Abstract: 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.

Abstract: The invention relates to surfactant-free reagent spheres useful for biological tests particularly those involving antigen/antibody reactions.

Abstract: A diagnostic device for testing a liquid sample has a carrier for receiving at least a portion of the sample and a sample delivery means. The sample delivery means has a delivery channel that is in fluid communication with the carrier. The delivery channel has a first delivery channel surface facing a second delivery channel surface, wherein the first delivery channel surface is spaced apart from said second delivery channel surface by a distance that promotes longitudinal advancement of the sample along the delivery channel by capillary action. A deposition channel, to promote lateral dispersal of the sample across a corner, is formed either in a housing or between the housing and the carrier.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: An apparatus and method for producing dry beads of a liquid reagent for use in various methods of analysis. The beads are formed by use of an x-y table that can be translated along both the x and the y axis. An insulated tray containing liquid cryogen is positioned atop the x-y table. A metal grid forms a plurality of cells in the tray so that the cryogen is free to enter the cells up to the level of the cryogen in the tray. The frozen drops form into beads and freely amass on the bottom of the tray. A drop forming device dispenses individual drops to fall by gravity into an individual, discrete cell. The table then translates to position another discrete cell for receiving the subsequent drop of reagent. The movement of the x-y table causes a agitation of the cryogen to enhance the freezing process.

Abstract: 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.

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.

Abstract: 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.

Abstract: The invention relates to a method for staging sepsis in a patient by concurrently measuring in a sample of the patient's blood four parameters which are indicative of the stage of sepsis: 1) the level of microbial product level in the blood; 2) the level of tumor necrosis factor (TNF) response reserve; 3) the maximum oxidant production by neutrophils, and 4) the responsiveness of the patient's neutrophils to immunocomplexes. Based on determining the stage of sepsis, appropriate treatment for the patient may be identified.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: The invention relates to a filter device for use in diagnostic assay procedures for the effective separation of unwanted particulate matter from the liquid sample of an analyte. The device comprises plural sheet-like cappillary forms prepared from porous media, and that are able to receive and filter the liquid sample. The filter is so configured that, as the pores of the porous media become blocked, the liquid and any particulate matter contained therein are able to travel laterally, and then transversly, to unblocked regions of pores, thereby facilitating optimal speed and efficiency of sample processing. The invention extends to test kits for medical technologists that embody the filter device, and to corresponding methods of testing comprising the separation of particulate matter from samples such as body fluids and the like.

Abstract: A method is provided for isolating substantially intact cardiac troponin I from cardiac tissue comprising extracting the, troponin I and purifying it in the presence of an effective amount of a mixture of protease inhibitors. The human cardiac troponin I prepared by the present method is characterised by a molecular weight of about 28 kDa.

Abstract: 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.