This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein).
This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein). The information and data obtained will be used to finish development of a convenience kit that allows doctors to provide their patients a method to have their blood tested for clinical laboratory tests in the convenience of their home without having to visit the doctor's office or clinic.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
128
This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein).
Mills-Peninsula Health Services
San Mateo, California, United States
L-MARC
Louisville, Kentucky, United States
Usability and HbA1c Method Comparison Study Using Lay-Person Micro-Blood Specimens
To establish that when using capillary blood collected in the Home Access Collection Cassette, lay-users can obtain HbA1c results equivalent to results from professionally-collected samples
Time frame: Outpoint measured within 3 months
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