公开(公告)号：US12123875B2

公开(公告)日：2024-10-22

申请号：US17840557

申请日：2022-06-14

申请人： ORTHO-CLINICAL DIAGNOSTICS, INC.

发明人： Brett Hirsch ,  Jian Zheng ,  Stephen Daggett

IPC分类号： G01N33/566 ,  C07K7/08

CPC分类号： G01N33/566 ,  C07K7/08 ,  G01N2333/165 ,  G01N2333/58 ,  G01N2333/635

摘要： An antigen with an increased half-life is provided for the formulation of more stable and consistent clinical diagnostic immunoassay controls and calibrators. An antigen analogue comprises a first and a second polypeptide which is identical or similar to corresponding terminal amino acid sequences of an antigen. The first and second polypeptides are connected with a PEG chain. Also provided are methods of calibrating assays using a compound disclosed herein.

公开(公告)号：US11867634B2

公开(公告)日：2024-01-09

申请号：US17127027

申请日：2020-12-18

申请人： Ortho-Clinical Diagnostics, Inc.

发明人： Qi Sun ,  Jian Zheng ,  Stephen Daggett

IPC分类号： G01N21/77 ,  G01N33/72 ,  G02B5/08 ,  H04N23/56

CPC分类号： G01N21/77 ,  G01N33/726 ,  G01N33/728 ,  G02B5/0833 ,  H04N23/56

摘要： The present disclosure is directed to a thin-film element that enables analytes to be analyzed on separate surfaces. In an example, a thin-film element includes a first layer for processing a fluid sample to generate a first analyte and a second analyte. The thin-film element also includes a second layer configured to be impermeable to the first analyte to enable the first analyte to be retained by the first layer and permeable to the second analyte to enable the second analyte to pass through the second layer. The thin-film element further includes a third layer configured to retain the second analyte. The second layer includes a first reflective surface and a second reflective surface to provide reflectance signals indicative of analytes present in the first and third layers to sensors located on opposite sides of the thin-film element.

公开(公告)号：US20240001358A1

公开(公告)日：2024-01-04

申请号：US17585914

申请日：2022-01-27

申请人： Ortho-Clinical Diagnostics, Inc. ,  The Research Foundation for the State University of New York ,  University of Rochester

发明人： Raymond F. Jakubowicz ,  Harold Warren ,  Benjamin Miller ,  Michael Bryan ,  Daniel Steiner ,  John Cognetti ,  Nathaniel Cady ,  Minhaz Abedin ,  Natalya Tokranova

IPC分类号： B01L3/00 ,  G02B6/42 ,  G02B6/293

CPC分类号： B01L3/502715 ,  G02B6/4215 ,  G02B6/29305 ,  G02B6/4262 ,  B01L2300/0654 ,  B01L2300/0816

摘要： An apparatus, methods, and a system for a photonic biosensor are disclosed. The photonic biosensor includes a substrate having a sample addition zone in fluid communication with a wicking zone and a sample detection zone. The substrate also includes an optical input port configured to optically couple to a light source and an optical output port configured to optically couple to a light detector. The photonic biosensor also includes a photonic integrated circuit (“PIC”) connected to the substrate. The PIC includes a first grating coupler aligned with the optical input port, a second grating coupler aligned with the optical output port, at least one waveguide between the first grating coupler and the second grating coupler, and at least one detection element disposed within the at least one waveguide.

公开(公告)号：US20220178914A1

公开(公告)日：2022-06-09

申请号：US17539903

申请日：2021-12-01

申请人： Ortho-Clinical Diagnostics, Inc.

发明人： Brett Hirsch ,  Paul Contestable

IPC分类号： G01N33/53 ,  G01N33/569

摘要： Described herein are blocking agents that can be used in diagnostic assays to prevent false positive results.

公开(公告)号：US20210190696A1

公开(公告)日：2021-06-24

申请号：US17127027

申请日：2020-12-18

申请人： Ortho-Clinical Diagnostics, Inc.

发明人： Qi Sun ,  Jian Zheng ,  Stephen Daggett

IPC分类号： G01N21/77 ,  H04N5/225 ,  G02B5/08 ,  G01N33/72

摘要： The present disclosure is directed to a thin-film element that enables analytes to be analyzed on separate surfaces. In an example, a thin-film element includes a first layer for processing a fluid sample to generate a first analyte and a second analyte. The thin-film element also includes a second layer configured to be impermeable to the first analyte to enable the first analyte to be retained by the first layer and permeable to the second analyte to enable the second analyte to pass through the second layer. The thin-film element further includes a third layer configured to retain the second analyte. The second layer includes a first reflective surface and a second reflective surface to provide reflectance signals indicative of analytes present in the first and third layers to sensors located on opposite sides of the thin-film element.

公开(公告)号：US11035783B2

公开(公告)日：2021-06-15

申请号：US15889765

申请日：2018-02-06

申请人： ORTHO-CLINICAL DIAGNOSTICS, INC.

发明人： David A. Heavner

IPC分类号： G01N21/27 ,  G01N21/64 ,  G01J3/44 ,  G01N35/00

摘要： A method to normalize at least one of a population of subordinate clinical diagnostic analyzer to a master clinical diagnostic analyzer such that an assay result from a subordinate clinical diagnostic analyzer can be converted to the equivalent result of the master clinical diagnostic analyzer by using a simple multiplicative factor when the assay executed on each analyzer uses a common fluorescently labeled dye. Also a method to re-normalize a subordinate clinical diagnostic analyzer assay result to a master clinical diagnostic analyzer assay result by using a simple multiplicative factor when the assay executed on the subordinate clinical diagnostic analyzer uses a different fluorescently labeled dye than the assay executed on the master clinical diagnostic analyzer.

公开(公告)号：US11026611B2

公开(公告)日：2021-06-08

申请号：US15686241

申请日：2017-08-25

申请人： ORTHO-CLINICAL DIAGNOSTICS, INC.

发明人： Kory A. Gunnerson ,  Raymond F. Jakubowicz ,  Andrew M. Kirsch ,  James Ellis Robinson ,  Daniel P. Salotto ,  David A. Tomasso ,  Zhong Ding ,  William Franklin Gottermeier ,  Aaron Michael Swick

IPC分类号： A61B5/15 ,  B01L3/00 ,  G01N33/49 ,  A61B5/145 ,  A61B5/1468 ,  A61B5/157 ,  A61B10/00

摘要： A sample collection device for a fluid includes: a substantially disk-shaped body having a periphery; a capillary channel extending through the body and bounded by the periphery, having a first end and a second end, wherein the first end is adapted to draw the fluid into the channel by capillary action; a sample collection well located in the vicinity of the second end and in fluid communication with the capillary channel; and an axis of rotation extending through the center of the disk and which is substantially perpendicular to the major surface of the disk-shaped body. In a preferred embodiment, the sample collection device is adapted to rotate about the axis of rotation within a cartridge having a housing comprising an air vent in fluid communication with the capillary channel when the disk is rotated in a first position.

公开(公告)号：US10125177B2

公开(公告)日：2018-11-13

申请号：US15865594

申请日：2018-01-09

申请人： Ortho-Clinical Diagnostics, Inc.

发明人： Jian Zheng ,  Renee Yura ,  Jianping Yang

IPC分类号： C07K14/20 ,  G01N33/571 ,  G01N33/569

摘要： A Treponema pallidum triplet antigen construct is disclosed which includes three Treponema pallidum antigens (TP15, TP17, and TP47), as well as a ten amino acid leader sequence (tag 261) and human copper zinc superoxide dismutase (hSOD). This construct is optimized for in vitro diagnosis of syphilis infection. Plasmids containing DNA encoding the triplet antigen, host cells, production methods, detection methods, and kits are also disclosed.

公开(公告)号：US10082502B2

公开(公告)日：2018-09-25

申请号：US15016585

申请日：2016-02-05

申请人： Ortho-Clinical Diagnostics, Inc.

发明人： James D. Kanaley ,  Zhong Ding ,  Philip C. Hosimer ,  Edward R. Scalice ,  Susan Danielson ,  David A. Tomasso ,  Timothy C. Warren

IPC分类号： G01N33/558 ,  B01L3/00 ,  G01N33/543

CPC分类号： G01N33/558 ,  B01L3/50273 ,  B01L2400/0406 ,  B01L2400/086 ,  G01N33/54366

摘要： An assay device includes: a detection zone which includes a first set of projections which are capable of generating capillary flow. A wicking zone (WZ) has a capacity to receive liquid sample flowing from the detection zone and includes a second set of projections which are capable of generating capillary flow. The WZ is rectangular in shape and the longer side of the rectangle extends in the direction of flow to thereby reduce the pressure gradient in the assay device which increases the total flow time of liquid sample compared to a WZ having equal length sides and same volume. At least a portion of the second set of projections have at least one dimension selected from a diameter, a center-to-center spacing, or a gap between projections that is different from the first set of projections, and is selected to increase the total flow time of the sample.

公开(公告)号：US20180141980A1

公开(公告)日：2018-05-24

申请号：US15865594

申请日：2018-01-09

申请人： Ortho-Clinical Diagnostics, Inc.

发明人： Jian ZHENG ,  Renee YURA ,  Jianping YANG

IPC分类号： C07K14/20 ,  G01N33/571 ,  G01N33/569

CPC分类号： C07K14/20 ,  C07K2319/00 ,  C07K2319/40 ,  G01N33/56911 ,  G01N33/571 ,  G01N2333/20 ,  G01N2800/26

摘要： A Treponema pallidum triplet antigen construct is disclosed which includes three Treponema pallidum antigens (TP15, TP17, and TP47), as well as a ten amino acid leader sequence (tag 261) and human copper zinc superoxide dismutase (hSOD). This construct is optimized for in vitro diagnosis of syphilis infection. Plasmids containing DNA encoding the triplet antigen, host cells, production methods, detection methods, and kits are also disclosed.