TY - JOUR
T1 - Evaluation of the Feasibility and Efficacy of Point-of-Care Antibody Tests for Biomarker-Guided Management of Coronavirus Disease 2019
AU - Reilly, Cavan
AU - Mylonakis, Eleftherios
AU - Dewar, Robin
AU - Young, Barnaby
AU - Nordwall, Jacqueline
AU - Bhagani, Sanjay
AU - Chia, Po-ying
AU - Davis, Ruby
AU - Files, Clark
AU - Ginde, Adit A.
AU - Hatlen, Timothy
AU - Helleberg, Marie
AU - Hayanga, Awori
AU - Jensen, Tomas O.
AU - Jain, Mamta K.
AU - Kalomenidis, Ioannis
AU - Kim, Kami
AU - Lallemand, Perrine
AU - Lindegaard, Birgitte
AU - Menon, Anupama
AU - Ognenovska, Katherine
AU - Poulakou, Garyfallia
AU - Thorup Røge, Birgit
AU - Rogers, Angela J.
AU - Shaw-Saliba, Katy
AU - Sandkovsky, Uriel
AU - Trautner, Barbara W.
AU - Vasudeva, Shikha S.
AU - Vekstein, Andrew
AU - Viens, Kimberley
AU - Wyncoll, James
AU - DuChateau, Brian
AU - Zhang, Zhenxing
AU - Wu, Shujiang
AU - Babiker, Abdel G.
AU - Davey, Victoria
AU - Gelijns, Annetine
AU - Higgs, Elizabeth
AU - Kan, Virginia
AU - Lundgren, Jens
AU - Matthews, Gail V.
AU - Lane, H. Cliff
N1 - © 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 [email protected] 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 [email protected].
PY - 2024/9/12
Y1 - 2024/9/12
N2 - 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.
AB - 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.
U2 - 10.1093/infdis/jiae452
DO - 10.1093/infdis/jiae452
M3 - Journal article
C2 - 39269490
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
SN - 0022-1899
ER -