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
Tab Title Description
Study type
ObservationalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Elitza Theel, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available