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US 2006/0040408 A1Published application
Lateral flow format, materials and methods
AssigneeWhatman, Inc.
InventorsKevin Jones, David Cox
Life of this patent
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Abstract
The present invention provides a lateral flow format and materials and methods for using the format in a variety of applications. More particularly, the present invention provides single-layer lateral flow formats, materials and methods for detecting the presence of an analyte using a test strip comprising a dry porous medium comprising a single hydrophilic matrix. Devices are also provided as well as methods of making and using the format. The format is particularly useful for diagnosis of physiological and genetic conditions. In addition, the present invention provides methods and materials for concentrating a reagent in a porous medium.
Claims80
A test strip for detecting the possible presence of an analyte in a liquid sample applied to the test strip, the test strip comprising a dry porous medium comprising a single hydrophilic matrix, wherein the single hydrophilic matrix comprises:
- a. a network of fibers;
- and
- b. a series of zones comprising:
- i. a sample application zone;
- ii. a conjugate release zone comprising a labeled binding reagent, wherein
- the labeled binding reagent specifically binds to the analyte to form a first complex comprising the labeled binding reagent and the analyte;
- the labeled binding reagent comprises a label;
- and
- the labeled binding reagent is dry on the test strip prior to application of the liquid sample and is released into mobile form upon contact with the liquid sample;
- iii. a capture test zone comprising a capture test reagent, wherein
- the capture test reagent specifically binds either to the analyte or to the first complex to form a second complex comprising the labeled binding reagent, the analyte, and the capture test reagent;
- and
- the capture test reagent is dry on the test strip prior to application of the liquid sample and is largely immobile;
- iv. a capture control zone comprising a capture control reagent, wherein
- the capture control reagent binds to the labeled binding reagent to form a third complex comprising the labeled binding reagent and the capture control reagent;
- and
- the capture control reagent is dry on the test strip prior to application of the liquid sample and is largely immobile;
- and
- v. an absorbent zone, wherein the absorbent zone draws the liquid sample through the dry porous medium of the test strip by capillary action.
16 more elements
A test strip for detecting the possible presence of an analyte in a liquid sample applied to the test strip, the test strip comprising a dry porous medium comprising a single hydrophilic matrix, wherein the single hydrophilic matrix comprises:
- a. a monolithic hydrophilic matrix comprising a network of fibers;
- and
- b. a series of zones comprising:
- i. a sample application zone;
- ii. a conjugate release zone comprising a labeled binding reagent, wherein
- (a) the labeled binding reagent comprises:
- (i) a label;
- (ii) a solid substrate comprising a carrier bead, wherein the carrier bead is mobile within the matrix when the carrier bead and matrix are wet;
- and
- (iii) a ligand that specifically binds to the analyte to form a first complex comprising the labeled binding reagent and the analyte;
- and
- (b) the labeled binding reagent is dry on the test strip prior to application of the liquid sample and is released into mobile form upon contact with the liquid sample;
- iii. a capture test zone comprising a capture test reagent, wherein:
- (a) the capture test reagent comprises:
- (i) a solid substrate comprising a capture test bead;
- and
- (ii) a ligand that specifically binds to the analyte or to the first complex to form a second complex comprising the labeled binding reagent, the analyte, and the capture reagent;
- and
- (b) the capture test reagent is dry on the test strip prior to application of the liquid sample and is substantially immobile;
- iv. a capture control zone comprising a capture control reagent, wherein
- (a) the capture control reagent comprises:
- (i) a solid substrate comprising a capture control bead;
- and
- (ii) a ligand that specifically binds to the labeled binding reagent to form a third complex comprising the labeled binding reagent and the capture control reagent;
- and
- (b) the capture control reagent is dry on the test strip prior to application of the liquid sample and is substantially immobile;
- and
- v. an absorbent zone, wherein the absorbent zone draws the liquid sample through the dry porous medium of the test strip by capillary action.
25 more elements
A method for making a test strip for detecting the possible presence of an analyte in a liquid sample applied to the test strip, the test strip comprising a dry porous medium comprising a single hydrophilic matrix comprising a monolithic hydrophilic matrix, wherein the method comprises:
- a. providing a monolithic hydrophilic matrix, wherein the monolithic hydrophilic matrix comprises a network of fibers;
- b. creating a conjugate release zone on the monolithic hydrophilic matrix by:
- i. providing a labeled binding reagent, wherein the labeled binding reagent comprises:
- a label;
- a solid substrate comprising a carrier bead, wherein the carrier bead is mobile within the matrix when the carrier bead and matrix are wet;
- and
- a ligand that specifically binds to the analyte to form a first complex comprising the labeled binding reagent and the analyte;
- and
- ii. suspending the labeled binding reagent in a buffer;
- iii. applying the labeled binding reagent suspension to a first zone of the monolithic hydrophilic matrix;
- c. creating a capture test zone on the monolithic hydrophilic matrix by:
- i. providing a capture test reagent, wherein the capture test reagent comprises:
- a solid substrate comprising a capture test bead;
- a ligand that specifically binds to the analyte or to the first complex to form a second complex comprising the labeled binding reagent, the analyte, and the capture test reagent;
- and
- ii. suspending the capture test reagent in a buffer;
- iii. applying the capture test reagent suspension to a second zone of the monolithic hydrophilic matrix, wherein the second zone is downstream from the first zone;
- and
- d. creating a capture control zone on the monolithic hydrophilic matrix by:
- i. providing a capture control reagent, wherein the capture control reagent comprises:
- a solid substrate comprising a capture control bead;
- and
- a ligand that binds to the labeled binding reagent to form a third complex comprising the labeled binding reagent and the capture control reagent;
- and
- ii. suspending the capture control reagent in a buffer;
- iii. applying the capture control reagent suspension to a third zone of the monolithic hydrophilic matrix, wherein the third zone is downstream from the second zone;
- and
- e. drying the monolithic hydrophilic matrix to yield a dry porous medium.
25 more elements
A test strip for detecting the possible presence of any one of multiple analytes in a liquid sample applied to the test strip, the test strip comprising a dry porous medium comprising a single hydrophilic matrix, wherein the single hydrophilic matrix comprises:
- a. a monolithic hydrophilic matrix comprising a network of fibers;
- and
- b. a series of zones comprising:
- i. a sample application zone;
- ii. a conjugate release zone comprising a plurality of labeled binding reagents, wherein
- (a) each labeled binding reagent comprises:
- (i) a label;
- (ii) a solid substrate comprising a carrier bead, wherein the carrier bead is mobile within the matrix when the carrier bead and matrix are wet;
- and
- (iii) a ligand that specifically binds to one of the analytes to form a first complex comprising the labeled binding reagent and the analyte;
- (b) each labeled binding reagent is dry on the test strip prior to application of the liquid sample and is released into mobile form upon contact with the liquid sample;
- and
- (c) each labeled binding reagent specifically binds to a different analyte among the multiple analytes of the test;
- iii. a capture test zone comprising a plurality of capture test reagents, wherein:
- (a) each capture test reagent comprises:
- (i) a solid substrate comprising a capture test bead;
- and
- (ii) a ligand that specifically binds to one of the analytes or to one of the first complexes to form a second complex comprising the labeled binding reagent, analyte, and the capture reagent;
- (b) each capture test reagent is dry on the test strip prior to application of the liquid sample and is substantially immobile;
- and
- (c) each capture test reagent specifically binds to a different analyte or first complex among the multiple analytes and first complexes of the test;
- iv. a capture control zone comprising at least one capture control reagent, wherein
- (a) the capture control reagent comprises:
- (i) a solid substrate comprising a capture control bead;
- and
- (ii) a ligand that specifically binds to the labeled binding reagent to form a third complex comprising the labeled binding reagent and the capture control reagent;
- and
- (b) the capture control reagent is dry on the test strip prior to application of the liquid sample and is substantially immobile;
- and
- v. an absorbent zone, wherein the absorbent zone draws the liquid sample through the dry porous medium of the test strip by capillary action.
27 more elements
The method of 73, wherein the method tests for the presence of each of the following pathogens:
- a. human immunodeficiency virus;
- b. tuberculosis;
- and
- c. malaria.
1 more element
A method for concentrating a reagent in a porous medium comprising a monolithic hydrophilic matrix, wherein the method comprises:
- a. providing a monolithic hydrophilic matrix;
- providing a reagent, wherein the reagent comprises:
- i. a solid substrate;
- and
- ii. an agglutinating agent activated upon contact with an aqueous liquid;
- b. suspending the reagent in a buffer to yield a reagent suspension;
- c. applying the reagent suspension to the monolithic hydrophilic matrix;
- d. drying the reagent suspension on the monolithic hydrophilic matrix;
- and
- e. applying an aqueous liquid to the porous medium to activate the agglutinating agent in order to self-agglutinate the solid substrate of the reagent for concentrating the reagent in the monolithic hydrophilic matrix of the porous medium.
7 more elements
A method for concentrating a reagent in a porous medium comprising a monolithic hydrophilic matrix, wherein the method comprises:
- a. providing a monolithic hydrophilic matrix;
- b providing a reagent, wherein the reagent comprises:
- i. a negatively-charged solid substrate;
- ii. a positively-charged ligand attached to the solid substrate;
- c. suspending the reagent in a buffer to yield a reagent suspension;
- d. applying the reagent suspension to the monolithic hydrophilic matrix;
- e. drying the reagent suspension on the monolithic hydrophilic matrix;
- f. contacting the ligand with an aqueous liquid having a pH below the pI of the ligand and comprising a substance to which the ligand binds;
- and
- g. altering the overall charge of the reagent in order to self-agglutinate the reagent for concentrating the reagent in the monolithic hydrophilic matrix of the porous medium.
7 more elements
Dependencies are inferred from the claim text.