- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05728970
Performance Evaluation of the LumiraDX SARS-CoV-2 Ag Ultra and LumiraDX SARS-CoV-2 & Flu A/B Tests at Point of Care (POC) Sites (PURSUE)
A Prospective Multicenter Study Conducted to Evaluate the Performance of the LumiraDX SARS-CoV-2 Ag Ultra and LumiraDX SARS-CoV-2 & Flu A/B Tests at Point of Care Sites
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Approximately two thousand (2000) subjects will be enrolled in this study. Patients presenting to the study sites that meet the eligibility criteria will be considered for the study.
A subject's participation in this study will consist of a single on-site visit. Following completion of the informed consent process and a review of inclusion/exclusion criteria to determine eligibility, each subject will receive a unique study identification number.
Specimens will be obtained from each subject enrolled using standard collection methods.
The objectives of this study are to evaluate and validate the performance of:
- LumiraDx SARS-CoV-2 Ag Ultra test in detecting SARS-CoV-2 from symptomatic patients as compared with a Food and Drug Administration (FDA) cleared reverse transcription-polymerase chain reaction (RT-PCR) test.
- LumiraDx SARS-CoV-2 & Flu A/B tests in detecting SARS-CoV-2, Flu A, and/or Flu B from symptomatic patients as compared with an FDA cleared RT-PCR test for SARS-CoV-2 and an FDA cleared RT-PCR test for Flu A and Flu B.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Florida
-
DeLand, Florida, United States, 32720
- Hillcrest Medical Research
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subject may be of any age or sex.
- Self-reported symptoms by the subject and/or preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 and/or Influenza at the time of the study visit. The subject must present as symptomatic, exhibiting one or more of the following signs and symptoms: 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 within the last twelve (12) days.
- Participant (or parent/legal guardian) capable and willing to give informed consent/assent.
Exclusion Criteria:
- The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
- 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.
- Subjects undergoing treatment currently and/or within the past thirty (30) days of the study with medication to treat novel Coronavirus SARS-CoV-2 viral infections, which may include but is not limited to; COVID-19 antivirals (Lagevrio, PAXLOVID), Remdesivir (Veklury) or receiving convalescent plasma therapy for SARS-CoV-2.
- Subjects undergoing treatment currently and/or within the past fourteen (14) days of the study visit with an inhaled influenza vaccine (FluMist®) or with anti-viral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), Baloxavir Marboxil (Xofluza™), Palivizumab (Synagis®), or ribavirin.
- The subject previously participated in this study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
symptomatic
Self-reported symptoms by the subject and/or preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 and/or Influenza at the time of the study visit.
The subject must present as symptomatic, exhibiting one or more of the following signs and symptoms: 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 within the last twelve (12) days
|
The LumiraDx SARS-CoV-2 & Flu A/B test is an automated rapid microfluidic immunofluorescence assay for use with the LumiraDx Platform, for near-patient testing, intended for the qualitative detection and differentiation of SARS-CoV-2, Influenza A and/or Influenza B viral antigens from nasal swab samples.
The LumiraDx SARS-CoV-2 Ag Ultra Test is an automated rapid microfluidic immunofluorescence assay for use with the LumiraDx Platform intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from anterior nasal swab samples collected from symptomatic individuals within the first twelve days of symptom onset suspected of COVID-19 by their healthcare provider.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance evaluation by health care professionals
Time Frame: 6 months
|
Evaluate the performance of the LumiraDx SARS-CoV-2 & Flu A/B test in detecting and differentiating SARS-CoV-2, influenza A and influenza B in fresh nasal swab specimens from symptomatic patients.
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.
|
6 months
|
Performance evaluation of the LumiraDx SARS-CoV-2 Ag Ultra by health care professionals
Time Frame: 6 months
|
Evaluate the performance of the LumiraDx SARS-CoV-2 Ag Ultra test in detecting SARS-CoV-2 in fresh nasal swab specimens from symptomatic patients.
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-CLIN-PROT-00056
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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