Clinical trial NCT04288921: Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing Sites
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
Overall status: UNKNOWN
Phase: NA
Conditions: Influenza, Human
Respiratory Syncytial Virus Infections
Lead sponsor: LumiraDx UK Limited
Sponsor class: INDUSTRY
First posted: 2020-02-28
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A performance evaluation study.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Performance evaluation by health care professionals
timeFrame: 4 months
measure: Performance evaluation by non-laboratory users
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: MedHelp Urgent Care
state: Alabama
city: Encinitas
country: United States
facility: Access Medical Center
state: California
city: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: Centennial
country: United States
facility: ImmunoE Health and Research
state: Colorado
city: Northglenn
country: United States
facility: Complete Family Care Research
state: Colorado
city: Thornton
country: United States
facility: ImmunoE Health and Research Center
state: Colorado
city: DeLand
country: United States
facility: Accel-West Volusia Pediatrics
state: Florida
city: Orlando
country: United States
facility: Nona Pediatric Center
state: Florida
city: Wichita
country: United States
facility: New Medical
state: Kansas
city: Millersville
country: United States
facility: Gvozden Pediatrics
state: Maryland
city: Jackson
country: United States
facility: Kent Plaza Pediatrics
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore UMC
state: New Jersey
city: Santa Fe
country: United States
facility: Southwest Care
state: New Mexico
city: Winston-Salem
country: United States
facility: Ardmore Family Practice
state: North Carolina
city: Norman
country: United States
facility: Lisa Connery MD
state: Oklahoma
city: Carrollton
country: United States
facility: Family Medical Associates
state: Texas
city: Plano
country: United States
facility: North Texas Family Practice
state: Texas
city: Bountiful
country: United States
facility: Pediatric Care
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Associates of Charlottesville
state: Virginia
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
Study officials:
affiliation: Advanced Pediatrics
name: Christina Ulen
role: PRINCIPAL_INVESTIGATOR
affiliation: Ardmore Family Practice
name: Robert Rosen
role: PRINCIPAL_INVESTIGATOR
affiliation: Access Medical Center
name: Ramin Farsad
role: PRINCIPAL_INVESTIGATOR
affiliation: Centura Health Physician Group
name: Matthew Morgan
role: PRINCIPAL_INVESTIGATOR
affiliation: Family Medical Associates
name: Jeffrey Stewart
role: PRINCIPAL_INVESTIGATOR
affiliation: Gvozden Pediatrics
name: Andre Gvozden
role: PRINCIPAL_INVESTIGATOR
affiliation: ImmunoE Health Center
name: Isaac Melamed
role: PRINCIPAL_INVESTIGATOR
affiliation: Jersey Shore UMC
name: Nader Nakhleh
role: PRINCIPAL_INVESTIGATOR
affiliation: Lisa Connery MD
name: Lisa Connery
role: PRINCIPAL_INVESTIGATOR
affiliation: Madera Family Medical Group
name: Aftab Naz
role: PRINCIPAL_INVESTIGATOR
affiliation: Nona Pediatric Center
name: Salma Elfaki
role: PRINCIPAL_INVESTIGATOR
affiliation: North Texas Family Practice
name: Adam Kaplan
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Research of Charlottesville
name: Paul Wisman
role: PRINCIPAL_INVESTIGATOR
affiliation: New Medical Healthcare
name: William Simon
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Care
name: Joshua Fuller
role: PRINCIPAL_INVESTIGATOR
affiliation: Southwest Care
name: David King
role: PRINCIPAL_INVESTIGATOR
affiliation: MedHelp Urgent Care
name: Song Yu
role: PRINCIPAL_INVESTIGATOR
affiliation: Accel-West Volusia Pediatrics
name: Michael Bell
role: PRINCIPAL_INVESTIGATOR
References:
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.