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Evaluation of the LumiraDx Point of Care D-Dimer and CRP Tests

NCT04375982 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-12-26

No results posted yet for this study

Summary

A Multicenter Study Conducted to Evaluate the Agreement between Fingerstick Whole Blood, Venous Whole Blood and Plasma Determined on the LumiraDx Point of Care D-Dimer and Point of Care CRP Tests to Results on the Reference Analyzer

Conditions

Interventions

DIAGNOSTIC_TEST

Venepuncture

Blood tube will be collected from standard venepuncture

DIAGNOSTIC_TEST

Fingerstick

Capillary blood will be collected by fingerstick

Sponsors & Collaborators

  • LumiraDx UK Limited

    lead INDUSTRY

Principal Investigators

  • Judith Kirstein · Rancho Paseo Medical Group

  • Matthew Morgan · Centura Health Physician Group

  • Anita Scribner · Diagnostic Clinic of Longview

  • William Simon · New Medical Healthcare

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-20
Primary Completion
2022-04-05
Completion
2024-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04375982 on ClinicalTrials.gov