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Healthy Volunteer COVID-19 Antibody Testing Study

NCT04529460 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2021-10-14

No results posted yet for this study

Summary

The need for large-scale testing for COVID-19 has been highlighted by both the World Health Organization (WHO) and the UK government.

Immunity to coronavirus 2019 (COVID-19) infection can be determined by detecting the presence of antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Immunoglobulins (Ig) to the SARS-CoV-2 develop during the second and third week of COVID-19 disease and can be detected by analyses conducted using laboratory tests. Accurate and scalable point-of-care testing (POCT) for the diagnosis of COVID-19 immunity would allow community diagnostic to be upscaled enormously. POCT for COVID-19 antibodies is possible using small disposable kits. POCT immunity testing using disposable kits will be imperative for effective surveillance and vaccinations programmes.

The study aims to test a novel, rapid antibody testing kit (IgG and IgM) in order to confirm its accuracy in a healthy volunteer population. The antibody testing kit intended for use in the study has already been CE marked for this purpose.

Conditions

  • Covid19

Interventions

DIAGNOSTIC_TEST

COVID-19 antibody point of care test kit

A disponible point of care test that identifies the presence of antibodies to COVID-19

Sponsors & Collaborators

  • Royal Free Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Daniel Martin, MB ChB · Royal Free Hospital NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-01-29
Completion
2021-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04529460 on ClinicalTrials.gov