SBIR-STTR Award

This proposal involves the development of a simple assay for measuring functional approximately-proteinase inhibitor levels in human tissues. Th procedure utilizes the fact that incubato of excess porcine pancreatic elastase with either plasma or serum samples will result in complex formation with functional approximately 1-proteinase inhibitor in these fluids. Residual enzyme activity can then be calculated and a determination made as to inhibitor levels present in the original sample. The techniques to be utilized should provide a rapid and reliable procedur for the early screening of individuals with a genetic deficiency in approximately 1-proteinase inhibitor and, thereby, reduce the risk of development of familial emphysema in this segment of the population.National Heart, Lung and Blood Institute (NHLBI)

In Phase I, Athens Research and Technology, Inc. (ART) developed a prototype qualitative chromophoric assay that measures the functional levels of alpha-l-proteinase inhibitor (ALPI, also known as alpha-l-antitrypsin) in plasma or serum. This assay, which ART refers to as PI Diagnostic, is a rapid and simple visual test for determining individuals who have a genetic deficiency in ALPI. In its present form, the assay is performed on plasma and does not require instrumentation to determine functional level.In Phase II, ART plans to modify the PI Diagnostic with respect to sample material to be used in the assay and assay substrate. After optimizing the parameters, ART will perform efficacy tests to determine the reliability and accuracy of the PI Diagnostic in detecting individuals with ALPI deficiency. The ultimate goal is to develop an assay that will be inexpensive and convenient to use in a variety of laboratory settings (newborn screening, reference, hospital laboratories, and/or physician's office) and for alternate site testing.

Anticipated Results:
Early diagnosis of ALPI deficiency could substantially reduce the number of people who develop emphysema.National Heart, Lung, And Blood Institute (NHLBI)