Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104154
Recruitment Status : Terminated (To conduct interim analysis and assess whether assay changes are recommended.)
First Posted : April 4, 2014
Last Update Posted : February 20, 2015
Sponsor:
Information provided by (Responsible Party):
Samsung Electronics

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.

Condition or disease Intervention/treatment
Hepatic Disease Device: Samsung LABGEO PT10 Hepatic Panel

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Samsung LABGEO PT10 Hepatic Panel in a Point-of-Care Setting
Study Start Date : November 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

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



Primary Outcome Measures :
  1. Bias between Samsung LABGEO PT10 serum results and matching FDA-cleared comparator assay [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. Mean percentage difference between all pairs of plasma and serum measurements using Bland-Altman plot of differences. [ Time Frame: baseline ]
  2. Standard deviation and coefficients of variation of between run, between day and total precision. [ Time Frame: 20 days ]
  3. 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 ]
  4. Mean percentage difference between all pairs of serum and whole blood measurements using Bland-Altman plot of differences. [ Time Frame: baseline ]
  5. Mean percentage difference between all pairs of plasma and whole blood measurements using Bland-Altman plot of differences. [ Time Frame: baseline ]

Biospecimen Retention:   Samples Without DNA
Retaining serum and plasma specimens


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinics
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104154


Locations
Layout table for location information
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Samsung Electronics
Investigators
Layout table for investigator information
Study Chair: Nam Shin Nexus-Dx

Layout table for additonal information
Responsible Party: Samsung Electronics
ClinicalTrials.gov Identifier: NCT02104154     History of Changes
Other Study ID Numbers: T10-02
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: February 20, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Digestive System Diseases