NOVILYTIC, LLC — Department of Health and Human Services SBIR Phase II: 100

Description

DESCRIPTION provided by applicant 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 or 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 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 min These dried samples can be transported from almost anywhere in to world to a laboratory for analysis within 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