Most clinical assays begin with blood collection in a laboratory setting. The Gates foundation and many others have recognized and attempted to deal with the fact that in much of the world clinical testing is done in a primitive setting. The luxury of having a phlebotomist to draw blood with a laboratory to prepare serum or plasma for analysis is not universal at many points-of-care, even in America. The most significant component of this proposal is that the world will obtain a plasma extraction technology that produces a small, reproducible aliquot of plasma without an energy source or human intervention. Moreover, 2.5 or 6 ?L plasma samples collected in this manner can be transported dry on a collection disc to a central laboratory by courier or mail. The technology proposed to accomplish this is based on blood fractionation by frontal loading of a miniature assemblage of membranes where plasma is transported through multiple membrane layers by capillary action. Blood cells are removed via a combination of adsorption and filtration as plasma migrates to a 6.4 mm diameter collection disc at the bottom of the membrane stack during roughly three min. Stripping (delaminating) the upper, cell bearing membrane layers from the system exposes the plasma loaded collection disc which dries in roughly 10 min. These dried samples can be transported from almost anywhere in to world to a laboratory for analysis within 24 hr. This plasma extraction technology is being developed and validated as component of a mass spectrometry (MS) analysis of vitamin D analogues. As part of the vitamin D test proposed and developed in Phase I, a reagent was developed (SecoSET) that derivatizes vitamin D species with high selectivity. The function of SecoSET is to impart a permanent positive charge to vitamin D species that increases their ionization efficiency in electrospray ionization MS and concomitantly reduces their LOQ.

Public Health Relevance

Blood tests are at the heart of modern health care, requiring a skilled phlebotomist to draw a blood sample by venipuncture and a well-equipped laboratory to prepare the blood for analysis. The significance of the work proposed here is that a new technology is being developed that circumvents this process, allowing a physician or individual to prepare their own sample by placing a drop of blood from a finger-stick on a small card that is transported to a laboratory by courier or mailed. Initial trails of this technology will be appliedin the development of a vitamin D test. This technology enables a new paradigm in that samples from large numbers of remote sites can be analyzed in a single, sophisticated central laboratory at reduced cost.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44GM097798-02
Application #
8781294
Study Section
Special Emphasis Panel (ZRG1-IMST-G (10))
Program Officer
Edmonds, Charles G
Project Start
2011-06-01
Project End
2016-08-31
Budget Start
2014-09-30
Budget End
2015-08-31
Support Year
2
Fiscal Year
2014
Total Cost
$489,940
Indirect Cost
Name
Novilytic, LLC
Department
Type
DUNS #
005367031
City
North Webster
State
IN
Country
United States
Zip Code
46555