Status:
UNKNOWN
Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing Sites
Lead Sponsor:
LumiraDx UK Limited
Conditions:
Influenza, Human
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
Phase:
NA
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, Influ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04288921
Start Date
February 6 2020
End Date
September 30 2023
Last Update
March 13 2023
Active Locations (20)
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1
MedHelp Urgent Care
Birmingham, Alabama, United States, 35235
2
Access Medical Center
Encinitas, California, United States, 92024
3
Madera Family Medical Group
Madera, California, United States, 93637
4
ImmunoE Health and Research
Centennial, Colorado, United States, 80112