Performance Evaluation of the LumiraDx SARS-CoV-2 & FLU A/B and SARS-CoV-2 & RSV Tests for Aid in the Assessment of COVID-19

NCT05268939 | Completed FDA Device

• 1 other identifier: S-CLIN-PROT-00034
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 8

Brief Summary

A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 \& FLU A/B Test, and LumiraDx SARS-CoV-2 \& RSV Test at Point of Care Testing Sites. Subjects presenting with symptoms suggestive of COVID-19 and/or Influenza and/or RSV will be consented and asked to donate swab sample(s) for testing in the device(s) under evaluation.

Conditions

COVID-19; Influenza A; Influenza Type B; RSV Infection

Outcome Measures

Primary Outcomes (2)

• Performance evaluation by health care professionals

  Evaluate the performance of the LumiraDx Tests in detecting and differentiating SARS-CoV-2, influenza A, influenza B and/or RSV in fresh nasal or nasopharyngeal swab specimens from patients with signs and symptoms of COVID-19, Influenza and/or RSV-like illness. Performance will be evaluated by use of statistical analysis techniques to assess sensitivity (true positive rate), specificity (true negative rate), Negative and Positive Percent Agreement (NPA, PPA) of the LumiraDx test results versus an FDA-approved method where a result of 100% sensitivity, specificity, NPA or PPA would equate to complete agreement with the reference method and 0% would equate to no agreement.

  4 months

• Point of Care usability

  Evaluate the point of care usability of the LumiraDx SARS-CoV-2 \& Flu A/B Test and LumiraDx SARS-CoV-2 \& RSV Tests. Usability will be assessed by means of a user questionnaire to be completed by naive users following their first test of the devices using standard Pack Leaflet and Quick Reference Instructions.

  4 months

Study Arms (2)

Nasal Swab

EXPERIMENTAL

Nasal swab from subjects with signs and symptoms of COVID-19 and/or Influenza and/or RSV-like illness

Diagnostic Test: LumiraDx SARS-CoV-2 & Flu A/B test; Diagnostic Test: LumiraDx SARS-CoV-2 & RSV test

Nasopharyngeal Swab

EXPERIMENTAL

Nasopharyngeal swab from subjects with signs and symptoms of COVID-19 and/or Influenza and/or RSV-like illness

Diagnostic Test: LumiraDx SARS-CoV-2 & Flu A/B test; Diagnostic Test: LumiraDx SARS-CoV-2 & RSV test

Interventions

LumiraDx SARS-CoV-2 & Flu A/B test DIAGNOSTIC_TEST

Swab Samples for Diagnostic test

Nasal Swab; Nasopharyngeal Swab

LumiraDx SARS-CoV-2 & RSV test DIAGNOSTIC_TEST

Swab Samples for Diagnostic test

Nasal Swab; Nasopharyngeal Swab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 and /or influenza and/or RSV at the time of the study visit.
• The subject must present in one of the following two cohorts:
• Covid Cohort:
• Preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 at the time of the study visit. The subject must present as symptomatic, meaning they have exhibited one or more of the following signs and symptoms for eligibility: fever, cough, shortness of breath, difficulty breathing, muscle pain, headache, sore throat, chills, repeated shaking with chills, new loss of taste or smell, congestion or runny nose, diarrhea, nausea or vomiting. The onset of these symptoms will be recorded and will be in the last twelve (12) days.
• or The subject must have presented with respiratory symptoms and a documented positive SARS-CoV-2 PCR or antigen test in the past forty-eight (48) hours.
• Influenza/RSV Cohort:
• Written informed consent must be obtained prior to study enrollment. A subject who is a legal adult must be willing to give written informed consent and must agree to comply with study procedures. The Legal Guardian or Legal Authorized Representative of a subject who is under the age of consent must give written informed consent and agree to comply with study procedures. Active assent should be obtained from children of appropriate intellectual age (as defined by the IRB)

You may not qualify if:

• The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
• Subjects undergoing treatment currently and/or within the past fourteen (14 days of the study visit with an inhaled influenza vaccine (FluMist®) or with antiviral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir Marboxil (Xofluza™)
• Subjects undergoing treatment currently and/or within the past thirty (30) days of the study with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury) or receiving convalescent plasma therapy for SARS-CoV-2;
• The subject is undergoing treatment currently or had undergone within the past fourteen (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 (CS-1262-01).

Sponsors & Collaborators

• LumiraDx UK Limited: lead

Study Sites (8)

Cullman Clinical Trials

Cullman, Alabama, 35055, United States

Location

Diagnamics, Inc

Encinitas, California, 92024, United States

Location

Marisela Gonzalez, MD, PA

Miami, Florida, 33155, United States

Location

Excellence Medical and Research

Miami Gardens, Florida, 33169, United States

Location

Koch Family Medicine

Morton, Illinois, 61550, United States

Location

Benchmark Research

Covington, Louisiana, 70433, United States

Location

Machuca Foundation

Las Vegas, Nevada, 89104, United States

Location

Clinical Research Solutions

Middleburg Heights, Ohio, 44130, United States

Location

MeSH Terms

Conditions

COVID-19; Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections

Study Officials

• Ramin Farsad

  Diagnamics, Inc

  PRINCIPAL INVESTIGATOR

• Sherri Casey

  Benchmark Research

  PRINCIPAL INVESTIGATOR

• Justin Wilson

  Cullman Clinical Trials

  PRINCIPAL INVESTIGATOR

• Miguel Perez

  Excellence Medical and Research

  PRINCIPAL INVESTIGATOR

• Mary Imig

  Koch Family Medicine

  PRINCIPAL INVESTIGATOR

• Marisela Gonzalez

  Marisela Gonzalez, MD, PA

  PRINCIPAL INVESTIGATOR

• Lawrence Gervasi

  Clinical Research Solutions

  PRINCIPAL INVESTIGATOR

• Rogelio Machuca

  Machuca Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Performance Evaluation study

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 7, 2022
• Study Start: January 4, 2022
• Primary Completion: April 25, 2022
• Study Completion: March 14, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)