Observational Study

. 2025 Mar 17;231(3):677-683.

doi: 10.1093/infdis/jiae452.

Evaluation of the Feasibility and Efficacy of Point-of-Care Antibody Tests for Biomarker-Guided Management of Coronavirus Disease 2019

Cavan Reilly¹, Eleftherios Mylonakis², Robin Dewar³, Barnaby Young⁴, Jacqueline Nordwall¹, Sanjay Bhagani⁵, Po-Ying Chia⁴, Ruby Davis⁶, Clark Files^{7

8}, Adit A Ginde⁹, Timothy Hatlen¹⁰, Marie Helleberg^{11

12}, Awori Hayanga¹³, Tomas O Jensen^{11

12}, Mamta K Jain¹⁴, Ioannis Kalomenidis¹⁵, Kami Kim¹⁶, Perrine Lallemand³, Birgitte Lindegaard^{17

18}, Anupama Menon¹⁹, Katherine Ognenovska²⁰, Garyfallia Poulakou²¹, Birgit Thorup Røge²², Angela J Rogers²³, Katy Shaw-Saliba²⁴, Uriel Sandkovsky²⁵, Barbara W Trautner²⁶, Shikha S Vasudeva²⁷, Andrew Vekstein²⁸, Kimberley Viens²⁹, James Wyncoll³⁰, Brian DuChateau³¹, Zhenxing Zhang³², Shujiang Wu³², Abdel G Babiker³⁰, Victoria Davey³³, Annetine Gelijns³⁴, Elizabeth Higgs²⁴, Virginia Kan²⁹, Jens Lundgren^{11

12}, Gail V Matthews²⁰, H Cliff Lane²⁴

Affiliations

¹ Division of Biostatistics and Health Data Science, University of Minnesota, Minneapolis.
² Department of Medicine, Houston Methodist Hospital, Texas.
³ Leidos Biomedical Research, Frederick, Maryland.
⁴ National Centre for Infectious Diseases, Singapore.
⁵ Division of Infection and Immunity, University College London, United Kingdom.
⁶ Department of Veterans Affairs, Perry Point, Maryland.
⁷ Department of Medicine, Duke University, Durham.
⁸ Section on Pulmonary, Critical Care, Allergy, and Immunology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.
⁹ Department of Emergency Medicine, University of Colorado School of Medicine, Aurora.
¹⁰ Department of Medicine, Harbor-UCLA Medical Center, Torrance, California.
¹¹ Centre of Excellence for Health, Immunity, and Infections, Department of Infectious Diseases.
¹² Department of Clinical Medicine, Rigshospitalet, University of Copenhagen.
¹³ School of Medicine, West Virginia University, Morgantown.
¹⁴ Division of Infectious Disease and Parkland Health, UT Southwestern Medical Center, Dallas, Texas.
¹⁵ Department of Critical Care and Pulmonary Medicine, Evaggelismos Hospital, National and Kapodistrian University of Athens, Greece.
¹⁶ Division of Infectious Disease and International Medicine, University of South Florida and Tampa General Hospital, Florida.
¹⁷ Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital, North Zealand.
¹⁸ Department of Clinical Medicine, University of Copenhagen, Denmark.
¹⁹ Department of Veterans Affairs, Providence, Rhode Island.
²⁰ Kirby Institute, University of New South Wales, Sydney, Australia.
²¹ Department of Internal Medicine, Attikon University Hospital, Athens, Greece.
²² Department of Medicine, Kolding Hospital, Denmark.
²³ Division of Pulmonary, Allergy, and Critical Care Medicine, Stanford University, California.
²⁴ Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.
²⁵ Baylor University Medical Center, Dallas.
²⁶ Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine, Houston, Texas.
²⁷ Department of Veterans Affairs, Salem, Virginia.
²⁸ Department of Surgery, Duke University, Durham, North Carolina.
²⁹ Veterans Affairs Medical Center, Washington, District of Columbia.
³⁰ Medical Research Council Clinical Trials Unit, University College London, United Kingdom.
³¹ LumiraDx, Waltham, Massachusetts.
³² Advin Biotech, San Diego, California.
³³ Department of Veterans Affairs, Washington, District of Columbia.
³⁴ Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.

PMID: 39269490
PMCID: PMC11911911
DOI: 10.1093/infdis/jiae452

Observational Study

Evaluation of the Feasibility and Efficacy of Point-of-Care Antibody Tests for Biomarker-Guided Management of Coronavirus Disease 2019

Cavan Reilly et al. J Infect Dis. 2025.

. 2025 Mar 17;231(3):677-683.

doi: 10.1093/infdis/jiae452.

Authors

Affiliations

¹ Division of Biostatistics and Health Data Science, University of Minnesota, Minneapolis.
² Department of Medicine, Houston Methodist Hospital, Texas.
³ Leidos Biomedical Research, Frederick, Maryland.
⁴ National Centre for Infectious Diseases, Singapore.
⁵ Division of Infection and Immunity, University College London, United Kingdom.
⁶ Department of Veterans Affairs, Perry Point, Maryland.
⁷ Department of Medicine, Duke University, Durham.
⁸ Section on Pulmonary, Critical Care, Allergy, and Immunology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.
⁹ Department of Emergency Medicine, University of Colorado School of Medicine, Aurora.
¹⁰ Department of Medicine, Harbor-UCLA Medical Center, Torrance, California.
¹¹ Centre of Excellence for Health, Immunity, and Infections, Department of Infectious Diseases.
¹² Department of Clinical Medicine, Rigshospitalet, University of Copenhagen.
¹³ School of Medicine, West Virginia University, Morgantown.
¹⁴ Division of Infectious Disease and Parkland Health, UT Southwestern Medical Center, Dallas, Texas.
¹⁵ Department of Critical Care and Pulmonary Medicine, Evaggelismos Hospital, National and Kapodistrian University of Athens, Greece.
¹⁶ Division of Infectious Disease and International Medicine, University of South Florida and Tampa General Hospital, Florida.
¹⁷ Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital, North Zealand.
¹⁸ Department of Clinical Medicine, University of Copenhagen, Denmark.
¹⁹ Department of Veterans Affairs, Providence, Rhode Island.
²⁰ Kirby Institute, University of New South Wales, Sydney, Australia.
²¹ Department of Internal Medicine, Attikon University Hospital, Athens, Greece.
²² Department of Medicine, Kolding Hospital, Denmark.
²³ Division of Pulmonary, Allergy, and Critical Care Medicine, Stanford University, California.
²⁴ Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.
²⁵ Baylor University Medical Center, Dallas.
²⁶ Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine, Houston, Texas.
²⁷ Department of Veterans Affairs, Salem, Virginia.
²⁸ Department of Surgery, Duke University, Durham, North Carolina.
²⁹ Veterans Affairs Medical Center, Washington, District of Columbia.
³⁰ Medical Research Council Clinical Trials Unit, University College London, United Kingdom.
³¹ LumiraDx, Waltham, Massachusetts.
³² Advin Biotech, San Diego, California.
³³ Department of Veterans Affairs, Washington, District of Columbia.
³⁴ Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.

PMID: 39269490
PMCID: PMC11911911
DOI: 10.1093/infdis/jiae452

Abstract

Background: Biomarker-guided therapy could improve management of inpatients with coronavirus disease 2019 (COVID-19). Although some results indicate that antibody tests are prognostic, little is known about patient management using point-of-care (POC) antibody tests.

Methods: COVID-19 inpatients were recruited to evaluate 2 POC tests: LumiraDx and RightSign. Ease of use data were collected. Blood was also collected for centralized testing using an established antibody assay (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.

Results: 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 whereas 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.

Conclusions: 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.

Clinical trials registration: NCT05227404.

Keywords: COVID-19; antibody tests; biomarkers; personalized medicine; point-of-care tests.

© 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.

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Conflict of interest statement

Potential conflicts of interest. B. D. is a former employee of LumiraDx. Z. Z. and S. W. are employees of Advin Biotech, a subsidiary of Biotest Biotech Company, the manufacturer of the RightSign test. All other authors report no potential conflicts. 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.

References

1. COVID-19 Treatment Guidelines Panel . Coronavirus disease 2019 (COVID-19) treatment guidelines. National Institutes of Health, 57. https://www.ncbi.nlm.nih.gov/books/NBK570371/pdf/Bookshelf_NBK570371.pdf. Accessed 17 September 2024.
1. RECOVERY Collaborative Group . Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet 2022; 399:665–76. - PMC - PubMed
1. ACTIV-3/TICO Bamlanivimab Study Group; Lundgren JD, Grund B, Barkauskas CE, et al. Responses to a neutralizing monoclonal antibody for hospitalized patients with COVID-19 according to baseline antibody and antigen levels: a randomized controlled trial. Ann Intern Med 2022; 175:234–43. - PMC - PubMed
1. Nerenz RD, Hubbard JA, Cervinski MA. Review of SARS-CoV-2 antigen and antibody testing in diagnosis and community surveillance. Clin Lab Med 2022; 42:687–704. - PMC - PubMed
1. Fox T, Geppert J, Dinnes J, et al. Antibody tests for identification of current and past infection with SARS-CoV-2. Cochrane Database Syst Rev 2022; 11:CD013652. - PMC - PubMed

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Evaluation of the Feasibility and Efficacy of Point-of-Care Antibody Tests for Biomarker-Guided Management of Coronavirus Disease 2019

Affiliations

Evaluation of the Feasibility and Efficacy of Point-of-Care Antibody Tests for Biomarker-Guided Management of Coronavirus Disease 2019

Authors

Affiliations

Abstract

Conflict of interest statement

References

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Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical