Quality/process control of a lateral flow assay device based on flow monitoring

• US 10,509,031 B2
• Filed: 09/23/2016
• Issued: 12/17/2019
• Est. Priority Date: 11/15/2012
• 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, Robinson, James E., Tomasso, David A., Heavner, David A.
• Primary Examiner(s): Martinez, Rebecca L
• Application Number:
  US15/274,495
• Publication Number:
  US 20170010262A1
• Time in Patent Office: 1,180 Days
• Field of Search: None
• CPC Class Codes: B01L 2200/143 Quality control, feedback systems
• CPC Class Codes: B01L 2300/0861 Configuration of multiple channels and/or chambers in a single devices
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 2021/6439 with indicators, stains, dyes, tags, labels, marks
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• 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 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387

Abstract

A method for providing quality control on a lateral flow assay device or for triggering a process-related step, the device including a substrate having at least one sample receiving area, at least one reagent zone downstream and in fluid communication with the at least one sample receiving area, at least one detection zone downstream and in fluid communication with the at least one reagent zone and at least one wicking zone downstream of the at least one detection zone, each fluidly interconnected therewith along at least one fluid flow path. The detection material provided in the at least one reagent zone produces a detectable signal that can be tracked and monitored prior to the completion of at least one test being performed on the lateral flow assay device.

Claims

1. A method for processing a lateral flow assay device, the lateral flow assay device comprising a substrate having at least one sample addition zone, a first detection zone downstream of the at least one sample addition zone, at least one wash zone down stream of the at least one sample addition zone and up stream of the first detection zone, and at least one wicking zone disposed downstream of the first detection zone wherein the at least one wicking zone includes a second detection zone, each of the zones being fluidly connected along a flow path in which a sample flows from the at least one sample addition zone to the at least one wicking zone, said method comprising the steps of:

adding a quantity of a sample to the at least one sample addition zone of the lateral flow assay device;

combining the sample and a reagent, wherein the sample and reagent may be combined prior to the adding of the sample to the at least one sample addition zone or on the assay device, the reagent including a detection material that produces a detectable signal that flows through the remainder of the lateral flow assay device along the flow path; and

triggering a process-related wash event including a dispense of at least one wash fluid into the at least one wash zone based upon the detection of the detectable signal in at least the first detection zone and a second signal at the second detection zone.

2. A method as recited in claim 1, wherein the reagent, including the detection material, is disposed in at least one reagent zone disposed downstream of the at least one sample addition zone and fluidly connected therewith.

3. A method as recited in claim 2, including the additional steps of:

monitoring the first detection zone, the second detection zone, or a combination thereof;

determining the time sample carrying the detectable signal is initially detected in the first detection zone, the second detection zone, or a combination thereof;

comparing the determined time to a known time period; and

triggering the process-related event upon the lateral flow assay device only if said determined time is within a threshold of the known time period.

4. A method as recited in claim 1, wherein the dispense of at least one wash fluid onto the wash zone is to flush out sample and detection material.

5. A method as recited in claim 1, wherein the second detection zone is at an initiation of the at least one wicking zone of the lateral flow assay device.

6. A method as recited in claim 1, further comprising the step of providing at least one capillary channel for diverting a portion of sample from the flow path across a linear detection path of the lateral flow assay device extending through the at least one detection zone;

and

detecting the presence or lack of presence of the detectable signal in the channel, the detecting step causing the triggering of the process-related event.

7. A method as recited in claim 1, wherein the detection material is a conjugate material that produces a fluorescent plume.

8. A method as recited in claim 1, wherein the lateral flow assay device includes a plurality of projections disposed on the at least one wicking zone, the plurality of projections being dimensioned to induce capillary flow along the flow path.

9. A method as recited in claim 2, including the additional step of monitoring at least one predetermined zone of the lateral flow assay device for the presence of detection material in any zone outside of the at least one reagent zone and prior to application of sample to the at least one sample addition zone.

10. A method as recited in claim 2, including the additional step of calculating at least one flow related parameter based on the monitoring of at least one of the appearance and cessation of the detectable signal at the first detection zone, the second detection zone, or a combination thereof.

11. A method as recited in claim 2, including the additional step of determining the cessation of the detectable signal at the first detection zone, the second detection zone, or a combination thereof.

12. A method as recited in claim 3, wherein the monitoring step is performed in the second detection zone.

13. A method as recited in claim 2, including the additional step of monitoring the first detection zone, the second detection zone, or a combination thereof and determining the amount of dissolved detection material in the at least one monitored area over a time period.

14. A method as recited in claim 2, including the additional step of monitoring the first detection zone, the second detection zone, or a combination thereof from the appearance to the termination of the detectable signal.

15. A method as recited in claim 14, including the additional step of creating a time history of the detectable signal relating to the at least one monitored area of the lateral flow assay device.

16. A method as recited in claim 1, wherein the dispense of wash fluid includes dispense of a reagent.

17. A method as recited in claim 1, wherein the second signal is the presence of a conjugate front.