Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA
NCT03776903 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 600
Last updated 2018-12-17
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.
Conditions
- Zika Virus Infection
Interventions
- OTHER
-
ZIKV Detect™ 2.0 IgM Capture ELISA
De-identified archive specimens are tested by ELISA and compared to reference testing (RT-PCR and CDC MAC-ELISA)
Sponsors & Collaborators
-
Fast-Track Drugs & Biologics, LLC
collaborator UNKNOWN -
Biomedical Advanced Research and Development Authority
collaborator FED -
InBios International, Inc.
lead INDUSTRY
Principal Investigators
-
Frances Chu, PhD · InBios International
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-04-01
- Primary Completion
- 2018-08-31
- Completion
- 2018-09-30
Countries
- United States
Study Locations
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