Test apparatus and methods for ST2 cardiac biomarker

• US 10,079,073 B2
• Filed: 12/11/2014
• Issued: 09/18/2018
• Est. Priority Date: 12/11/2014
• Status: Expired due to Fees

• Current Assignee: Critical Care Diagnostics Inc.
• Original Assignee: Critical Care Diagnostics Inc.
• Inventors: Snider, James V., Bender, Jillian Elizabeth, Kuo, Shrin P., Chung, Roy A.
• Primary Examiner(s): Gabel, Gailene
• Application Number:
  US14/566,955
• Publication Number:
  US 20160169882A1
• Time in Patent Office: 1,377 Days
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: G01N 2333/7155 for interleukins [IL]
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54387 Immunochromatographic test strips
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

The technology described in this document can be embodied in a test strip for use in measuring a level of an ST2 cardiac biomarker in a blood plasma sample. The test strip includes a base, and a plurality of conjugates, wherein each conjugate includes a reporter group bound to a first antibody that binds to ST2. A conjugate pad disposed along a length of the base and is configured to hold the plurality of conjugates that bind with ST2 to produce conjugate-ST2 complexes. The conjugate pad is further configured to receive the blood plasma sample. The test strip also includes a plurality of second and third antibodies that bind to ST2, and the conjugate-ST2 complexes, respectively. The plurality of second antibodies are bound to a membrane in a test location and the plurality of third antibodies are bound to the membrane in a control location.

Claims

1. A test apparatus comprising:

a test strip having a first end and an opposite second end;

a radio frequency identification (RFID) tag configured to store information related to a sample of blood plasma to be dispensed onto the test strip; and

a housing for the test strip, wherein the housing comprises;

a first section comprising an outer face and an inner face, wherein the inner face of the first section comprises a channel to receive the test strip along the length of the first section, and

a second section comprising an outer face and an inner face, wherein the second section is configured to be attached to the first section such that in an attached configuration the inner face of the first section faces the inner face of the second section, and the first and second sections together enclose the RFID tag and the test strip within the housing, wherein the second section comprises;

a buffer port configured to allow a buffer solution to be dispensed to a portion of the test strip proximate to the first end of the test strip,

a test window configured to facilitate imaging of one or both of a test location and a control location on the test strip,

a sample port disposed between the buffer port and the test window, the sample port configured to enable the sample of blood plasma to be dispensed to the test strip, and

a set of projections disposed on the inner face of the second section between the test window and the sample port such that in the attached configuration with the first section, each projection in the set of projections is in contact with the test strip and configured to apply pressure on the test strip in accordance with a pressure gradient, wherein a height of at least one projection in the set of projections is different from a height of another projection in the set of projections, and heights of the different projections are configured such that, in the attached configuration, the set of projections produces the pressure gradient within the test strip that allows a fluid to flow at a predetermined flow rate from a portion of the test strip adjacent to the sample port to a portion of the test strip adjacent to the test window along the length of the test strip.

2. The test apparatus of claim 1, wherein the predetermined flow rate is such that the fluid flows from the portion of the test strip adjacent to the buffer port of the second section to the portion of the test strip adjacent to the test window of the second section in about 20 minutes.

3. The test apparatus of claim 1, wherein the set of projections is a set of ridges.

4. The test apparatus of claim 3, wherein distances between ridges are substantially equal.

5. The test apparatus of claim 3, wherein the set of projections includes four ridges, a first ridge being disposed closer to the sample port than the other ridges, a fourth ridge being disposed closer to the test window than the other ridges, and a second ridge and a third ridge being disposed between the first and fourth ridges.

6. The test apparatus of claim 1, wherein the first section includes multiple attachment projections that are configured to attach to corresponding attachment receptacles disposed on the second section to form the housing, wherein dimensions of the attachment projections and attachment receptacles are configured such that in the attached configuration of the housing, the set of projections produces the pressure gradient that allows the fluid to flow at the predetermined flow rate along the length of the test strip.

7. The test apparatus of claim 1, wherein, in the attached configuration, the set of projections support the test strip without creating a pressure point that hinders the flow rate along the length of the test strip.

8. The test apparatus of claim 1, wherein the set of projections includes three projections.

9. The test apparatus of claim 8, wherein a ratio of the heights of the three projections of the set with respect to a common baseline is 3:

11;

27.

10. The test apparatus of claim 8, wherein a first projection is disposed closer to the sample port than the other projections, a third projection is disposed closer to the test window than the other projections, and a second projection is disposed between the first and third projections.

11. The test apparatus of claim 1, wherein the heights of the projections of the set of projections are increasingly larger in a direction from the sample port towards the test window.