Abstract:
An apparatus suitable for measuring at least one plasma analyte in plasma extracted from a whole blood sample within the apparatus is provided. The apparatus can be adapted for insertion into a slot in a meter, which can preferably perform at least spectroscopic or biosensor measurement. The apparatus comprises a whole blood flow path, which begins at the inlet opening of the apparatus, and terminates at a vent or a suction chamber. Included in the blood flow path is a flow-through filtration chamber. The filtration chamber comprises at least one membrane separating a blood compartment from a plasma compartment. The apparatus further comprises a plasma flow path, which begins at the plasma compartment and terminates at a vent or a suction chamber. The plasma flow path includes a plasma analyte signal providing means. The signal is transmitted to a processor in the meter for preparing analyte measurements.
Abstract:
Some embodiments of the present invention provide a sample holder that is suitable for collection and spectroscopic measurement of a blood sample. In some embodiments, the sample holder is provided with an optical chamber that is specifically designed to spread blood into a thin film, thereby reducing the average attenuation of electromagnetic radiation (EMR) due to scattering of EMR by the red blood cells in a blood sample, without having to hemolyze the red blood cells using sound waves or reagents. The inlet of some embodiments of the sample holder is a piece of capillary tube, and in other embodiments, the inlet is configured to engage a syringe. In some embodiments, the inlet of the sample holder can accommodate adaptors with different configurations, thereby allowing the sample holder to receive blood from any source, for example a pin prick or a syringe.
Abstract:
The present invention provides a method of analyzing plasma from a sample of whole blood. The method includes a) obtaining a sample of whole blood from a subject in a container, the container having a first end and a second end, the first end of the container for receiving a sample of whole blood; b) centrifuging the container under conditions to separate the whole blood into a cell layer, a gel layer and a plasma layer, wherein the centrifuging produces in relative juxtaposition the first end of the container, the cell layer, the gel layer, the plasma layer and the second end of the container; and c) inserting into a spectrophotometric device the second end of the container which includes the plasma layer in closest relative juxtaposition, to analyze the plasma from the whole blood.
Abstract:
Some embodiments of the invention provide a needle comprising a shaft with a sharp open end and a hub with a blunt open end, housed in a barrel with an open anterior end and an open posterior end. The hub of the needle can move forward inside the barrel, for extending the sharp open end of the shaft of the needle for insertion into a vessel, e.g. a blood vessel, a catheter, or a capped tube. After use, the hub can move backwards inside the barrel for retracting the shaft of the needle into the barrel. The blunt open end of the needle can be fluidly connected to the inlet opening of a measurement apparatus, so that the blood can flow directly from a vessel, into the measurement apparatus, without the use of a syringe. The hollow needle assembly can also be used with a traditional syringe, as an alternative to traditional needles, in order to minimize the risk of needle-stick injury.
Abstract:
A sample tab for retaining a sample during spectroscopic analysis includes a base plate, a sample well, and a cover plate. The sample well may vary in size to accommodate different sample volumes, and the base of the sample well may be positioned above or below the plane of the base plate. The walls of the sample well may also include one, or more than one overflow opening for draining excess sample, and an overflow channel to retain the excess sample.
Abstract:
Described is a method for calibrating a spectrophotometric apparatus. This method involves obtaining a first set of absorbance measurements of a set of calibrators on a First Apparatus that is in control at wavelengths from a first wavelength calibration table. A second wavelength calibration table on a second apparatus is established, wherein the first and the second wavelength calibration tables may be the same or different. A second set of absorbance measurements of the set of calibrators is obtained on the Second Apparatus, at wavelengths from the second wavelength calibration table. First and second interpolated absorbances are determined, for the first and the second absorbance measurement, respectively, for at least one wavelength of a Standard Set of Wavelengths. Using the first and the second interpolated absorbances, a linear regression equation for each wavelength of said Standard Set of Wavelengths is determined. The linear regression equation and at least one Primary Calibration Algorithm are incorporated onto the Second Apparatus, to produce a calibrated apparatus. The present invention is also directed to a medium storing instructions adapted to be executed by a processor to determine analyte concentration within a sample. Furthermore, the present invention provides an apparatus for determining analyte concentration of a sample, and a system for determining presence of an analyte in a sample.
Abstract:
Apparatus and method for detecting patient sample quality, and/or analytes, in the tip used to aspirate the patient sample liquid and then dispense it onto a slide test element. Spectrophotometric analysis is done on the liquid while still in the tip, by scanning the tip for transmittance in a light-tight enclosure, using NIR and adjacent visible radiation, and detecting the absorbence spectra of the liquid. Much smaller liquid volumes, and no through-the-label detection, are required, compared to doing the scanning of the liquid in a primary patient collection container.
Abstract:
Some embodiments of the invention provide one sample holder that is suitable for collection and spectroscopic measurement of a blood sample. In some very specific embodiments, the sample holder is provided with an optical chamber that is specifically designed to spread blood into a thin film, thereby reducing the average attenuation of electromagnetic radiation (EMR) due to scattering of EMR by the red blood cells in a blood sample, without having to hemolyze the red blood cells. Also, the sample holder is designed so that air bubbles are easily pushed through the optical chamber and guided out of the sample holder through a vent. In some embodiments, the inlet of the sample holder can be reconfigured with adaptors to receive blood from for example, a pin prick or a syringe. Use of adaptors makes the housing simpler when considering the manufacturing process.
Abstract:
A sample tab for retaining a sample during spectroscopic analysis includes a base plate, a sample well, and a cover plate. The sample well may vary in size to accommodate different sample volumes, and the base of the sample well may be positioned above or below the plane of the base plate. The walls of the sample well may also include one, or more than one overflow opening for draining excess sample, and an overflow channel to retain the excess sample.
Abstract:
The present invention provides a method for monitoring degradation of Hb-based blood substitutes, in a sample. This method involves determining a concentration of met-Hb within the sample, by applying a calibration algorithm for met-Hb to an absorbance obtained from the sample at one or more than one wavelengths, and using the concentration of met-Hb, as a measurement of degradation of the Hb-based blood substitutes. Using this assay, a concentration of met-Hb that is equal to or greater than 3% may be used as an indicator of degradation of Hb. Alternatively, by obtaining samples over a period of time, the concentration of met-Hb and the concentration of Hb-based blood substitute may be determined in each of these samples, and an increase in the concentration of met-Hb over the period of time is an indicator of degradation of Hb. The sample may be a whole blood sample, a serum sample, or a plasma sample obtained from a patient transfused with one or more than one Hb-based blood substitutes, a stock Hb-based blood substitute sample, or a body part of a patient.