Validation of Point of Care Liver Function Tests

Terminated

• Conditions: Fibrosis; Liver Diseases; Cirrhosis, Liver; Healthy
• Interventions: Device: Group K Diagnostic point of care device

• Registration Number: NCT03800069
• Lead Sponsor: University of Pennsylvania

Brief 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.

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 Timeline

• Study Start: 2018-12-03
• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-09
• Study First Posted: 2019-01-10
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-02
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 68

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1	Group K Diagnostic point of care device	A finger stick sample is collected and tested on the study device.

Primary Outcome Measures

Name	Time	Method
Regression curve and correlation coefficient	1 year	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.

Secondary Outcome Measures

Name	Time	Method
The consistent accuracy of the diagnostic device	1 year	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.

Trial Locations

Locations (1)

The Hospital of the University of Pennslyvania; 🇺🇸 Philadelphia, Pennsylvania, United States