COVID-19 Immunity Assessment

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05080231

Enrollment

662

Registered

2021-10-15

Start date

2021-07-15

Completion date

2021-09-10

Last updated

2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results