Abstract: Methods and systems to collect a sample of bodily fluid from a patient using an integrated needle and test strip assembly are provided. The test strip and needle form one unit that captures the sample of blood or interstitial fluid from the patient once the apparatus is pressed to the skin. The hollow needle includes more than one opening at a distal end, each opening coming into contact with the bodily fluid when disposed within a cutaneous or subcutaneous layer of the patient's skin. The sample may flow through the needle onto a test region by capillary action and/or the positive pressure of the bodily fluid (e.g. blood or interstitial fluid) relative to the external environment. The disclosed test strip includes at least one reaction site for testing analyte concentrations and a means for interfacing with many commercially available test strip meters to provide readout of the analyte concentration.

Abstract: Methods and systems to collect a sample of bodily fluid from a patient using an integrated needle and test strip assembly are provided. In this novel assembly, the test strip and needle form one unit that captures the sample of blood or interstitial fluid from the patient once the apparatus is pressed to the skin. The hollow aspiration needle includes more than one opening at a distal end, each opening coming into contact with the bodily fluid when disposed within a cutaneous or subcutaneous layer of the patient's skin. The disclosed test strip includes at least one reaction site for testing analyte concentrations and a means for linking to many commercially available test strip meters to provide readout of the analyte concentration. The sample may be captured by capillary flow, by an integrated aspirator, or by a differential vacuum device resident on the test strip meter.

Abstract: Methods and systems to collect a sample of bodily fluid from a patient using an integrated needle and test strip assembly are provided. In this novel assembly, the test strip and needle form one unit that captures the sample of blood or interstitial fluid from the patient once the apparatus is pressed to the skin. The hollow aspiration needle includes more than one opening at a distal end, each opening coming into contact with the bodily fluid when disposed within a cutaneous or subcutaneous layer of the patient's skin. The disclosed test strip includes at least one reaction site for testing analyte concentrations and a means for linking to many commercially available test strip meters to provide readout of the analyte concentration. The sample may be captured by capillary flow, by an integrated aspirator, or by a differential vacuum device resident on the test strip meter.

Abstract: Methods and systems to collect a sample of bodily fluid from a patient using an integrated needle and test strip assembly are provided. The test strip and needle form one unit that captures the sample of blood or interstitial fluid from the patient once the apparatus is pressed to the skin. The hollow needle includes more than one opening at a distal end, each opening coming into contact with the bodily fluid when disposed within a cutaneous or subcutaneous layer of the patient's skin. The sample may flow through the needle onto a test region by capillary action and/or the positive pressure of the bodily fluid (e.g. blood or interstitial fluid) relative to the external environment. The disclosed test strip includes at least one reaction site for testing analyte concentrations and a means for interfacing with many commercially available test strip meters to provide readout of the analyte concentration.

Abstract: Noninvasive, in-vivo, methods and system for determining a person's relative individual percentages of a plurality of hemoglobin species and for determining a person's total hemoglobin concentration, as well as, the concentration of the hemoglobin species which contribute to this total concentration, i.e., oxy-, deoxy-, carboxy-, met- and suf- hemoglobin are described. In a first embodiment, analyte wavelengths are selected in the visible region from 510 nm to 620 nm, with separate analyte wavelengths for each hemoglobin species to determine relative individual percentages. The measurements are then combined in a series of simultaneous equations which are then solved for the concentration of each species and the total concentration of hemoglobin.

Abstract: The present invention comprises methods for minimally invasive and noninvasive analyte determination using infrared spectroscopy. A minimally invasive in vitro method comprises obtaining a volume of a fluid sample. A minimally invasive manner of obtaining the sample includes using a laser to form a micropore on a user's skin. The sample is placed on a plane of an optically clear window, such as by pressing the window against the micropore. Infrared light is directed through the window and the sample at an angle such that the light path is approximately vertical. The resulting spectrum is measured and subjected to multivariate analysis to determine the presence of at least one analyte. A noninvasive in vivo method comprises obtaining a spectral measurement of a sample in conjunction with the arterial pulse measurement. A difference spectrum is determined by subtracting the arterial pulse trough measurement from the peak measurement.

Abstract: Non-invasive in-vivo and in-vitro methods for determining a person's total hemoglobin concentration as well as the concentration of the hemoglobin species which contribute to this total concentration, i.e., oxy-, deoxy-, carboxy-, and methemoglobin are described. The measurement comprises a ratio formed by dividing absorbance data at analyte wavelengths by absorbance data at reference wavelengths. In a first embodiment the analyte wavelengths occur at a local maximum of each of the hemoglobin species in the visible region. The reference wavelengths include those in the short wavelength near-infrared region from 800 to 1300 nm. In order to determine the concentration of each hemoglobin species a dA/A treatment is utilized comprising a difference term of absorbance data in the region from 800 to 1300 nm divided by the absorbance at a local maximum for each species.

Abstract: A method of noninvasive and in-vitro glucose and cholesterol concentration measurement employing nuclear magnetic resonance (NMR) spectroscopy is described. The measurement comprises a ratio formed by dividing the area of the resonance of the desired analyte, e.g., glucose or cholesterol, by the area of the water resonance in a spectrum of blood or tissue. In the in-vivo setting, the spectrum is obtained either in linkage with the pulsation of blood or by using a slice selection gradient such as that employed in the magnetic resonance imager. This measurement is then correlated to a traditional serum analyte concentration.