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

NCT04597047 | Unknown FDA Device

• 1 other identifier: S-CLIN-PROT-0031
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

POC; SARS-CoV-2; Antibody

Outcome Measures

Primary Outcomes (1)

• Performance Evaluation

  Evaluation of the agreement between fingerstick samples and venous blood samples on the device; and venous blood, serum and plasma samples on the device versus reference method, using standard qualitative comparison techniques.

  4 months

Study Arms (1)

All Patients:

OTHER

Capillary and Venous Blood Collections

Diagnostic Test: Capillary Collection & Testing; Diagnostic Test: Venous Draw & Testing

Interventions

Capillary Collection & Testing DIAGNOSTIC_TEST

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

All Patients:

Venous Draw & Testing DIAGNOSTIC_TEST

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

All Patients:

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects aged ≥ 2 years.
• The subject must have a documented SARS-CoV-2 PCR test in the past 7-30 days. (subjects must be 14+ days post symptom onset at the time of recruitment).
• Written informed consent must be obtained prior to study enrollment.
• A subject who is 18 years or older must be willing to give written informed consent and must agree to comply with study procedures.
• The Legal Guardian or Legal Authorized Representative of a subject who is under the age of 18 must give written informed consent and agree to comply with study procedures. Active written assent should be obtained from children of appropriate intellectual age (as defined by the IRB).

You may not qualify if:

• Skin lesions or conditions that would preclude a fingerstick and or a venous blood draw.
• The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
• The subject has previously participated in this research study.

Sponsors & Collaborators

• LumiraDx UK Limited: lead

Study Sites (4)

Eclipse Clinical Research

Tucson, Arizona, 85745, United States

Location

Centura Health Physician Group, Northglenn Office

Northglenn, Colorado, 80234, United States

Location

Professional Research Network of Kansas

Wichita, Kansas, 67203, United States

Location

Physicians Quality Care of Jackson

Jackson, Tennessee, 38305, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Vicki Kalen

  Eclipse Clinical Research

  PRINCIPAL INVESTIGATOR

• William Simon

  Professional Research Network of Kansas

  PRINCIPAL INVESTIGATOR

• Matthew Morgan

  Centura Health Physician Group

  PRINCIPAL INVESTIGATOR

• Melanie Hoppers

  Physicians Quality Care of Jackson

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are asked to provide Capillary and Venous Blood Samples.

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 22, 2020
• Study Start: July 9, 2020
• Primary Completion: December 22, 2020
• Study Completion: September 30, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)