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

Completed

• Conditions: Zika Virus Infection
• Interventions: Other: ZIKV Detect™ 2.0 IgM Capture ELISA

• Registration Number: NCT03776903
• Lead Sponsor: InBios International, Inc.

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 Timeline

• Study Start: 2018-04-01
• Primary Completion: 2018-08-31
• Study Completion: 2018-09-30
• Status Verified: 2018-12
• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-13
• Last Update Submitted: 2018-12-13
• Study First Posted: 2018-12-17
• Last Update Posted: 2018-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
endemic	ZIKV Detect™ 2.0 IgM Capture ELISA	Samples collected from areas endemic for zika. Subject specimens underwent testing with the study device and reference method.
non-endemic	ZIKV Detect™ 2.0 IgM Capture ELISA	Samples collected from areas non-endemic for zika. Subject specimens underwent testing with the study device and reference method.

Primary Outcome Measures

Name	Time	Method
Positive Percent Agreement and Negative Percent Agreement	From symptom onset to 12 weeks after symptom onset.	The positive percent agreement (PPA) and negative percent agreement (NPA) of the ZIKV Detect™ 2.0 IgM Capture ELISA versus the reference test.

Secondary Outcome Measures

Name	Time	Method
Duration of Positive Percent Agreement	From symptom onset to 12 weeks after symptom onset.	The time period relative to onset of symptoms that a positive result can be identified and the time period after onset of symptoms that the positive percent agreement is maximized and the longest elapsed time after symptom onset that positive test results are observed.

Trial Locations

Locations (1)

InBios International; 🇺🇸 Seattle, Washington, United States