Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| endemic 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
De-identified archive specimens are tested by ELISA and compared to reference testing (RT-PCR and CDC MAC-ELISA)
|
| non-endemic 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
De-identified archive specimens are tested by ELISA and compared to reference testing (RT-PCR and CDC MAC-ELISA)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | InBios International | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- InBios International, Inc.
- Fast-Track Drugs & Biologics, LLC
- Biomedical Advanced Research and Development Authority
Investigators
- Study Director: Frances Chu, PhD, InBios International
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZIKV-2016-01