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Diagnostics of COVID-19/DARTS (Development and Assessment of Rapid Testing for SARS-CoV-2 Outbreak)

NCT04351646 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2020-04-17

No results posted yet for this study

Summary

This project will evaluate point-of-care / point-of-need (POC/PON) tests for the detection of the novel strain of coronavirus (2019 nCoV). We are working with Mologic Ltd, who have been funded by DFID/Wellcome Trust to develop a rapid, accurate and low cost, lateral flow assay (LFA) to detect viral circulating antigens and IgM/G against SARS-CoV-2 in less than 15 minutes.

These POC/PON tests are intended for the rapid triage of patients with fever and/or cough and to identify patients likely to be immune from previous infections. In addition to this the POC/PON tests will be designed as self-tests, offering the additional benefit of enabling wide deployment in the home and community settings. In addition, we will evaluate ELISA assays, also produced by Mologic to detect IgG and IgM (and possibly IgA) against SARS-CoV-2. Comparison of antibody and antigen dynamics over time will compare with ELISA and quantitative RT-PCR.

Conditions

Sponsors & Collaborators

  • St George's, University of London

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-15
Primary Completion
2022-04-15
Completion
2022-04-15

Countries

  • United Kingdom

Study Locations

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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 NCT04351646 on ClinicalTrials.gov