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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatic Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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symptoms of liver disease

Device: Samsung LABGEO PT10 Hepatic Panel

Samsung LABGEO PT10 Hepatic Panel

Intervention Type DEVICE

Interventions

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Samsung LABGEO PT10 Hepatic Panel

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes