Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test (ASPIRE)

December 22, 2023 updated by: LumiraDx UK Limited

A Multicenter COVID-19 Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 Ag Test at Point of Care Testing Sites

Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to a reference method.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a prospective, multi-center study. One (1) reference laboratory and approximately six (6) geographically diverse POC (Point of Care) locations (e.g. physician office laboratories, urgent cares, emergency departments, outpatient clinics, drive through testing sites or research centers) in the U.S. will participate in the study. Testing in the reference laboratory will be performed by trained laboratory personnel. Testing at the POC sites will be performed by non-laboratory health professionals who are representative of typical intended use operators (e.g. nurses, physician assistants, medical assistants, etc.). Each site will have a minimum of one (1) untrained intended use operator who will perform testing under this protocol.

A subject's participation in this study will consist of a single 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.

Subjects will have nasopharyngeal or nasal or throat swabs collected. Capillary blood may be collected alongside nasal swabs. Saliva samples may also be collected. Specimens will be obtained from each subject enrolled using standard collection methods.

The LumiraDx SARS-CoV-2 Ag Test will be performed at POC sites by intended use operators (e.g. nurses, physician assistants, medical assistants, etc.). Each site will have a minimum of one (1) untrained intended use operator who will perform testing under this protocol.

The LumiraDx SARS-CoV-2 Ag Test will be performed at the site on the same day as the date of collection using one swab for each subject enrolled. A central laboratory will perform reference testing.

Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be estimated for the LumiraDx SARS-CoV-2 Ag Test results as compared with the reference Test.

A minimum of thirty (30) positive SARS-CoV-2 are required, but it is likely because of the prevalence of SARS-CoV-2 in the population, that a greater number of negatives will be obtained during the prospective collection of positive samples; therefore, approximately four-hundred (400) subjects will be enrolled. A minimum of thirty (30) negative samples are required.

Study Type

Interventional

Enrollment (Actual)

1134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Children's Pediatric Associates of Altamonte Springs
      • Kissimmee, Florida, United States, 34744
        • Chappel Group
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Good Samaritan Minute Clinic, Georgia Tech
    • Maryland
      • Millersville, Maryland, United States, 21108
        • Gvozden Pediatrics
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Ardmore Family Practice
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Physicians Quality Care of Jackson
    • Texas
      • Plano, Texas, United States, 75024
        • Village Health Partners

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. The subject may be of any age and either sex.
  • 2. 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.

  • 3. Written informed consent must be obtained prior to study enrollment.

    1. 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.
    2. 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).

Exclusion Criteria:

  • 1. The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
  • 2. 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.
  • 3. The subject has previously participated in this research study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A: Sample Collection
Nasal Swab and Saliva Sample Collection
Diagnostic test: Nasal Swab
Collection of one more nasal swabs
Diagnostic test: Saliva specimen
Collection of free drool
Other: Group B: Sample Collection
Nasal swab, Capillary Blood (from fingerstick) and Saliva Collection
Diagnostic test: Nasal Swab
Collection of one more nasal swabs
Diagnostic test: Saliva specimen
Collection of free drool
Diagnostic test: Fingerstick
Collection of capillary blood from one or more fingersticks
Other: Group C: Sample Collection
Nasal Swab, Throat Swab and Saliva Sample Collection
Diagnostic test: Nasal Swab
Collection of one more nasal swabs
Diagnostic test: Saliva specimen
Collection of free drool
Diagnostic test: Throat swab
Collection of one more throat swabs
Other: Group D: Sample Collection
Nasopharyngeal Swab and Saliva Sample Collection
Diagnostic test: Nasopharyngeal swab
Collection of one more nasopharyngeal swabs
Diagnostic test: Saliva specimen
Collection of free drool
Other: Group E: Sample Collection
Nasal swab
Diagnostic test: Nasal Swab
Collection of one more nasal swabs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance Evaluation
Time Frame: 4 months
Evaluation of performance of the device versus a reference method using standard qualitative comparison techniques (Percent Agreement)
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LumiraDx UK Limited

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2020

Primary Completion (Actual)

March 24, 2021

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

September 17, 2020

First Submitted That Met QC Criteria

September 17, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-CLIN-PROT-00032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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