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 provides a method of sonic treatment to selectively reduce the void volume of a sintered polymer such as porous high density polyethylene (HDPE). The invention also provides a method and an article of manufacture for receiving a liquid sample, where a first portion of the sintered polymer (1a) overlies a solid surface (4a) and a second portion of the polymer (1b) overlies a window (4b). Sonic treatment of the sintered polymer reduces the void volume of the first portion (1a) compared to the second portion (1b). As a result, a liquid sample applied to the polymer will preferentially migrate through the second portion (1b), rather than through the first portion (1a). When the article of manufacture is used to analyze a liquid sample such as blood, less sample is required because of the preferential migration in the sonically treated sintered polymer.

Abstract: The present invention provides a method of using a reflectance-reading device to determine an initiation time point for measuring the chemical reaction of an analyte from a biological liquid sample on a test surface. The initiation time point is determined by using a device to read a reflectance of a test surface at a plurality of time points, and calculating the K/S ratio of the test surface at each time point according to the Kubelka-Munk equation. As the device continues to calculate a K/S ratio for each time point, the device monitors the rate of change of the K/S ratio with respect to time. The device then determines the initiation time point to be when the rate of change of the K/S ratio is maximal. The present invention also provides a method of measuring the concentration of an analyte on a test surface. The concentration is measured by determining an initiation time point according to the method described above and then measuring the concentration of the analyte at a variable end point.

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.