Multiplanar Lateral Flow Assay with Sample Compressor
First Claim
1. A lateral flow device for detecting an analyte in a sample comprising:
- a sample compressor;
a sample collector comprising a sample collection portion for collection of the sample;
a test strip comprising a sample application zone and a test zone;
a conjugate comprising a first binding partner for the analyte and a label; and
a second binding partner for the analyte;
wherein a component selected from the group consisting of the conjugate, the second binding partner and both the conjugate and the second binding partner is not located on the test strip prior to use of the lateral flow device; and
wherein the sample compressor, the sample collector, and the test strip form a vertical stack to apply the sample to the test strip by compression;
wherein the sample collector is located between the sample compressor and the test strip in the vertical stack.
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Accused Products
Abstract
A sample compressor applies pressure to a sample collector and a sample application zone of a test strip to transfer a sample from the sample collector and a binding partner of an analyte to the sample application zone in a lateral flow device. At least one of the binding partners of the analyte is not located on the test strip prior to use of the lateral flow device. The test strip may be a universal test strip with no molecule that specifically binds the analyte is located on the test strip. The sample compressor may be a universal sample compressor also with no molecule that specifically binds the analyte on the sample compressor. The lateral flow device may also include one or more enhancement elements, where the enhancement elements bind to the analyte sandwich to increase a detection signal in the test zone.
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Citations
50 Claims
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1. A lateral flow device for detecting an analyte in a sample comprising:
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a sample compressor; a sample collector comprising a sample collection portion for collection of the sample; a test strip comprising a sample application zone and a test zone; a conjugate comprising a first binding partner for the analyte and a label; and a second binding partner for the analyte; wherein a component selected from the group consisting of the conjugate, the second binding partner and both the conjugate and the second binding partner is not located on the test strip prior to use of the lateral flow device; and wherein the sample compressor, the sample collector, and the test strip form a vertical stack to apply the sample to the test strip by compression; wherein the sample collector is located between the sample compressor and the test strip in the vertical stack. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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- 11. A universal test strip for use in a lateral flow device, the universal test strip comprising a test zone and comprising no molecule which specifically binds an analyte.
- 15. A sample compressor for use in a lateral flow device, the sample compressor comprising a pad and at least one binding partner on the pad, wherein the binding partner binds an analyte.
- 17. A universal sample compressor for use in a lateral flow device, the sample compressor comprising no molecule which specifically binds an analyte.
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19. A lateral flow device for detecting an analyte comprising:
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a test strip comprising a sample application zone and a test zone; a first conjugate comprising a first binding partner for the analyte; a second binding partner for the analyte; and an enhancement element; wherein the analyte, the conjugate, and the second binding partner form a sandwich which is immobilized in the test zone when the analyte is present; and wherein the enhancement element binds to the sandwich to increase a detection signal in the test zone. - View Dependent Claims (20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. A method of applying a sample to a test strip of a lateral flow device, the method comprising the steps of:
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a) placing a sample collector comprising a sample collection portion with the sample in a vertical stack between a sample compressor and a sample application zone of the test strip; and b) applying a pressure to the sample collection portion using the sample compressor to transfer at least a portion of the sample to the sample application zone. - View Dependent Claims (31, 32, 33, 34)
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35. A lateral flow device for detecting an analyte in a sample comprising:
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a sample compressor; a sample collector comprising a sample collection portion for collection of the sample; a test strip comprising a sample application zone and a test zone; a conjugate comprising a first binding partner for the analyte and a label; and a second binding partner for the analyte; wherein a component selected from the group consisting of the conjugate, the second binding partner and both the conjugate and the second binding partner is not located on the test strip prior to use of the lateral flow device; and wherein the sample compressor, the sample collector, and the component not on the test strip prior to use of the lateral flow device form a vertical stack to apply the sample to the test strip by compression. - View Dependent Claims (36)
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37. A lateral flow device for detecting an analyte in a sample comprising:
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a sample compressor; a sample collector comprising a sample collection portion for collection of the sample; a test strip comprising a sample application zone and a test zone; a conjugate comprising a first binding partner for the analyte and a label; and a second binding partner for the analyte; wherein a component selected from the group consisting of the conjugate, the second binding partner and both the conjugate and the second binding partner is not located on the test strip prior to use of the lateral flow device; and wherein the conjugate and the second binding partner come into contact with the sample after pressure transfers the sample onto the test strip.
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38. A method of enhancing a signal on a lateral flow device comprising a test strip comprising a sample application zone and a test zone, a conjugate comprising a first binding partner for an analyte in a sample and a label, a second binding partner for the analyte;
- and an enhancement element, comprising the steps of;
a) immobilizing a sandwich formed between the analyte, if present in the sample, the conjugate, and the second binding partner in a test zone of the lateral flow device; and b) binding the enhancement element to the sandwich such that the enhancement element increases a detection signal in the test zone. - View Dependent Claims (39, 40, 41, 42, 43, 44)
- and an enhancement element, comprising the steps of;
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45. A method of detecting at least one analyte in a sample using a point-of-care assay device, the method comprising the steps of:
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a) adding a sample to a sample application zone of a chromatographic test strip; b) after step a), adding at least one labeled first binding partner for the analyte to the sample application zone such that, if the analyte is present in the sample, a first analyte complex forms between the first binding partner and the analyte; c) exposing the sample to at least one second tagged binding partner for the analyte; wherein, when the analyte is present, steps a) through c) result in the formation of a second analyte complex between the first binding partner, the analyte, and the second binding partner; and d) capturing the second analyte complex with an immobilized tag in a detection zone of the chromatographic test strip, wherein the immobilized tag complexes with a tag portion of the second binding partner. - View Dependent Claims (46, 47, 48, 49, 50)
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Specification