Study Stopped
To conduct interim analysis and assess whether assay changes are recommended.
Evaluation of the Samsung LABGEO PT10 Hepatic Panel in a Point-of-Care Setting
1 other identifier
observational
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 13, 2013
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFebruary 20, 2015
February 1, 2015
10 months
December 13, 2013
February 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Bias between Samsung LABGEO PT10 serum results and matching FDA-cleared comparator assay
baseline
Secondary Outcomes (5)
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
Study Arms (1)
symptoms of liver disease
Device: Samsung LABGEO PT10 Hepatic Panel
Interventions
Eligibility Criteria
Primary care clinics
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Science University
Portland, Oregon, 97239, United States
Biospecimen
Retaining serum and plasma specimens
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
Nam Shin
Nexus DX
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2013
First Posted
April 4, 2014
Study Start
November 1, 2013
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
February 20, 2015
Record last verified: 2015-02