Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing Sites

Summary

A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx Influenza A/B + RSV Test at Point of Care Testing Sites

Conditions

• Influenza, Human
• Respiratory Syncytial Virus Infections

Interventions

DIAGNOSTIC_TEST

Swab

Swab samples for diagnostic test

Sponsors & Collaborators

• LumiraDx UK Limited

  lead INDUSTRY

Principal Investigators

• Christina Ulen · Advanced Pediatrics

• Robert Rosen · Ardmore Family Practice

• Ramin Farsad · Access Medical Center

• Matthew Morgan · Centura Health Physician Group

• Jeffrey Stewart · Family Medical Associates

• Andre Gvozden · Gvozden Pediatrics

• Isaac Melamed · ImmunoE Health Center

• Nader Nakhleh · Jersey Shore UMC

• Lisa Connery · Lisa Connery MD

• Aftab Naz · Madera Family Medical Group

• Salma Elfaki · Nona Pediatric Center

• Adam Kaplan · North Texas Family Practice

• Paul Wisman · Pediatric Research of Charlottesville

• William Simon · New Medical Healthcare

• Joshua Fuller · Pediatric Care

• David King · Southwest Care

• Song Yu · MedHelp Urgent Care

• Michael Bell · Accel-West Volusia Pediatrics

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-06

Primary Completion

2023-09-30

Completion

2023-09-30

FDA Device

Yes

Countries

• United States

Study Locations