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

Zika Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776903
• Other study ID #: ZIKV-2016-01
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: December 2018
• Source: InBios International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 30, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Virus Diseases
• Zika Virus Infection

Intervention

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)

Locations

Country	Name	City	State
United States	InBios International	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
InBios International, Inc.	Biomedical Advanced Research and Development Authority, Fast-Track Drugs & Biologics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.