Lateral flow assay device

• US 10,073,091 B2
• Filed: 08/06/2015
• Issued: 09/11/2018
• Est. Priority Date: 08/08/2014
• Status: Active Grant

• Current Assignee: Ortho-Clinical Diagnostics Incorporated (The Carlyle Group LP (Corporate Private Equity))
• Original Assignee: Ortho-Clinical Diagnostics Incorporated (The Carlyle Group LP (Corporate Private Equity))
• Inventors: Ding, Zhong, Hosmier, Philip C., Scalice, Edward R., Salotto, Daniel P., Heavner, David A.
• Primary Examiner(s): Martinez, Rebecca L
• Application Number:
  US14/819,893
• Publication Number:
  US 20160041163A1
• Time in Patent Office: 1,132 Days
• Field of Search: None
• CPC Class Codes: B01L 3/50 Containers for the purpose of retaining a material to be analysed, e.g. test tubes devices for taking samples of blood A61B5/15
• CPC Class Codes: G01N 2021/7763 Sample through flow
• CPC Class Codes: G01N 21/77 by observing the effect on a chemical indicator
• CPC Class Codes: G01N 33/5306 Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding
• CPC Class Codes: G01N 33/536 with immune complex formed in liquid phase
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/54389 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 Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387

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.

Claims

1. A lateral flow assay device comprising:

a non-porous substrate having a top surface;

a sample addition area including a cover having an aperture and a filter peripherally supported within the aperture configured for adding a sample fluid, the cover being disposed above the substrate and defining a spacing therebetween, the supported filter including a portion in direct contact with the top surface of the substrate, in which the filter includes a surface section extending between the portion directly contacting the substrate and a supporting edge of the cover aperture, said surface section forming an angle α

with the top surface of the substrate, and creating a peripheral reservoir of sample fluid that passes through the filter, said peripheral reservoir being retained by capillary forces between the filter and the substrate that retains a volume of fluid sample; and

a sample receiving zone extending along a portion of the substrate and into contact with only a portion of the peripheral reservoir, the sample receiving zone being defined by a plurality of projections extending from the top surface of the substrate, the plurality of projections having dimensions and reciprocal spacing that creates lateral capillary pressure for drawing fluid from said peripheral reservoir without disturbing the integrity of the reservoir.

2. The lateral flow assay device of claim 1, wherein the sample receiving zone is disposed along a fluid flow path of the assay device, said assay device further including at least one reagent zone and an absorbing zone each disposed along the fluid flow path.

3. The lateral flow assay device of claim 1, in which the angle α

is greater than zero.

4. The lateral flow assay device of claim 1, wherein the angle α

is about 10 degrees.

5. The lateral flow assay device of claim 1, including a plurality of sample receiving zones interconnecting with separate portions of the peripheral reservoir and extending in different planar directions therefrom.

6. The lateral flow assay device of claim 2, wherein the fluid flow path further comprises a flow channel interconnecting the reagent zone, the detection zone and the absorbing zone and in which the sample receiving zone has an overall width dimension that is larger than the width dimension that is between about one and three times the width dimension of the flow channel.

7. The lateral flow assay device of claim 6, in which the width dimension of the sample receiving zone is two times the width dimension of the flow channel.

8. The lateral flow assay device of claim 7, wherein the width dimension of the flow channel is between about 0.5 and 1.5 mm.