NCT03800069

Validation of Point of Care Liver Function Tests

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 68 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Liver Diseases
• Healthy
• Cirrhosis, Liver
• Fibrosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-12-03
• Primary completion: 2019-05-30
• Completion: 2019-05-30
• First posted: 2019-01-10
• Last updated: 2020-12-04

Locations

1 site across 1 country: United States