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

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

doi:10.1093/infdis/jiae452

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

J Infect Dis. 2024 Sep 12:jiae452. doi: 10.1093/infdis/jiae452. Online ahead of print.

Authors

Cavan Reilly¹, Eleftherios Mylonakis², Robin Dewar³, Barnaby Young⁴, Jacqueline Nordwall¹, Sanjay Bhagani⁵, Po-Ying Chia⁴, Ruby Davis⁶, Clark Files⁷, Adit A Ginde⁸, Timothy Hatlen⁹, Marie Helleberg¹⁰, Awori Hayanga¹¹, Tomas O Jensen¹⁰, Mamta K Jain¹², Ioannis Kalomenidis¹³, Kami Kim¹⁴, Perrine Lallemand³, Birgitte Lindegaard¹⁵, Anupama Menon¹⁶, Katherine Ognenovska¹⁷, Garyfallia Poulakou¹⁸, Birgit Thorup Røge¹⁹, Angela J Rogers²⁰, Katy Shaw-Saliba²¹, Uriel Sandkovsky²², Barbara W Trautner²³, Shikha S Vasudeva²⁴, Andrew Vekstein²⁵, Kimberley Viens²⁶, James Wyncoll²⁷, Brian DuChateau²⁸, Zhenxing Zhang²⁹, Shujiang Wu²⁹, Abdel G Babiker²⁷, Victoria Davey³⁰, Annetine Gelijns³¹, Elizabeth Higgs²¹, Virginia Kan²⁶, Jens Lundgren¹⁰, Gail V Matthews¹⁷, H Cliff Lane²¹

Affiliations

¹ Division of Biostatistics and Health Data Science, University of Minnesota, Minneapolis, MN, USA.
² Department of Medicine, Houston Methodist Hospital, Houston, TX, USA.
³ Leidos Biomedical Research, Frederick, MD, USA.
⁴ National Centre for Infectious Diseases, Singapore.
⁵ Division of Infection & Immunity, University College London. London, UK.
⁶ Department of Veterans Affairs, Perry Point, MD, USA.
⁷ 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.
⁸ Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA.
⁹ Department of Medicine, Harbor-UCLA Medical Center, Torrance, CA, USA.
¹⁰ 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.
¹¹ School of Medicine, West Virginia University, Morgantown, WV, USA.
¹² Division of Infectious Disease and Parkland Health, UT Southwestern Medical Center, Dallas, TX, USA.
¹³ Department of Critical Care and Pulmonary Medicine, Evaggelismos Hospital, National and Kapodistrian University of Athens, Athens, Greece.
¹⁴ Division of Infectious Disease and International Medicine, University of South Florida and Tampa General Hospital, Tampa, FL, USA.
¹⁵ Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital, North Zealand and the Department of Clinical Medicine, University of Copenhagen, Denmark.
¹⁶ Department of Veterans Affairs, Providence, RI, USA.
¹⁷ Kirby Institute, University of New South Wales, Sydney, Australia.
¹⁸ Department of Internal Medicine, Attikon University Hospital, Athens, Greece.
¹⁹ Department of Medicine, Kolding Hospital, Kolding, Denmark.
²⁰ Division of Pulmonary, Allergy, and Critical Care Medicine, Stanford University, Stanford, CA, USA.
²¹ Division of Clinical Research at National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
²² Baylor University Medical Center, Dallas, TX, USA.
²³ Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine, Houston, TX, USA.
²⁴ Department of Veterans Affairs, Salem, VA, USA.
²⁵ Department of Surgery, Duke University, Durham, NC, USA.
²⁶ Veterans Affairs Medical Center, Washington D.C., USA.
²⁷ Medical Research Counsel Clinical Trials Unit at University College London, London, UK.
²⁸ LumiraDX, Waltham, MA, USA (Formally). MeMed Diagnostics, Andover, MA, USA (Current).
²⁹ Advin Biotech, San Diego, CA, USA.
³⁰ Department of Veterans Affairs, Washington D.C., USA.
³¹ Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

PMID: 39269490
DOI: 10.1093/infdis/jiae452

Abstract

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: 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: 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: 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.

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

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