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

Samsung Electronics32 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatic Disease

Interventions

Samsung LABGEO PT10 Hepatic PanelDEVICE

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Bias between Samsung LABGEO PT10 serum results and matching FDA-cleared comparator assay

Time frame: baseline

Secondary Outcomes

Mean percentage difference between all pairs of plasma and serum measurements using Bland-Altman plot of differences.

Time frame: baseline

Standard deviation and coefficients of variation of between run, between day and total precision.

Time frame: 20 days

Estimates of reference intervals by computing the 2.5th percentile of associated distribution of test measurement (for each analyte) and the 97.5th percentile of associated distribution.

Time frame: baseline

Mean percentage difference between all pairs of serum and whole blood measurements using Bland-Altman plot of differences.

Time frame: baseline

Mean percentage difference between all pairs of plasma and whole blood measurements using Bland-Altman plot of differences.

Time frame: baseline

Data from ClinicalTrials.gov

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