Accessible assay and method of use
First Claim
1. A lateral flow assay test device for detection of target analytes in a sample, said device comprising:
- a housing member shaped and configured to have two arms connected by a spanning portion, thereby generally forming an open space between the two arms, the housing also having an interior space exposed on one side of the housing;
a cover element shaped and configured to enclose the interior space of the housing member;
at least one analytical test strip positioned between the two arms, the strip also being at least partially sandwiched between the housing member and the cover element, the strip comprising;
a base member;
an analytical membrane having a first end and a second end;
a conjugate pad at the first end of the analytical membrane; and
at least one capture region in the analytical membrane intermediate said first and second ends thereof, said capture region being configured to capture labeled analytes moving from said first end of said analytical membrane toward said second end of said analytical membrane;
the open space in the housing member being shaped and configured to provide lateral access to the test strip and to enable the determination of the presence of target analytes in the capture region of the test strip while the test strip remains mounted to the housing.
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Accused Products
Abstract
An assay test strip and cassette. The test strip is positioned in a housing shaped and configured to allow a detector to access the test strip from the side, rather than from the lengthwise axis of the test strip. The housing may contain one or more test strips which may also be disposed on one or more surfaces of the housing. Preferably, the housing is generally C-shaped with the test strip spanning the space between the two arms of the C-shape. The housing is sealed to protect both the operator and instrument from possible contamination. The test strip is preferably embedded with paramagnetic particles and process chemistry specific for a particular application. Quantitative analysis may be accomplished using a magnetic reader device. In additional embodiments, detection is accomplished by visual means.
39 Citations
29 Claims
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1. A lateral flow assay test device for detection of target analytes in a sample, said device comprising:
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a housing member shaped and configured to have two arms connected by a spanning portion, thereby generally forming an open space between the two arms, the housing also having an interior space exposed on one side of the housing;
a cover element shaped and configured to enclose the interior space of the housing member;
at least one analytical test strip positioned between the two arms, the strip also being at least partially sandwiched between the housing member and the cover element, the strip comprising;
a base member;
an analytical membrane having a first end and a second end;
a conjugate pad at the first end of the analytical membrane; and
at least one capture region in the analytical membrane intermediate said first and second ends thereof, said capture region being configured to capture labeled analytes moving from said first end of said analytical membrane toward said second end of said analytical membrane;
the open space in the housing member being shaped and configured to provide lateral access to the test strip and to enable the determination of the presence of target analytes in the capture region of the test strip while the test strip remains mounted to the housing. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A lateral flow assay test device for detection of target analytes in a sample, said device comprising:
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a housing member having an interior space exposed on one side of the housing;
a cover element shaped and configured to enclose the interior space of the housing member;
at least one analytical test strip positioned within the housing, the strip also being sandwiched between the housing member and the cover, the strip comprising;
a base member;
an analytical membrane having a first end and a second end;
a conjugate containing element in contact with the first end of the analytical membrane; and
at least one capture region in the analytical membrane intermediate said first and second ends thereof, said capture region being configured to capture conjugates moving from said first end of said analytical membrane toward said second end of said analytical membrane;
the open space in the housing member being shaped and configured to provide lateral access to the test strip and to enable the determination of the presence of target analytes in the capture region of the test strip while the test strip remains mounted to the housing. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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29. A method for quantitative detection of target analytes in a sample using a lateral flow immunoassay, the method comprising:
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applying the sample to one end of a porous membrane of a lateral flow test strip;
coupling superparamagnetic conjugate particles residing in the test strip at said one end, the superparamagnetic particles being treated to bind with any target analyte in the sample;
capturing the bound complexes of analyte and superparamagnetic particles in the capture region of the porous membrane as the sample and bound complexes move through the porous membrane by capillary action;
inserting at least a portion of the test strip sideways into a magnetic reader device;
reading the quantity of labeled analytes in the capture region; and
providing an output representative of the quantity of labeled analytes in the capture region.
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Specification