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

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.

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.