Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing Sites
Purpose
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
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- A performance evaluation study.
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Nasal swab |
Nasal swab from subjects with signs and symptoms of influenza and/or RSV-like illness |
|
|
Experimental Nasopharyngeal swab |
Nasopharyngeal swab from subjects with signs and symptoms of influenza and/or RSV-like illness |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35235
Song Yu
Encinitas 5346646, California 5332921 92024
Ramin Farsad
Madera 5369568, California 5332921 93637
Aftab Naz
Centennial 5416541, Colorado 5417618 80112
Isaac Melamed
Northglenn 5433124, Colorado 5417618 80234
Matthew Morgan
Thornton 5441492, Colorado 5417618 80233
Isaac Melamed
DeLand 4152890, Florida 4155751 32720
Orlando 4167147, Florida 4155751 32829
Salma Elfaki
Wichita 4281730, Kansas 4273857 67205
William Simon
Millersville 4362543, Maryland 4361885 21108
Andre Gvozden
Jackson 4502434, New Jersey 5101760 08527
Nader Nakhleh
Neptune City 5101687, New Jersey 5101760 07753
Nader Nakhleh
Santa Fe 5490263, New Mexico 5481136 87505
David King
Winston-Salem 4499612, North Carolina 4482348 27103
Robert Rosen
Norman 4543762, Oklahoma 4544379 73069
Lisa Connery
Carrollton 4679195, Texas 4736286 75010
Jeffrey Stewart
Plano 4719457, Texas 4736286 75093
Adam Kaplan
Bountiful 5771826, Utah 5549030 84010
Joshua Fuller
Charlottesville 4752031, Virginia 6254928 22902
Paul Wisman
Vienna 4791160, Virginia 6254928 22180
Christina Ulen
More Details
- NCT ID
- NCT04288921
- Status
- Unknown status
- Sponsor
- LumiraDx UK Limited
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.