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

Study Overview
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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.

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

Conditions
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Zika Virus Infection

Intervention / Treatment
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* Other: ZIKV Detect™ 2.0 IgM Capture ELISA


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| endemic<br>Samples collected from areas endemic for zika. Subject specimens underwent testing with the study device and reference method. | Other: ZIKV Detect™ 2.0 IgM Capture ELISA<br>* De-identified archive specimens are tested by ELISA and compared to reference testing (RT-PCR and CDC MAC-ELISA)<br>|
| non-endemic<br>Samples collected from areas non-endemic for zika. Subject specimens underwent testing with the study device and reference method. | Other: ZIKV Detect™ 2.0 IgM Capture ELISA<br>* De-identified archive specimens are tested by ELISA and compared to reference testing (RT-PCR and CDC MAC-ELISA)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Positive Percent Agreement | 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. | From symptom onset to 12 weeks after symptom onset. |