Quantitative lateral flow assays and devices

• US 6,924,153 B1
• Filed: 03/06/1997
• Issued: 08/02/2005
• Est. Priority Date: 03/06/1997
• Status: Expired due to Fees

• Current Assignee: Quidel Corporation
• Original Assignee: Quidel Corporation
• Inventors: Boehringer, Hans, Rowley, Gerald, Pronovost, Allan
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US08/812,616
• Time in Patent Office: 3,071 Days
• Field of Search: 422 55- 58, 422/61, 435/7.92, 435/7.93, 435/7.94, 435/7.5, 435/287.1, 435/287.2, 435/287.7, 435/287.9, 435/805, 435/810, 435/969, 435/970, 435/973, 435/975, 436/513, 436/514, 436/518, 436/531, 436/533, 436/534, 436/169, 436/805, 436/810, 436/808
• US Class Current: 436/514
• 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
• CPC Class Codes: G01N 33/689 related to pregnancy or the gonads
• CPC Class Codes: G01N 33/76 Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/969 Multiple layering of reactants
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 435/973 Simultaneous determination of more than one analyte
• CPC Class Codes: Y10S 435/975 Kit
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

This invention provides solid phase specific binding lateral flow assay methods, devices and kits for quantitating high and low molecular weight analytes. The methods and devices of the invention employ labelled reagents which are either analyte analogs or complementary specific binding pair members for the analyte and a novel arrangement of capture zones comprising immobilized specific binding substances for either the analyte or the labelled reagent to effect bound from unbound labelled reagent as a function of analyte concentration. The capture zones are disposed on a non-bibulous matrix defining a flow path from a sample receiving zone to the capture zone. The devices of this invention also include multilane flow paths and multiple capture zones to quantitate analyte.

Claims

1. A method of visually quantifying an amount of an analyte in a sample, wherein the analyte is a member of a specific binding pair (sbp member), comprising:

providing a lateral flow matrix which defines a flow path and which comprises in series, a sample receiving zone, a labeling zone, and a plurality of serially oriented capture zones, wherein the labeling zone comprises a diffusively bound labeled first sbp member that is complementary to or analogous to the analyte, and each of the capture zones comprises at least a second sbp member immobilized in the capture zones;

the second sbp member being complementary to the analyte;

contacting the sample with the sample receiving zone, whereby the sample flows along the flow path;

observing a pattern of label that accumulates at the plurality of capture zones; and

correlating a pattern of label accumulated in the capture zones to the amount of analyte in the sample;

wherein the sample receiving zone comprises an amount of a third sbp member immobilized within the sample receiving zone and complementary to the analyte, the amount being sufficient to bind a threshold level of the analyte.

2. A method of determining an amount of an analyte in a sample, wherein the analyte is a member of a specific binding pair (sbp member), comprising:

providing a lateral flow matrix which defines a flow path and which comprises in series, a sample receiving zone, a labeling zone, and one a plurality of serially oriented capture zones, wherein the labeling zone comprises a diffusively bound labeled first sbp member that is complementary to the analyte, and each of the capture zones comprises at least a second sbp member immobilized in the capture zones, the second sbp member being analogous to the analyte;

contacting the sample with the sample receiving zone, whereby the sample flows along the flow path;

observing a pattern of labeled first sbp member that accumulates at the plurality of capture zones; and

correlating a pattern of label accumulated in the capture zones to the amount of analyte in the sample;

wherein the labeled first sbp member includes a visually detectable label;

wherein the sample receiving zone comprises an amount of a third sbp member immobilized within the sample receiving zone and complementary to the analyte, the amount being sufficient to bind a threshold level of the analyte.

3. A device for determining an amount of an analyte in a sample, wherein the analyte is a member of a specific binding pair (sbp member), comprising a lateral flow matrix which defines a flow path and which comprises in series:

a sample receiving zone;

a labeling zone; and

a plurality of serially oriented capture zones;

wherein the labeling zone comprises a diffusively bound labeled first sbp member that is complementary to or analogous to the analyte, and each of the capture zones comprises at least a second sbp member immobilized in the capture zones, the second sbp member being complementary to the analyte;

wherein the sample receiving zone comprises an amount of a third sbp member immobilized within the sample receiving zone and complementary to the analyte, the amount being sufficient to bind a threshold level of the analyte.

4. A device for determining an amount of an analyte in a sample, wherein the analyte is a member of a specific binding pair (sbp member), the device comprising a lateral flow matrix which defines a flow path and which comprises in series:

a sample receiving zone;

a labeling zone; and

a plurality of serially oriented capture zones;

wherein the labeling zone comprises a diffusively bound labeled first sbp member that is complementary to or analogous to the analyte, and each of the one or more capture zones comprises at least a second sbp member immobilized in the capture zone, the second sbp member being complementary to the analyte;

wherein the sample receiving zone comprises an amount of a third sbp member immobilized within the sample receiving zone and complementary to the analyte, the amount being sufficient to bind a threshold level of the analyte.