NCT04557046

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,134

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2020

Completed
Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

September 17, 2020

Last Update Submit

June 10, 2026

Conditions

Covid19

Keywords

POCSARS-CoV-2Antigen

Outcome Measures

Primary Outcomes (1)

  • Performance Evaluation

    Evaluation of performance of the device versus a reference method using standard qualitative comparison techniques (Percent Agreement)

    On day of the medical encounter (1 day)

Study Arms (5)

Group A: Sample Collection

Nasal Swab and Saliva Sample Collection

Diagnostic Test: Nasal SwabDiagnostic Test: Saliva specimen

Group B: Sample Collection

Nasal swab, Capillary Blood (from fingerstick) and Saliva Collection

Diagnostic Test: Nasal SwabDiagnostic Test: FingerstickDiagnostic Test: Saliva specimen

Group C: Sample Collection

Nasal Swab, Throat Swab and Saliva Sample Collection

Diagnostic Test: Nasal SwabDiagnostic Test: Throat swabDiagnostic Test: Saliva specimen

Group D: Sample Collection

Nasopharyngeal Swab and Saliva Sample Collection

Diagnostic Test: Nasopharyngeal swabDiagnostic Test: Saliva specimen

Group E: Sample Collection

Nasal swab

Diagnostic Test: Nasal Swab

Interventions

Nasal SwabDIAGNOSTIC_TEST

Collection of one more nasal swabs

Group A: Sample CollectionGroup B: Sample CollectionGroup C: Sample CollectionGroup E: Sample Collection
Nasopharyngeal swabDIAGNOSTIC_TEST

Collection of one more nasopharyngeal swabs

Group D: Sample Collection
Throat swabDIAGNOSTIC_TEST

Collection of one more throat swabs

Group C: Sample Collection
FingerstickDIAGNOSTIC_TEST

Collection of capillary blood from one or more fingersticks

Group B: Sample Collection
Saliva specimenDIAGNOSTIC_TEST

Collection of free drool

Group A: Sample CollectionGroup B: Sample CollectionGroup C: Sample CollectionGroup D: Sample Collection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Approximately six (6) geographically diverse POC (Point of Care) locations (e.g. physician office laboratories, urgent cares, emergency departments, outpatient clinics including drive through testing sites or research centers) in the U.S. will participate in the study. Males and females of any age may be enrolled, and should be represented in proportions representative of the population.

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

Location

Chappel Group

Kissimmee, Florida, 34744, United States

Location

Good Samaritan Minute Clinic, Georgia Tech

Atlanta, Georgia, 30318, United States

Location

Gvozden Pediatrics

Millersville, Maryland, 21108, United States

Location

Ardmore Family Practice

Winston-Salem, North Carolina, 27103, United States

Location

Physicians Quality Care of Jackson

Jackson, Tennessee, 38305, United States

Location

Village Health Partners

Plano, Texas, 75024, United States

Location

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: 36152227DERIVED

  • Drain 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

* nasal swabs collected from both nostrils * fingerstick sample and a saliva * throat swab * nasopharyngeal swabs * mouth swab

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
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

September 24, 2020

Study Completion

September 24, 2020

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(7)