IP Library Granted Patent US 11,931,734
Granted Patent B2
US 11,931,734 · App. 17/578,317 · Granted Mar 19, 2024

Lateral-flow assay device having flow constrictions

Inventors: Zhong Ding (Pittsford, NY); Edward R. Scalice (Penfield, NY); Daniel P. Salotto (Rochester, NY)
Assignee: Ortho-Clinical Diagnostics, Inc.
B01L3/5023G01N33/54388B01L2300/041B01L2300/0867B01L2300/161B01L2400/0406
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Quick Facts
Patent No.
US 11,931,734
App. No.
17/578,317
Granted
Mar 19, 2024
Kind
B2
Abstract

A lateral-flow assay device includes a substrate having a sample addition zone and a wash addition zone downstream thereof along a fluid flow path through which a sample flows. The fluid flow path is configured to receive a wash fluid in the wash addition zone. A hydrophilic surface is arranged in the wash addition zone. Flow constriction(s) are spaced apart from the fluid flow path and arranged to define, with the hydrophilic surface, a reservoir configured to retain the wash fluid by formation of a meniscus between the hydrophilic surface and the flow constriction(s). The fluid flow path draws the wash fluid from the reservoir by capillary pressure. Apparatus for analyzing a fluidic sample and methods of displacing a fluidic sample in a fluid flow path of an assay device are also described.

Claims (14)

1. An apparatus for analyzing a fluidic sample, the apparatus comprising:

a) at least one assay device including a sample addition zone and a wash addition zone disposed along a fluid flow path;

b) a sample-metering mechanism configured to selectively apply the fluidic sample to the sample addition zone;

c) a wash-metering mechanism configured to selectively apply a wash fluid to the wash addition zone, wherein the wash addition zone includes one or more flow constriction(s) comprising at least one groove spaced apart from and forming a substantially arcuate path disposed substantially around a portion of the fluid flow path to form a meniscus in the applied wash fluid;

d) at least one measurement device; and

e) a controller configured to operate each of the sample-metering mechanism, the wash-metering mechanism, and the at least one measurement device in accordance with a predetermined timing protocol in order to determine at least one characteristic of the applied fluidic sample, wherein the controller operates the wash-metering mechanism after operating the sample-metering mechanism.

2. The apparatus of claim 1 , wherein the fluid flow path draws applied wash fluid out of a reservoir defined at least partly by the meniscus.

3. The apparatus of claim 1 , wherein the one or more flow constriction(s) includes at least one groove.

4. The apparatus of claim 1 , wherein the one or more flow constriction(s) is disposed substantially about a centerline of the fluid flow path leaving the wash addition zone.

5. The apparatus of claim 1 , wherein the one or more flow constriction(s) includes a plurality of grooves arranged about a centerline of the fluid flow path leaving the wash addition zone.

6. The apparatus of claim 1 , wherein the at least one assay device includes a hydrophilic surface, and wherein the hydrophilic surface includes the one or more flow constriction(s).

7. The apparatus of claim 1 , wherein the one or more flow constriction(s) includes at least one protrusion.

8. The apparatus of claim 7 , wherein the at least one protrusion protrudes from a cover of the at least one assay device.

9. The apparatus of claim 1 , wherein the at least one assay device includes a wash port for application of the wash fluid to the wash addition zone, the one or more flow constriction(s) formed around the wash port.

Assignments (4)
SECURITY AGREEMENT Recorded Aug 22, 2025
From: CRIMSON INTERNATIONAL ASSETS LLC; MICRO TYPING SYSTEMS, INC.; ORTHO-CLINICAL DIAGNOSTICS, INC.; QUIDEL CARDIOVASCULAR INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 072526/0643 →
RELEASE (REEL 060220 / FRAME 0711) Recorded Aug 22, 2025
From: BANK OF AMERICA, N.A.
To: QUIDEL CORPORATION; BIOHELIX CORPORATION; DIAGNOSTIC HYBRIDS, INC.; QUIDEL CARDIOVASCULAR INC.; ORTHO-CLINICAL DIAGNOSTICS, INC.; CRIMSON U.S. ASSETS LLC; CRIMSON INTERNATIONAL ASSETS LLC; MICRO TYPING SYSTEMS, INC.
Reel/Frame 072577/0536 →
SECURITY AGREEMENT Recorded May 31, 2022
From: QUIDEL CORPORATION; BIOHELIX CORPORATION; DIAGNOSTIC HYBRIDS, INC.; QUIDEL CARDIOVASCULAR INC.; ORTHO-CLINICAL DIAGNOSTICS, INC.; CRIMSON U.S. ASSETS LLC; CRIMSON INTERNATIONAL ASSETS LLC; MICRO TYPING SYSTEMS, INC.
To: BANK OF AMERICA, N.A.
Reel/Frame 060220/0711 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 18, 2022
From: DING, ZHONG; SCALICE, EDWARD R.; SALOTTO, DANIEL P.
To: ORTHO-CLINICAL DIAGNOSTICS, INC.
Reel/Frame 058685/0198 →