Evaluation of N Latex Beta Trace Protein on BN™ Systems as eGFR and RKF Marker

Overview

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

Samples that do not meet all inclusion 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

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

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