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  Patient sample classification based upon low angle light scatteringUSPTO Application #: 20070054405Title: Patient sample classification based upon low angle light scattering Abstract: An apparatus for classifying a liquid patient sample includes at least one sample container having a quantity of a sample that is aggressively acted upon so as to create a flow field. A measurement mechanism includes at least one low angle light emitter aligned with a measurement window of the at least one sample container and a detector oppositely disposed relative to the measurement window. Measurement of the scattered light detects particle characteristics of a moving flow field from the sample to determine, for example, the amount of agglutination of the sample so as to perform blood typing or other classifications without spatial separation. (end of abstract) Agent: Wall Marjama & Bilinski - Syracuse, NY, US Inventors: Merrit N. Jacobs, Michael W. Sundberg, Zhong Ding USPTO Applicaton #: 20070054405 - Class: 436069000 (USPTO) Related Patent Categories: Chemistry: Analytical And Immunological Testing, Clotting Or Clotting Factor Level Tests The Patent Description & Claims data below is from USPTO Patent Application 20070054405. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS REFERENCE TO RELATED APPLICATION [0001] This application is based upon a provisional application, U.S. Ser. No. 60/513,753 filed Oct. 23, 2003, the entire contents of which are incorporated herein by reference. FIELD OF THE INVENTION [0002] The invention is directed to the field of clinical chemistry and more particularly to apparatus and a related method for blood typing patient samples. BACKGROUND OF THE INVENTION [0003] Currently known column blood-typing systems, including, for example, the AutoVue systems manufactured by Ortho Clinical Diagnostics Inc., of Raritan, N.J., among others, were originally optimized for manual testing. As a consequence, a number of characteristics of the systems, while supporting the manual determination of a positive reaction, do not support facile automation. [0004] First, agglutination strength is determined in a manner that is optimized for a subjective visual read. This determination is based upon a perceived distribution of red color from red blood cells, RBCs, in an elongated column, with an agglutinated sample being characterized by red color that is distributed above the bottom of the column, with a non-agglutinated sample having red color localized at the bottom thereof. [0005] Automated reading of the distribution of red color is complex and requires a vision system that is coupled with relatively sophisticated software algorithms in order to appropriately classify the wide range of color distribution patterns that can be encountered. Such a technique is described, for example, in U.S. Pat. Nos. 5,594,808 and 5,768,407. [0006] In these systems, a centrifugation step of relatively long duration (e.g., approximately 15 to 20 minutes) is typically required in order to achieve a necessary spatial separation of the agglutinated from the unagglutinated cells, including both incubation and centrifugation times. [0007] Analysis of agglutination patterns however, is often an urgent procedure, for example in the case of injury, and the elimination of time in the blood typing process is therefore highly significant and greatly desired in the field. [0008] A technique that permits agglutination to be detected without centrifugation has been more recently described by Applicants' in U.S. Publication Nos. US 2002/0076826 and US 2002/0081747, each of which is incorporated by reference in its entirety. This technique defines apparatus and a method for aspirating within a probe tip and is defined such that most of the liquid is forced to move past a defined transition zone between two different inside diameters of the tip to cause rotational mixing of the liquid. This method is useful in providing agglutination of blood, which can then in turn be used in blood typing. The classification and determination of agglutination strength, however, regardless of the technique used to cause separation, is the same as described above, e.g., thereby requiring spatial separation of the agglutinated/unagglutinated cells. SUMMARY OF THE INVENTION [0009] It is therefore a primary object of the present invention to alleviate or substantially minimize the above-noted deficiencies of the prior art. [0010] It is another primary object of the present invention to provide a blood typing methodology that is more efficient in terms of time and accuracy than any previously known typing technique. [0011] It is yet another primary object of the present invention to provide an agglutination reaction detection system and a related method that is not solely dependent upon spatial separation in order to be able to detect the amount of agglutination of a sample liquid. [0012] Therefore and according to a preferred aspect of the present invention, there is described a method of classifying a patient sample, said method including the steps of: [0013] providing a mixture of a blood sample and an agglutination reagent into the confines of a sample container; [0014] moving the mixture within the sample container such that an agglutination reaction occurs and that the agglutinated cells are moved as a flow field past a measurement window of the sample container; [0015] aiming a light source into the sample container and probing the flow field with the light beam; and [0016] detecting the number and size of particles in the light beam to determine the amount of agglutination of said sample. [0017] According to one technique, the mixture is moved by means of a vertical (e.g., up and down) movement of the sample within a reaction vessel serving as the sample container in order to mix the sample and to move the agglutinated cells through at least one defined transition zone of the vessel, the transition zone having a smaller inside diameter than the adjacent portion through which the sample is moved under the force of gravity. In this manner, agglutinated material is separated from non-agglutinated material. [0018] According to another technique, the sample container can be centrifuged using at least one fluid having a viscosity and specific gravity that effectively excludes the sample prior to centrifugation, but which allows the particles to enter when the centrifugal force is applied, while excluding small molecules and controlling the rate at which the material moves within the fluid under the centrifugal field. [0019] According to the present technique, a cloud of cells are formed in the sample container. A low-angle particle measurement system comprising at least one light emitter and at least one light detector is used to detect the agglutination in the cloud of cells at specified times after initiating the reaction. [0020] Preferably, the sample container is elongated in configuration and includes a flat planar wall defining the measurement window for permitting the light beam to be effectively scattered by the particles contained in the moving flow field. According to another preferred aspect of the invention, there is described an apparatus for classifying a patient sample, said apparatus including: Continue reading... 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