COVID-19 Immunity Assessment

August 8, 2023 updated by: DxTerity Diagnostics

Blood Specimen Collection for COVID-19 Immunity Assessment Mailer Kit Clinical Study

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

662

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Compton, California, United States, 90220
        • DxTerity Diagnostics Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
COVID-19 Vaccinated Individuals
Males and females, 13years old and above, vaccinated for COVID-19
Previously positive for COVID-19 and unvaccinated individuals
Males and females, 13years old and above, unvaccinated for COVID-19 and previously tested positive for COVID-19.
No previous COVID infection or vaccination
Males and females, 13years old and above, unvaccinated for COVID-19 and previously not tested positive for COVID-19.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neutralizing Antibody Levels
Time Frame: 3 months
Measuring neutralizing antibody levels with COVID-19 immunity assessment test
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DxTerity Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2021

Primary Completion (Actual)

September 10, 2021

Study Completion (Actual)

September 10, 2021

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROT-0239

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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