Cme Telemetrix Inc.

Spectromedical Inc.

Nir Diagnostics Inc.

Other

Ortho-clinical Diagnostics, Inc

Johnson & Johnson Clinical Diagnostics, Inc.

Niresults Inc.

James Samsoondar

Duncan MacIntyre

Ashwani Kaushal

Merrit Nyles Jacobs

Theodore E Cadell

James D Shaw

Romuald Pawluczyk

Bronislaw Bednarz

Davis Freeman, Iii

Thomas Moffett

Paul Drennan

John Kuta

Theordore E Cadell

Petersen Borge

Duncan Maclntyre

Bernard Zinman

Douglas George Given

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.

Spectrophotometric analysis of plasma in a closed-container

A method and apparatus for measuring Tot-Hb in a sample are provided. The method involves collecting absorbance measurements of a sample using a spectroscopic apparatus that includes a first primary calibration algorithm for one of Oxy-Hb, 'Oxy-Hb plus Deoxy-Hb', or 'Total-Hb minus Met-Hb' and a second primary calibration algorithm for one or more than one of Met-Hb, Carboxy-Hb, or Sulf-Hb, or includes a third primary calibration algorithm obtained by adding terms of the first primary calibration algorithm and the second primary calibration algorithm together. Followed by predicting either a first value for one of Oxy-Hb, &#x201c;Oxy-Hb plus Deoxy-Hb,&#x201d; or &#x201c;Total-Hb minus Met-Hb&#x201d; and predicting second value for one or more than one of Met-Hb, Carboxy-Hb, or Sulf-Hb in the sample and adding the first and second value together, or predicting a value for Total-Hb.

Spectroscopic method and apparatus for total hemoglobin measurement

The present invention provides a method for identifying a concentration of a compound within a part of a subject. The method involves measuring the amount of electromagnetic radiation reflected by, or transmitted through the part with a detector, and using a quantitative mathematical analysis to determine the concentration of the compound in one, or more than one compartment, including a blood, interstitial, cellular, lymph, or bone compartment, of the part. A corrected concentration of the compound may be then determined within a compartment of interest, or a total concentration of the compound may be accurately determined. Preferably, the compound is glucose. From this determination, a clinical condition in a human or animal may be made by correlating the concentration of a measured compound in the compartment of a part of the human or animal to a clinical condition in need of treatment.

Measurement of body compounds

The present invention provides an apparatus and a method for identifying the risk of a clinical condition in a human or animal by correlating Near Infrared (NIR) absorbance spectral data with one or several parameters including a concentration of one or more substances in the skin, a concentration of one or more substances in skin plus subdermal tissue, a score derived from one or more clinical tests like a stress test on a treadmill, coronary angiography, or intravascular coronary ultrasound. The method determines the concentration of a compound in the skin of a human or animal and comprises the steps of placing a part of the skin against a receptor, directing electromagnetic radiation (EMR) from the near-infrared spectrum onto the skin, measuring a quantity of EMR reflected by, or transmitted through, the skin with a detector; and performing a quantitative mathematical analysis of the quantity of EMR to determine the concentration of the compound, for example free and esterfied cholesterol. An example of a clinical condition is cardiovascular disease.

Near infrared risk assessment of diseases

A method is disclosed whereby the concentration of a blood substitute, such as cross-linked hemoglobin, in a serum or plasma specimen is rapidly and accurately identified and quantified. The method further takes the measured concentration of the blood substitute and uses it to correct for its effect, if any, on a measured analyte concentration, e.g., serum/plasma total protein. Further, the method allows for the determination of the concentration of true hemoglobin in the presence of blood substitutes. The method is carried out in respect of samples contained in a primary or secondary labelled tube, or a pipette tip used to dispense serum or plasma in a blood analyzer.

Method and apparatus for measurement of blood substitutes

A method of monitoring calibration of a spectrophotometric apparatus that includes one or more than one calibration algorithm for one or more than one analyte, involves measuring absorbance of a quality control material with the apparatus to obtain a measurement, calculating one or more than one value from the measurement using the one or more than one calibration algorithm, and comparing the one or more than one value with an assigned value given to the quality control material for each of the one or more than one analyte. The quality control material exhibits an absorbance spectrum having a negative slope for a continuous spectral segment from about 5 nm to about 200 nm in length, and the spectral segment includes a principal calibration wavelength for the one or more than one analyte. A reagentless method for determining the concentration of one or more than one analyte in a sample in a spectrophotometric apparatus having at least one primary calibration algorithm is also disclosed. Also provided is a method for selecting one or more than one substance as a quality control material for monitoring one or more than one primary calibration algorithm on a spectrophotometric apparatus. Also described is a quality control material for monitoring the calibration algorithms for two or more than two analytes including one or more than one substance having a combined absorption spectrum exhibiting a negative slope for a continuous spectral segment from about 5 nm to 200 nm in length, in a portion of an absorption spectrum.

Quality control material for reagentless measurement of analytes

A method of monitoring calibration of a spectrophotometric apparatus having one or more than one calibration algorithm for one or more than one analyte. This method involves measuring an absorbance of a quality control material to obtain a measurement, calculating one or more than one concentration value from the measurement using the one or more than one calibration algorithm, and comparing the one or more than one concentration value with an assigned value given to the quality control material for each of the one or more than one analyte. The quality control material exhibits an absorbance spectra having a negative slope for a continuous spectral segment from about 5 nm to about 400 nm in length, or a wavelength therebetween. A reagentless method for determining the concentration of one or more than one analyte in a sample in a spectrophotometric apparatus containing one or more than one primary calibration algorithm is also provided. Also provided is a method for selecting one or more than one substance as a quality control material for monitoring one or more than one primary calibration algorithm on a spectrophotometric apparatus. Also described is a quality control material for mimicking two or more than two analytes, containing one or more than one substance having a combined absorption spectrum exhibiting a negative slope for a continuous spectral segment of from about 5 nm to 400 nm in length, or a wavelength therebetween.

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.

Sample tab

The present invention provides a method for determining a concentration of at least one analyte in a sample contained in a blood bag or in tubing in fluid communication with said blood bag, using an instrument comprising at least one calibration algorithm for the at least one analyte. The method comprises irradiating a sample in the tubing or the blood bag, using a near infrared and adjacent visible radiation source. Then measuring absorbance from the sample for the at least one analyte, and calculating a concentration of the at least one analyte using the absorbance and the at least one calibration algorithm.

Method and apparatus for measuring analytes in blood bags

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.

Method for monitoring degradation of Hb-based blood substitutes

The present invention provides a photometric reference member comprising PTFE and glass. The member exhibits an absorbance change of less than 0.0001 absorbance units per degree C. over a range of temperatures, preferably from about 20&#xb0; C. to about 40&#xb0; C., and over wavelengths from about 600 nm to about 1650 nm, preferably about 600 nm to about 1050 nm. The invention also pertains to methods of using the photometric reference member to correct for temperature variations or drift in absorbance measurements.

Device for reference measurement and photometric correction in non-invasive glucose measurement using near infrared spectroscopy

A sample lab for retaining a sample during spectrophorometric analysis includes a base plate, a sample well, and a cover plate. The sample tab may also include one, or more than one overflow opening for draining excess sample, and an overflow channel to retain the excess sample.

The present invention provides a method of monitoring calibration of a spectrophotometric apparatus that comprises one or more calibration algorithms for one or more analytes. This method comprises measuring absorbance of a quality control material with the apparatus to obtain a measurement, where the quality control material exhibits an absorbance spectra characterized as having a negative slope for a continuous spectral segment from about 5 nm to about 200 nm in length, and where the spectral segment includes a principal calibration wavelength for the one or more analytes. The method then involves calculating on or more concentration values from the measurement using the one or more calibration algorithms, followed by comparing the one or more concentration values with an assigned value given to the quality control material for each of the one or more analytes, and determining if there is a violation of a pre-established quality control rule. In this way one or more calibration algorithms of the apparatus may be monitored. A reagentless method for determining the concentration of one or more analytes in a sample in a spectrophotometric apparatus comprising at least one primary calibration algorithm is also disclosed. The present invention also provides to a method for selecting one or more substances as a quality control material for monitoring at least one primary calibration algorithm on a spectrophotometric apparatus. The present invention includes a quality control material for mimicking two or more analytes comprising, one or more substances having a combined absorption spectrum exhibiting a negative slope for a continuous spectral segment from about 5 nm to 200 nm in length, in a portion of an absorption spectrum, including one or more principal calibration wavelengths, for the two or more analytes.

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.

Method for calibrating spectrophotometric apparatus

The invention provides a method of monitoring calibration of a spectrophotometric apparatus including one or more calibration algorithms for one or more analytes. This method includes measuring absorbance of a quality control material with the apparatus to obtain a measurement, where the quality control material exhibits an absorbance spectra having a negative slope for a continuous spectral segment from about 5 nm to about 200 nm in length, and where the spectral segment includes a principal calibration wavelength for the one or more analytes. The method then involves calculating one or more concentration values from the measurement using the one or more calibration algorithms, followed by comparing the one or more concentration values with an assigned value given to the quality control material for each of the one or more analytes, and determining if there is a violation of a pre-established quality control rule. In this way one or more calibration algorithms of the apparatus may be monitored.

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Cambridge, Canada

James Samsoondar