Validation of Point of Care Liver Function Tests

Healthy Clinical Trial

Official title:

Biomedical Device Trial of Validation of Point of Care Liver Function Tests

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03800069
• Other study ID #: 829476
• Status: Terminated
• Start date: December 3, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: December 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is testing the accuracy of a point of care device that tests liver function within 20 minutes. The target population will be any adult who had liver function tests ordered and to be drawn on the same day as enrollment.

Description:

Outpatient diagnostics are slow and expensive due to turnaround times, complex workflows and high cost. Sometimes patients do not make it to laboratory testing if a lab is not available on site. Delays in testing can affect medical outcomes or patients can be lost to follow up.

Group K developed a paper microfluidic platform with an accompanying mobile application(app). The paper microfluidic device is a simple, inexpensive wax backed device with three testing areas. These areas have a mix of dried proprietary reagents that when combined with a patients drop of blood, or in the future, saliva or urine, will produce results in a color change. An app is then used to interpret the color change and output results to a doctor. The target population is adults who have an indication to collect a liver function panel that will be drawn on the same day as their clinic visit or during their inpatient hospital

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a liver function testing for the required 6 tests completed (Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), albumin, bilirubin, and total protein)

• 18 years or older

Exclusion Criteria:

• Inadequate blood sample obtained from finger stick

• Inconclusive liver function testing

• Not all 6 liver tests completed on the same sample

• Liver tests not drawn for normal method at same time as finger stick.

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Healthy
• Liver Cirrhosis
• Liver Diseases

Intervention

Device:
• Group K Diagnostic point of care device
Arm 1 will have a finger prick sample collected to test the ability of Group K Diagnostic point of care device and app to identify liver function values.

Locations

Country	Name	City	State
United States	The Hospital of the University of Pennslyvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Group K Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regression curve and correlation coefficient	Each data point will represent one observation or one test run. The investigators will use regression methods to determine the linear relationship between standard lab results and Group K diagnostic's device.	1 year
Secondary	The consistent accuracy of the diagnostic device	Lowest level frequency of detection must be detected 90% of the time. This will become the functional lower limit. The same with the highest level of frequency.	1 year