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| Name | Class |
|---|---|
| Fast-Track Drugs & Biologics, LLC | UNKNOWN |
| Biomedical Advanced Research and Development Authority | FED |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endemic | Samples collected from areas endemic for zika. Subject specimens underwent testing with the study device and reference method. |
| |
| non-endemic | Samples collected from areas non-endemic for zika. Subject specimens underwent testing with the study device and reference method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZIKV Detect™ 2.0 IgM Capture ELISA | Other | De-identified archive specimens are tested by ELISA and compared to reference testing (RT-PCR and CDC MAC-ELISA) |
|
| 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. |
| 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. |
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Inclusion criteria:
Exclusion criteria:
• Samples that are not de-identified.
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Human males and females of varying ages and geographical locations where Zika virus is endemic and not endemic.
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| Name | Affiliation | Role |
|---|---|---|
| Frances Chu, PhD | InBios International | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| InBios International | Seattle | Washington | 98109 | United States |
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| ID | Term |
|---|---|
| D000071243 | Zika Virus Infection |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |