Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA
1 other identifier
observational
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedFirst Submitted
Initial submission to the registry
December 12, 2018
CompletedFirst Posted
Study publicly available on registry
December 17, 2018
CompletedDecember 17, 2018
December 1, 2018
5 months
December 12, 2018
December 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Positive Percent Agreement and Negative Percent Agreement
The positive percent agreement (PPA) and negative percent agreement (NPA) of the ZIKV Detect™ 2.0 IgM Capture ELISA versus the reference test.
From symptom onset to 12 weeks after symptom onset.
Secondary Outcomes (1)
Duration of Positive Percent Agreement
From symptom onset to 12 weeks after symptom onset.
Study Arms (2)
endemic
Samples collected from areas endemic for zika. Subject specimens underwent testing with the study device and reference method.
non-endemic
Samples collected from areas non-endemic for zika. Subject specimens underwent testing with the study device and reference method.
Interventions
De-identified archive specimens are tested by ELISA and compared to reference testing (RT-PCR and CDC MAC-ELISA)
Eligibility Criteria
Human males and females of varying ages and geographical locations where Zika virus is endemic and not endemic.
You may qualify if:
- 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.
You may not qualify if:
- Samples that are not de-identified.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
InBios International
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Frances Chu, PhD
InBios International
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2018
First Posted
December 17, 2018
Study Start
April 1, 2018
Primary Completion
August 31, 2018
Study Completion
September 30, 2018
Last Updated
December 17, 2018
Record last verified: 2018-12