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COMPLETED
NCT04408066

COVID-19: A POC Test Under Research & Evaluation

Sponsor: LumiraDx UK Limited

View on ClinicalTrials.gov

Summary

Collection of nasal/nasopharyngeal/throat swabs and blood samples from patients presenting at their designated care facility displaying symptoms of COVID-19 and undergoing a SOC SARS-CoV-2 test or those who have tested positive in the past to aid development, calibration and performance evaluation for the LumiraDx POC test.

Official title: Specimen Collection for Development and Performance Evaluation of the LumiraDx Platform Point of Care Tests for Sars-Cov-2 IgG/IgM & Antigen to be Used as an Aid in Diagnosis of COVID-19

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

523

Start Date

2020-05-01

Completion Date

2020-05-26

Last Updated

2026-06-15

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

Sample Collection/Performance Evaluation (A)

This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention. Sample types include: * Nasal/Throat/Nasal Throat Combo/ Nasopharyngeal (as per sites SOC) Swab * Whole Venous Blood

DIAGNOSTIC_TEST

Sample Collection/Performance Evaluation (B)

This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention. Sample types include: * Whole Venous Blood * Fingerstick Capillary Sample

Locations (3)

Barts Health NHS Trust

London, United Kingdom

Homerton University Hospital NHS Foundation Trust

London, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom