Method of improving liquid sample flow in assay device

Patent metadata

Field	Value
Publication number	US-12523650-B2
Application number	US-202117315894-A
Country	US
Kind code	B2
Filing date	May 10, 2021
Priority date	May 19, 2015
Publication date	Jan 13, 2026
Grant date	Jan 13, 2026

Abstract

Disclosed is method of improving flow of a liquid sample in an assay device, as well as a method of performing an assay on a liquid sample for the detection of one or more analytes of interest. The methods use the addition of a reagent, such as a wash reagent, to wet the fluid flow path of a sample prior to sample addition, thereby improving flow of the sample through the fluid flow path that has been wetted as opposed to flow of the sample through the fluid flow path that has not been wetted. The reagent wets the fluid flow path between the sample addition zone and the wicking zone.

First claim

The invention is claimed as follows:

1 . A method of improving flow of a liquid sample in an assay device, the method comprising:
providing a liquid sample addition zone; providing a reagent zone downstream and in fluid communication with the sample addition zone containing a reagent material; providing a detection zone in fluid communication with the reagent zone; providing a wicking zone in fluid communication with the detection zone having a capacity to receive liquid sample flowing from the detection zone, wherein the sample addition zone, the reagent zone, the detection zone and the wicking zone define a fluid flow path; further providing 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; adding a reagent to the reagent addition zone, wherein the reagent flows upstream toward the sample addition zone and downstream toward the wicking zone, wetting the fluid flow path; and adding a liquid sample to the sample addition zone, wherein the sample moves through the fluid flow path that has been wetted with the reagent, and wherein flow of the sample through the fluid flow path that has been wetted with the reagent is improved over flow of the sample through the fluid flow path when no reagent is used.

2 . The method of claim 1 , wherein the reagent added to the reagent addition zone is a wash reagent.

3 . The method of claim 1 , wherein the liquid sample is whole blood.

4 . The method of claim 1 , further comprising providing at least a portion of the fluid flow path with a plurality of adjacent projections, the plurality of projections having a height, width and distance or distances between the projections such that lateral capillary flow is achieved.

5 . The method of claim 4 , further comprising providing the plurality of projections over the entire fluid flow path.

6 . The method of claim 5 , wherein the flow path is open such that a lid or cover is not required at a capillary distance.

7 . The method of claim 5 , wherein the plurality of projections provide for capillary flow of the applied reagent to flow upstream toward the sample addition zone and downstream toward the wicking zone to wet the fluid flow path.

8 . The method of claim 4 , further comprising giving the plurality of projections a chemical, biological, or physical functionality.

9 . The method of claim 4 , wherein the detection zone includes the plurality of adjacent projections.

10 . The method of claim 9 , further comprising attaching capture elements to the projections in the detection zone.

11 . A method of performing an assay on a liquid sample for the detection of one or more analytes of interest, comprising:
providing a liquid sample addition zone; providing a reagent zone downstream and in fluid communication with the sample addition zone containing a reagent material; providing a detection zone in fluid communication with the reagent zone; providing a wicking zone in fluid communication with the detection zone having a capacity to receive liquid sample flowing from the detection zone, wherein the sample addition zone, the reagent zone, the detection zone and the wicking zone define a fluid flow path; further providing 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; adding a reagent to the reagent addition zone, wherein the reagent flows upstream toward the sample addition zone and downstream toward the wicking zone, wetting the fluid flow path; adding a liquid sample containing an analyte of interest to the sample addition zone, wherein the sample moves through the fluid flow path that has been wetted with the reagent, and wherein flow of the sample through the fluid flow path that has been wetted with the reagent is improved over flow of the sample through the fluid flow path when no reagent is used; moving the sample by capillary action into the reagent zone wherein the sample dissolves the reagent material; flowing the sample away from the reagent zone with the dissolved reagent material therein into the detection zone by capillary action, wherein the analyte of interest is detected in the detection zone by reading a signal that is generated; and flowing the sample and any unbound material into the wicking zone.

12 . The method of claim 11 , further comprising providing at least a portion of the fluid flow path with a plurality of adjacent projections, the plurality of projections having a height, width and distance or distances between the projections such that lateral capillary flow is achieved.

13 . The method of claim 12 , further comprising providing the plurality of projections over the entire fluid flow path.

14 . The method of claim 13 , wherein the flow path is open such that a lid or cover is not required at a capillary distance.

15 . The method of claim 13 , wherein the plurality of projections provide for capillary flow of the applied reagent to flow upstream toward the sample addition zone and downstream toward the wicking zone to wet the fluid flow path.

16 . The method of claim 13 , further comprising giving the plurality of projections a chemical, biological, or functional functionality.

17 . The method of claim 13 , wherein the detection zone includes the plurality of adjacent projections and including the further step of attaching capture elements to the projections in the detection zone.

18 . The method of claim 11 , wherein the reagent added to the reagent addition zone is a wash reagent.

19 . The method of claim 11 , wherein the liquid sample is whole blood.

20 . The method of claim 11 , wherein a volume of the reagent is less than a volume of the liquid sample.

Assignees

• Ortho Clinical Diagnostics Inc

Inventors

• Ding Zhong
• Hosimer Philip C
• Scalice Edward

Classifications

• G01N33/521 Primary

  Single-layer analytical elements · CPC title

• G01N33/54388

  based on lateral flow · CPC title

• B01L3/5027

  by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip · CPC title

• G01N33/54366

  Apparatus specially adapted for solid-phase testing · CPC title

• G01N33/543 Primary

  with an insoluble carrier for immobilising immunochemicals · CPC title