Troponin I composition
AssigneeSpectral Diagnostics, Inc.
InventorsShigui Liu, Min Yuan Zhang, Qinwei Shi
Life of this patent
Estimating the term…
Abstract
The present invention relates to stable compositions useful as primary standards and calibrators and controls comprising a cardiac troponin I (cTnI) such as native, recombinant, addition and deletion forms thereof, whether or not complexed with other troponin subunits such as TnC and/or TnT, in an inactivated human serum. The compositions are obtained by incubating troponin complexes with human serum. The compositions are characterized by an immunodetectability ratio of epitopes on the N-terminal segment to epitopes on the C-terminal segment substantially equivalent to that of pooled, fresh serum from acute myocardial infarction patients.
Claims18
A substantially stable composition for use as a cardiac troponin I standard comprising a proteolytically-degraded cardiac troponin I in proteinase-inactivated human serum, wherein an immunodetectability ratio of N-terminal epitopes to C-terminal epitopes of said proteolytically-degraded cardiac troponin I is substantially equivalent to the immunodetectability ratio of N-terminal epitopes to C-terminal epitopes of cardiac troponin I in pooled, fresh serum of acute myocadial infarction patients.
A method for preparing a substantially stable proteolytically-degraded cardiac troponin I composition comprising sequential steps of
- (a) adding a cardiac troponin I into human serum;
- (b) incubating the serum containing the cardiac troponin I for a period of time to undergo proteolytic degradation by proteinases to achieve an immunodetectability ratio of N-terminal epitopes to C-terminal epitopes substantially equivalent to the immunodetectability ratio of cardiac troponin I in pooled, fresh serum of acute myocardial infarction patients;
- and
- (c) inactivating said proteinases in said serum.
Dependencies are inferred from the claim text.