Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
662 participants
OBSERVATIONAL
2021-07-15
2021-09-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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COVID-19 Vaccinated Individuals
Males and females, 13years old and above, vaccinated for COVID-19
No interventions assigned to this group
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 interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 complete informed consent and/or questionnaire.
* Unable to complete the study activities in a timely manner.
13 Years
ALL
Yes
Sponsors
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DxTerity Diagnostics
INDUSTRY
Responsible Party
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Locations
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DxTerity Diagnostics Inc.
Compton, California, United States
Countries
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Other Identifiers
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PROT-0239
Identifier Type: -
Identifier Source: org_study_id
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