Spectral Diagnostics, Inc.

Qinwei Shi

Shigui Liu

Mingfu Ling

Helmut E Freitag

Charles A Harrington

Qian-Li Song

Min Yuan Zhang

Rowel Tobias

Polypeptides corresponding to stable, circulating degradation products of troponin I (TnI) are described. The fragments comprise a sequence of the N-terminus of native cardiac TnI with 95-115 amino acid and additionally include fragments lacking about the 20-30 N-terminal amino acids. Utilities of these fragments and antibodies thereto include sensitive detection of myocardial infarction and purification of antibodies sensitive to the detection of troponin I degradation products.

Troponin I polypeptide fragments and uses thereof

This invention relates to single-chain polypeptides and their genetic sequences comprising human cardiac troponin I and troponin C. The single-chain polypeptide may be expressed recombinantly, and a linker peptide may be interposed between the troponin sequences. A linker peptide of about 6 to about 30 amino acids is preferred. The single-chain polypeptide has utility as a control or calibrator for troponin assays, for the purification of troponin subunits and as an antigen for the preparation of antibodies.

Single-chain polypeptides comprising troponin I and troponin C

An analytical test device is described for the immunochromatographic determination of the presence of one or more analytes in fluid samples. The device is configured such that the sample is allowed to enter the detection zone simultaneously from many different directions, eliminating stagnation of the flow of the sample. By selection of the porous substrate, the device also allows for the separation of red blood cells from plasma, providing a rapid test for one or more analytes in a sample of whole blood. The device of the present invention may measure more than one analyte simultaneously from a single sample, either by having multiple immunochromatographic pathways fed by a single sample, or multiple analytes detected in the same pathway by way of multiple capture antibodies.

Analytical test device and method

The invention provides assay methods and kits that in general measure the level of a first analyte in a sample reduced by the level of a second analyte present in the same sample. In one embodiment, where levels of a first analyte from a first source is desirably determined and first analyte in the sample released from a second source is accompanied by proportional co-release of a second analyte, the assay identifies the level of first analyte released only from the first source. For analytes within bodily fluids, the assay can differentiate between elevated levels of analyte specific to the particular physiological or pathological state and elevated levels not specific to the particular state, providing single tests with diagnostic utility.

Differential immunoassay

This invention relates to single-chain polypeptides and their genetic sequences comprising a human cardiac troponin I N-terminal fragment and troponin C. The N-terminal fragment may or may not have the intact N-terminus. The single-chain polypeptide may be expressed recombinantly, and a linker or spacer polypeptide or peptide may be interposed between the troponin sequences. The single-chain polypeptides have utility as controls or calibrators for troponin assays, for the purification of troponin subunits and as an antigen for the preparation of antibodies.

Single-chain polypeptides comprising troponin I N-terminal fragments and troponin C

Analytical test device and method for use in medical diagnoses

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.

Troponin I composition

Stable troponin subunits and complexes and methods for their preparation are described. Among other uses, these subunits and complexes are useful as antigens for the preparation of antibodies, and as controls and calibrators for troponin assays. One complex comprises a modified human cardiac troponin I together with human cardiac troponin T and human cardiac troponin C. Another complex comprises a modified human cardiac troponin I with human cardiac troponin C.

Stable troponin subunits and complexes

This invention relates to single-chain polypeptides and their genetic sequences comprising creatine kinase M and creatine kinase B. The single-chain polypeptide may be expressed recombinantly. A linker peptide may be interposed between the creatine kinase sequences. A linker peptide of about 6 to about 50 amino acids is preferred. The single-chain polypeptide has utility as a control or calibrator for creatine kinase MB assays, for the purification of creatine kinase antibodies, and as an antigen for the preparation of antibodies.

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Etobicoke, Canada

Qinwei Shi