Validation of Point of Care Liver Function Tests
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies, Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/24/2019 |
| Start Date: | December 3, 2018 |
| End Date: | December 3, 2019 |
| Contact: | Grace Thiele, BS |
| Email: | grace.thiele@pennmedicine.upenn.edu |
| Phone: | 215-349-5845 |
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.
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.
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
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
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.
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