Methods And Devices For Using Mucolytic Agents Including N-Acetyl Cysteine (NAC)
AssigneeRapid Pathogen Screening, Inc.
InventorsUma Mahesh Babu, Robert P. Sambursky
Life of this patent
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Abstract
Devices and methods incorporate mucolytic agents into a point-of-care testing device. The sample is loaded, and then the sample travels until it encounters one or more lysis agents and/or mucolytic agents. The mucolytic agent is preferably pre-loaded onto the collection device. In a preferred embodiment, the mucolytic agent is localized between the sample application zone and the conjugate zone. In embodiments with a sample compressor, one or more mucolytic agents may be pre-loaded and dried on the sample compressor, the sample collector, in various locations on the test strip, or in the running buffer.
Claims35
A device for the detection of a target in a sample comprising:
- a) a sample application zone for applying a sample to the device;
- b) a detection zone located downstream of the sample application zone;
- c) a conjugate zone comprising at least one labeled binding partner that is able to migrate with an elution medium, wherein the conjugate zone is located on the device at a location such that the sample encounters the labeled binding partner during an assay run on the device;
- and
- d) a mucolytic zone comprising at least one mucolytic agent, wherein the mucolytic zone is located in a location on the device selected from the group consisting of:
- i) upstream of the sample application zone;
- ii) between the sample application zone and the conjugate zone;
- iii) a location where at least a portion of the mucolytic zone overlaps the sample application zone;
- iv) a location where at least a portion of the mucolytic zone overlaps the conjugate zone;
- and
- v) a location where at least a portion of the mucolytic zone overlaps the sample application zone and at least a portion of the mucolytic zone overlaps the conjugate zone.
A method for detecting at least one target in a sample, comprising the steps of:
- a) transferring a sample from a mucosal membrane fluid that has not been pretreated onto a sample application zone of a sample analysis device;
- b) applying an elution medium to the sample analysis device to transfer the sample from the sample application zone to a detection zone, wherein the sample encounters at least one mucolytic agent on the sample analysis device or in the elution medium such that the sample is mucolysed prior to reaching the detection zone;
- and
- c) analyzing the sample;
- wherein the sample application zone, the mucolytic agent and the detection zone are on a chromatographic test strip, and the chromatographic test strip further comprises a conjugate zone, wherein the conjugate zone comprises at least one labeled binding partner that is able to migrate with the elution medium and wherein the labeled binding partner encounters the sample while the sample is being transferred from the sample application zone to the detection zone.
A device for the detection of a target in a sample comprising;
- a) a sample application zone for applying a sample to the device;
- b) a detection zone located downstream of the sample application zone;
- and
- c) a conjugate zone comprising at least one labeled binding partner that is able to migrate with an elution medium, wherein the conjugate zone is located on the device at a location such that the sample encounters the labeled binding partner during an assay run on the device;
- and
- wherein the elution medium comprises at least one mucolytic agent.
A lateral flow assay device for the detection of a target in a sample, the device comprising at least one mucolytic agent pre-loaded onto the lateral flow assay device.
A method of detecting at least one target in a sample using a lateral flow device, comprising the steps of:
- a) transferring a sample from a mucosal membrane fluid that is not pretreated onto a sample application zone of the lateral flow device;
- and
- b) mucolysing the sample during a running of an assay on the lateral flow device.
A lateral flow device for detecting an analyte in a sample comprising:
- a sample compressor comprising at least one mucolytic agent;
- 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.
A method of applying a sample to a test strip of a lateral flow device, the method comprising the steps of:
- 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, wherein the sample compressor comprises at least one mucolytic agent;
- 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.
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;
- a second binding partner for the analyte;
- and
- a mucolytic agent located in a location selected from the group consisting of:
- i) on the sample compressor;
- ii) on the sample collection portion of the sample collector and iii) on the test strip;
- 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.
Dependencies are inferred from the claim text.