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

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

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

Study Overview

• Status: Recruiting
• Conditions: Influenza, Human; Respiratory Syncytial Virus Infections
• Intervention / Treatment: Diagnostic test: Swab

Detailed Description

The LumiraDx Influenza A/B + RSV Test is a rapid microfluidic immunofluorescence assay for use with the LumiraDx instrument for the qualitative detection and differentiation of Influenza type A, Influenza type B and respiratory syncytial virus (RSV) viral antigens. The test is not intended to detect influenza C antigens. The LumiraDx Influenza A/B + RSV assay uses nasal swabs or nasopharyngeal swab specimens, collected from symptomatic patients.

Approximately 2000 subjects will be enrolled in this study. 120 influenza A positive, 120 influenza B positive and 120 RSV positive samples are required, in addition to at least 120 samples negative for influenza and 120 negative RSV samples, representing four (4) age groups: ≤ 5 years, 6 to 21 years, 22 to 59 years, and ≥ 60 years. Depending on the prevalence of influenza A, influenza B or RSV, it will be necessary to collect a significantly higher number of total samples to obtain the required number of positives. Banked specimens may be used to supplement the data set.

The objectives of this clinical study are twofold:

• 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.
• 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.

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Recruiting
      • MedHelp Urgent Care
  • California
    • Encinitas, California, United States, 92024
      • Recruiting
      • Access Medical Center
    • Madera, California, United States, 93637
      • Recruiting
      • Madera Family Medical Group
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Recruiting
      • ImmunoE Health and Research
    • Northglenn, Colorado, United States, 80234
      • Recruiting
      • Complete Family Care Research
    • Thornton, Colorado, United States, 80233
      • Recruiting
      • ImmunoE Health and Research Center
  • Florida
    • DeLand, Florida, United States, 32720
      • Recruiting
      • Accel-West Volusia Pediatrics
    • Orlando, Florida, United States, 32829
      • Recruiting
      • Nona Pediatric Center
  • Kansas
    • Wichita, Kansas, United States, 67205
      • Recruiting
      • New Medical
  • Maryland
    • Millersville, Maryland, United States, 21108
      • Recruiting
      • Gvozden Pediatrics
  • New Jersey
    • Jackson, New Jersey, United States, 08527
      • Recruiting
      • Kent Plaza Pediatrics
    • Neptune, New Jersey, United States, 07753
      • Recruiting
      • Jersey Shore UMC
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • Recruiting
      • Southwest Care
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Ardmore Family Practice
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Recruiting
      • Lisa Connery MD
  • Texas
    • Carrollton, Texas, United States, 75010
      • Recruiting
      • Family Medical Associates
    • Plano, Texas, United States, 75093
      • Recruiting
      • North Texas Family Practice
  • Utah
    • Bountiful, Utah, United States, 84010
      • Recruiting
      • Pediatric Care
  • Virginia
    • Charlottesville, Virginia, United States, 22902
      • Recruiting
      • Pediatric Associates of Charlottesville
    • Vienna, Virginia, United States, 22180
      • Recruiting
      • Advanced Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.
• The subject must have a fever of 100.0 °F or greater with the onset of the fever being within the past three (3) days and/or present at the time of the visit. Fever can be reported or taken at time of visit. Subjects 18 years and older must report having a fever, but a quantitative reported measurement is not necessary for inclusion.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasal swab; Nasal swab from subjects with signs and symptoms of influenza and/or RSV-like illness	Diagnostic test: Swab; Swab samples for diagnostic test
Experimental: Nasopharyngeal swab; Nasopharyngeal swab from subjects with signs and symptoms of influenza and/or RSV-like illness	Diagnostic test: Swab; Swab samples for diagnostic test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: LumiraDx UK Limited

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2020
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Paramyxoviridae Infections; Mononegavirales Infections; Orthomyxoviridae Infections; Pneumovirus Infections; Influenza, Human; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: S-CLIN-PROT-00015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No