NCT04360954

Brief Summary

The purpose of this study is to evaluate the sensitivity and specificity of several marketed commercial or prototype test kits for antibody to SARS-CoV-2. The focus will be on rapid-format, point-of-care antibody test kits that detect both IgM and IgG antibodies to recombinant viral proteins. Note: No voluntary enrolment into this study will be conducted; all testing is to be conducted anonymously.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
461

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

April 23, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2020

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

April 20, 2020

Last Update Submit

June 1, 2024

Conditions

COVIDCoronavirus

Keywords

COVIDCoronavirusAntibody test kit

Outcome Measures

Primary Outcomes (2)

  • Test Sensitivity

    Test sensitivity relative to RT-PCR for acute samples; sensitivity relative to ELISA for convalescent samples.

    2020

  • Test Specificity

    Percent positivity with pre-COVID samples

    2020

Study Arms (4)

Acute COVID infection

Active infection with positive RT-PCR

Diagnostic Test: Diagnostic test

Convalescent COVID

Recent documented infection. Now asymptomatic and RT-PCR negative.

Diagnostic Test: Diagnostic test

US Controls

Human samples pre-COVID.

Diagnostic Test: Diagnostic test

LMIC Controls

Samples from LMIC pre-COVID.

Diagnostic Test: Diagnostic test

Interventions

Diagnostic testDIAGNOSTIC_TEST

There is no intervention. This study will test deidentified archived biosamples.

Acute COVID infectionConvalescent COVIDLMIC ControlsUS Controls

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Sera/plasma from patients in St. Louis, Missouri who have been hospitalized and tested positive for SARS-CoV-2 * Sera/plasma from people in St. Louis, Missouri who have recovered from COVID-19 * Sera/plasma from from healthy humans in the US and from rural areas of low and middle income countries Note: No voluntary enrolment into this study will be conducted; all testing is to be conducted anonymously.

You may qualify if:

  • Sera/plasma from patients who have been hospitalized and tested positive for SARS-CoV-2
  • Sera/plasma from people who have recovered from COVID-19
  • Sera/plasma from from healthy humans and persons with parasitic diseases

You may not qualify if:

  • Persons under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (8)

  • Bogus J, Gankpala L, Fischer K, Krentel A, Weil GJ, Fischer PU, Kollie K, Bolay FK. Community Attitudes Toward Mass Drug Administration for Control and Elimination of Neglected Tropical Diseases After the 2014 Outbreak of Ebola Virus Disease in Lofa County, Liberia. Am J Trop Med Hyg. 2016 Mar;94(3):497-503. doi: 10.4269/ajtmh.15-0591. Epub 2015 Dec 14.

    PMID: 26666700BACKGROUND

  • Chesnais CB, Awaca-Uvon NP, Bolay FK, Boussinesq M, Fischer PU, Gankpala L, Meite A, Missamou F, Pion SD, Weil GJ. A multi-center field study of two point-of-care tests for circulating Wuchereria bancrofti antigenemia in Africa. PLoS Negl Trop Dis. 2017 Sep 11;11(9):e0005703. doi: 10.1371/journal.pntd.0005703. eCollection 2017 Sep.

    PMID: 28892473BACKGROUND

  • Corman VM, Landt O, Kaiser M, Molenkamp R, Meijer A, Chu DK, Bleicker T, Brunink S, Schneider J, Schmidt ML, Mulders DG, Haagmans BL, van der Veer B, van den Brink S, Wijsman L, Goderski G, Romette JL, Ellis J, Zambon M, Peiris M, Goossens H, Reusken C, Koopmans MP, Drosten C. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020 Jan;25(3):2000045. doi: 10.2807/1560-7917.ES.2020.25.3.2000045.

    PMID: 31992387BACKGROUND

  • Li Z, Yi Y, Luo X, Xiong N, Liu Y, Li S, Sun R, Wang Y, Hu B, Chen W, Zhang Y, Wang J, Huang B, Lin Y, Yang J, Cai W, Wang X, Cheng J, Chen Z, Sun K, Pan W, Zhan Z, Chen L, Ye F. Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis. J Med Virol. 2020 Sep;92(9):1518-1524. doi: 10.1002/jmv.25727. Epub 2020 Apr 13.

    PMID: 32104917BACKGROUND

  • Okba NMA, Muller MA, Li W, Wang C, GeurtsvanKessel CH, Corman VM, Lamers MM, Sikkema RS, de Bruin E, Chandler FD, Yazdanpanah Y, Le Hingrat Q, Descamps D, Houhou-Fidouh N, Reusken CBEM, Bosch BJ, Drosten C, Koopmans MPG, Haagmans BL. Severe Acute Respiratory Syndrome Coronavirus 2-Specific Antibody Responses in Coronavirus Disease Patients. Emerg Infect Dis. 2020 Jul;26(7):1478-1488. doi: 10.3201/eid2607.200841. Epub 2020 Jun 21.

    PMID: 32267220BACKGROUND

  • Tang YW, Schmitz JE, Persing DH, Stratton CW. Laboratory Diagnosis of COVID-19: Current Issues and Challenges. J Clin Microbiol. 2020 May 26;58(6):e00512-20. doi: 10.1128/JCM.00512-20. Print 2020 May 26.

    PMID: 32245835BACKGROUND

  • Weil GJ, Curtis KC, Fakoli L, Fischer K, Gankpala L, Lammie PJ, Majewski AC, Pelletreau S, Won KY, Bolay FK, Fischer PU. Laboratory and field evaluation of a new rapid test for detecting Wuchereria bancrofti antigen in human blood. Am J Trop Med Hyg. 2013 Jul;89(1):11-15. doi: 10.4269/ajtmh.13-0089. Epub 2013 May 20.

    PMID: 23690552BACKGROUND

  • Weil GJ, Lammie PJ, Weiss N. The ICT Filariasis Test: A rapid-format antigen test for diagnosis of bancroftian filariasis. Parasitol Today. 1997 Oct;13(10):401-4. doi: 10.1016/s0169-4758(97)01130-7.

    PMID: 15275155BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma or serum.

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 24, 2020

Study Start

April 23, 2020

Primary Completion

July 8, 2020

Study Completion

July 8, 2020

Last Updated

June 4, 2024

Record last verified: 2024-06

Locations

US(1)