COVID-19 Immunity Assessment

Completed

• Conditions: COVID-19

• Registration Number: NCT05080231
• Lead Sponsor: DxTerity Diagnostics

Brief Summary

The purpose of this study is to collect blood specimens from individuals post infection or post vaccination over time to assess COVID19 Immunity.

Detailed Description

The DxTerity COVID-19 Immunity Assessment Collection Mailer Kit contains the DxCollect MicroCollection Device (MCD) Serology fingerstick blood collection device packaged as a home collection kit, designed for collection and shipment of fingerstick blood back to DxTerity CLIA (Clinical Laboratory Improvements Amendment) certified laboratory for testing.

The clinical performance of the collection device for use with anti-SARS-CoV-2 antibody tests will be evaluated for use with cPASS™ anti-SARS-CoV-2 neutralizing antibody detection kit (EUA 201427).

The samples may also be used for assessing immunity or protection post COVID-19 vaccination.

Study Timeline

• Study Start: 2021-07-15
• Primary Completion: 2021-09-10
• Study Completion: 2021-09-10
• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 662

Inclusion Criteria

• Males and females ≥13 years old.
• Not vaccinated and were previously positive for COVID-19 OR are vaccinated for COVID-19.
• Provides test report to demonstrate prior COVID-19 positive result (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects).
• Provides informed consent and completed questionnaire.
• Able to register the collection kit on the DxTerity portal.
• Able to collect and ship blood samples back to DxTerity.

Exclusion Criteria

• Unable to provide COVID-19 positive test report (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects).
• Unable to complete informed consent and/or questionnaire.
• Unable to complete the study activities in a timely manner.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neutralizing Antibody Levels	3 months	Measuring neutralizing antibody levels with COVID-19 immunity assessment test

Trial Locations

Locations (1)

DxTerity Diagnostics Inc.; 🇺🇸 Compton, California, United States