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Research & Evaluation of LumiraDx SARS-CoV-2 (COVID-19) Point of Care Ab Test
Sponsor: LumiraDx UK Limited
Summary
Evaluation of the agreement between fingerstick samples, venous blood, serum and plasma samples when using the LumiraDx SARS-CoV-2 Ab Test against the reference method, using standard qualitative comparison techniques.
Official title: A Multicenter Covid-19 Study Conducted to Evaluate the Agreement Between Fingerstick Whole Blood, Venous Whole Blood, Plasma & Serum as Determined on the LumiraDx POC SARS-CoV-2 Ab Test & to Evaluate the Ease of Use at Point of Care Sites
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
OBSERVATIONAL
Enrollment
42
Start Date
2020-07-09
Completion Date
2020-09-03
Last Updated
2026-06-15
Healthy Volunteers
No
Conditions
Interventions
Capillary Collection & Testing
Two (2) fingersticks will be performed on each subject and capillary blood tested in the LumiraDx SARS-CoV-2 Ab test
Venous Draw & Testing
One (1) Venous Draw (to include one (1) 6.0 mL EDTA tube and one (1) 3.5 mL serum separator tube) will be collected from each subject. Blood will be tested in the LumiraDx SARS-CoV-2 Ab test
Locations (4)
Eclipse Clinical Research
Tucson, Arizona, United States
Centura Health Physician Group, Northglenn Office
Northglenn, Colorado, United States
Professional Research Network of Kansas
Wichita, Kansas, United States
Physicians Quality Care of Jackson
Jackson, Tennessee, United States