ALT Routinely Recorded Remotely: A Comparator Study of Liver Function Tests Using the Tasso+ to Venipuncture.

Study Overview
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Brief Summary
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A direct comparison study of blood samples collected using the Tasso+ device and venous blood samples in patients with elevated alanine transaminase (ALT).

Detailed Description
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This is a prospective, non-blinded, multi-center study to be conducted within the USA. This study will consist of a single arm. Blood will be drawn from each subject, using two different collection methods: the Tasso+ device and the conventional venipuncture method. The results will be compared assess correlation between blood collected at home, by the patient, using the Tasso+ device and blood collected in the office using a Vacutainer (SST, Red Top tube) using venipuncture for alanine transaminase (ALT), aspartate aminotransferase (AST) and total bilirubin. Participants can complete up to 3 visits and will include self-collected blood samples using the Tasso+ device at home on the day of visit 2 and visit 3.

Official Title
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Project ARRR, ALT Routinely Recorded Remotely: A Comparator Study of Liver Function Tests Using the Tasso+ to Venipuncture.

Conditions
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Elevated Alanine Transaminase (ALT)

Intervention / Treatment
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* Other: Tasso+ SST


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be willing and able to provide written informed consent prior to study entry Subject is ≥ 18 years of age. Subject must meet the following criterion: known recent history of liver function abnormality and requiring follow-up Liver tests (including ALT>3XULN) Subject must be willing and able to adhere to the assessments, study schedule, prohibitions and restrictions as described in the protocol. Patients may be on any treatment / therapeutic clinical trial as indicated by treating physician Exclusion Criteria: Pregnant or nursing female by self-report. Presents with abnormal skin integrity or atypical skin health within the areas to be tested (upper shoulders). Subjects who have applied lotion to the skin on the shoulder the day of the visit. Patients with hepatic encephalopathy Vulnerable populations (children, prisoners, pregnant women, participants with diminished decision-making capacity, illiterate populations, educationally disadvantaged populations).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with elevated alanine transaminase (ALT)<br>patients with alanine transaminase (ALT) > 3x upper limit of normal (ULN). | Other: Tasso+ SST<br>* alternative site blood sample collection.<br>* Other names: Tasso+;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous and Tasso+ blood sample comparison for ALT | Correlation between blood collected at home, by the patient, using the Tasso+ device and blood collected in the office using a Vacutainer (SST, Red Top tube) using venipuncture for ALT, AST and total bilirubin, quantified using a Roche Cobas 8000/c702 or an equivalent analyzer. | through study completion, an average of 1 Year and 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous and Tasso+ blood sample comparison for additional analytes | Correlation of additional analytes including Total Protein, Albumin, Glucose, Sodium, Potassium, Chloride, Magnesium, Calcium, Phosphorus, Enzymatic Creatinine and alkaline Phosphatase (ALP) in blood collected with the Tasso+ device and by venipuncture in a Vacutainer (SST, Red Top tube) analyzed using a Roche Cobas 8000/c702 or an equivalent analyzer or an equivalent analyzer. | through study completion, an average of 1 Year and 6 Months | 
| To collect patient experience with the Tasso blood collection | To collect patient experience with the Tasso blood collection utilizing a brief survey aimed at understanding patient experience and preferences on the use and adoption of Tasso+ to collect a blood sample independently (with the help of a caregiver if needed), outside of the clinic. | through study completion, an average of 1 Year and 6 Months |