Validate Volumetric Absorptive Microsampling (VAMS) Assay
Conditions
Brief summary
This is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center. Patients who have undergone heart transplantation who meet eligibility requirements will be approached to participate in the study. The purpose of this study is to establish a reliable, home-based method for collecting samples as well as a standardized method for use of small-volume samples on both inpatients and outpatients.
Interventions
DEVICEMitra Microsampler
an FDA Class I medical device for direct specimen collection of blood or other biological fluids
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
1. Pediatric, adolescent, or young adult patients ≥1 and ≤21 years of age 1. Aim 1: All patients presenting for routine post-transplant care including, but not limited to: cardiac catheterization, cardiac biopsy, inpatient admission, or outpatient visits 2. Aim 2: outpatient 2. Currently taking tacrolimus
Exclusion criteria
1. Non-English-speaking patients 2. Unable to access overnight delivery services (Aim 2 only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of +/-10% | 18-24 months from start of enrollment | A VAMS-based tacrolimus trough values will be accurate +/-10% when compared with standard whole blood values achieved via venipuncture. |
Countries
United States
Outcome results
None listed