Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test
NCT04557046 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1134
Last updated 2023-12-26
Summary
Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to a reference method.
Conditions
- Covid19
Interventions
- DIAGNOSTIC_TEST
-
Nasal Swab
Collection of one more nasal swabs
- DIAGNOSTIC_TEST
-
Nasopharyngeal swab
Collection of one more nasopharyngeal swabs
- DIAGNOSTIC_TEST
-
Throat swab
Collection of one more throat swabs
- DIAGNOSTIC_TEST
-
Fingerstick
Collection of capillary blood from one or more fingersticks
- DIAGNOSTIC_TEST
-
Saliva specimen
Collection of free drool
Sponsors & Collaborators
-
LumiraDx UK Limited
lead INDUSTRY
Principal Investigators
-
Christopher Chappel · Chappel Group
-
Robert Rosen · Ardmore Family Practice
-
Andre Gvozden · Gvozden Pediatrics
-
Madhavi Ampajwala · Village Health Partners
-
Edward Zissman · Pediatric Associates of Altamonte Springs
-
Melanie Hoppers · Physicians Quality Care of Jackson
-
Kimberley Henderson · Good Samaritan Minute Clinic
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-26
- Primary Completion
- 2021-03-24
- Completion
- 2024-03-31
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Observational, Prospective Clinical Study to Evaluate Biomarkers as Indicators of Acute Bacterial or Viral Infections
NCT01917461 ·Status: COMPLETED
-
Clinical Performance Study for EDAN's COVID-19/Flu A/Flu B/RSV Test Kits on Subjects Suspected of Respiratory Infection
NCT06175611 ·Status: RECRUITING
-
Detection of SARS-CoV-2 RNA in Coughed Droplets From Patients With COVID-19
NCT04912895 ·Status: COMPLETED ·Phase: NA
-
Clinical Validation of Breath Analyser Tests for Diagnosis of COVID-19.
NCT05094674 ·Status: UNKNOWN ·Phase: NA
-
Evaluation of the Performance of Rapid Diagnostics for SARS-CoV-2 Self-testing in the Hands of Untrained
NCT05605769 ·Status: COMPLETED
-
SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings
NCT06191393 ·Status: COMPLETED ·Phase: NA
-
COVID-19 Contact Study by Antigen Detection Test
NCT04745533 ·Status: WITHDRAWN
-
ASPIRE I: Supporting Antibiotic Stewardship in Primary Care Via POCT
NCT06912022 ·Status: COMPLETED
-
Rapid Detection of COVID-19 by Portable and Connected Biosensor
NCT04367142 ·Status: COMPLETED
-
Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting
NCT02232711 ·Status: COMPLETED
-
Sensitivity Evaluation of Serological Tests for Covid-19
NCT04678024 ·Status: UNKNOWN
-
Evaluation of a COVID-19 Rapid Diagnostic Test in ER Departments in Mexico: a Multi-center Study
NCT04894760 ·Status: COMPLETED
-
Screening for COVID-19 and Monitoring of Serological Responses to SARS-CoV-2 in Healthcare Workers
NCT04370119 ·Status: COMPLETED
-
Clinical Feasibility of the BinaxNOW™ COVID-19/Flu A&B Combo in the Southern Hemisphere
NCT06928129 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Immunophenotyping Assessment in a COVID-19 Cohort
NCT04378777 ·Status: COMPLETED
-
A Follow On Community Testing Study To Evaluate The Performance of the Lucira COVID-19 All-In-One Test Kit
NCT04720235 ·Status: COMPLETED ·Phase: NA
-
Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Device and the Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test Device
NCT05715515 ·Status: COMPLETED ·Phase: NA
-
SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies
NCT05765396 ·Status: ACTIVE_NOT_RECRUITING
-
Epidemiological Multicohort Study of Latent COVID-19 Infections
NCT04695678 ·Status: COMPLETED
-
Testing for COVID-19 Infection in Asymptomatic Persons
NCT04345510 ·Status: COMPLETED
-
Detection of Microorganisms and Antibiotic Resistance Genes Using the Curetis Unyvero LRT55 Application
NCT01922024 ·Status: COMPLETED
-
Diagnostic Performance of the ID Now™ COVID-19 Screening Test Versus Simplexa™ COVID-19 Direct Assay
NCT04785898 ·Status: COMPLETED ·Phase: NA
-
Communities Fighting COVID-19!
NCT05148936 ·Status: COMPLETED ·Phase: NA
-
A COVID-19 Symptom, Exposure and Immune Response Registry
NCT04348942 ·Status: COMPLETED
-
COVID Breath Test - Ancon
NCT04760639 ·Status: COMPLETED