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.

Study Overview

• Status: Completed
• Conditions: Zika Virus Infection
• Intervention / Treatment: Other: ZIKV Detect™ 2.0 IgM Capture ELISA

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 Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • InBios International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Human males and females of varying ages and geographical locations where Zika virus is endemic and not endemic.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: InBios International, Inc.
• Collaborators: Biomedical Advanced Research and Development Authority; Fast-Track Drugs & Biologics, LLC
• Investigators: Study Director: Frances Chu, PhD, InBios International

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): December 17, 2018
• Last Update Submitted That Met QC Criteria: December 13, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Zika Virus Infection
• Other Study ID Numbers: ZIKV-2016-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No