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Mass Evaluation of Lateral Flow Immunoassays for the Detection of SARS-CoV-2 (Covid-19) Antibodies

NCT05148806 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28411

Last updated 2024-12-09

Study results available
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Summary

DESIGN Observational epidemiological study

AIMS - To determine:

1. The proportion of immunosuppressed people who have detectable SARS-CoV-2 antibodies following a primary vaccine course (3 doses), and the demographic, disease, and treatment characteristics that influence antibody status.
2. If the detection of antibodies inversely correlates with subsequent risk of severe acute respiratory syndrome coronavirus-2 infection and/or severity of disease in immunosuppressed people.

Conditions

Interventions

DIAGNOSTIC_TEST

self-administered lateral flow assays

The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%.

Sponsors & Collaborators

  • NHS Blood and Transplant

    collaborator OTHER_GOV

  • IPSOS

    collaborator INDUSTRY

  • University of Nottingham

    collaborator OTHER

  • Nottingham University Hospitals NHS Trust

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Michelle Willicombe, MBBS, MD · Imperial College London

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT05148806 on ClinicalTrials.gov