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

Primary Purpose

Influenza, Human, Respiratory Syncytial Virus Infections

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Swab
Sponsored by
LumiraDx UK Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Influenza, Human

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MedHelp Urgent CareRecruiting
  • Access Medical CenterRecruiting
  • Madera Family Medical GroupRecruiting
  • ImmunoE Health and ResearchRecruiting
  • Complete Family Care ResearchRecruiting
  • ImmunoE Health and Research CenterRecruiting
  • Accel-West Volusia PediatricsRecruiting
  • Nona Pediatric CenterRecruiting
  • New MedicalRecruiting
  • Gvozden PediatricsRecruiting
  • Kent Plaza PediatricsRecruiting
  • Jersey Shore UMCRecruiting
  • Southwest CareRecruiting
  • Ardmore Family PracticeRecruiting
  • Lisa Connery MDRecruiting
  • Family Medical AssociatesRecruiting
  • North Texas Family PracticeRecruiting
  • Pediatric CareRecruiting
  • Pediatric Associates of CharlottesvilleRecruiting
  • Advanced PediatricsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nasal swab

Nasopharyngeal swab

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 26, 2020
Last Updated
March 10, 2023
Sponsor
LumiraDx UK Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04288921
Brief Title
Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing Sites
Acronym
INSPIRE
Official Title
A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx Influenza A/B + RSV Test at Point of Care Testing Sites
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LumiraDx UK Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human, Respiratory Syncytial Virus Infections

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A performance evaluation study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nasal swab
Arm Type
Experimental
Arm Description
Nasal swab from subjects with signs and symptoms of influenza and/or RSV-like illness
Arm Title
Nasopharyngeal swab
Arm Type
Experimental
Arm Description
Nasopharyngeal swab from subjects with signs and symptoms of influenza and/or RSV-like illness
Intervention Type
Diagnostic Test
Intervention Name(s)
Swab
Intervention Description
Swab samples for diagnostic test
Primary Outcome Measure Information:
Title
Performance evaluation by health care professionals
Description
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.
Time Frame
4 months
Title
Performance evaluation by non-laboratory users
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Craig
Phone
00441786533232
Email
david.craig@lumiradx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Ulen
Organizational Affiliation
Advanced Pediatrics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Rosen
Organizational Affiliation
Ardmore Family Practice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ramin Farsad
Organizational Affiliation
Access Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew Morgan
Organizational Affiliation
Centura Health Physician Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Stewart
Organizational Affiliation
Family Medical Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andre Gvozden
Organizational Affiliation
Gvozden Pediatrics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Isaac Melamed
Organizational Affiliation
ImmunoE Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nader Nakhleh
Organizational Affiliation
Jersey Shore UMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Connery
Organizational Affiliation
Lisa Connery MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aftab Naz
Organizational Affiliation
Madera Family Medical Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Salma Elfaki
Organizational Affiliation
Nona Pediatric Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam Kaplan
Organizational Affiliation
North Texas Family Practice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Wisman
Organizational Affiliation
Pediatric Research of Charlottesville
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Simon
Organizational Affiliation
New Medical Healthcare
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joshua Fuller
Organizational Affiliation
Pediatric Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David King
Organizational Affiliation
Southwest Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Song Yu
Organizational Affiliation
MedHelp Urgent Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Bell
Organizational Affiliation
Accel-West Volusia Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedHelp Urgent Care
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song Yu
Facility Name
Access Medical Center
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramin Farsad
Facility Name
Madera Family Medical Group
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aftab Naz
Facility Name
ImmunoE Health and Research
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isaac Melamed
Facility Name
Complete Family Care Research
City
Northglenn
State/Province
Colorado
ZIP/Postal Code
80234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Morgan
Facility Name
ImmunoE Health and Research Center
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isaac Melamed
Facility Name
Accel-West Volusia Pediatrics
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Recruiting
Facility Name
Nona Pediatric Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32829
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salma Elfaki
Facility Name
New Medical
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Simon
Facility Name
Gvozden Pediatrics
City
Millersville
State/Province
Maryland
ZIP/Postal Code
21108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Gvozden
Facility Name
Kent Plaza Pediatrics
City
Jackson
State/Province
New Jersey
ZIP/Postal Code
08527
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nader Nakhleh
Facility Name
Jersey Shore UMC
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nader Nakhleh
Facility Name
Southwest Care
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David King
Facility Name
Ardmore Family Practice
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Rosen
Facility Name
Lisa Connery MD
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Connery
Facility Name
Family Medical Associates
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Stewart
Facility Name
North Texas Family Practice
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Kaplan
Facility Name
Pediatric Care
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Fuller
Facility Name
Pediatric Associates of Charlottesville
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Wisman
Facility Name
Advanced Pediatrics
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22180
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Ulen

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36152227
Citation
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.
Results Reference
derived

Learn more about this trial

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

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