NCT03776903

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (actual)
• Sponsor: InBios International, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Zika Virus Infection

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-04-01
• Primary completion: 2018-08-31
• Completion: 2018-09-30
• First posted: 2018-12-17
• Last updated: 2018-12-17

Locations

1 site across 1 country: United States