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

NCT04288921 | Unknown FDA Device

• 1 other identifier: S-CLIN-PROT-00015
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 20

Brief 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

Outcome Measures

Primary Outcomes (2)

• Performance evaluation by health care professionals

  Evaluate the performance of the LumiraDx Influenza A/B + RSV Test in detecting and differentiating influenza A, influenza B and RSV in fresh nasal or nasopharyngeal swab specimens from patients with signs and symptoms of influenza and or RSV-like illness, as compared with an FDA-cleared comparative method.

  4 months

• Performance evaluation by non-laboratory users

  Evaluate LumiraDx Influenza A/B + RSV Test performance when the test is run by non-laboratory users in point-of-care (POC) locations representative of sites who perform testing under a CLIA certificate of waiver.

  4 months

Study Arms (2)

Nasal swab

EXPERIMENTAL

Nasal swab from subjects with signs and symptoms of influenza and/or RSV-like illness

Diagnostic Test: Swab

Nasopharyngeal swab

EXPERIMENTAL

Nasopharyngeal swab from subjects with signs and symptoms of influenza and/or RSV-like illness

Diagnostic Test: Swab

Interventions

Swab DIAGNOSTIC_TEST

Swab samples for diagnostic test

Nasal swab; Nasopharyngeal swab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject may be of any age and either sex.
• Preliminary assessment of the subject by the Investigator/designee should be suggestive of influenza and/or RSV at the time of the study visit. The subject must exhibit two (2) or more of the following signs and symptoms for eligibility: stuffy or runny nose, sneezing, cough, sore throat, dyspnea (labored, difficult breathing), wheezing, fatigue, weakness and/or malaise, arthralgia (joint pain), myalgia (deep muscle aches), anorexia, vomiting, diarrhea, or headache. The onset of these symptoms must not have begun more than four (4) days prior to study enrollment.

You may not qualify if:

• The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
• The subject is undergoing treatment currently and/or within the past 14 days of the study visit with an inhaled influenza vaccine (FluMist®) or anti-viral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir Marboxil (Xofluza™).
• The subject is undergoing treatment currently or had undergone within the past 14 days of the study visit with RSV-related medication which may include but is not limited to Ribavirin (Virazole), RSV-IGIV (RespiGam) or palivizumab (Synagis).
• The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
• The subject has previously participated in this research study

Sponsors & Collaborators

• LumiraDx UK Limited: lead

Study Sites (20)

MedHelp Urgent Care

Birmingham, Alabama, 35235, United States

RECRUITING

Access Medical Center

Encinitas, California, 92024, United States

RECRUITING

Madera Family Medical Group

Madera, California, 93637, United States

RECRUITING

ImmunoE Health and Research

Centennial, Colorado, 80112, United States

RECRUITING

Complete Family Care Research

Northglenn, Colorado, 80234, United States

RECRUITING

ImmunoE Health and Research Center

Thornton, Colorado, 80233, United States

RECRUITING

Accel-West Volusia Pediatrics

DeLand, Florida, 32720, United States

RECRUITING

Nona Pediatric Center

Orlando, Florida, 32829, United States

RECRUITING

New Medical

Wichita, Kansas, 67205, United States

RECRUITING

Gvozden Pediatrics

Millersville, Maryland, 21108, United States

RECRUITING

Kent Plaza Pediatrics

Jackson, New Jersey, 08527, United States

RECRUITING

Jersey Shore UMC

Neptune City, New Jersey, 07753, United States

RECRUITING

Southwest Care

Santa Fe, New Mexico, 87505, United States

RECRUITING

Ardmore Family Practice

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Lisa Connery MD

Norman, Oklahoma, 73069, United States

RECRUITING

Family Medical Associates

Carrollton, Texas, 75010, United States

RECRUITING

North Texas Family Practice

Plano, Texas, 75093, United States

RECRUITING

Pediatric Care

Bountiful, Utah, 84010, United States

RECRUITING

Pediatric Associates of Charlottesville

Charlottesville, Virginia, 22902, United States

RECRUITING

Advanced Pediatrics

Vienna, Virginia, 22180, United States

RECRUITING

Related Publications (1)

• Ellis JE, Guest P, Lawson V, Loecherbach J, Lindner N, McCulloch A. Performance Evaluation of the Microfluidic Antigen LumiraDx SARS-CoV-2 and Flu A/B Test in Diagnosing COVID-19 and Influenza in Patients with Respiratory Symptoms. Infect Dis Ther. 2022 Dec;11(6):2099-2109. doi: 10.1007/s40121-022-00696-8. Epub 2022 Sep 24.

  PMID: 36152227 DERIVED

MeSH Terms

Conditions

Influenza, Human; Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections

Study Officials

• Christina Ulen

  Advanced Pediatrics

  PRINCIPAL INVESTIGATOR

• Robert Rosen

  Ardmore Family Practice

  PRINCIPAL INVESTIGATOR

• Ramin Farsad

  Access Medical Center

  PRINCIPAL INVESTIGATOR

• Matthew Morgan

  Centura Health Physician Group

  PRINCIPAL INVESTIGATOR

• Jeffrey Stewart

  Family Medical Associates

  PRINCIPAL INVESTIGATOR

• Andre Gvozden

  Gvozden Pediatrics

  PRINCIPAL INVESTIGATOR

• Isaac Melamed

  ImmunoE Health Center

  PRINCIPAL INVESTIGATOR

• Nader Nakhleh

  Jersey Shore UMC

  PRINCIPAL INVESTIGATOR

• Lisa Connery

  Lisa Connery MD

  PRINCIPAL INVESTIGATOR

• Aftab Naz

  Madera Family Medical Group

  PRINCIPAL INVESTIGATOR

• Salma Elfaki

  Nona Pediatric Center

  PRINCIPAL INVESTIGATOR

• Adam Kaplan

  North Texas Family Practice

  PRINCIPAL INVESTIGATOR

• Paul Wisman

  Pediatric Research of Charlottesville

  PRINCIPAL INVESTIGATOR

• William Simon

  New Medical Healthcare

  PRINCIPAL INVESTIGATOR

• Joshua Fuller

  Pediatric Care

  PRINCIPAL INVESTIGATOR

• David King

  Southwest Care

  PRINCIPAL INVESTIGATOR

• Song Yu

  MedHelp Urgent Care

  PRINCIPAL INVESTIGATOR

• Michael Bell

  Accel-West Volusia Pediatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Craig

CONTACT

00441786533232; david.craig@lumiradx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A performance evaluation study.

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: February 6, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)