Validation of Point of Care Liver Function Tests
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About
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.
Full 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
Enrollment
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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.
Trial design
68 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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