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

Completed

Conditions studied: Influenza, Human, Respiratory Syncytial Virus Infections

In brief

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

Key facts

Study ID

NCT04288921

Run by

LumiraDx UK Limited

People needed

525

Starts

2020-02-06

Expected to finish

2020-03-02

Last updated by the study team

2026-06-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.