Abstract: The present invention is directed to a single test system and method for determining the integrated glycemic condition of a subject by measuring the concentration of glucose and the level of protein-bound glucose in a subject's body fluid, such as whole blood. The glucose concentration is indicative of the subject's immediate glycemic condition, whereas the protein-bound glucose concentration is indicative of either intermediate or long-term glycemic condition. Optionally, other analytes indicative of glycemic condition, such as ketone bodies or fatty acid derivatives, can also be measured. The present invention also provides a method of diagnosing diabetes. The invention additionally provides a method for analyzing the concentration of fructosamine in less than or equal to five minutes without the use of a reaction accelerator.

Abstract: The present invention is directed to a single test system and method for determining the integrated glycemic condition of a subject by measuring the concentration of glucose and the level of protein-bound glucose in a subject's body fluid, such as whole blood. The glucose concentration is indicative of the subject's immediate glycemic condition, whereas the protein-bound glucose concentration is indicative of either intermediate or long-term glycemic condition. Optionally, other analytes indicative of glycemic condition, such as ketone bodies or fatty acid derivatives, can also be measured. The present invention also provides a method of diagnosing diabetes. The invention additionally provides a method for analyzing the concentration of fructosamine in less than or equal to five minutes without the use of a reaction accelerator.

Abstract: The present invention is directed to a single test system and method for determining the integrated glycemic condition of a subject by measuring the concentration of glucose and the level of protein-bound glucose in a subject's body fluid, such as whole blood. The glucose concentration is indicative of the subject's immediate glycemic condition, whereas the protein-bound glucose concentration is indicative of either intermediate or long-term glycemic condition. Optionally, other analytes indicative of glycemic condition, such as ketone bodies or fatty acid derivatives, can also be measured. The present invention also provides a method of diagnosing diabetes. The invention additionally provides a method for analyzing the concentration of fructosamine in less than or equal to five minutes without the use of a reaction accelerator.

Abstract: The present invention is directed to a single test system and method for determining the integrated glycemic condition of a subject by measuring the concentration of glucose and the level of protein-bound glucose in a subject's body fluid, such as whole blood. The glucose concentration is indicative of the subject's immediate glycemic condition, whereas the protein-bound glucose concentration is indicative of either intermediate or long-term glycemic condition. Optionally, other analytes indicative of glycemic condition, such as ketone bodies or fatty acid derivatives, can also be measured. The present invention also provides a method of diagnosing diabetes. The invention additionally provides a method for analyzing the concentration of fructosamine in less than or equal to five minutes without the use of a reaction accelerator.

Abstract: The present invention relates to a method and to a device for separating plasma from whole blood. The method and device utilize a permeable non-glass fiber matrix containing a polyol which is capable of clumping red blood cells. The matrix, in the absence of such a polyol, would otherwise be porous to red blood cells. The polyol-containing matrix has a first surface and a second surface such that a whole blood sample which is applied to the first surface flows directionally toward the second surface. Plasma separated from whole blood becomes available at the second surface of the matrix and can be tested for the presence of a particular analyte, such as glucose or fructosamine, as provided by multi-layer test devices of the present invention.

Abstract: The present invention relates to a method and to a device for separating plasma from whole blood. The method and device utilize a permeable non-glass fiber matrix containing a polyol which is capable of clumping red blood cells. The matrix, in the absence of such a polyol, would otherwise be porous to red blood cells. The polyol-containing matrix has a first surface and a second surface such that a whole blood sample which is applied to the first surface flows directionally toward the second surface. Plasma separated from whole blood becomes available at the second surface of the matrix and can be tested for the presence of a particular analyte, such as glucose or fructosamine, as provided by multi-layer test devices of the present invention.

Abstract: The present invention is directed to a single test system and method for determining the integrated glycemic condition of a subject by measuring the concentration of glucose and the level of protein-bound glucose in a subject's body fluid, such as whole blood. The glucose concentration is indicative of the subject's immediate glycemic condition, whereas the protein-bound glucose concentration is indicative of either intermediate or long-term glycemic condition. Optionally, other analytes indicative of glycemic condition, such as ketone bodies or fatty acid derivatives, can also be measured. The present invention also provides a method of diagnosing diabetes. The invention additionally provides a method for analyzing the concentration of fructosamine in less than or equal to five minutes without the use of a reaction accelerator.

Abstract: The present invention relates to a method for electrochemically measuring the concentration of fructosamine, or its high alkalinity eneaminol tautomer in a body fluid sample.

Abstract: The present invention is directed to a multi-layer test device and method for analyzing the concentration of fructosamine in a liquid sample. The multi-layer test device has a buffer layer containing a buffer having a pH value of at least 9 which is either superposed above or juxtaposed to an indicator layer containing an indicator capable of being reduced by fructosamine. Supporting the buffer layer, the indicator layer, and any additional layers in the multi-layer device is at least one support member which optionally has a detection aperture for analyzing the concentration of fructosamine on the indicator layer. An additional support member having a sample aperture can be used. Where two support members are used the multi-layers are sandwiched between the first support member having a sample aperture and the second support member optionally having a detection aperture.