Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test
ASPIRE
A Multicenter COVID-19 Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 Ag Test at Point of Care Testing Sites
1 other identifier
interventional
1,134
1 country
7
Brief Summary
Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to a reference method.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Jun 2020
Longer than P75 for not_applicable covid19
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2020
CompletedFirst Submitted
Initial submission to the registry
September 17, 2020
CompletedFirst Posted
Study publicly available on registry
September 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedDecember 26, 2023
December 1, 2023
9 months
September 17, 2020
December 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Performance Evaluation
Evaluation of performance of the device versus a reference method using standard qualitative comparison techniques (Percent Agreement)
4 months
Study Arms (5)
Group A: Sample Collection
OTHERNasal Swab and Saliva Sample Collection
Group B: Sample Collection
OTHERNasal swab, Capillary Blood (from fingerstick) and Saliva Collection
Group C: Sample Collection
OTHERNasal Swab, Throat Swab and Saliva Sample Collection
Group D: Sample Collection
OTHERNasopharyngeal Swab and Saliva Sample Collection
Group E: Sample Collection
OTHERNasal swab
Interventions
Collection of one more nasal swabs
Collection of one more nasopharyngeal swabs
Collection of capillary blood from one or more fingersticks
Collection of free drool
Eligibility Criteria
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 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. The onset of these symptoms will be recorded.
- or The subject must have a documented SARS-CoV-2 PCR test in the past 48 hours.
- \. Written informed consent must be obtained prior to study enrollment.
- A subject who is eighteen (18) years or older 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 eighteen (18) must give written informed consent and agree to comply with study procedures. Active written 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.
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Children's Pediatric Associates of Altamonte Springs
Altamonte Springs, Florida, 32701, United States
Chappel Group
Kissimmee, Florida, 34744, United States
Good Samaritan Minute Clinic, Georgia Tech
Atlanta, Georgia, 30318, United States
Gvozden Pediatrics
Millersville, Maryland, 21108, United States
Ardmore Family Practice
Winston-Salem, North Carolina, 27103, United States
Physicians Quality Care of Jackson
Jackson, Tennessee, 38305, United States
Village Health Partners
Plano, Texas, 75024, United States
Related Publications (2)
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.
PMID: 36152227DERIVEDDrain PK, Ampajwala M, Chappel C, Gvozden AB, Hoppers M, Wang M, Rosen R, Young S, Zissman E, Montano M. A Rapid, High-Sensitivity SARS-CoV-2 Nucleocapsid Immunoassay to Aid Diagnosis of Acute COVID-19 at the Point of Care: A Clinical Performance Study. Infect Dis Ther. 2021 Jun;10(2):753-761. doi: 10.1007/s40121-021-00413-x. Epub 2021 Feb 24.
PMID: 33629225DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Chappel
Chappel Group
- PRINCIPAL INVESTIGATOR
Robert Rosen
Ardmore Family Practice
- PRINCIPAL INVESTIGATOR
Andre Gvozden
Gvozden Pediatrics
- PRINCIPAL INVESTIGATOR
Madhavi Ampajwala
Village Health Partners
- PRINCIPAL INVESTIGATOR
Edward Zissman
Pediatric Associates of Altamonte Springs
- PRINCIPAL INVESTIGATOR
Melanie Hoppers
Physicians Quality Care of Jackson
- PRINCIPAL INVESTIGATOR
Kimberley Henderson
Good Samaritan Minute Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2020
First Posted
September 21, 2020
Study Start
June 26, 2020
Primary Completion
March 24, 2021
Study Completion
March 31, 2024
Last Updated
December 26, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share