Evaluation of the Samsung LABGEO PT10 Hepatic Panel in a Point-of-Care Setting

Samsung

Status: Terminated

Conditions: Hepatic Disease

Treatments: Device: Samsung LABGEO PT10 Hepatic Panel

Study type: Observational

Funder types: Industry

Identifiers

NCT02104154

T10-02

Details and patient eligibility

About

To establish the performance characteristics of the Samsung LABGEO PT10 by comparing the test results of the PT10 Hepatic assay with results obtained from an FDA-cleared chemistry analyzer.

Full description

To establish the correlation between measurand values as obtained from the Samsung LABGEO PT10 Hepatic Panel at the point of care, and the corresponding measurand values as obtained on a commercial clinical chemistry analyzer, with respect to prospectively collected human serum specimens.

Enrollment: 32 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female subjects with a history of elevated liver enzymes or symptoms suggestive of elevated liver enzymes
• Presenting to the site and requiring testing for levels of liver enzymes as part of routine care at the site
• Subjects able and willing to provide written informed consent

Exclusion criteria

• Subjects unable or unwilling to provide written informed consent
• Subjects with a life-threatening disease or any serious, potentially life-threatening medical illness that may compromise patient safety or study conduct

Trial design

32 participants in 1 patient group

symptoms of liver disease

Description:

Device: Samsung LABGEO PT10 Hepatic Panel

Treatment:

Device: Samsung LABGEO PT10 Hepatic Panel