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

InBios International

Status

Completed

Conditions

Zika Virus Infection

Treatments

Other: ZIKV Detect™ 2.0 IgM Capture ELISA

Study type

Observational

Funder types

Industry

Other U.S. Federal agency

Other

Identifiers

NCT03776903

ZIKV-2016-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.