Automated method for detecting, quantifying and monitoring exogenous hemoglobin in whole blood, plasma and serum
First Claim
1. A method for the determination, quantification and monitoring of extracellular hemoglobin in a whole blood, plasma or serum sample performed on an automated hematology analyzer having at least two analytic channels for hemoglobin measurement, comprising:
- (a) determining total hemoglobin concentration in an aliquot of the sample in a hemoglobin analytic channel of the analyzer;
(b) determining cellular hemoglobin concentration in the sample aliquot in a red blood cell analytic channel of the analyzer; and
(c) calculating the difference between the total hemoglobin concentration determined from the hemoglobin analytic channel and the cellular hemoglobin concentration determined from the red blood cell analytic channel of the analyzer to yield the extracellular hemoglobin concentration in the whole blood, plasma, or serum sample.
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Abstract
The invention provides a new method and system for detecting and monitoring extracellular or exogenously added hemoglobin, i.e., a cell-free hemoglobin substitute or derivative, in a blood, plasma, or serum sample of an individual, particularly a whole blood sample. The invention further describes the use of automated hematology analyzers to determine and quantify at the same time the concentration of total, cellular and exogenous hemoglobin in a blood, plasma, or serum sample, and is particularly advantageous for medical use during or after patient trauma or surgery, as well as for monitoring hemoglobin levels during patient recovery.
27 Citations
31 Claims
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1. A method for the determination, quantification and monitoring of extracellular hemoglobin in a whole blood, plasma or serum sample performed on an automated hematology analyzer having at least two analytic channels for hemoglobin measurement, comprising:
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(a) determining total hemoglobin concentration in an aliquot of the sample in a hemoglobin analytic channel of the analyzer;
(b) determining cellular hemoglobin concentration in the sample aliquot in a red blood cell analytic channel of the analyzer; and
(c) calculating the difference between the total hemoglobin concentration determined from the hemoglobin analytic channel and the cellular hemoglobin concentration determined from the red blood cell analytic channel of the analyzer to yield the extracellular hemoglobin concentration in the whole blood, plasma, or serum sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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16. The method according to claim 1, wherein the extracellular hemoglobin in the sample is due to the presence of a cell-free hemoglobin product or an oxygen-carrying hemoglobin substitute in the blood, plasma or serum.
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17. The method according to claim 16, wherein the cell-free hemoglobin product or the oxygen-carrying hemoglobin substitute is selected from the group consisting of purified hemoglobin, recombinant hemoglobin, cross-linked hemoglobin, polymerized hemoglobin and hemoglobin coupled to polyethylene glycol (PEG-HGB).
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18. The method according to claim 17, wherein the purified hemoglobin is purified bovine hemoglobin or purified human hemoglobin.
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19. The method according to claim 17, wherein the recombinant hemoglobin is recombinant human hemoglobin.
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20. An automated method for the determination, quantification and monitoring of extracellular hemoglobin in a whole blood, plasma or serum sample performed on an automated hematology analyzer having at least two analytic channels for hemoglobin measurement, comprising:
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(a) determining total hemoglobin concentration in an aliquot of the whole blood, plasma, or serum sample in a hemoglobin analytic channel of the analyzer, wherein said hemoglobin analytic channel measures the total hemoglobin concentration in the sample by hemolysis and extraction of hemes from their biological complex with globin by forming a ligated ferric heme species capturable in a surfactant micelle, and further wherein the total hemoglobin concentration is determined from calorimetric absorbance in the hemoglobin analytic channel of the analyzer;
(b) determining cellular hemoglobin concentration in the sample aliquot in a red blood cell analytic channel of the analyzer, wherein the red blood cell analytic channel measures red cell concentration, red cell volume and hemoglobin concentration of individual red blood cells as they pass through two light scattering detectors virtually one cell at a time; and
(c) calculating the difference between the total hemoglobin concentration determined from the hemoglobin analytic channel and the cellular hemoglobin concentration determined from the red blood cell analytic channel of the analyzer to yield the extracellular hemoglobin concentration in the whole blood, plasma, or serum sample. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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Specification