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

Influenza, Human Clinical Trial

— INSPIRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04288921
• Other study ID #: S-CLIN-PROT-00015
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2023
• Source: LumiraDx UK Limited
• Contact: David Craig
• Phone: 00441786533232
• Email: david.craig[@]lumiradx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza, Human
• Respiratory Syncytial Virus Infections

Intervention

Diagnostic Test:
• Swab
Swab samples for diagnostic test

Locations

Country	Name	City	State
United States	MedHelp Urgent Care	Birmingham	Alabama
United States	Pediatric Care	Bountiful	Utah
United States	Family Medical Associates	Carrollton	Texas
United States	ImmunoE Health and Research	Centennial	Colorado
United States	Pediatric Associates of Charlottesville	Charlottesville	Virginia
United States	Accel-West Volusia Pediatrics	DeLand	Florida
United States	Access Medical Center	Encinitas	California
United States	Kent Plaza Pediatrics	Jackson	New Jersey
United States	Madera Family Medical Group	Madera	California
United States	Gvozden Pediatrics	Millersville	Maryland
United States	Jersey Shore UMC	Neptune	New Jersey
United States	Lisa Connery MD	Norman	Oklahoma
United States	Complete Family Care Research	Northglenn	Colorado
United States	Nona Pediatric Center	Orlando	Florida
United States	North Texas Family Practice	Plano	Texas
United States	Southwest Care	Santa Fe	New Mexico
United States	ImmunoE Health and Research Center	Thornton	Colorado
United States	Advanced Pediatrics	Vienna	Virginia
United States	New Medical	Wichita	Kansas
United States	Ardmore Family Practice	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
LumiraDx UK Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance evaluation by health care professionals	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.	4 months
Primary	Performance evaluation by non-laboratory users	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.	4 months