Evidence map›Paper›PMID 39269490›Full record

Observational studyThe Journal of infectious diseases2025

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

Cavan Reilly, Eleftherios Mylonakis, Robin Dewar, Barnaby Young, Jacqueline Nordwall, Sanjay Bhagani, Po-Ying Chia, Ruby Davis, Clark Files, Adit A Ginde and 32 more

Registry-linked trialAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05227404 (Evaluation of the Feasibility and Reproducibility of 2 Point-of-Care Tests for SARS-Co-V-2 Antibodies), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05227404 completednot on this map

Evaluation of the Feasibility and Reproducibility of 2 Point-of-Care Tests for SARS-Co-V-2 Antibodies (INSIGHT 017)

TypeobservationalSponsorUniversity of MinnesotaRan2022 to 2022Enrolled330ConditionsCOVID-19, SARS CoV 2 InfectionArmsLumiraDX, RightSign, Case Control
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

42 authors.

Cavan ReillyDivision of Biostatistics and Health Data Science, University of Minnesota, Minneapolis.ORCID 0000-0002-6695-9113
Eleftherios MylonakisDepartment of Medicine, Houston Methodist Hospital, Texas.ORCID 0000-0002-4624-0777
Robin DewarLeidos Biomedical Research, Frederick, Maryland.
Barnaby YoungNational Centre for Infectious Diseases, Singapore.
Jacqueline NordwallDivision of Biostatistics and Health Data Science, University of Minnesota, Minneapolis.
Sanjay BhaganiDivision of Infection and Immunity, University College London, United Kingdom.
Po-Ying ChiaNational Centre for Infectious Diseases, Singapore.
Ruby DavisDepartment of Veterans Affairs, Perry Point, Maryland.
Clark FilesDepartment of Medicine, Duke University, Durham.
Adit A GindeDepartment of Emergency Medicine, University of Colorado School of Medicine, Aurora.
Timothy HatlenDepartment of Medicine, Harbor-UCLA Medical Center, Torrance, California.ORCID 0000-0003-3755-4309
Marie HellebergCentre of Excellence for Health, Immunity, and Infections, Department of Infectious Diseases.
Awori HayangaSchool of Medicine, West Virginia University, Morgantown.
Tomas O JensenCentre of Excellence for Health, Immunity, and Infections, Department of Infectious Diseases.
Mamta K JainDivision of Infectious Disease and Parkland Health, UT Southwestern Medical Center, Dallas, Texas.
Ioannis KalomenidisDepartment of Critical Care and Pulmonary Medicine, Evaggelismos Hospital, National and Kapodistrian University of Athens, Greece.
Kami KimDivision of Infectious Disease and International Medicine, University of South Florida and Tampa General Hospital, Florida.ORCID 0000-0003-3384-152X
Perrine LallemandLeidos Biomedical Research, Frederick, Maryland.
Birgitte LindegaardDepartment of Pulmonary and Infectious Diseases, Copenhagen University Hospital, North Zealand.
Anupama MenonDepartment of Veterans Affairs, Providence, Rhode Island.
Katherine OgnenovskaKirby Institute, University of New South Wales, Sydney, Australia.
Garyfallia PoulakouDepartment of Internal Medicine, Attikon University Hospital, Athens, Greece.
Birgit Thorup RøgeDepartment of Medicine, Kolding Hospital, Denmark.
Angela J RogersDivision of Pulmonary, Allergy, and Critical Care Medicine, Stanford University, California.
Katy Shaw-SalibaDivision of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.
Uriel SandkovskyBaylor University Medical Center, Dallas.
Barbara W TrautnerMichael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine, Houston, Texas.
Shikha S VasudevaDepartment of Veterans Affairs, Salem, Virginia.
Andrew VeksteinDepartment of Surgery, Duke University, Durham, North Carolina.
Kimberley ViensVeterans Affairs Medical Center, Washington, District of Columbia.
James WyncollMedical Research Council Clinical Trials Unit, University College London, United Kingdom.
Brian DuChateauLumiraDx, Waltham, Massachusetts.
Zhenxing ZhangAdvin Biotech, San Diego, California.
Shujiang WuAdvin Biotech, San Diego, California.
Abdel G BabikerMedical Research Council Clinical Trials Unit, University College London, United Kingdom.
Victoria DaveyDepartment of Veterans Affairs, Washington, District of Columbia.ORCID 0000-0001-7402-6607
Annetine GelijnsDepartment of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.
Elizabeth HiggsDivision of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.
Virginia KanVeterans Affairs Medical Center, Washington, District of Columbia.
Jens LundgrenCentre of Excellence for Health, Immunity, and Infections, Department of Infectious Diseases.ORCID 0000-0001-8901-7850
Gail V MatthewsKirby Institute, University of New South Wales, Sydney, Australia.
H Cliff LaneDivision of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.

Funding

WORK ORDER 126643 B539 EXPAND IC SUITE75N91019D00024 · NIAID · LEIDOS BIOMEDICAL RESEARCH, INC. · PI BRISCOE, LYNN · 2019 to 2025
$3932.6M
ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating CenterOT2HL156812 · NHLBI · RESEARCH TRIANGLE INSTITUTE · PI NOLEN, TRACY L, THOMAS, SONIA M · 2020 to 2024
$1270.7M
National Institute of Allergy and Infectious DiseasesNCI NIH HHS 75N91019D00024NHLBI NIH HHS OT2 HL156812NIH HHS 1OT2HL156812-01
6 · The paper itself

Abstract

backgroundBiomarker-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.

methodsCOVID-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.

resultsWhile 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.

conclusionsAlthough 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.

Indexed as

Antibodies, ViralCOVID-19COVID-19 Serological TestingPoint-of-Care SystemsPoint-of-Care TestingAdultAgedBiomarkersCase-Control StudiesFeasibility StudiesFemaleHumansMaleMiddle AgedSensitivity and SpecificityAntibodies, ViralBiomarkersantibody testsbiomarkersCOVID-19personalized medicinepoint-of-care tests

Identifiers

PMID39269490
PMCPMC11911911

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.