Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing Sites
NCT ID: NCT04288921
Last Updated: 2023-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
2000 participants
INTERVENTIONAL
2020-02-06
2023-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Nasal swab
Nasal swab from subjects with signs and symptoms of influenza and/or RSV-like illness
Swab
Swab samples for diagnostic test
Nasopharyngeal swab
Nasopharyngeal swab from subjects with signs and symptoms of influenza and/or RSV-like illness
Swab
Swab samples for diagnostic test
Interventions
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Swab
Swab samples for diagnostic test
Eligibility Criteria
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Inclusion Criteria
* 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 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
ALL
No
Sponsors
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LumiraDx UK Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Christina Ulen
Role: PRINCIPAL_INVESTIGATOR
Advanced Pediatrics
Robert Rosen
Role: PRINCIPAL_INVESTIGATOR
Ardmore Family Practice
Ramin Farsad
Role: PRINCIPAL_INVESTIGATOR
Access Medical Center
Matthew Morgan
Role: PRINCIPAL_INVESTIGATOR
Centura Health Physician Group
Jeffrey Stewart
Role: PRINCIPAL_INVESTIGATOR
Family Medical Associates
Andre Gvozden
Role: PRINCIPAL_INVESTIGATOR
Gvozden Pediatrics
Isaac Melamed
Role: PRINCIPAL_INVESTIGATOR
ImmunoE Health Center
Nader Nakhleh
Role: PRINCIPAL_INVESTIGATOR
Jersey Shore UMC
Lisa Connery
Role: PRINCIPAL_INVESTIGATOR
Lisa Connery MD
Aftab Naz
Role: PRINCIPAL_INVESTIGATOR
Madera Family Medical Group
Salma Elfaki
Role: PRINCIPAL_INVESTIGATOR
Nona Pediatric Center
Adam Kaplan
Role: PRINCIPAL_INVESTIGATOR
North Texas Family Practice
Paul Wisman
Role: PRINCIPAL_INVESTIGATOR
Pediatric Research of Charlottesville
William Simon
Role: PRINCIPAL_INVESTIGATOR
New Medical Healthcare
Joshua Fuller
Role: PRINCIPAL_INVESTIGATOR
Pediatric Care
David King
Role: PRINCIPAL_INVESTIGATOR
Southwest Care
Song Yu
Role: PRINCIPAL_INVESTIGATOR
MedHelp Urgent Care
Michael Bell
Role: PRINCIPAL_INVESTIGATOR
Accel-West Volusia Pediatrics
Locations
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MedHelp Urgent Care
Birmingham, Alabama, United States
Access Medical Center
Encinitas, California, United States
Madera Family Medical Group
Madera, California, United States
ImmunoE Health and Research
Centennial, Colorado, United States
Complete Family Care Research
Northglenn, Colorado, United States
ImmunoE Health and Research Center
Thornton, Colorado, United States
Accel-West Volusia Pediatrics
DeLand, Florida, United States
Nona Pediatric Center
Orlando, Florida, United States
New Medical
Wichita, Kansas, United States
Gvozden Pediatrics
Millersville, Maryland, United States
Kent Plaza Pediatrics
Jackson, New Jersey, United States
Jersey Shore UMC
Neptune City, New Jersey, United States
Southwest Care
Santa Fe, New Mexico, United States
Ardmore Family Practice
Winston-Salem, North Carolina, United States
Lisa Connery MD
Norman, Oklahoma, United States
Family Medical Associates
Carrollton, Texas, United States
North Texas Family Practice
Plano, Texas, United States
Pediatric Care
Bountiful, Utah, United States
Pediatric Associates of Charlottesville
Charlottesville, Virginia, United States
Advanced Pediatrics
Vienna, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Song Yu
Role: primary
Ramin Farsad
Role: primary
Aftab Naz
Role: primary
Isaac Melamed
Role: primary
Matthew Morgan
Role: primary
Isaac Melamed
Role: primary
Salma Elfaki
Role: primary
William Simon
Role: primary
Andre Gvozden
Role: primary
Nader Nakhleh
Role: primary
Nader Nakhleh
Role: primary
David King
Role: primary
Robert Rosen
Role: primary
Lisa Connery
Role: primary
Jeffrey Stewart
Role: primary
Adam Kaplan
Role: primary
Joshua Fuller
Role: primary
Paul Wisman
Role: primary
Christina Ulen
Role: primary
References
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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.
Other Identifiers
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S-CLIN-PROT-00015
Identifier Type: -
Identifier Source: org_study_id
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