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

Hepatic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02104154
• Other study ID #: T10-02
• Status: Terminated
• Phase: N/A
• First received: December 13, 2013
• Last updated: February 18, 2015
• Start date: November 2013
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: Samsung Electronics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatic Disease
• Liver Diseases

Intervention

Device:
• Samsung LABGEO PT10 Hepatic Panel

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Electronics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bias between Samsung LABGEO PT10 serum results and matching FDA-cleared comparator assay		baseline	No
Secondary	Mean percentage difference between all pairs of plasma and serum measurements using Bland-Altman plot of differences.		baseline	No
Secondary	Standard deviation and coefficients of variation of between run, between day and total precision.		20 days	No
Secondary	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	No
Secondary	Mean percentage difference between all pairs of serum and whole blood measurements using Bland-Altman plot of differences.		baseline	No
Secondary	Mean percentage difference between all pairs of plasma and whole blood measurements using Bland-Altman plot of differences.		baseline	No