Cirrhosis, Liver, Fibrosis, Healthy, Liver Diseases
Conditions
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
Interventions
DEVICEGroup 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.
Sponsors
Group K Diagnostics Inc.
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed