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

February 18, 2015 updated by: Samsung Electronics
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinics

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
symptoms of liver disease
Device: Samsung LABGEO PT10 Hepatic Panel
Device: Samsung LABGEO PT10 Hepatic Panel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean percentage difference between all pairs of plasma and serum measurements using Bland-Altman plot of differences.
Time Frame: baseline
baseline
Standard deviation and coefficients of variation of between run, between day and total precision.
Time Frame: 20 days
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
baseline
Mean percentage difference between all pairs of serum and whole blood measurements using Bland-Altman plot of differences.
Time Frame: baseline
baseline
Mean percentage difference between all pairs of plasma and whole blood measurements using Bland-Altman plot of differences.
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Electronics

Investigators

  • Study Chair: Nam Shin, Nexus DX

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

December 13, 2013

First Submitted That Met QC Criteria

April 1, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

February 20, 2015

Last Update Submitted That Met QC Criteria

February 18, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T10-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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