Automated blood analyzer

• US 9,002,657 B2
• Filed: 03/09/2012
• Issued: 04/07/2015
• Est. Priority Date: 10/17/2011
• Status: Active Grant

• Current Assignee: Daxor Corp.
• Original Assignee: Daxor Corp.
• Inventors: Feldschuh, Joseph, Feldschuh, Jonathan
• Primary Examiner(s): BORIN, MICHAEL L
• Application Number:
  US13/416,909
• Publication Number:
  US 20130096846A1
• Time in Patent Office: 1,124 Days
• US Class Current: 702/19
• CPC Class Codes: A61B 5/02755 Radioactive tracers
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 2333/76 Assays involving albumins other than in routine use for blocking surfaces or for anchoring haptens during immunisation
• CPC Class Codes: G01N 33/6827 Total protein determination, e.g. albumin in urine
• CPC Class Codes: G16B 25/10 Gene or protein expression profiling; Expression-ratio estimation or normalisation
• CPC Class Codes: G16B 99/00 Subject matter not provided for in other groups of this subclass

Abstract

A computer-based method for automatically determining total body albumin of a living being based on the calculated intravascular albumin, the calculated observed ratio of amount of albumin in the intravascular system to amount of albumin in the extravascular system at the first time, and the baseline of expected ratio of amount of albumin in the intravascular system to amount of albumin in the extravascular system at the first time.

Claims

1. A computer-based method for automatically analyzing blood of a human subject comprising the steps of:

injecting radio-labeled albumin into the bloodstream of the human subject;

collecting blood samples from the human subject over a time period after injection;

gathering data related to a number of counts of radio-labeled albumin within each sample;

calculating, using one or more processors, a set of data points representing blood volume of the human subject at one or more points in time after the human subject is injected with radio-labeled albumin based on detected counts of the radio-labeled albumin at the one or more points in time;

performing, using one or more processors, a first regression analysis on the set of data points using all of the one or more data points and one or more second regression analyses on the set of data points with each second regression analysis calculated with a different data point removed, each of the first and second regression analyses comprising calculation of r-squared, residual standard error and slope values; and

selecting, using one or more processors, based on the calculated r-squared, residual standard error and slope values of the first and second regression analyses which of the first and second regression analyses to use in further analysis of the blood of the human subject,

wherein the further analysis comprises determining total body albumin of the human subject, and the method further comprises;

determining a baseline of expected ratio of amount of albumin in an intravascular system of the human subject to amount of albumin in an extravascular system of the human subject, wherein the baseline is a baseline curve based on a locally weighted scatterplot smoothing analysis of ratios of count values of radio-labeled albumin over a period of time after the radio-labeled albumin is initially injected into a control group of human subjects to count values of radio-labeled albumin at a time when the radio-labeled albumin is initially injected into the control group of human subjects;

determining albumin concentration of the human subject;

calculating, using one or more processors, plasma volume of the human subject based on detected counts of radio-labeled albumin injected into the human subject;

calculating, using one or more processors, an amount of intravascular albumin within the human subject based on the calculated plasma volume and the determined albumin concentration;

calculating, using one or more processors, an observed ratio of amount of albumin in the intravascular system of the human subject to amount of albumin in the extravascular system of the human subject at a first time after injecting the radio-labeled albumin into the human subject; and

calculating, using one or more processors, the total body albumin of the human subject based on the calculated intravascular albumin, the calculated observed ratio of amount of albumin in the intravascular system to amount of albumin in the extravascular system at the first time, and the baseline of expected ratio of amount of albumin in the intravascular system to amount of albumin in the extravascular system at the first time, wherein the calculated observed ratio is known to exhibit a consistent deviation from the baseline, and wherein the step of calculating the total body albumin is performed before rate of loss of albumin in the intravascular system of the human subject to the extravascular system of the human subject is stabilized.

2. The computer-based method of claim 1, wherein the step of selecting comprises determining which of the first and second regression analyses have a combination of the highest r-squared value, the lowest residual standard error value, a slope value within an acceptable slope value range and a residual standard error value within an acceptable residual standard error range.

3. The computer-based method of claim 2, wherein the acceptable slope value range is 0% to 0.06%.

4. The computer-based method of claim 2, wherein the acceptable residual standard error range is less than 2.5%.