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BinaxNow COVID-19 IgG Rapid Test Device and Antibody Self Test

NCT04959760 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2022-05-09

No results posted yet for this study

Summary

Performance evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device (Professional Use) and with BinaxNOW™ COVID-19 Antibody Self Test wehn used with fingerstick capillary whole blood and plasma samples. The BinaxNOW™ Antibody Tests are lateral flow tests that measure SARS-CoV-2 IgG antibodies.

Conditions

  • COVID-19 Respiratory Infection

Interventions

DIAGNOSTIC_TEST

The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.

The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2 in fingestick capillary blood and plasma samples.

Sponsors & Collaborators

  • Abbott Rapid Diagnostics Jena GmbH

    lead INDUSTRY

Principal Investigators

  • Simon Kordowich · Abbott

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2022-01-20
Completion
2022-01-20
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 NCT04959760 on ClinicalTrials.gov