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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02104154

Enrollment

Registered

2014-04-04

Start date

2013-11-30

Completion date

2014-09-30

Last updated

2015-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Disease

Brief summary

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.

Detailed 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.

Interventions

DEVICESamsung LABGEO PT10 Hepatic Panel

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bias between Samsung LABGEO PT10 serum results and matching FDA-cleared comparator assay	baseline

Secondary

Measure	Time frame
Mean percentage difference between all pairs of plasma and serum measurements using Bland-Altman plot of differences.	baseline
Standard deviation and coefficients of variation of between run, between day and total precision.	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.	baseline
Mean percentage difference between all pairs of serum and whole blood measurements using Bland-Altman plot of differences.	baseline
Mean percentage difference between all pairs of plasma and whole blood measurements using Bland-Altman plot of differences.	baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026