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Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood

NCT04699903 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 201

Last updated 2021-06-18

No results posted yet for this study

Summary

Prospective, multi-center, observational, blinded clinical trial to compare a new point of care (POC) SARS-CoV-2 IgG antibody test to a reference SARS-CoV-2 PCR test using fingerstick whole blood.

Conditions

  • SARS-Cov-2, Covid19

Interventions

DIAGNOSTIC_TEST

POC SARS-Cov-2 IgG Antibody test

All patients will undergo a Point of care (POC) SARS-Cov-2 IgG Antibody test in fingerstick whole blood

Sponsors & Collaborators

  • Rapid Pathogen Screening

    collaborator INDUSTRY

  • Lumos Diagnostics

    lead INDUSTRY

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-05
Primary Completion
2021-01-29
Completion
2021-04-09
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 NCT04699903 on ClinicalTrials.gov