Status:
COMPLETED
Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA
Lead Sponsor:
InBios International, Inc.
Collaborating Sponsors:
Fast-Track Drugs & Biologics, LLC
Biomedical Advanced Research and Development Authority
Conditions:
Zika Virus Infection
Eligibility:
All Genders
Brief Summary
The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples.
Detailed Description
The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples. The FDA guida...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Human males and females of varying ages and geographical locations where Zika virus is endemic and not endemic.
- Retrospective (archived) and prospective human serum samples. Archived samples will fall under the category of "leftover" specimens as described by FDA guidance.
- Exclusion criteria:
- • Samples that are not de-identified.
Exclusion
Key Trial Info
Start Date :
April 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2018
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03776903
Start Date
April 1 2018
End Date
September 30 2018
Last Update
December 17 2018
Active Locations (1)
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1
InBios International
Seattle, Washington, United States, 98109