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1. Characteristics of Patients With Initial Clostridioides difficile Infection (CDI) That Are Associated With Increased Risk of Multiple CDI Recurrences

Author

Guh, Alice Y, primary, Li, Rongxia, additional, Korhonen, Lauren, additional, Winston, Lisa G, additional, Parker, Erin, additional, Czaja, Christopher A, additional, Johnston, Helen, additional, Basiliere, Elizabeth, additional, Meek, James, additional, Olson, Danyel, additional, Fridkin, Scott K, additional, Wilson, Lucy E, additional, Perlmutter, Rebecca, additional, Holzbauer, Stacy M, additional, D’Heilly, Paige, additional, Phipps, Erin C, additional, Flores, Kristina G, additional, Dumyati, Ghinwa K, additional, Pierce, Rebecca, additional, Ocampo, Valerie L S, additional, Wilson, Christopher D, additional, Watkins, Jasmine J, additional, Gerding, Dale N, additional, and McDonald, L Clifford, additional

Published
2024
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2. 1796. Use of SARS-CoV-2 Antibody Tests by U.S. Infectious Disease Physicians: Qualitative Results of an Emerging Infections Network Survey, March 2022

Author

Santibanez, Scott S, primary, Gundlapalli, Adi, additional, Beekmann, Susan E, additional, Uyeki, Timothy M, additional, Satheshkumar, Panayampalli, additional, Plumb, Ian D, additional, David-Ferdon, Corinne, additional, Polgreen, Philip M, additional, McDonald, L Clifford, additional, and Jones, Jefferson M, additional

Published
2023
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3. 684. Characteristics of Patients with Initial Clostridioides difficile Infection (CDI) That Are Associated With Increased Risk of Multiple CDI Recurrences

Author

Guh, Alice, primary, Li, Rongxia, additional, Korhonen, Lauren C, additional, Winston, Lisa Gail, additional, Parker, Erin, additional, Czaja, Christopher A, additional, Johnston, Helen, additional, Basiliere, Elizabeth, additional, Meek, James, additional, Olson, Danyel M, additional, Fridkin, Scott, additional, Wilson, Lucy E, additional, Perlmutter, Rebecca, additional, Holzbauer, Stacy, additional, D’Heilly, Paige, additional, Phipps, Erin, additional, Flores, Kristina, additional, Dumyati, Ghinwa, additional, Pierce, Rebecca, additional, Ocampo, Valerie, additional, Wilson, Christopher, additional, Watkins, Jasmine, additional, Gerding, Dale, additional, and Clifford McDonald, L, additional

Published
2023
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4. Use of SARS-CoV-2 Antibody Tests by U.S. Infectious Disease Physicians: Results of an Emerging Infections Network Survey, March 2022

Author

Gundlapalli, Adi V, primary, Beekmann, Susan, additional, Jones, Jefferson M, additional, Thornburg, Natalie, additional, Clarke, Kristie E N, additional, Uyeki, Timothy M, additional, Satheshkumar, Panayampalli S, additional, Carroll, Darin, additional, Plumb, Ian, additional, Briggs-Hagen, Melissa, additional, Santibañez, Scott, additional, David-Ferdon, Corinne, additional, Polgreen, Philip M, additional, and McDonald, L Clifford, additional

Published
2023
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5. Risk Factors for Community-Associated Clostridium difficile Infection in Adults: A Case-Control Study

Author

Guh, Alice Y, Adkins, Susan Hocevar, Li, Qunna, Bulens, Sandra N, Farley, Monica M, Smith, Zirka, Holzbauer, Stacy M, Whitten, Tory, Phipps, Erin C, Hancock, Emily B, Dumyati, Ghinwa, Concannon, Cathleen, Kainer, Marion A, Rue, Brenda, Lyons, Carol, Olson, Danyel M, Wilson, Lucy, Perlmutter, Rebecca, Winston, Lisa G, Parker, Erin, Bamberg, Wendy, Beldavs, Zintars G, Ocampo, Valerie, Karlsson, Maria, Gerding, Dale N, and McDonald, L Clifford

Published
2017
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6. 1941. Describing the immune response kinetics to mRNA COVID-19 vaccines among previously SARS-CoV-2–infected and –uninfected nursing home residents, a prospective longitudinal observational cohort evaluation—Georgia, October 2020 – September 2021

Author

Chisty, Zeshan A, primary, Haile, Melia, additional, DaSilva, Juliana, additional, Biology, M A, additional, Houston, Hollis, additional, Le, Shoshona, additional, Li, Deana, additional, Overton, Rahsaan, additional, Arons, Melissa, additional, Schuh, Amy J, additional, Tsang, Clarisse A, additional, Selenic, Dejana, additional, Clemente, Jacob, additional, Bugrysheva, Julia, additional, Branch, Alicia, additional, Thornburg, Natalie J, additional, Epperson, Monica, additional, Rasheed, Mohammed A, additional, Bohannon, Caitlin D, additional, Stuckey, Matthew J, additional, McDonald, L C, additional, Brown, Allison C, additional, and Kutty, Preeta K, additional

Published
2022
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7. 2314. Hospitalizations and Antibiotic Use in the Year Prior to an Incident C. difficile Infection for Medicare Beneficiaries in Four States, 2016–2018

Author

Hatfield, Kelly M, primary, Baggs, James, additional, Reddy, Sujan, additional, Aranmolate, Rasaki, additional, Meek, James, additional, Fridkin, Scott, additional, Szydlowski, Jill, additional, Hatwar, Trupti T, additional, Dumyati, Ghinwa, additional, Watkins, Jasmine, additional, Wilson, Christopher, additional, Clifford McDonald, L, additional, Jernigan, John A, additional, and Guh, Alice, additional

Published
2022
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9. High Cellular Monocyte Activation in People Living With Human Immunodeficiency Virus on Combination Antiretroviral Therapy and Lifestyle-Matched Controls Is Associated With Greater Inflammation in Cerebrospinal Fluid

Author

Booiman, Thijs, Wit, Ferdinand W., Maurer, Irma, De Francesco, Davide, Sabin, Caroline A., Harskamp, Agnes M., Prins, Maria, Garagnani, Paolo, Pirazzini, Chiara, Franceschi, Claudio, Fuchs, Dietmar, Gisslén, Magnus, Winston, Alan, Reiss, Peter, Kootstra, Neeltje A., Reiss, P., Wit, F. W. N. M., Schouten, J., Kooij, K. W., van Zoest, R. A., Elsenga, B. C., Janssen, F. R., Heidenrijk, M., Zikkenheiner, W., van der Valk, M., Kootstra, N. A., Booiman, T., Harskamp-Holwerda, A. M., Boeser-Nunnink, B., Maurer, I., Mangas Ruiz, M. M., Girigorie, A. F., Villaudy, J., Frankin, E., Pasternak, A., Berkhout, B., van der Kuyl, T., Portegies, P., Schmand, B. A., Geurtsen, G. J., ter Stege, J. A., Klein Twennaar, M., Majoie, C. B. L. M., Caan, M. W. A., Su, T., Weijer, K., Bisschop, P. H. L. T., Kalsbeek, A., Wezel, M., Visser, I., Ruhé, H. G., Franceschi, C., Garagnani, P., Pirazzini, C., Capri, M., Dall’Olio, F., Chiricolo, M., Salvioli, S., Hoeijmakers, J., Pothof, J., Prins, M., Martens, M., Moll, S., Berkel, J., Totté, M., Kovalev, S., Gisslén, M., Fuchs, D., Zetterberg, H., Winston, A., Underwood, J., McDonald, L., Stott, M., Legg, K., Lovell, A., Erlwein, O., Doyle, N., Kingsley, C., Sharp, D. J., Leech, R., Cole, J. H., Zaheri, S., Hillebregt, M. M. J., Ruijs, Y. M. C., Benschop, D. P., Burger, D., de Graaff-Teulen, M., Guaraldi, G., Bürkle, A., Sindlinger, T., Moreno-Villanueva, M., Keller, A., Sabin, C., de Francesco, D., Libert, C., and Dewaele, S.

Published
2017
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10. Use of Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Tests by US Infectious Disease Physicians: Results of an Emerging Infections Network Survey, March 2022.

Author

Gundlapalli, Adi V, Beekmann, Susan E, Jones, Jefferson M, Thornburg, Natalie J, Clarke, Kristie E N, Uyeki, Timothy M, Satheshkumar, Panayampalli S, Carroll, Darin S, Plumb, Ian D, Briggs-Hagen, Melissa, Santibañez, Scott, David-Ferdon, Corinne, Polgreen, Philip M, and McDonald, L Clifford

Abstract

Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody tests have had limited recommended clinical application during the coronavirus disease 2019 (COVID-19) pandemic. To inform clinical practice, an understanding is needed of current perspectives of United States–based infectious disease (ID) physicians on the use, interpretation, and need for SARS-CoV-2 antibody tests. Methods In March 2022, members of the Emerging Infections Network (EIN), a national network of practicing ID physicians, were surveyed on types of SARS-CoV-2 antibody assays ordered, interpretation of test results, and clinical scenarios for which antibody tests were considered. Results Of 1867 active EIN members, 747 (40%) responded. Among the 583 who managed or consulted on COVID-19 patients, a majority (434/583 [75%]) had ordered SARS-CoV-2 antibody tests and were comfortable interpreting positive (452/578 [78%]) and negative (405/562 [72%]) results. Antibody tests were used for diagnosing post–COVID-19 conditions (61%), identifying prior SARS-CoV-2 infection (60%), and differentiating prior infection and response to COVID-19 vaccination (37%). Less than a third of respondents had used antibody tests to assess need for additional vaccines or risk stratification. Lack of sufficient evidence for use and nonstandardized assays were among the most common barriers for ordering tests. Respondents indicated that statements from professional societies and government agencies would influence their decision to order SARS-CoV-2 antibody tests for clinical decision making. Conclusions Practicing ID physicians are using SARS-CoV-2 antibody tests, and there is an unmet need for clarifying the appropriate use of these tests in clinical practice. Professional societies and US government agencies can support clinicians in the community through the creation of appropriate guidance. [ABSTRACT FROM AUTHOR]

Published
2023
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11. Validation of a Novel Multivariate Method of Defining HIV-Associated Cognitive Impairment

Author

Underwood, Jonathan, De Francesco, Davide, Cole, James H, Caan, Matthan W A, van Zoest, Rosan A, Schmand, Ben A, Sharp, David J, Sabin, Caroline A, Reiss, Peter, Winston, Alan Coolaboratori: Reiss P, Wit FWNM, Schouten J, Kooij KW, van Zoest RA, Elsenga BC, Janssen FR, Heidenrijk M, Zikkenheiner W, van der Valk M, Kootstra NA, Harskamp-Holwerda AM, Maurer I, Mangas Ruiz MM, Girigorie AF, Villaudy J, Frankin E, Pasternak A, Berkhout B, van der Kuyl T, Portegies P, Schmand BA, Geurtsen GJ, Ter Stege JA, Klein Twennaar M, Majoie CBLM, Caan MWA, Su T, Weijer K, Bisschop PHLT, Kalsbeek A, Wezel M, Visser I, Ruhé HG, Franceschi C, Garagnani P, Pirazzini C, Capri M, Dall'Olio F, Chiricolo M, Salvioli S, Hoeijmakers J, Pothof J, Prins M, Martens M, Moll S, Berkel J, Totté M, Kovalev S, Gisslén M, Fuchs D, Zetterberg H, Winston A, Underwood J, McDonald L, Stott M, Legg K, Lovell A, Erlwein O, Doyle N, Kingsley C, Sharp DJ, Leech R, Cole JH, Zaheri S, Hillebregt MMJ, Ruijs YMC, Benschop DP, Burger D, de Graaff-Teulen M, Guaraldi G, Bürkle A, Sindlinger T, Moreno-Villanueva M, Keller A, Sabin C, de Francesco D, Libert C, Dewaele S, Boffito M, Mallon P, Post F, Sachikonye M, Anderson J, Asboe D, Garvey L, Pozniak A, Vera J, Williams I, Campbell L, Yurdakul S, Okumu S, Pollard L, Otiko D, Phillips L, Laverick R, Fisher M, Clarke A, Bexley A, Richardson C, Macken A, Ghavani-Kia B, Maher J, Byrne M, Flaherty A, Mguni S, Clark R, Nevin-Dolan R, Pelluri S, Johnson M, Ngwu N, Hemat N, Jones M, Carroll A, Whitehouse A, Burgess L, Babalis D, Higgs C, Seah E, Fletcher S, Anthonipillai M, Moyes A, Deats K, Syed I, Matthews C., Underwood, Jonathan, De Francesco, Davide, Cole, James H, Caan, Matthan W A, van Zoest, Rosan A, Schmand, Ben A, Sharp, David J, Sabin, Caroline A, Reiss, Peter, Winston, Alan Coolaboratori: Reiss P, Wit FWNM, Schouten J, Kooij KW, van Zoest RA, Elsenga BC, Janssen FR, Heidenrijk M, Zikkenheiner W, van der Valk M, Kootstra NA, Harskamp-Holwerda AM, Maurer I, Mangas Ruiz MM, Girigorie AF, Villaudy J, Frankin E, Pasternak A, Berkhout B, van der Kuyl T, Portegies P, Schmand BA, Geurtsen GJ, Ter Stege JA, Klein Twennaar M, Majoie CBLM, Caan MWA, Su T, Weijer K, Bisschop PHLT, Kalsbeek A, Wezel M, Visser I, Ruhé HG, Franceschi C, Garagnani P, Pirazzini C, Capri M, Dall'Olio F, Chiricolo M, Salvioli S, Hoeijmakers J, Pothof J, Prins M, Martens M, Moll S, Berkel J, Totté M, Kovalev S, Gisslén M, Fuchs D, Zetterberg H, Winston A, Underwood J, McDonald L, Stott M, Legg K, Lovell A, Erlwein O, Doyle N, Kingsley C, Sharp DJ, Leech R, Cole JH, Zaheri S, Hillebregt MMJ, Ruijs YMC, Benschop DP, Burger D, de Graaff-Teulen M, Guaraldi G, Bürkle A, Sindlinger T, Moreno-Villanueva M, Keller A, Sabin C, de Francesco D, Libert C, Dewaele S, Boffito M, Mallon P, Post F, Sabin C, Sachikonye M, Winston A, Anderson J, Asboe D, Boffito M, Garvey L, Mallon P, Post F, Pozniak A, Sabin C, Sachikonye M, Vera J, Williams I, Winston A, Post F, Campbell L, Yurdakul S, Okumu S, Pollard L, Williams I, Otiko D, Phillips L, Laverick R, Fisher M, Clarke A, Vera J, Bexley A, Richardson C, Mallon P, Macken A, Ghavani-Kia B, Maher J, Byrne M, Flaherty A, Anderson J, Mguni S, Clark R, Nevin-Dolan R, Pelluri S, Johnson M, Ngwu N, Hemat N, Jones M, Carroll A, Whitehouse A, Burgess L, Babalis D, Winston A, Garvey L, Underwood J, Stott M, McDonald L, Boffito M, Asboe D, Pozniak A, Higgs C, Seah E, Fletcher S, Anthonipillai M, Moyes A, Deats K, Syed I, Matthews C., Molecular Genetics, Biomedical Engineering and Physics, Radiology and Nuclear Medicine, ACS - Atherosclerosis & ischemic syndromes, ACS - Diabetes & metabolism, ACS - Microcirculation, AMS - Restoration & Development, Amsterdam Neuroscience - Brain Imaging, Amsterdam Neuroscience - Neurovascular Disorders, Graduate School, AII - Infectious diseases, APH - Aging & Later Life, Medical Psychology, Amsterdam Neuroscience - Neurodegeneration, Global Health, Infectious diseases, APH - Mental Health, APH - Methodology, Commission of the European Communities, Imperial College Healthcare NHS Trust- BRC Funding, and National Institute for Health Research

Subjects
Multivariate statistics, medicine.medical_specialty, COmorBidity in Relation to AIDS (COBRA) Collaboration and the Pharmacokinetic and clinical Observations in PePle over fiftY (POPPY) Study Group, Immunology, Human immunodeficiency virus (HIV), Audiology, medicine.disease_cause, Microbiology, 03 medical and health sciences, 0302 clinical medicine, multivariate, SDG 3 - Good Health and Well-being, Neuroimaging, Medicine and Health Sciences, medicine, Major Article, OLDER-PEOPLE, 030212 general & internal medicine, VALIDITY, Cognitive impairment, cognitive impairment, Science & Technology, neuroimaging, SCORES, business.industry, Biology and Life Sciences, HIV, MEN, Cognition, Mental health, White matter microstructure, PREVALENCE, 3. Good health, Infectious Diseases, Oncology, REGISTRATION, business, Life Sciences & Biomedicine, Neurocognitive, 030217 neurology & neurosurgery
Abstract

Background The optimum method of defining cognitive impairment in virally suppressed people living with HIV is unknown. We evaluated the relationships between cognitive impairment, including using a novel multivariate method (NMM), patient– reported outcome measures (PROMs), and neuroimaging markers of brain structure across 3 cohorts. Methods Differences in the prevalence of cognitive impairment, PROMs, and neuroimaging data from the COBRA, CHARTER, and POPPY cohorts (total n = 908) were determined between HIV-positive participants with and without cognitive impairment defined using the HIV-associated neurocognitive disorders (HAND), global deficit score (GDS), and NMM criteria. Results The prevalence of cognitive impairment varied by up to 27% between methods used to define impairment (eg, 48% for HAND vs 21% for NMM in the CHARTER study). Associations between objective cognitive impairment and subjective cognitive complaints generally were weak. Physical and mental health summary scores (SF-36) were lowest for NMM-defined impairment (P < .05). There were no differences in brain volumes or cortical thickness between participants with and without cognitive impairment defined using the HAND and GDS measures. In contrast, those identified with cognitive impairment by the NMM had reduced mean cortical thickness in both hemispheres (P < .05), as well as smaller brain volumes (P < .01). The associations with measures of white matter microstructure and brain-predicted age generally were weaker. Conclusion Different methods of defining cognitive impairment identify different people with varying symptomatology and measures of brain injury. Overall, NMM-defined impairment was associated with most neuroimaging abnormalities and poorer self-reported health status. This may be due to the statistical advantage of using a multivariate approach., We have previously described a novel multivariate method (NMM) with theoretical statistical advantages over existing methods, which we assessed here in 3 cohorts of people living with HIV. Overall, NMM-defined impairment was associated with most neuroimaging abnormalities and poorer self-reported health status.

Published
2019

12. SARS-CoV-2 Serologic Assay Needs for the Next Phase of the US COVID-19 Pandemic Response

Author

Gundlapalli, Adi V, Salerno, Reynolds M, Brooks, John T, Averhoff, Francisco, Petersen, Lyle R, McDonald, L Clifford, Iademarco, Michael F, Carroll, Yulia I, Gorwitz, Rachel, Lin-Gibson, Sheng, Wang, Lili, and Pinto, Ligia A

Subjects
0301 basic medicine, Emergency Use Authorization, biology, business.industry, Review Article, Immunoglobulin G, Neutralization, Serology, 03 medical and health sciences, Titer, AcademicSubjects/MED00290, 030104 developmental biology, 0302 clinical medicine, Immune system, Infectious Diseases, Oncology, Immunology, Pandemic, biology.protein, Medicine, 030212 general & internal medicine, Antibody, business
Abstract

Background There is a need for validated and standardized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative immunoglobulin G (IgG) and neutralization assays that can be used to understand the immunology and pathogenesis of SARS-CoV-2 infection and support the coronavirus disease 2019 (COVID-19) pandemic response. Methods Literature searches were conducted to identify English language publications from peer-reviewed journals and preprints from January 2020 through November 6, 2020. Relevant publications were reviewed for mention of IgG or neutralization assays for SARS-CoV-2, or both, and the methods of reporting assay results. Results Quantitative SARS-CoV-2 IgG results have been reported from a limited number of studies; most studies used in-house laboratory-developed tests in limited settings, and only two semiquantitative tests have received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA). As of November 6, 2020, there is only one SARS-CoV-2 neutralization assay with FDA EUA. Relatively few studies have attempted correlation of quantitative IgG titers with neutralization results to estimate surrogates of protection. The number of individuals tested is small compared with the magnitude of the pandemic, and persons tested are not representative of disproportionately affected populations. Methods of reporting quantitative results are not standardized to enable comparisons and meta-analyses. Conclusions Lack of standardized SARS-CoV-2 quantitative IgG and neutralization assays precludes comparison of results from published studies. Interassay and interlaboratory validation and standardization of assays will support efforts to better understand antibody kinetics and longevity of humoral immune responses postillness, surrogates of immune protection, and vaccine immunogenicity and efficacy. Public–private partnerships could facilitate realization of these advances in the United States and worldwide.

Published
2020

13. Infectious Period of Severe Acute Respiratory Syndrome Coronavirus 2 in 17 Nursing Home Residents—Arkansas, June–August 2020

Author

Surie, Diya, primary, Huang, Jennifer Y, additional, Brown, Allison C, additional, Gable, Paige, additional, Biedron, Caitlin, additional, Gilbert, Sarah E, additional, Garner, Kelley, additional, Bollinger, Susan, additional, Gulley, Trent, additional, Haney, Tafarra, additional, Lyons, Amanda K, additional, Beshearse, Elizabeth, additional, Gregory, Christopher J, additional, Sabour, Sarah, additional, Clemmons, Nakia S, additional, James, Allison E, additional, Tamin, Azaibi, additional, Reese, Natashia, additional, Perry-Dow, K Allison, additional, Brown, Robin, additional, Harcourt, Jennifer L, additional, Campbell, Davina, additional, Houston, Hollis, additional, Chakravorty, Rohan, additional, Paulick, Ashley, additional, Whitaker, Brett, additional, Murdoch, Jordan, additional, Spicer, Lori, additional, Stumpf, Megan M, additional, Mills, Lisa, additional, Coughlin, Melissa M, additional, Higdem, Pamela, additional, Rasheed, Mohammad Ata Ur, additional, Lonsway, David, additional, Bhatnagar, Amelia, additional, Kothari, Atul, additional, Anderson, Karen, additional, Thornburg, Natalie J, additional, Breaker, Erin, additional, Adamczyk, Michelle, additional, McAllister, Gillian A, additional, Halpin, Alison L, additional, Seely, Kathryn A, additional, Patil, Naveen, additional, McDonald, L Clifford, additional, and Kutty, Preeta K, additional

Published
2021
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14. 837. Prior Hospitalizations Among Cases of Community-Associated Clostridioides difficile Infection—10 US States, 2014–2015

Author

Hatfield, Kelly M, primary, Baggs, James, additional, Winston, Lisa Gail, additional, Parker, Erin, additional, Johnston, Helen, additional, Brousseau, Geoff, additional, Olson, Danyel M, additional, Fridkin, Scott, additional, Wilson, Lucy, additional, Perlmuter, Rebecca, additional, Holzbauer, Stacy, additional, Phipps, Erin C, additional, Hancock, Emily B, additional, Dumyati, Ghinwa, additional, Ocampo, Valerie, additional, Kainer, Marion A, additional, Korhonen, Lauren C, additional, Jernigan, John A, additional, McDonald, L Clifford, additional, and Guh, Alice, additional

Published
2019
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16. 490. Comparison of Clostridium difficile Infection Outcomes by Diagnostic Testing Method

Author

Guh, Alice, primary, Hatfield, Kelly, additional, Winston, Lisa G, additional, Martin, Brittany, additional, Johnston, Helen, additional, Brousseau, Geoff, additional, Farley, Monica M, additional, Wilson, Lucy E, additional, Perlmutter, Rebecca, additional, Phipps, Erin C, additional, Dumyati, Ghinwa, additional, Nelson, Deborah, additional, Hatwar, Trupti, additional, Kainer, Marion A, additional, and McDonald, L Clifford, additional

Published
2018
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18. 492. Long-Term Outcomes of Clostridium difficile Infection Among Medicare Beneficiaries

Author

Hatfield, Kelly M, primary, Baggs, James, additional, Winston, Lisa G, additional, Parker, Erin, additional, Martin, Brittany, additional, Meek, James I, additional, Olson, Danyel, additional, Farley, Monica M, additional, Revis, Andrew, additional, Holzbauer, Stacy, additional, Bye, Maria, additional, Wilson, Lucy, additional, Perlmutter, Rebecca, additional, Phipps, Erin C, additional, Pierce, Rebecca, additional, Ocampo, Valerie L S, additional, Kainer, Marion A, additional, Smith, Miranda, additional, McDonald, L Clifford, additional, Jernigan, John A, additional, and Guh, Alice, additional

Published
2018
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19. SARS-CoV-2 Serologic Assay Needs for the Next Phase of the US COVID-19 Pandemic Response.

Author

Gundlapalli, Adi V, Salerno, Reynolds M, Brooks, John T, Averhoff, Francisco, Petersen, Lyle R, McDonald, L Clifford, Iademarco, Michael F, and Response, CDC COVID-19

Subjects
COVID-19 pandemic, COVID-19, SARS-CoV-2, HUMORAL immunity, IMMUNOGLOBULIN G
Abstract

Background There is a need for validated and standardized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative immunoglobulin G (IgG) and neutralization assays that can be used to understand the immunology and pathogenesis of SARS-CoV-2 infection and support the coronavirus disease 2019 (COVID-19) pandemic response. Methods Literature searches were conducted to identify English language publications from peer-reviewed journals and preprints from January 2020 through November 6, 2020. Relevant publications were reviewed for mention of IgG or neutralization assays for SARS-CoV-2, or both, and the methods of reporting assay results. Results Quantitative SARS-CoV-2 IgG results have been reported from a limited number of studies; most studies used in-house laboratory-developed tests in limited settings, and only two semiquantitative tests have received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA). As of November 6, 2020, there is only one SARS-CoV-2 neutralization assay with FDA EUA. Relatively few studies have attempted correlation of quantitative IgG titers with neutralization results to estimate surrogates of protection. The number of individuals tested is small compared with the magnitude of the pandemic, and persons tested are not representative of disproportionately affected populations. Methods of reporting quantitative results are not standardized to enable comparisons and meta-analyses. Conclusions Lack of standardized SARS-CoV-2 quantitative IgG and neutralization assays precludes comparison of results from published studies. Interassay and interlaboratory validation and standardization of assays will support efforts to better understand antibody kinetics and longevity of humoral immune responses postillness, surrogates of immune protection, and vaccine immunogenicity and efficacy. Public–private partnerships could facilitate realization of these advances in the United States and worldwide. [ABSTRACT FROM AUTHOR]

Published
2021
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20. Risk Factors for Community-Associated Clostridium difficile Infection in Children

Author

Weng, Mark, primary, Adkins, Susan H, additional, Farley, Monica, additional, Espinosa, Catherine C, additional, Reisenauer, Claire, additional, Whitten, Tory, additional, Hancock, Emily B, additional, Dumyati, Ghinwa, additional, Davis, Corinne M, additional, Wilson, Lucy, additional, Beldavs, Zintars G, additional, Mcdonald, L Clifford, additional, and Guh, Alice, additional

Published
2017
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22. Burden of Nursing Home-Onset Clostridium difficile Infection in the United States: Estimates of Incidence and Patient Outcomes

Author

Hunter, Jennifer C., primary, Mu, Yi, additional, Dumyati, Ghinwa K., additional, Farley, Monica M., additional, Winston, Lisa G., additional, Johnston, Helen L., additional, Meek, James I., additional, Perlmutter, Rebecca, additional, Holzbauer, Stacy M., additional, Beldavs, Zintars G., additional, Phipps, Erin C., additional, Dunn, John R., additional, Cohen, Jessica A., additional, Avillan, Johannetsy, additional, Stone, Nimalie D., additional, Gerding, Dale N., additional, McDonald, L. Clifford, additional, and Lessa, Fernanda C., additional

Published
2016
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23. Lack of Evidence for Toxin Immunoassay-Negative Patients as a Significant Source of Clostridium difficile Transmission at an Academic Medical Center

Author

Polage, Christopher, primary, Sjolund-Karlsson, Maria, additional, Gulvik, Christopher, additional, Eyre, David, additional, Gyorke, Clare, additional, Kennedy, Michael, additional, Cohen, Stuart H., additional, Dubberke, Erik R., additional, McDonald, L. Clifford, additional, and Limbago, Brandi, additional

Published
2016
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24. 529Frequent Transmission of Clostridium Difficile by Asymptomatically Colonized Long-term Care Facility Residents during Hospital Admissions

Author

Nimalie D. Stone, Dale N. Gerding, Jeanmarie Mayer, Curtis J. Donskey, Sunkesula, Carolyn V. Gould, Annette L. Jencson, Matthew H. Samore, Susan M. Pacheco, Susan P. Sambol, Mcdonald L, and Laurica A. Petrella

Subjects
Gerontology, medicine.medical_specialty, business.industry, Clostridium difficile, law.invention, IDWeek 2014 Abstracts, Long-term care, Infectious Diseases, Transmission (mechanics), Oral Abstracts, Oncology, law, Emergency medicine, Medicine, business
Published
2014

25. Risk Factors for Community-Associated Clostridium difficile Infection: A Case Control Study

Author

Hocevar, Susan N., primary, Bulens, Sandra N., additional, Farley, Monica, additional, Holzbauer, Stacy, additional, Hancock, Emily B., additional, Dumyati, Ghinwa, additional, Davis, Corinne M., additional, Lyons, Carol, additional, Perlmutter, Rebecca, additional, Parker, Erin, additional, Reisenauer, Claire, additional, Ocampo, Valerie L. S., additional, Mu, Yi, additional, and Mcdonald, L. Clifford, additional

Published
2015
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26. Association Between Outpatient Antibiotic Prescribing Practices and Community-Associated Clostridium difficile Infection

Author

Dantes, Raymund, primary, Mu, Yi, additional, Hicks, Lauri A., additional, Cohen, Jessica, additional, Bamberg, Wendy, additional, Beldavs, Zintars G., additional, Dumyati, Ghinwa, additional, Farley, Monica M., additional, Holzbauer, Stacy, additional, Meek, James, additional, Phipps, Erin, additional, Wilson, Lucy, additional, Winston, Lisa G., additional, McDonald, L. Clifford, additional, and Lessa, Fernanda C., additional

Published
2015
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28. Detection of Clostridium difficile by Real-Time Polymerase Chain Reaction in Young Children Does Not Predict Diarrhea

Author

Pahud, Barbara, primary, Harrison, Christopher, additional, Hassan, Ferdaus, additional, Halasa, Natasha, additional, Chappell, James D., additional, Englund, Janet, additional, Klein, Eileen, additional, Szilagyi, Peter G., additional, Weinberg, Geoffrey, additional, Polage, Christopher, additional, Wikswo, Mary E., additional, Mcdonald, L. Clifford, additional, Payne, Daniel, additional, and Selvarangan, Rangaraj, additional

Published
2015
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30. Risk Factors for Clostridium difficile Infection Recurrence

Author

Reddy, Sujan C., primary, Guh, Alice, additional, Lessa, Fernanda C., additional, Mu, Yi, additional, Beldavs, Zintars G., additional, Davis, Corinne M., additional, Dumyati, Ghinwa, additional, Holzbauer, Stacy M., additional, Johnston, Helen L., additional, Lyons, Carol, additional, Phipps, Erin C., additional, Wilson, Lucy E., additional, Winston, Lisa G., additional, Gerding, Dale N., additional, McDonald, L. Clifford, additional, and Farley, Monica M., additional

Published
2015
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31. 1638Clostridium difficile Strains Colonizing Long-Term Care Facility (LTCF) Residents are Similar to Strains Causing Infection in both LTCF and Hospital Patients Suggesting a Shared Continuum of Transmission

Author

Pacheco, Susan M., primary, Donskey, Curtis J., additional, Samore, Matthew, additional, Mayer, Jeanmarie, additional, Stone, Nimalie, additional, Gould, Carolyn, additional, Mcdonald, L. Clifford, additional, Petrella, Laurica A., additional, Sambol, Susan, additional, Jencson, Annette, additional, Sunkesula, Venkata, additional, and Gerding, Dale, additional

Published
2014
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32. Determinants of Clostridium difficile Infection Incidence Across Diverse United States Geographic Locations

Author

Lessa, Fernanda C., primary, Mu, Yi, additional, Winston, Lisa G., additional, Dumyati, Ghinwa K., additional, Farley, Monica M., additional, Beldavs, Zintars G., additional, Kast, Kelly, additional, Holzbauer, Stacy M., additional, Meek, James I., additional, Cohen, Jessica, additional, McDonald, L. Clifford, additional, and Fridkin, Scott K., additional

Published
2014
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33. 524National estimates of incidence, recurrence, hospitalization, and death of nursing home-onset Clostridium difficile infections — United States, 2012

Author

Hunter, Jennifer C., primary, Mu, Yi, additional, Dumyati, Ghinwa K., additional, Farley, Monica M., additional, Winston, Lisa G., additional, Johnston, Helen L., additional, Meek, James I., additional, Wilson, Lucy E., additional, Stacy, M, additional, Beldavs, Zintars G., additional, Phipps, Erin C., additional, Dunn, John R., additional, Cohen, Jessica a., additional, Stone, Nimalie D., additional, Clifford Mcdonald, L., additional, and Lessa, Fernanda C., additional

Published
2014
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36. 529Frequent Transmission of Clostridium Difficile by Asymptomatically Colonized Long-term Care Facility Residents during Hospital Admissions

Author

Donskey, Curtis J., primary, Sunkesula, Venkata C.K., additional, Stone, Nimalie D., additional, Gould, Carolyn V., additional, Mcdonald, L. Clifford, additional, Samore, Matthew, additional, Mayer, Jeanmarie, additional, Pacheco, Susan M., additional, Jencson, Annette, additional, Sambol, Susan, additional, Petrella, Laurica a., additional, and Gerding, Dale, additional

Published
2014
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37. Care Navigation Increases Initiation of Hepatitis C Treatment After Release From Prison in a Prospective Randomized Controlled Trial: The C-LINK Study.

Author

Papaluca T, Craigie A, McDonald L, Edwards A, Winter R, Hoang A, Pappas A, Waldron A, McCoy K, Stoove M, Doyle J, Hellard M, Holmes J, MacIsaac M, Desmond P, Iser D, and Thompson AJ

Abstract

Background: Prison-based hepatitis C treatment is safe and effective; however, many individuals are released untreated due to time or resource constraints. On community re-entry, individuals face a number of immediate competing priorities, and in this context, linkage to hepatitis C care is low. Interventions targeted at improving healthcare continuity after prison release have yielded positive outcomes for other health diagnoses; however, data regarding hepatitis C transitional care are limited., Methods: We conducted a prospective randomized controlled trial comparing a hepatitis C care navigator intervention with standard of care for individuals released from prison with untreated hepatitis C infection. The primary outcome was prescription of hepatitis C direct-acting antivirals (DAA) within 6 months of release., Results: Forty-six participants were randomized. The median age was 36 years and 59% were male. Ninety percent ( n  = 36 of 40) had injected drugs within 6 months before incarceration. Twenty-two were randomized to care navigation and 24 were randomized to standard of care. Individuals randomized to the intervention were more likely to commence hepatitis C DAAs within 6 months of release (73%, n  = 16 of 22 vs 33% n  = 8 of 24, P  < .01), and the median time between re-entry and DAA prescription was significantly shorter (21 days [interquartile range {IQR}, 11-42] vs 82 days [IQR, 44-99], P  = .049)., Conclusions: Care navigation increased hepatitis C treatment uptake among untreated individuals released from prison. Public policy should support similar models of care to promote treatment in this high-risk population. Such an approach will help achieve hepatitis C elimination as a public health threat., Competing Interests: Potential conflicts of interest. J. D. reports investigator-initiated research funding to institution from Gilead and AbbVie and honoraria to institution from Gilead. M. H. reports investigator-initiated research funding from Gilead Sciences and AbbVie. D. I. reports honoraria for speaking duties from AbbVie. A. J. T. reports the following: involvement in advisory boards for AbbVie, Gilead Sciences, Roche Diagnostics, BMS, Merck, Immunocore, Janssen, Assembly Biosciences, Arbutus, Vir Biotechnology, Eisai, Ipsen, and Bayer; honoraria for speaking duties from AbbVie, Gilead Sciences, Roche, and BMS; and investigator-initiated research funding from Gilead Sciences, BMS, AbbVie, and Roche Molecular Systems. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Published
2022
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