Device for collection and assay of oral fluids
First Claim
1. A method for rapid collection and assay of oral fluids, comprising the steps of:
- (a) placing an assay device into an oral cavity, said assay device comprising;
(i) an assay portion housing an immunochromatographic lateral flow assay strip, said lateral flow assay strip containing at least one reagent selected from an antigen and an antibody that is used to detect one of the presence or absence of at least one analyte in a fluid;
(ii) a neck portion extending from said assay portion, said neck portion forming a channel for delivery of fluid to said assay strip and said channel being defined by a first, narrow part proximal to the assay portion and a second part including an opening for receiving the oral fluid, wherein said second part includes a channel width that is substantially wider than the channel width at the narrow end;
(iii) a collection strip in fluid communication with said lateral flow assay strip, said collection strip having a first portion disposed within the channel and a second portion protruding outwardly from the neck portion opening; and
(iv) a blocking strip coupled between and in flow communication with said lateral flow assay strip and said collection strip;
(b) removing said assay device from said oral cavity; and
(c) determining the presence or absence of at least one analyte.
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Accused Products
Abstract
A method for rapid collection and assay of oral fluids is disclosed. The method comprising the steps of: (a) placing an assay device into an oral cavity, (b) removing said assay device from said oral cavity; and (c) determining the presence or absence of at least one analyte. The assay device used in the method comprises: (i) an assay portion housing an immunochrornatographic lateral flow assay strip, the lateral flow assay strip containing at least one reagent selected from an antigen and an antibody that is used to detect one of the presence or absence of at least one analyte in a fluid; (ii) a neck portion extending from the assay portion, the neck portion forming a channel for delivery of fluid to said assay strip and the channel being defined by a first, narrow part proximal to the assay portion and a second part including an opening for receiving the oral fluid, wherein the second part includes a channel width that is substantially wider than the channel width at the narrow end; (iii) a collection strip in fluid communication with the lateral flow assay strip, the collection strip having a first portion disposed within the channel and a second portion protruding outwardly from the neck portion opening; and (iv) a blocking strip coupled between and in flow communication with the lateral flow assay strip and the collection strip.
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Citations
24 Claims
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1. A method for rapid collection and assay of oral fluids, comprising the steps of:
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(a) placing an assay device into an oral cavity, said assay device comprising; (i) an assay portion housing an immunochromatographic lateral flow assay strip, said lateral flow assay strip containing at least one reagent selected from an antigen and an antibody that is used to detect one of the presence or absence of at least one analyte in a fluid; (ii) a neck portion extending from said assay portion, said neck portion forming a channel for delivery of fluid to said assay strip and said channel being defined by a first, narrow part proximal to the assay portion and a second part including an opening for receiving the oral fluid, wherein said second part includes a channel width that is substantially wider than the channel width at the narrow end; (iii) a collection strip in fluid communication with said lateral flow assay strip, said collection strip having a first portion disposed within the channel and a second portion protruding outwardly from the neck portion opening; and (iv) a blocking strip coupled between and in flow communication with said lateral flow assay strip and said collection strip; (b) removing said assay device from said oral cavity; and (c) determining the presence or absence of at least one analyte. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. An assay method for HIV using oral fluids, comprising the steps of:
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(a) placing an assay device into an oral cavity, said assay device comprising; (i) an assay portion housing an immunochromatographic lateral flow assay strip, said lateral flow assay strip containing at least one reagent that is used to detect one of the presence or absence of at least one HIV antibody in a fluid; (ii) a neck portion extending from said assay portion, said neck portion forming a channel for delivery of fluid to said assay strip and said channel being defined by a first, narrow part proximal to the assay portion and a second part including an opening for receiving the oral fluid, wherein said second part includes a channel width that is substantially wider than the channel width at the narrow end; (iii) a collection strip in fluid communication with said lateral flow assay strip, said collection strip having a first portion disposed within the channel and a second portion protruding outwardly from the neck portion opening; and (iv) a blocking strip coupled between and in flow communication with said lateral flow assay strip and said collection strip, wherein said blocking strip contains a blocking agent or a buffer; (b) removing the assay device from the oral cavity; and (c) determining the presence or absence of HIV antibodies. - View Dependent Claims (23, 24)
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Specification