公开(公告)号：US08133738B2

公开(公告)日：2012-03-13

申请号：US13116837

申请日：2011-05-26

申请人： Robert A. Levine ,  Stephen C. Wardlaw ,  Darryn Unfricht ,  Niten V. Lalpuria

发明人： Robert A. Levine ,  Stephen C. Wardlaw ,  Darryn Unfricht ,  Niten V. Lalpuria

IPC分类号： G01N33/48 ,  G01N33/86

CPC分类号： G01N33/80 ,  A61B5/145 ,  G01N15/1463 ,  G01N15/1475 ,  G01N33/48 ,  G01N33/49 ,  G01N33/721 ,  G01N33/86

摘要： A method for determining the hematocrit of a blood sample is provided that includes the steps of: 1) depositing the sample into an analysis chamber adapted to quiescently hold the sample for analysis, the chamber defined by the interior surfaces of first and second panels and a height extending there between, wherein both panels are transparent, and the height is such that at least some of the red blood cells within the sample contact both interior surfaces of the panels and one or more lacunae within the quiescent sample extend between the interior surfaces; 2) imaging at least a portion of the quiescent sample, which sample portion contains the red blood cells and one or more lacunae to determine an optical density of the imaged portion of the sample on a per image unit basis; 3) selecting and averaging the optical density values of the image units aligned with the red blood cells contacting the interior surfaces, and assigning an upper boundary value of 100% to the average optical density value of those image units; 4) selecting the optical density values of the image units aligned with the one or more lacunae, and assigning a lower boundary value of 0% to the optical density values of those image units; and 5) determining the hematocrit of the sample by assigning relative values to the optical density value of each image of the imaged sample portion as a function of the upper and lower boundary values, and averaging the relative values.

摘要翻译： 提供了一种用于确定血液样本的血细胞比容的方法，其包括以下步骤：1）将样品沉积到适于静态保持样品进行分析的分析室中，由第一和第二面板的内表面限定的腔室和 高度在其间延伸，其中两个面板是透明的，并且高度使得样品中的至少一些红细胞接触面板的两个内表面，并且静止样品内的一个或多个空隙在内表面之间延伸; 2）对静止样品的至少一部分进行成像，该样品部分包含红细胞和一个或多个空隙，以基于每个图像单位确定样品的成像部分的光密度; 3）选择和平均与内表面接触的红细胞对准的图像单元的光密度值，并将上限边界值分配给这些图像单元的平均光密度值; 4）选择与一个或多个空白对齐的图像单元的光密度值，并为这些图像单元的光密度值分配0％的下边界值; 以及5）通过将所述成像样本部分的每个图像的光密度值分配相对值作为上边界值和下边界值的函数来确定样本的血细胞比容，并平均相对值。

公开(公告)号：US20110256573A1

公开(公告)日：2011-10-20

申请号：US13051705

申请日：2011-03-18

申请人： Graham Davis ,  Stephen C. Wardlaw ,  Robert A. Levine ,  Darryn W. Unfricht ,  Niten Lalpuria ,  Paul G. Mitsis

发明人： Graham Davis ,  Stephen C. Wardlaw ,  Robert A. Levine ,  Darryn W. Unfricht ,  Niten Lalpuria ,  Paul G. Mitsis

IPC分类号： C12Q1/02 ,  C12M1/34

CPC分类号： G01N33/726 ,  G01N15/1475 ,  G01N2015/0073

摘要： A method and apparatus for determining at least one hemoglobin related parameter of a whole blood sample is provided. The method includes the steps of: a) depositing the sample into an analysis chamber adapted to quiescently hold the sample for analysis, the chamber defined by an interior surface of a first panel, and an interior surface of a second panel, and the chamber has a height extending between the interior surfaces of the panels, wherein the chamber is configured to increase the oxygenation state of the sample to a substantially oxygenated state within a predetermined amount of time after entry into the chamber; b) imaging the at least one red blood cell contacting the interior surfaces, and producing image signals; c) determining an optical density of at least a portion of the imaged red blood cell contacting both interior surfaces; and d) determining the at least one hemoglobin related parameter of the red blood cell contacting the interior surfaces, using the determined optical density and a molar extinction coefficient for oxygenated hemoglobin.

摘要翻译： 提供了一种用于确定全血样品的至少一种血红蛋白相关参数的方法和装置。 该方法包括以下步骤：a）将样品沉积到适于静态保持样品进行分析的分析室中，所述室由第一面板的内表面和第二面板的内表面限定，并且所述室具有 在所述面板的内表面之间延伸的高度，其中所述腔被配置为在进入所述腔室之后的预定量的时间内将所述样品的氧合状态增加到基本上氧合状态; b）对与内表面接触的至少一个红细胞进行成像，并产生图像信号; c）确定接触两个内表面的成像红细胞的至少一部分的光密度; 以及d）使用确定的光密度和氧合血红蛋白的摩尔消光系数来确定与内表面接触的红细胞的至少一种血红蛋白相关参数。

公开(公告)号：US20110230740A1

公开(公告)日：2011-09-22

申请号：US13116837

申请日：2011-05-26

申请人： Robert A. Levine ,  Stephen C. Wardlaw ,  Darryn W. Unfricht ,  Niten V. Lalpuria

发明人： Robert A. Levine ,  Stephen C. Wardlaw ,  Darryn W. Unfricht ,  Niten V. Lalpuria

IPC分类号： A61B5/1455

CPC分类号： G01N33/80 ,  A61B5/145 ,  G01N15/1463 ,  G01N15/1475 ,  G01N33/48 ,  G01N33/49 ,  G01N33/721 ,  G01N33/86

摘要： A method for determining the hematocrit of a blood sample is provided that includes the steps of: 1) depositing the sample into an analysis chamber adapted to quiescently hold the sample for analysis, the chamber defined by the interior surfaces of first and second panels and a height extending there between, wherein both panels are transparent, and the height is such that at least some of the red blood cells within the sample contact both interior surfaces of the panels and one or more lacunae within the quiescent sample extend between the interior surfaces; 2) imaging at least a portion of the quiescent sample, which sample portion contains the red blood cells and one or more lacunae to determine an optical density of the imaged portion of the sample on a per image unit basis; 3) selecting and averaging the optical density values of the image units aligned with the red blood cells contacting the interior surfaces, and assigning an upper boundary value of 100% to the average optical density value of those image units; 4) selecting the optical density values of the image units aligned with the one or more lacunae, and assigning a lower boundary value of 0% to the optical density values of those image units; and 5) determining the hematocrit of the sample by assigning relative values to the optical density value of each image of the imaged sample portion as a function of the upper and lower boundary values, and averaging the relative values.

摘要翻译： 提供了一种用于确定血液样本的血细胞比容的方法，其包括以下步骤：1）将样品沉积到适于静态保持样品进行分析的分析室中，由第一和第二面板的内表面限定的腔室和 高度在其间延伸，其中两个面板是透明的，并且高度使得样品中的至少一些红细胞接触面板的两个内表面，并且静止样品内的一个或多个空隙在内表面之间延伸; 2）对静止样品的至少一部分进行成像，该样品部分包含红细胞和一个或多个空隙，以基于每个图像单位确定样品的成像部分的光密度; 3）选择和平均与内表面接触的红细胞对准的图像单元的光密度值，并将上限边界值分配给这些图像单元的平均光密度值; 4）选择与一个或多个空白对齐的图像单元的光密度值，并为这些图像单元的光密度值分配0％的下边界值; 以及5）通过将所述成像样本部分的每个图像的光密度值分配相对值作为上边界值和下边界值的函数来确定样本的血细胞比容，并平均相对值。

公开(公告)号：US20110201045A1

公开(公告)日：2011-08-18

申请号：US13016347

申请日：2011-01-28

申请人： Joshua D. Levine ,  Robert A. Levine ,  Stephen C. Wardlaw ,  Craig Stout ,  David A. Clipper

发明人： Joshua D. Levine ,  Robert A. Levine ,  Stephen C. Wardlaw ,  Craig Stout ,  David A. Clipper

IPC分类号： C12Q1/02 ,  C12M1/34

CPC分类号： G01N33/491 ,  B01L3/50215 ,  B01L9/065 ,  B01L2300/027 ,  B01L2300/0609 ,  B01L2300/0654 ,  B01L2300/0838 ,  G01N15/042 ,  G01N15/05 ,  G01N2015/045 ,  G01N2800/22 ,  G06T7/0012 ,  G06T2207/30024

摘要： A method and device for analyzing a hematologic sample centrifuged within a capillary tube is provided. The device includes a tube holder, a sample imaging device, a processor, and a sample data display. The sample imaging device is operable to create a digital image of the sample within a region of the tube. The region is defined by substantially all of the radial width and axial length of the sample residing within the internal cavity of the tube in the region where the float resides after centrifugation. The sample imaging device is operable to produce signals representative of the image. The processor is adapted to produce information relating to bands of interest within the image based on the signals from the sample imaging device. The sample data display is adapted to display the results therefrom and/or a digital image of the sample within the region.

摘要翻译： 提供了用于分析在毛细管内离心的血液样品的方法和装置。 该装置包括管座，样品成像装置，处理器和样品数据显示器。 样品成​​像装置可操作以在管的区域内产生样品的数字图像。 该区域由离心后浮子所在的区域中位于管内腔中的样品的基本上所有的径向宽度和轴向长度限定。 样品成​​像装置可操作以产生表示图像的信号。 处理器适于基于来自样本成像装置的信号产生与图像内的感兴趣的频带相关的信息。 样本数据显示器适于在该区域内显示样本的结果和/或数字图像。

公开(公告)号：US20090251683A1

公开(公告)日：2009-10-08

申请号：US12417246

申请日：2009-04-02

申请人： Stephen C. Wardlaw ,  Robert A. Levine

发明人： Stephen C. Wardlaw ,  Robert A. Levine

IPC分类号： G01N33/48

CPC分类号： G01N33/48 ,  G01N21/6428 ,  G01N33/5304 ,  G01N33/54373 ,  G01N33/54386

摘要： Detection and characterization of immunologically detected substances are performed electronically on human and animal biological fluids such as whole blood, serum, plasma, urine, milk, pleural and peritoneal fluids, and semen, which fluids are contained in a thin chamber forming a quiescent fluid sample, which chamber has at least two parallel planar walls, at least one of which is transparent.

摘要翻译： 免疫检测物质的检测和表征以人和动物生物流体如全血，血清，血浆，尿，牛奶，胸膜和腹膜液以及精液电子方式进行，这些流体包含在形成静态流体样品的薄室中 该室具有至少两个平行的平面壁，其中至少一个是透明的。

公开(公告)号：US20090162940A1

公开(公告)日：2009-06-25

申请号：US11569640

申请日：2005-05-17

申请人： Stephen C. Wardlaw ,  Robert A. Levine

发明人： Stephen C. Wardlaw ,  Robert A. Levine

IPC分类号： G01N1/10 ,  B01L3/00

CPC分类号： B01L3/5021 ,  A61B5/150022 ,  A61B5/150213 ,  A61B5/150343 ,  A61B5/150351 ,  A61B5/150755 ,  B01L2300/0838 ,  B01L2400/0406 ,  Y10T436/2575

摘要： A method and apparatus for analyzing a fluid sample. More particularly, this relates to a specimen analysis tube (2) for containing the specimen (12) sample and to a method of drawing the specimen sample (12) into the tube (2) by capillary action. When the sample (12) is drawn into the tube (2), air is expelled from the tube (2) in the direction which is counter to the flow of the sample (12) into the tube (2). The tube (2) can be U-shaped or it can be linear and can be disposed in a closed-ended holder (22) that is operative to vent air from the tube (2) in a direction which is counter to the direction of flow of the sample into the tube (2).

摘要翻译： 一种用于分析流体样品的方法和装置。 更具体地，涉及用于容纳样本（12）样本的样本分析管（2）和通过毛细管作用将样本样品（12）拉入管（2）的方法。 当样品（12）被吸入管（2）中时，空气从与样品（12）的流动相反的方向从管（2）排出到管（2）中。 管（2）可以是U形的，或者它可以是线性的，并且可以设置在闭合端的保持器（22）中，该保持器可操作以沿着与管（2）的方向相反的方向从管（2）排出空气 样品流入管（2）。

公开(公告)号：US06448088B1

公开(公告)日：2002-09-10

申请号：US09317818

申请日：1999-05-25

申请人： Robert A. Levine ,  Stephen C. Wardlaw

发明人： Robert A. Levine ,  Stephen C. Wardlaw

IPC分类号： G01N2101

CPC分类号： G01N33/523 ,  B01L3/5027 ,  B01L3/50273 ,  B01L2300/0663 ,  B01L2300/0816 ,  B01L2300/0864 ,  B01L2300/0887 ,  B01L2400/0481 ,  B01L2400/0611 ,  G01N33/493 ,  G01N33/5002 ,  Y10S436/808 ,  Y10S436/809 ,  Y10T436/25125 ,  Y10T436/25375

摘要： A urine sample is analyzed for urine chemistry, formed bodies, and rare event evidence, all in a single sample container and under low power magnification. The sample container includes a urine sample receiving chamber which is connected to a urine chemistry chamber, to a formed body isolation chamber, and to a rare events detection chamber, so that the urine can flow from the receiving chamber to the other three chambers. The scanning instrument will scan the isolation chamber and can identify formed bodies by their characteristic light wave emission properties which result from the formed bodies exposure to the stains. The formed bodies can also be morphologically examined in the isolation chamber. The rare event detection chamber will include a component which will absorb essentially all of the water in the urine thus concentrating formed bodies on a surface in the chamber. This chamber can also be provided with one or more stains which will differentially highlight any rare events noted in the chamber by the scanning instrument. Rare events such as casts can be detected in this chamber.

摘要翻译： 分析尿液样品的尿液化学成分，成形体和罕见的事件证据，全部在单个样品容器中，在低功率放大下。 样品容器包括尿液接收室，尿液接收室连接到尿化学室，形成体隔离室，并且与稀有事件检测室相连，使得尿液可以从接收室流到另外的三个室。 扫描仪器将扫描隔离室，并且可以通过其形成的物体暴露于污渍产生的特征性光波发射特性来识别成形体。 成型体也可以在隔离室中进行形态学检查。 罕见事件检测室将包括将吸收尿液中基本上所有的水的成分，从而将成形体集中在腔室的表面上。 该室还可以具有一个或多个污渍，其将通过扫描仪器差异地突出腔室中注明的罕见事件。 在这个房间里可以检测到诸如铸件的罕见事件。

公开(公告)号：US5705739A

公开(公告)日：1998-01-06

申请号：US703509

申请日：1996-08-27

申请人： Robert A. Levine ,  Stephen C. Wardlaw

发明人： Robert A. Levine ,  Stephen C. Wardlaw

IPC分类号： G01N15/04 ,  G01N33/49 ,  G01N30/00

CPC分类号： G01N15/042 ,  G01N33/491 ,  Y10T436/25375

摘要： In most mammals studied, a histogram of the erythrocytes' density of a healthy individual normally has a Gaussian distribution. Gaussian or near-Gaussian distributions may be characterized by their mean, by their standard deviation, and their absence of skewness. A measurement of the erythrocyte density distribution (EDD) in mammalian whole blood which has been anticoagulated with heparin can yield information which is indicative of certain physiologic and pathophysiologic conditions that are characterized by various EDD abnormalities. These abnormalities may include abnormalities in the standard deviation of the EDD; the mean erythrocyte density; and any skewness of the EDD curve. The hematocrit or percent packed red cell volume, which is obtained at the same time as the EDD can also yield information. The EDD measurement is made by providing a sample of heparin anticoagulated whole mammalian blood to which is added a plurality of density markers having known individual specific gravities that are within the range of specific gravity values of mammalian erythrocytes. The blood sample-density marker mixture is centrifuged, and measurements are taken of the location of the density markers within the centrifuged erythrocyte cell pack. These measurements are analyzed to determine the standard deviation of the EDD in the sample; the mean erythrocyte density in the sample; the hematocrit value of the sample; and any skewness in the EDD curve in the sample. The resultant data is compared to empirical data obtained from patient populations with known normal and abnormal medical histories in order to determine whether there is any variation from norm of one or more of the parameters measured which are characteristic of abnormal medical conditions. Alternatively since an erythrocyte's hemoglobin concentration (HC) is the main determinant of an ethrocyte's density, HC measured on a cell counter that determines each erythrocyte's HC may be used as a surrogate for erythrocyte density. Suitable cell counters can also derive HCT from a blood sample.

公开(公告)号：US5635362A

公开(公告)日：1997-06-03

申请号：US247336

申请日：1994-05-23

申请人： Robert A. Levine ,  Stephen C. Wardlaw ,  Rodolfo R. Rodriguez ,  Adrien P. Malick ,  Alvydas J. Ozinskas

发明人： Robert A. Levine ,  Stephen C. Wardlaw ,  Rodolfo R. Rodriguez ,  Adrien P. Malick ,  Alvydas J. Ozinskas

IPC分类号： G01N33/543 ,  B01L3/14 ,  G01N33/49 ,  G01N33/537 ,  G01N33/569 ,  G01N33/58 ,  G01N33/558

CPC分类号： B01L3/5021 ,  G01N33/491 ,  G01N33/5375 ,  G01N33/56972 ,  G01N33/585 ,  Y10S435/81 ,  Y10S435/967 ,  Y10S435/971 ,  Y10S435/973 ,  Y10S436/805 ,  Y10S436/81 ,  Y10S436/824 ,  Y10S436/829 ,  Y10T436/111666

摘要： A patient's health may be diagnosed by centrifuging blood samples in a transparent tube, which tube contains one or more bodies or groups of bodies such as floats, inserts, liposomes, or plastic beads of different densities. Each density-defined body carries analyte-capture binding materials such as antigens or antibodies, which are specific to an epitope, or other specific high affinity binding site on a target analyte which target analyte may be in the blood or other sample being tested; and the level of which analyte is indicative of the patient's health. At least one labeled binding material which is also specific to an epitope, or other specific high affinity binding site on the target analyte is added to the sample so as to form labeled binding material/analyte/body complexes in the sample. Upon centrifugation, the complexes will settle out in different areas in the tube according to the respective density of the body or bodies; and the degree of label emission of the complex layers can enable qualitative and/or quantitative analyses of the sample to be made. Unbound labeled binding materials will be separated from the complexed layers by the washing action of ascending or descending components of the sample during the centrifugation step. Unbound labeled binding material will thus not interfere with the analysis.

摘要翻译： 可以通过将透明管中的血液样品离心来诊断患者的健康，该管包含一个或多个不同密度的浮体，插入物，脂质体或塑料珠的主体或组。 每个密度定义的身体携带分析物 - 捕获结合材料，例如抗原或抗体，其对靶分析物是特异性的，或靶分析物上的其它特异性高亲和力结合位点，其目标分析物可能在待测试的血液或其他样品中; 并且其分析物的水平表示患者的健康。 将至少一种对靶分析物上的表位或其他特异性高亲和力结合位点特异性的标记结合物质加入到样品中，以便在样品中形成标记的结合材料/分析物/身体复合物。 离心后，复合物将根据身体或身体的相应密度沉淀在管中的不同区域; 并且复合层的标签发射程度可以使得要进行样品的定性和/或定量分析。 通过在离心步骤期间样品的上升或下降组分的洗涤作用，未结合的标记结合材料将从复合层分离。 因此，未结合的标签结合材料不会影响分析。

公开(公告)号：US5460979A

公开(公告)日：1995-10-24

申请号：US192629

申请日：1994-02-07

申请人： Robert A. Levine ,  Stephen C. Wardlaw ,  Leon W. M. M. Terstappen ,  Thomas J. Mercolino ,  Diether J. Recktenwald

发明人： Robert A. Levine ,  Stephen C. Wardlaw ,  Leon W. M. M. Terstappen ,  Thomas J. Mercolino ,  Diether J. Recktenwald

IPC分类号： G01N33/543 ,  B01L3/14 ,  G01N33/49 ,  G01N33/537 ,  G01N33/569 ,  G01N33/58 ,  G01N33/538 ,  G01N33/546

CPC分类号： B01L3/5021 ,  G01N33/491 ,  G01N33/5375 ,  G01N33/56972 ,  G01N33/585 ,  Y10S435/81 ,  Y10S435/967 ,  Y10S435/971 ,  Y10S435/973 ,  Y10S436/805 ,  Y10S436/81 ,  Y10S436/824 ,  Y10S436/829 ,  Y10T436/111666

摘要： A patient's health is diagnosed by centrifuging blood samples in a transparent tube, which tube contains one or more groups of particles such as lyposomes or plastic beads of different densities for each group. Each group of density-defined particles carries antigens or antibodies which are specific to a complement antigen or antibody which may be in the blood sample being tested, and which are indicative of the patient's health. A label-tagged antibody which is specific to all bound antibody/antigen couples is added to the blood sample so as to form labelled antibody+antigen-antibody complexes (AAAC) in the blood sample. Upon centrifugation, the complexed particles will settle out in different areas in the tube according to the respective density of the particles, and the degree of label emission of the particle layers can enable qualitative or quantitative analyses of the blood sample to be made. Unbound labelled antibodies will be washed away from the complexed layers by the washing action of the descending blood cells during the centrifugation step. Unbound labelled antibodies will thus not interfere with the analysis.

摘要翻译： 通过在透明管中离心血液样品来诊断患者的健康，该管含有一组或多组颗粒，例如每组的不同密度的溶血细胞或塑料珠。 每组密度定义的颗粒携带对可能在被测试的血液样品中的补体抗原或抗体特异性的抗原或抗体，并且其表示患者的健康。 向血液样品中加入对所有结合的抗体/抗原对特异性的标记标签抗体，以在血液样品中形成标记抗体+抗原 - 抗体复合物（AAAC）。 离心后，根据颗粒的相应密度，络合的颗粒将沉淀在管中的不同区域中，并且颗粒层的标签发射程度可以使得要进行血液样品的定性或定量分析。 在离心步骤中，未结合的标记抗体将通过下降血细胞的洗涤作用从复合层中洗去。 因此，未结合的标记抗体不会干扰分析。