo, Kerrin, Kavetska, Iryna, Healy, Tyler, Taylor, Alex, Jones, Matthew, Todorov, Toma, Lu, Zhenmei, Cloud, Joann, Buccambuso, Maggie, Graham, Brad, Boone, Jeremy, Wood, Hillary, Rogatcheva, Margarita“…BACKGROUND: The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for multiple PCR-based tests to aid in the diagnosis and containment of COVID-19. …”
Publicado 2020
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495por Chen, Hui, Li, Zhao, Feng, Sheng, Wang, Anni, Richard-Greenblatt, Melissa, Hutson, Emily, Andrianus, Stefen, Glaser, Laurel J., Rodino, Kyle G., Qian, Jianing, Jayaraman, Dinesh, Collman, Ronald G., Glascock, Abigail, Bushman, Frederic D., Lee, Jae Seung, Cherry, Sara, Fausto, Alejandra, Weiss, Susan R., Koo, Hyun, Corby, Patricia M., O’Doherty, Una, Garfall, Alfred L., Vogl, Dan T., Stadtmauer, Edward A., Wang, Ping“…The assay had high analytical specificity towards SARS-CoV-2. Compared to EUA-approved rRT-PCR methods, the Microbubbling Antigen Assay demonstrated a positive percent agreement (PPA) of 97% (95% confidence interval (CI), 92–99%) in symptomatic individuals within 7 days of symptom onset and positive SARS-CoV-2 nucleic acid results, and a negative percent agreement (NPA) of 97% (95% CI, 94–100%) in symptomatic and asymptomatic individuals with negative nucleic acid results. …”
Publicado 2021
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496por Assis, Rafael, Jain, Aarti, Nakajima, Rie, Jasinskas, Algis, Khan, Saahir, Davies, Huw, Corash, Laurence, Dumont, Larry J., Kelly, Kathleen, Simmons, Graham, Stone, Mars, Di Germanio, Clara, Busch, Michael, Felgner, Philip L.“…Results compared with an FDA emergency use authorized (EUA) SARS-CoV2 S1-based total Ig chemiluminescence immunoassay (Ortho Clinical Diagnostics VITROS Anti-SARS-CoV-2 Total, CoV2T) and with a SARS-CoV-2 S1-S2 spike-based pseudovirus micro neutralization assay (SARS-CoV-2 reporter viral particle neutralization titration (RVPNT) showed high concordance between the three assays. …”
Publicado 2021
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497por Ashley, Elizabeth Dodds, Dyer, April, Jones, Travis M, Johnson, Melissa D, Davis, Angelina, Foy, Katherine R, Nelson, Alicia, Advani, Sonali D, Advani, Sonali D, Cromer, Andrea, Doughman, Danielle, Akinboyo, Ibukunoluwa, Sickbert-Bennett, Emily, Moehring, Rebekah W, Anderson, Deverick J, Spires, Steven S“…Remdesivir Allocation Strategy [Image: see text] Proportion of facilities implementing specific remdesivir allocation strategies from the time of the first US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) through FDA approval CONCLUSION: Pandemic response diverted routine ASP work and has not yet returned to baseline. …”
Publicado 2021
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498por Filippis, C., Binder, F., Lickfeld, M., Schröder, A.K., Klemens, J.M., Saschenbrecker, S., Steller, U.“…METHODS & MATERIALS: The assays´ diagnostic performance was compared to CE-IVD/FDA-EUA-marked reference PCR tests. RNA was extracted from patient samples collected as nasopharyngeal or oropharyngeal swabs. …”
Publicado 2022
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499por Nagy-Szakal, Dorottya, Couto-Rodriguez, Mara, Barrows, Joseph, Wells, Heather L, Debieu, Marilyne, Hager, Courteny, Butcher, Kristin, Chen, Siyuan, Boorstein, Robert, Mason, Christopher, O’Hara, Niamh B“…To measure the sensitivity and specificity of the assay, the positive and negative percent agreement (PPA, NPA) was defined in comparison to an orthogonal EUA RT-PCR assay (PPA [95% CI]: 96.77% [90.56%-100%] and NPA [95% CI]: 100% [100%-100%]). …”
Publicado 2020
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500por Yuen, Rachel R., Steiner, Dylan, Pihl, Riley M.F., Chavez, Elizabeth, Olson, Alex, Smith, Erika L., Baird, Lillia A., Korkmaz, Filiz, Urick, Patricia, Sagar, Manish, Berrigan, Jacob L., Gummuluru, Suryaram, Corley, Ronald B., Quillen, Karen, Belkina, Anna C., Mostoslavsky, Gustavo, Rifkin, Ian R., Kataria, Yachana, Cappione, Amedeo J., Gao, Wenda, Lin, Nina H., Bhadelia, Nahid, Snyder-Cappione, Jennifer E.“…Also, we measured SARS-CoV-2 RBD- and N- specific IgM, IgG, and IgA antibodies from 29 SARS-CoV-2 infected individuals at varying disease states, including 10 acute COVID-19 hospitalized subjects with negative serology results by the EUA approved Abbott IgG chemiluminescent microparticle immunoassay. …”
Publicado 2021
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