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OpenTrials
Completed

NCT Number: NCT05080231

COVID-19 Immunity Assessment

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

DxTerity Diagnostics Inc.

Compton, California, 90220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Neutralizing Antibody Levels

    Time frame: 3 months

    Measuring neutralizing antibody levels with COVID-19 immunity assessment test

Sponsors and collaborators

Lead sponsor

DxTerity Diagnostics

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 15, 2021
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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