Evaluation of N Latex Beta Trace Protein on BN™ Systems as eGFR and RKF Marker
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: 16-009170
Sponsor Protocol Number: D.10011 - A
About this study
The purpose of this study is to test specific analytical performance characteristics of the beta trace protein (BTP) assay on the BN ProSpec System to generate performance data necessary for regulatory submission to the U.S. Food and Drug Administration and international regulatory submissions; therefore, data generated is subject to audit by regulatory agencies.
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:
- Remnant serum samples meeting the IVDD/FDA requirements for use of leftover specimen
- Specimen volume of ≥ 1.0 mL
- Samples stored under the appropriate conditions
Exclusion Criteria:
Pre-analytical exclusion criteria
Post-analytical exclusion criteria
- Non-reportable results with instrument error flags
- Operator identified and confirmed sample mix-up
- Operator error
- Instrument malfunction
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 John Lieske, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available