Validation of Point of Care Liver Function Tests

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

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.

Study Overview

• Status: Terminated
• Conditions: Liver Diseases; Fibrosis; Healthy; Cirrhosis, Liver
• Intervention / Treatment: Device: Group K Diagnostic point of care device

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Hospital of the University of Pennslyvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population will be selected from inpatient and clinic setting at The Hospital of the University of Pennsylvania.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm 1; A finger stick sample is collected and tested on the study device.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Group K Diagnostics Inc.
• Investigators: Principal Investigator: Vandana Khungar, MD, MSc, Director of Inpatient Hepatology

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Fibrosis; Liver Diseases; Liver Cirrhosis
• Other Study ID Numbers: 829476

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No