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Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA

NCT ID: NCT03776903

Last Updated: 2018-12-17

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Zika Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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endemic

Samples collected from areas endemic for zika. Subject specimens underwent testing with the study device and reference method.

ZIKV Detect™ 2.0 IgM Capture ELISA

Intervention Type OTHER

De-identified archive specimens are tested by ELISA and compared to reference testing (RT-PCR and CDC MAC-ELISA)

non-endemic

Samples collected from areas non-endemic for zika. Subject specimens underwent testing with the study device and reference method.

ZIKV Detect™ 2.0 IgM Capture ELISA

Intervention Type OTHER

De-identified archive specimens are tested by ELISA and compared to reference testing (RT-PCR and CDC MAC-ELISA)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fast-Track Drugs & Biologics, LLC

UNKNOWN

Sponsor Role collaborator

Biomedical Advanced Research and Development Authority

FED

Sponsor Role collaborator

InBios International, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frances Chu, PhD

Role: STUDY_DIRECTOR

InBios International

Locations

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InBios International

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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ZIKV-2016-01

Identifier Type: -

Identifier Source: org_study_id