Polyelectrolytic internal calibration system of a flow-through assay
First Claim
1. A flow-through assay device for detecting an analyte within a test sample, the flow-through assay device comprising a porous membrane in fluid communication with detectable probes conjugated with a specific binding member, the conjugated probes having a net charge prior to the application of a test sample to the device, the porous membrane defining:
- a detection zone that contains a capture reagent configured to bind with the conjugated probes or complexes thereof to generate a detection signal; and
a calibration zone positioned downstream from the detection zone, wherein a polyelectrolyte is substantially non-diffusively immobilized on the porous membrane within the calibration zone, the polyelectrolyte having a net charge opposite to that of the conjugated probes, the polyelectrolyte being configured to bind with the conjugated probes to generate a calibration signal.
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Abstract
A flow-through assay for detecting the quantity of an analyte residing in a test sample is provided. The flow-through assay contains a porous membrane that is in fluid communication with probe conjugates that contain a specific binding member and a detectable probe. The porous membrane also defines a detection zone and a calibration zone. The calibration zone contains a polyelectrolyte substantially non-diffusively immobilized on the porous membrane. The polyelectrolyte is capable of generating a detectable calibration signal that can be readily compared (visually, quantitatively, and the like) to a detection signal to determine the amount of analyte in the test sample.
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Citations
15 Claims
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1. A flow-through assay device for detecting an analyte within a test sample, the flow-through assay device comprising a porous membrane in fluid communication with detectable probes conjugated with a specific binding member, the conjugated probes having a net charge prior to the application of a test sample to the device, the porous membrane defining:
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a detection zone that contains a capture reagent configured to bind with the conjugated probes or complexes thereof to generate a detection signal; and a calibration zone positioned downstream from the detection zone, wherein a polyelectrolyte is substantially non-diffusively immobilized on the porous membrane within the calibration zone, the polyelectrolyte having a net charge opposite to that of the conjugated probes, the polyelectrolyte being configured to bind with the conjugated probes to generate a calibration signal. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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Specification