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

COVID-19 antibody tests biomarkers point-of-care tests

Journal

The Journal of infectious diseases
ISSN: 1537-6613
Titre abrégé: J Infect Dis
Pays: United States
ID NLM: 0413675

Informations de publication

Date de publication:
12 Sep 2024
Historique:
received: 19 01 2024
revised: 17 06 2024
accepted: 10 09 2024
medline: 13 9 2024
pubmed: 13 9 2024
entrez: 13 9 2024
Statut: aheadofprint

Résumé

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.

Sections du résumé

BACKGROUND BACKGROUND
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.
METHODS METHODS
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.
RESULTS 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 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.
CONCLUSIONS 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.

Identifiants

DOI: 10.1093/infdis/jiae452 PMID: 39269490
pubmed: 39269490
pii: 7756370
doi: 10.1093/infdis/jiae452
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 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.

Auteurs

Cavan Reilly (C)

Division of Biostatistics and Health Data Science, University of Minnesota, Minneapolis, MN, USA.
ORCID: 0000-0002-6695-9113

Eleftherios Mylonakis (E)

Department of Medicine, Houston Methodist Hospital, Houston, TX, USA.
ORCID: 0000-0002-4624-0777

Robin Dewar (R)

Leidos Biomedical Research, Frederick, MD, USA.

Barnaby Young (B)

National Centre for Infectious Diseases, Singapore.

Jacqueline Nordwall (J)

Division of Biostatistics and Health Data Science, University of Minnesota, Minneapolis, MN, USA.

Sanjay Bhagani (S)

Division of Infection & Immunity, University College London. London, UK.

Po-Ying Chia (PY)

National Centre for Infectious Diseases, Singapore.

Ruby Davis (R)

Department of Veterans Affairs, Perry Point, MD, USA.

Clark Files (C)

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.

Adit A Ginde (AA)

Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA.

Timothy Hatlen (T)

Department of Medicine, Harbor-UCLA Medical Center, Torrance, CA, USA.
ORCID: 0000-0003-3755-4309

Marie Helleberg (M)

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.

Awori Hayanga (A)

School of Medicine, West Virginia University, Morgantown, WV, USA.

Tomas O Jensen (TO)

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.

Mamta K Jain (MK)

Division of Infectious Disease and Parkland Health, UT Southwestern Medical Center, Dallas, TX, USA.

Ioannis Kalomenidis (I)

Department of Critical Care and Pulmonary Medicine, Evaggelismos Hospital, National and Kapodistrian University of Athens, Athens, Greece.

Kami Kim (K)

Division of Infectious Disease and International Medicine, University of South Florida and Tampa General Hospital, Tampa, FL, USA.
ORCID: 0000-0003-3384-152X

Perrine Lallemand (P)

Leidos Biomedical Research, Frederick, MD, USA.

Birgitte Lindegaard (B)

Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital, North Zealand and the Department of Clinical Medicine, University of Copenhagen, Denmark.

Anupama Menon (A)

Department of Veterans Affairs, Providence, RI, USA.

Katherine Ognenovska (K)

Kirby Institute, University of New South Wales, Sydney, Australia.

Garyfallia Poulakou (G)

Department of Internal Medicine, Attikon University Hospital, Athens, Greece.

Birgit Thorup Røge (B)

Department of Medicine, Kolding Hospital, Kolding, Denmark.

Angela J Rogers (AJ)

Division of Pulmonary, Allergy, and Critical Care Medicine, Stanford University, Stanford, CA, USA.

Katy Shaw-Saliba (K)

Division of Clinical Research at National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.

Uriel Sandkovsky (U)

Baylor University Medical Center, Dallas, TX, USA.

Barbara W Trautner (BW)

Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine, Houston, TX, USA.

Shikha S Vasudeva (SS)

Department of Veterans Affairs, Salem, VA, USA.

Andrew Vekstein (A)

Department of Surgery, Duke University, Durham, NC, USA.

Kimberley Viens (K)

Veterans Affairs Medical Center, Washington D.C., USA.

James Wyncoll (J)

Medical Research Counsel Clinical Trials Unit at University College London, London, UK.

Brian DuChateau (B)

LumiraDX, Waltham, MA, USA (Formally). MeMed Diagnostics, Andover, MA, USA (Current).

Zhenxing Zhang (Z)

Advin Biotech, San Diego, CA, USA.

Shujiang Wu (S)

Advin Biotech, San Diego, CA, USA.

Abdel G Babiker (AG)

Medical Research Counsel Clinical Trials Unit at University College London, London, UK.

Victoria Davey (V)

Department of Veterans Affairs, Washington D.C., USA.
ORCID: 0000-0001-7402-6607

Annetine Gelijns (A)

Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Elizabeth Higgs (E)

Division of Clinical Research at National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.

Virginia Kan (V)

Veterans Affairs Medical Center, Washington D.C., USA.

Jens Lundgren (J)

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.
ORCID: 0000-0001-8901-7850

Gail V Matthews (GV)

Kirby Institute, University of New South Wales, Sydney, Australia.

H Cliff Lane (HC)

Division of Clinical Research at National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.

Classifications MeSH