Patents by Inventor Edward R. Scalice

Edward R. Scalice has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).

  • Publication number: 20220219162
    Abstract: A lateral-flow assay device includes a substrate having a sample addition zone and a wash addition zone downstream thereof along a fluid flow path through which a sample flows. The fluid flow path is configured to receive a wash fluid in the wash addition zone. A hydrophilic surface is arranged in the wash addition zone. Flow constriction(s) are spaced apart from the fluid flow path and arranged to define, with the hydrophilic surface, a reservoir configured to retain the wash fluid by formation of a meniscus between the hydrophilic surface and the flow constriction(s). The fluid flow path draws the wash fluid from the reservoir by capillary pressure. Apparatus for analyzing a fluidic sample and methods of displacing a fluidic sample in a fluid flow path of an assay device are also described.
    Type: Application
    Filed: January 18, 2022
    Publication date: July 14, 2022
    Inventors: Zhong DING, Edward R. SCALICE, Daniel P. SALOTTO
  • Patent number: 11293879
    Abstract: The present disclosure is directed to a method and apparatus for performing an assay on a dry slide or other solid media using a reduced reading window. In an embodiment, method of performing at least one assay comprises obtaining an image of a fluid sample located on a dry slide, positioning a reading window to correspond to an area of the fluid sample in the image, determining an interference area within the reading window based on light intensity, reducing the reading window to eliminate the interference area from the reading window, and performing at least one assay using the reduced reading window.
    Type: Grant
    Filed: July 1, 2019
    Date of Patent: April 5, 2022
    Assignee: ORTHO-CLINICAL DIAGNOSTICS, INC.
    Inventors: Zhong Ding, Andrew M. Kirsch, Edward R. Scalice, Benjamin Wojtasiewicz
  • Patent number: 11287424
    Abstract: A method for performing an assay on a liquid sample for the detection of one or more analytes of interest in an assay device having a flow path which includes a sample zone and detection zone thereon includes: dispensing the sample onto the sample zone; combining the sample and a reagent, wherein the sample and reagent may be combined prior to addition of the sample to the sample zone or on the assay device, flowing the combined sample/reagent by capillary action into and through the detection zone having capture elements bound thereto, wherein a signal at least partially representative of the presence or concentration of analyte(s) is produced and detected; determining a reaction time or reaction volume; and determining the concentration of the analyte by using both the detected signal and the reaction time or reaction volume.
    Type: Grant
    Filed: February 2, 2018
    Date of Patent: March 29, 2022
    Assignee: ORTHO-CLINICAL DIAGNOSTICS, INC.
    Inventors: Zhong Ding, Edward R. Scalice
  • Patent number: 11260390
    Abstract: A lateral-flow assay device includes a substrate having a sample addition zone and a wash addition zone downstream thereof along a fluid flow path through which a sample flows. The fluid flow path is configured to receive a wash fluid in the wash addition zone. A hydrophilic surface is arranged in the wash addition zone. Flow constriction(s) are spaced apart from the fluid flow path and arranged to define, with the hydrophilic surface, a reservoir configured to retain the wash fluid by formation of a meniscus between the hydrophilic surface and the flow constriction(s). The fluid flow path draws the wash fluid from the reservoir by capillary pressure. Apparatus for analyzing a fluidic sample and methods of displacing a fluidic sample in a fluid flow path of an assay device are also described.
    Type: Grant
    Filed: August 3, 2018
    Date of Patent: March 1, 2022
    Assignee: ORTHO-CLINICAL DIAGNOSTICS, INC.
    Inventors: Zhong Ding, Edward R. Scalice, Daniel P. Salotto
  • Publication number: 20210268496
    Abstract: Described herein are clinical diagnostics and more specifically to a lateral-flow assay devices.
    Type: Application
    Filed: May 12, 2021
    Publication date: September 2, 2021
    Inventors: Zhong Ding, Edward R. Scalice, Philip C. Hosimer
  • Patent number: 11033896
    Abstract: A lateral-flow assay device includes a substrate with a sample addition zone and a fluid flow path. A cover supports a filter having a portion contacting the substrate to create a contact area that at least partly overlaps the sample addition zone. Another portion extends from the contact portion to the supported periphery of the filter to define with the substrate a reservoir configured to retain the filtrate by capillary pressure between the substrate and the extending portion. The reservoir volume is based on an acute angle formed between the substrate and the extending portion of the filter and on a fluid meniscus of the filtrate. The filter and sample addition zone are configured to provide capillary pressure drawing the filtrate from the reservoir to the sample addition zone. Methods for controlling flow characteristics in a lateral-flow assay device are also described.
    Type: Grant
    Filed: August 4, 2015
    Date of Patent: June 15, 2021
    Assignee: ORTHO-CLINICAL DIAGNOSTICS, INC.
    Inventors: Zhong Ding, Edward R. Scalice, Philip C. Hosimer
  • Publication number: 20200300841
    Abstract: Disclosed is an assay device which comprises a liquid sample addition zone, a reagent zone, a detection zone, and a wicking zone, all defining a fluid flow path. The device further comprises a reagent addition zone along and in fluid communication with the fluid flow path downstream of the sample addition zone and upstream of the detection zone. An interrupting wash is added at this reagent addition zone in accordance with the method of the subject invention to control sample volume. The interrupting wash fluid is added at a predetermined fill volume on the chip device and also serves to wash the detection channel and fill the remaining chip volume.
    Type: Application
    Filed: June 8, 2020
    Publication date: September 24, 2020
    Inventors: Edward R. Scalice, Philip C. Hosimer, Zhong Ding, James D. Kanaley, David A. Tomasso, Daniel P. Salotto, Timothy C. Warren
  • Patent number: 10712340
    Abstract: Disclosed is an assay device which comprises a liquid sample addition zone, a reagent zone, a detection zone, and a wicking zone, all defining a fluid flow path. The device further comprises a reagent addition zone along and in fluid communication with the fluid flow path downstream of the sample addition zone and upstream of the detection zone. An interrupting wash is added at this reagent addition zone in accordance with the method of the subject invention to control sample volume. The interrupting wash fluid is added at a predetermined fill volume on the chip device and also serves to wash the detection channel and fill the remaining chip volume.
    Type: Grant
    Filed: January 18, 2013
    Date of Patent: July 14, 2020
    Assignee: ORTHO-CLINICAL DIAGNOSTICS, INC.
    Inventors: Edward R. Scalice, Philip C. Hosimer, Zhong Ding, James D. Kanaley, David A. Tomasso, Daniel P. Salotto, Timothy C. Warren
  • Publication number: 20200003699
    Abstract: The present disclosure is directed to a method and apparatus for performing an assay on a dry slide or other solid media using a reduced reading window. In an embodiment, method of performing at least one assay comprises obtaining an image of a fluid sample located on a dry slide, positioning a reading window to correspond to an area of the fluid sample in the image, determining an interference area within the reading window based on light intensity, reducing the reading window to eliminate the interference area from the reading window, and performing at least one assay using the reduced reading window.
    Type: Application
    Filed: July 1, 2019
    Publication date: January 2, 2020
    Inventors: Zhong Ding, Andrew M. Kirsch, Edward R. Scalice, Benjamin Wojtasiewicz
  • Publication number: 20180345277
    Abstract: A lateral-flow assay device includes a substrate having a sample addition zone and a wash addition zone downstream thereof along a fluid flow path through which a sample flows. The fluid flow path is configured to receive a wash fluid in the wash addition zone. A hydrophilic surface is arranged in the wash addition zone. Flow constriction(s) are spaced apart from the fluid flow path and arranged to define, with the hydrophilic surface, a reservoir configured to retain the wash fluid by formation of a meniscus between the hydrophilic surface and the flow constriction(s). The fluid flow path draws the wash fluid from the reservoir by capillary pressure. Apparatus for analyzing a fluidic sample and methods of displacing a fluidic sample in a fluid flow path of an assay device are also described.
    Type: Application
    Filed: August 3, 2018
    Publication date: December 6, 2018
    Inventors: Zhong Ding, Edward R. Scalice, Daniel P. Salotto
  • Patent number: 10082502
    Abstract: 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.
    Type: Grant
    Filed: February 5, 2016
    Date of Patent: September 25, 2018
    Assignee: ORTHO-CLINICAL DIAGNOSTICS, INC.
    Inventors: James D. Kanaley, Zhong Ding, Philip C. Hosimer, Edward R. Scalice, Susan Danielson, David A. Tomasso, Timothy C. Warren
  • Patent number: 10073091
    Abstract: A lateral flow assay device includes a substrate having a top surface, as well as a sample receiving area disposed upon the top surface. At least one fluid flow path extends along the substrate from the sample receiving area, wherein the sample receiving area can be placed in contact with a peripheral reservoir formed at a sample addition area to draw sample therefrom in a controlled manner. The device can further include a reagent area that is designed to promote uniform dissolution of a deposited detection material by a sample moved through the device along the fluid flow path as well, as a flow channel configure to promote mixing of sample and reagent and an absorbing or wicking zone configured to affect various flow characteristics.
    Type: Grant
    Filed: August 6, 2015
    Date of Patent: September 11, 2018
    Assignee: Ortho-Clinical Diagnostics, Inc.
    Inventors: Zhong Ding, Philip C. Hosmier, Edward R. Scalice, Daniel P. Salotto, David A. Heavner
  • Patent number: 10071373
    Abstract: A lateral-flow assay device includes a substrate having a sample addition zone and a wash addition zone downstream thereof along a fluid flow path through which a sample flows. The fluid flow path is configured to receive a wash fluid in the wash addition zone. A hydrophilic surface is arranged in the wash addition zone. Flow constriction(s) are spaced apart from the fluid flow path and arranged to define, with the hydrophilic surface, a reservoir configured to retain the wash fluid by formation of a meniscus between the hydrophilic surface and the flow constriction(s). The fluid flow path draws the wash fluid from the reservoir by capillary pressure. Apparatus for analyzing a fluidic sample and methods of displacing a fluidic sample in a fluid flow path of an assay device are also described.
    Type: Grant
    Filed: August 4, 2015
    Date of Patent: September 11, 2018
    Assignee: ORTHO-CLINICAL DIAGNOSTICS, INC.
    Inventors: Zhong Ding, Edward R. Scalice, Daniel P. Salotto
  • Publication number: 20180156791
    Abstract: A method for performing an assay on a liquid sample for the detection of one or more analytes of interest in an assay device having a flow path which includes a sample zone and detection zone thereon includes: dispensing the sample onto the sample zone; combining the sample and a reagent, wherein the sample and reagent may be combined prior to addition of the sample to the sample zone or on the assay device, flowing the combined sample/reagent by capillary action into and through the detection zone having capture elements bound thereto, wherein a signal at least partially representative of the presence or concentration of analyte(s) is produced and detected; determining a reaction time or reaction volume; and determining the concentration of the analyte by using both the detected signal and the reaction time or reaction volume.
    Type: Application
    Filed: February 2, 2018
    Publication date: June 7, 2018
    Inventors: Zhong Ding, Edward R. Scalice
  • Patent number: 9885712
    Abstract: A method for performing an assay on a liquid sample for the detection of one or more analytes of interest in an assay device having a flow path which includes a sample zone and detection zone thereon includes: dispensing the sample onto the sample zone; combining the sample and a reagent, wherein the sample and reagent may be combined prior to addition of the sample to the sample zone or on the assay device, flowing the combined sample/reagent by capillary action into and through the detection zone having capture elements bound thereto, wherein a signal at least partially representative of the presence or concentration of analyte(s) is produced and detected; determining a reaction time or reaction volume; and determining the concentration of the analyte by using both the detected signal and the reaction time or reaction volume.
    Type: Grant
    Filed: November 15, 2013
    Date of Patent: February 6, 2018
    Assignee: Ortho-Clinical Diagnostics, Inc.
    Inventors: Zhong Ding, Edward R. Scalice
  • Patent number: 9625457
    Abstract: An assay device includes: a liquid sample zone; a reagent zone downstream and in fluid communication with the sample zone containing a reagent material; a detection zone in fluid communication with the reagent zone having capture elements bound thereto; and a wicking zone in fluid communication with the capture zone having a capacity to receive liquid sample flowing from the detection zone. The sample receiving zone, the reagent zone, the detection zone and the wicking zone define a fluid flow path and at least a part of the fluid flow path has a substrate and projections which extend substantially vertically from the substrate, wherein the projections have a height, cross-section and a distance between one another that defines a space between the projections capable of generating capillary flow parallel to the substrate surface. In addition, the fluid flow path having projections includes a corner section which changes the direction of the flow path.
    Type: Grant
    Filed: November 13, 2014
    Date of Patent: April 18, 2017
    Assignee: Ortho-Clinical Diagnostics, Inc.
    Inventors: James D. Kanaley, Zhong Ding, Philip C. Hosimer, Edward R. Scalice, Susan Danielson, David A. Tomasso, Timothy C. Warren
  • Publication number: 20160153982
    Abstract: 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.
    Type: Application
    Filed: February 5, 2016
    Publication date: June 2, 2016
    Inventors: James D. Kanaley, Zhong Ding, Philip C. Hosimer, Edward R. Scalice, Susan Danielson, David A. Tomasso, Timothy C. Warren
  • Publication number: 20160038936
    Abstract: A lateral-flow assay device includes a substrate having a sample addition zone and a wash addition zone downstream thereof along a fluid flow path through which a sample flows. The fluid flow path is configured to receive a wash fluid in the wash addition zone. A hydrophilic surface is arranged in the wash addition zone. Flow constriction(s) are spaced apart from the fluid flow path and arranged to define, with the hydrophilic surface, a reservoir configured to retain the wash fluid by formation of a meniscus between the hydrophilic surface and the flow constriction(s). The fluid flow path draws the wash fluid from the reservoir by capillary pressure. Apparatus for analyzing a fluidic sample and methods of displacing a fluidic sample in a fluid flow path of an assay device are also described.
    Type: Application
    Filed: August 4, 2015
    Publication date: February 11, 2016
    Inventors: Zhong Ding, Edward R. Scalice, Daniel P. Salotto
  • Publication number: 20160041163
    Abstract: A lateral flow assay device includes a substrate having a top surface, as well as a sample receiving area disposed upon the top surface. At least one fluid flow path extends along the substrate from the sample receiving area, wherein the sample receiving area can be placed in contact with a peripheral reservoir formed at a sample addition area to draw sample therefrom in a controlled manner. The device can further include a reagent area that is designed to promote uniform dissolution of a deposited detection material by a sample moved through the device along the fluid flow path as well, as a flow channel configure to promote mixing of sample and reagent and an absorbing or wicking zone configured to affect various flow characteristics.
    Type: Application
    Filed: August 6, 2015
    Publication date: February 11, 2016
    Inventors: Zhong Ding, Philip C. Hosmier, Edward R. Scalice, Daniel P. Salotto, David A. Heavner
  • Publication number: 20160038937
    Abstract: A lateral-flow assay device includes a substrate with a sample addition zone and a fluid flow path. A cover supports a filter having a portion contacting the substrate to create a contact area that at least partly overlaps the sample addition zone. Another portion extends from the contact portion to the supported periphery of the filter to define with the substrate a reservoir configured to retain the filtrate by capillary pressure between the substrate and the extending portion. The reservoir volume is based on an acute angle formed between the substrate and the extending portion of the filter and on a fluid meniscus of the filtrate. The filter and sample addition zone are configured to provide capillary pressure drawing the filtrate from the reservoir to the sample addition zone. Methods for controlling flow characteristics in a lateral-flow assay device are also described.
    Type: Application
    Filed: August 4, 2015
    Publication date: February 11, 2016
    Inventors: Zhong Ding, Edward R. Scalice, Philip C. Hosimer