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Performance Evaluation of the LumiraDx SARS-CoV-2 & FLU A/B and SARS-CoV-2 & RSV Tests for Aid in the Assessment of COVID-19

NCT05268939 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 668

Last updated 2023-08-14

No results posted yet for this study

Summary

A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 \& FLU A/B Test, and LumiraDx SARS-CoV-2 \& RSV Test at Point of Care Testing Sites. Subjects presenting with symptoms suggestive of COVID-19 and/or Influenza and/or RSV will be consented and asked to donate swab sample(s) for testing in the device(s) under evaluation.

Conditions

Interventions

DIAGNOSTIC_TEST

LumiraDx SARS-CoV-2 & Flu A/B test

Swab Samples for Diagnostic test

DIAGNOSTIC_TEST

LumiraDx SARS-CoV-2 & RSV test

Swab Samples for Diagnostic test

Sponsors & Collaborators

  • LumiraDx UK Limited

    lead INDUSTRY

Principal Investigators

  • Ramin Farsad · Diagnamics, Inc

  • Sherri Casey · Benchmark Research

  • Justin Wilson · Cullman Clinical Trials

  • Miguel Perez · Excellence Medical and Research

  • Mary Imig · Koch Family Medicine

  • Marisela Gonzalez · Marisela Gonzalez, MD, PA

  • Lawrence Gervasi · Clinical Research Solutions

  • Rogelio Machuca · Machuca Foundation

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-04
Primary Completion
2022-04-25
Completion
2023-03-14
FDA Device
Yes

Countries

  • United States

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 NCT05268939 on ClinicalTrials.gov