Skip NavigationSkip to Content
Return Return to Search Results

Evaluation of the feasibility and efficacy of point-of-care antibody tests for biomarker guided management of COVID-19

  1. Author:
    Reilly, Cavan [ORCID]
    Mylonakis, Eleftherios [ORCID]
    Dewar,Robin
    Young, Barnaby
    Nordwall, Jacqueline
    Bhagani, Sanjay
    Chia, Po-Ying
    Davis, Ruby
    Files, Clark
    Ginde, Adit A
    Hatlen, Timothy [ORCID]
    Helleberg, Marie
    Hayanga, Awori
    Jensen, Tomas O
    Jain, Mamta K
    Kalomenidis, Ioannis
    Kim, Kami [ORCID]
    Lallemand,Perrine
    Lindegaard, Birgitte
    Menon, Anupama
    Ognenovska, Katherine
    Poulakou, Garyfallia
    Thorup Røge, Birgit
    Rogers, Angela J
    Shaw-Saliba, Katy
    Sandkovsky, Uriel
    Trautner, Barbara W
    Vasudeva, Shikha S
    Vekstein, Andrew
    Viens, Kimberley
    Wyncoll, James
    DuChateau, Brian
    Zhang, Zhenxing
    Wu, Shujiang
    Babiker, Abdel G
    Davey, Victoria [ORCID]
    Gelijns, Annetine
    Higgs, Elizabeth
    Kan, Virginia
    Lundgren, Jens [ORCID]
    Matthews, Gail V
    Lane, H Cliff

  2. Author Address

    Division of Biostatistics and Health Data Science, University of Minnesota, Minneapolis, MN, USA., Department of Medicine, Houston Methodist Hospital, Houston, TX, USA., Leidos Biomedical Research, Frederick, MD, USA., National Centre for Infectious Diseases, Singapore., Division of Infection & Immunity, University College London. London, UK., Department of Veterans Affairs, Perry Point, MD, USA., Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem, NC, USA., Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA., Department of Medicine, Harbor-UCLA Medical Center, Torrance, CA, USA., CHIP Center of Excellence for Health, Immunity, and Infections, The Department of Infectious Diseases and the Department of Clinical Medicine, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark., School of Medicine, West Virginia University, Morgantown, WV, USA., Division of Infectious Disease and Parkland Health, UT Southwestern Medical Center, Dallas, TX, USA., Department of Critical Care and Pulmonary Medicine, Evaggelismos Hospital, National and Kapodistrian University of Athens, Athens, Greece., Division of Infectious Disease and International Medicine, University of South Florida and Tampa General Hospital, Tampa, FL, USA., Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital, North Zealand and the Department of Clinical Medicine, University of Copenhagen, Denmark., Department of Veterans Affairs, Providence, RI, USA., Kirby Institute, University of New South Wales, Sydney, Australia., Department of Internal Medicine, Attikon University Hospital, Athens, Greece., Department of Medicine, Kolding Hospital, Kolding, Denmark., Division of Pulmonary, Allergy, and Critical Care Medicine, Stanford University, Stanford, CA, USA., Division of Clinical Research at National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA., Baylor University Medical Center, Dallas, TX, USA., Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine, Houston, TX, USA., Department of Veterans Affairs, Salem, VA, USA., Department of Surgery, Duke University, Durham, NC, USA., Veterans Affairs Medical Center, Washington D.C., USA., Medical Research Counsel Clinical Trials Unit at University College London, London, UK., LumiraDX, Waltham, MA, USA (Formally). MeMed Diagnostics, Andover, MA, USA (Current)., Advin Biotech, San Diego, CA, USA., Department of Veterans Affairs, Washington D.C., USA., Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.,
    1. Year: 2024
    2. Date: Sep 12
    3. Epub Date: 2024 09 12
  2. Journal: The Journal of Infectious Diseases
  4. Type of Article: Article
  5. Article Number: jiae45
  1. Abstract:

    Biomarker guided therapy could improve management of COVID-19 inpatients. Although some results indicate that antibody tests are prognostic, little is known about patient management using point-of-care (POC) antibody tests. COVID-19 inpatients were recruited to evaluate 2 POC tests: LumiraDX and RightSign. Ease of use data was collected. Blood was also collected for centralized testing using established antibody assays (GenScript cPass). A nested case-control study assessed if POC tests conducted on stored specimens were predictive of time to sustained recovery, mortality, and a composite safety outcome. While both POC tests exhibited moderate agreement with the GenScript assay (both agreeing with 89% of antibody determinations), they were significantly different from the GenScript assay. Treating the GenScript assay as the gold standard, the LumiraDX assay had 99.5% sensitivity and 58.1% specificity while the RightSign assay had 89.5% sensitivity and 84.0% specificity. The LumiraDX assay frequently gave indeterminant results. Both tests were significantly associated with clinical outcomes. Although both POC tests deviated moderately from the GenScript assay, they predicted outcomes of interest. The RightSign test was easier to use and was more likely to detect those lacking antibody compared to the LumiraDX test treating GenScript as the gold standard. © The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.

    See More

  1. Keywords:

External Sources

  1. View Full Text
  2. DOI: 10.1093/infdis/jiae452
  3. PMID: 39269490
  4. PII : 7756370

Library Notes

  1. Fiscal Year: FY2024-2025
NCI at Frederick

You are leaving a government website.

This external link provides additional information that is consistent with the intended purpose of this site. The government cannot attest to the accuracy of a non-federal site.

Linking to a non-federal site does not constitute an endorsement by this institution or any of its employees of the sponsors or the information and products presented on the site. You will be subject to the destination site's privacy policy when you follow the link.

ContinueCancel