Immunoassay test device with two fluid flow paths for detection and differentiation of two or more analytes

Patent metadata

Field	Value
Publication number	US-12590960-B2
Application number	US-202318504971-A
Country	US
Kind code	B2
Filing date	Nov 8, 2023
Priority date	Aug 27, 2015
Publication date	Mar 31, 2026
Grant date	Mar 31, 2026

Abstract

A device for determining presence or absence of infection due to an infectious agent is described. The device comprises a sample receiving zone configured to receive a liquid sample from a subject suspected of having an infection due to an infectious agent, the sample receiving zone positioned to distribute the sample along a first fluid flow path to a first label zone and along a second fluid flow path to a second label zone. Test lines in each fluid flow path capture a mobile detectable species as an indicator of presence or absence of the infectious agent. The device also comprises a reference line positioned in the one of the fluid flow paths. The bidirectional fluid flow paths emanate from a common sample zone and provide an efficient approach to detection and differentiate two species as indicators of the same infectious agent or as indicators of two different infectious agents.

First claim

The invention claimed is:

1 . A method for diagnosing an infection in a subject, comprising:
depositing a fluid sample from the subject on a sample receiving zone configured to receive a fluid sample, wherein the sample receiving zone is the sole sample receiving zone provided on a device comprising a plurality of fluid flow paths; distributing the fluid sample along a first fluid flow path and a second fluid flow path; wherein a first portion of the fluid sample is distributed via the first fluid flow path to a first label zone comprising a first mobilizable, detectable species that binds IgM antibodies present in the fluid sample, and subsequently to a first test line positioned downstream of the first label zone, wherein the first test line comprises a first immobilized species capable of specifically binding a conjugate comprising the first mobilizable, detectable species and one or more IgM antibodies from the fluid sample; wherein a second portion of the fluid sample is distributed via the second fluid flow path to a second label zone comprising a second mobilizable, detectable species that binds IgG antibodies present in the fluid sample, and subsequently to a second test line positioned downstream of the second label zone, wherein the second test line comprises a second immobilized species capable of specifically binding a conjugate comprising the second mobilizable, detectable species and one or more IgG antibodies from the fluid sample; wherein only one of the first and second fluid flow paths comprises a reference line comprising an immobilized species having binding affinity for a detectable moiety provided upstream of the reference line; and inspecting the first and second test lines for the presence or absence of the mobilizable, detectable species.

2 . The method of claim 1 , wherein the fluid sample is a blood sample, a cerebrospinal fluid sample, or a urine sample.

3 . The method of claim 1 , wherein the first fluid flow path and the second fluid flow path are at an angle selected from a straight angle (180°), an obtuse angle and an acute angle.

4 . The method of claim 1 , wherein the first and second mobilizable species comprise antigens from an analyte of interest.

5 . The method of claim 1 , wherein the mobilizable, detectable species in the first label zone comprises a nonhuman anti-human IgM antibody.

6 . The method of claim 1 , wherein the mobilizable, detectable species comprises a label detectable optically.

7 . The method of claim 6 , wherein the optically detectable label is a fluorescent or chemiluminescent marker.

8 . The method of claim 1 , wherein the sample receiving zone is positioned between the first label zone and the second label zone.

9 . The method of claim 1 , wherein the sample receiving zone, the first and second fluid flow paths, the first and second label zones, the first and second test lines, and the reference line are deposited on a substrate.

10 . The method of claim 1 , wherein inspecting the first and second test lines is performed using an instrument with an optical reader.

11 . The method of claim 10 , wherein the first and second test lines are within a single optical window for inspection by the instrument.

12 . The method of claim 1 , wherein the sample receiving zone dispenses sample to the first label zone and the second label zone in essentially equal amounts or at essentially equal rates.

13 . The method of claim 1 , wherein the infection is a viral infection.

14 . The method of claim 13 , wherein the viral infection is an infection by one or more herpes simplex viruses, one or more influenza viruses, respiratory syncytial virus (RSV), and/or Zika virus.

15 . The method of claim 13 , wherein the first test line comprises an immobilized antigen with binding affinity for antibodies against herpes simplex virus-1 and the second test line comprises an immobilized antigen with binding affinity for antibodies against herpes simplex virus-2.

16 . The method of claim 13 , wherein the first mobilizable, detectable species comprises a mobilizable, detectable anti-influenza A antibody, the second mobilizable, detectable species comprises a mobilizable, detectable anti-influenza B antibody, the first test line comprises an immobilized anti-influenza A antibody, and the second test line comprises an immobilized anti-influenza B antibody.

17 . The method of claim 13 , wherein the first mobilizable, detectable species comprises mobilizable, detectable anti-influenza A or anti-influenza B antibody, the second mobilizable, detectable species comprises a mobilizable, detectable anti-respiratory syncytial virus (RSV) antibody, the first test line comprises an immobilized anti-influenza A or anti-influenza B antibody, and the second test line comprises an immobilized anti-RSV antibody.

18 . The method of claim 1 , wherein the infection is a bacterial infection.

19 . The method of claim 18 , wherein the immobilized species in the first test line comprises a plurality of antigens for B. burgdorferi with binding affinity for human IgM antibodies against B. burgdorferi , and the immobilized species in the second test line comprises a plurality of antigens for B. burgdorferi with binding affinity for human IgG antibodies against B. burgdorferi.

Assignees

• Quidel Corp
• Ortho Clinical Diagnostics Inc

Inventors

• Reed Robert
• Sinn-Blandy Irene
• Weiller Robert
• Mcclure Jason

Classifications

• G01N33/54388 Primary

  based on lateral flow · CPC title

• G01N33/54389

  with bidirectional or multidirectional lateral flow, e.g. wherein the sample flows from a single, common sample application point into multiple strips, lanes or zones · CPC title

• Y02A50/30

  Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change · CPC title

• G01N2800/56

  Staging of a disease; Further complications associated with the disease · CPC title

• G01N2469/20

  Detection of antibodies in sample from host which are directed against antigens from microorganisms · CPC title