IP Library Granted Patent US 11,162,947
Granted Patent B2
US 11,162,947 · App. 15/865,037 · Granted Nov 2, 2021

Real-time detection of influenza virus

Inventors: Elizabeth A. Holmes (Palo Alto, CA); Ian Gibbons (Newark, CA)
Assignee: Labrador Diagnostics LLC
G01N33/56983B01L3/5027C12Q1/701G01N33/54366B01L3/502738B01L2200/10B01L2200/142B01L2200/16B01L2300/044B01L2300/0672B01L2300/0874B01L2400/049B01L2400/0481B01L2400/0683G01N2333/11
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Quick Facts
Patent No.
US 11,162,947
App. No.
15/865,037
Granted
Nov 2, 2021
Kind
B2
Abstract

The present invention provides system and methods for detecting an analyte indicative of an influenza viral infection in a sample of bodily fluid. The present invention also provides for systems and method for detection a plurality of analytes, at least two of which are indicative of an influenza viral infection in a sample of bodily fluid.

Claims (34)

1. A system for detecting an influenza viral particle in a sample of bodily fluid, the system comprising:

a sample collection unit configured to receive the sample of bodily fluid from a subject suspected to contain the influenza viral particle;

an assay assembly in fluidic communication with the sample collection unit, the assay assembly comprising a first reagent chamber, a second reagent chamber, a reaction site, and a fluidic channel that connects the first and second reagent chambers with the reaction site, wherein the first reagent chamber comprises a first immunoassay reagent and the second reagent chamber comprises a second immunoassay reagent;

a waste chamber in fluidic communication with the assay assembly; and

a reader assembly comprising a detection assembly,

wherein the assay assembly is configured to:

receive the sample from the sample collection unit;

release the first and second immunoassay reagents from the first and second reagent chambers to the reaction site through the fluidic channel by one or more actuating elements;

allow the sample to react with the first and second immunoassay reagents at the reaction site, wherein the first immunoassay reagent binds to a hemagglutinin molecule to form a first immune complex on the influenza viral particle, and wherein the second immunoassay reagent binds to a neuraminidase molecule to form a second immune complex on the influenza viral particle; and

yield one or more signals indicative of the simultaneous presence of hemagglutinin and neuraminidase on the influenza viral particle based on the first and second immune complexes; and

wherein the detection assembly is configured to:

detect the influenza viral particle in the sample based on detection of the one or more signals indicative of the simultaneous presence of hemagglutinin and neuraminidase.

2. The system of claim 1 , wherein the one or more actuating elements comprise at least one pump and one valve to control and direct movement of fluids in the system.

3. The system of claim 1 , wherein detection of the one or more signals indicative of the simultaneous presence of hemagglutinin and neuraminidase is indicative of an influenza type A viral infection.

4. The system of claim 1 , wherein detection of the one or more signals indicative of the simultaneous presence of hemagglutinin and neuraminidase is indicative of an influenza type B viral infection.

5. The system of claim 1 , wherein the hemagglutinin is selected from the group consisting of H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15, and H16, and the neuraminidase is selected from the group consisting of N1, N2, N3, N4, and N5.

6. The system of claim 1 , wherein the hemagglutinin is H5 and the neuraminidase is N1.

7. The system of claim 1 , wherein the assay assembly comprises an immunoassay assembly.

8. The system of claim 1 , wherein the waste chamber comprises an absorbent material that is configured to absorb waste liquids from the assay assembly.

9. A fluidic device comprising:

a sample collection unit configured to receive a sample of bodily fluid from a subject suspected to contain an influenza viral particle;

an assay assembly in fluidic communication with the sample collection unit, the assay assembly comprising a first reagent chamber, a second reagent chamber, a reaction site, and a fluidic channel that connects the first and second reagent chambers with the reaction site, wherein the first reagent chamber comprises a first immunoassay reagent and the second reagent chamber comprises a second immunoassay reagent; and

a waste chamber in fluidic communication with the assay assembly,

wherein the assay assembly is configured to:

receive the sample from the sample collection unit;

release the first and second immunoassay reagents from the first and second reagent chambers to the reaction site through the fluidic channel by one or more actuating elements;

allow the sample to react with the first and second immunoassay reagents at the reaction site, wherein the first immunoassay reagent binds to a hemagglutinin molecule to form a first immune complex on the influenza viral particle, and wherein the second immunoassay reagent binds to a neuraminidase molecule to form a second immune complex on the influenza viral particle;

yield one or more signals indicative of the simultaneous presence of hemagglutinin and neuraminidase on the influenza viral particle based on the first and second immune complexes; and

detect the influenza viral particle in the sample based on detection of the one or more signals indicative of the simultaneous presence of hemagglutinin and neuraminidase.

10. The fluidic device of claim 9 , wherein the one or more actuating elements comprise at least one pump and one valve to control and direct movement of fluids in the system.

11. The fluidic device of claim 9 , wherein detection of the one or more signals indicative of the simultaneous presence of hemagglutinin and neuraminidase is indicative of an influenza type A viral infection.

12. The fluidic device of claim 9 , wherein detection of the one or more signals indicative of the simultaneous presence of hemagglutinin and neuraminidase is indicative of an influenza type B viral infection.

13. The fluidic device of claim 9 , wherein the hemagglutinin is selected from the group consisting of H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15, and H16, and the neuraminidase is selected from the group consisting of N1, N2, N3, N4, and N5.

14. The fluidic device of claim 9 , wherein the hemagglutinin is H5 and the neuraminidase is N1.

Assignments (3)
CHANGE OF NAME Recorded Apr 7, 2020
From: THERANOS IP COMPANY LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 052329/0716 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 18, 2018
From: THERANOS, INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 044656/0728 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 8, 2018
From: HOLMES, ELIZABETH A.; GIBBONS, IAN
To: THERANOS, INC.
Reel/Frame 044565/0540 →
Continuity (6)
Continuation 14155150 · Jan 14, 2014
Continuation 13187960 · Jul 21, 2011
Continuation 11746535 · May 9, 2007
Provisional Application 60800939 · May 16, 2006
Provisional Application 60799442 · May 10, 2006
Related Publication 20180209976A1 · Jul 26, 2018