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Completed

NCT Number: NCT03776903

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.

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Key information

Conditions

Zika Virus Infection Arbovirus Infections Flaviviridae Infections Flavivirus Infections Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

InBios International

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. Positive Percent Agreement and Negative Percent Agreement

    Time frame: 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 outcomes

  1. Duration of Positive Percent Agreement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

InBios International, Inc.

Industry

Collaborators

  • Biomedical Advanced Research and Development Authority
  • Fast-Track Drugs & Biologics, LLC

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 17, 2018
Registry last updated
Dec 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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