Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2026-02-27 @ 4:31 PM
Study NCT ID:
NCT03776903
Status:
COMPLETED
Last Update Posted:
2018-12-17
First Post:
2018-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA
Sponsor:
InBios International, Inc.
Organization:
Study Overview
Official Title:
Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 guidance document (ZIKA SEROLOGY DE NOVO/510(K) PRE-MARKET SUBMISSIONS - Recommended Analytical and Clinical Studies for Zika Virus IgM Assays; Dated 02Jun2017; FDA/CDRH/OIR/DMD) allows for the utilization of archival serum specimens to evaluate test performance. This study will follow this guidance. Test samples will be collected from endemic sites (both presumed positive and presumed negative samples) and from non-endemic sites (presumed negative samples). All samples will be shipped to the sponsor for randomization and will be tested at three sites in the United States.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: