A Study to Evaluate the Performance of Chembio Diagnostics Systems, Inc. DPP® Zika IgM Assay System With Fingerstick Whole Blood (MVSS CBD002-18 PRO)

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 19-000776
    Sponsor Protocol Number: 2457528-ZIKVSF04

About this study

The purpose of this study is to support the use of fingerstick whole blood on the Chembio DPP® Zika IgM Assay System.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Healthy male and/or female age ≥18 years (no upper limit);
  • Able to provide consent to participate and having signed an Informed Consent Form;
  • Able and willing to comply with study procedures.

Exclusion Criteria:

  • Judgment by the Investigator that the subject should not participate in the study if they have any ongoing or recent clinically significant illness, medical/surgical procedure, or trauma that may put the subject at risk because of participation in the study;
  • Vulnerable subjects; e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Elitza Theel, Ph.D.

Open for enrollment

Contact information:

Julie Faust R.N.

(507)266-3242

Faust.Julie@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20457168

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