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COMPLETED
NCT04597047

Research & Evaluation of LumiraDx SARS-CoV-2 (COVID-19) Point of Care Ab Test

Sponsor: LumiraDx UK Limited

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

Capillary Collection & Testing

Two (2) fingersticks will be performed on each subject and capillary blood tested in the LumiraDx SARS-CoV-2 Ab test

DIAGNOSTIC_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