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

NCT04597047 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2023-03-13

No results posted yet for this study

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.

Conditions

  • Covid19

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

Sponsors & Collaborators

  • LumiraDx UK Limited

    lead INDUSTRY

Principal Investigators

  • Vicki Kalen · Eclipse Clinical Research

  • William Simon · Professional Research Network of Kansas

  • Matthew Morgan · Centura Health Physician Group

  • Melanie Hoppers · Physicians Quality Care of Jackson

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2020-12-22
Completion
2023-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04597047 on ClinicalTrials.gov