Device for collection and assay of oral fluids

Abstract

A method and a device for collection and assay of oral fluids are disclosed. The method places an assay device into an oral cavity, removes the device, and determines the presence or absence of an analyte. The assay device comprises an assay portion housing a lateral flow assay strip, a neck portion extending from the assay portion and forming a channel for fluid delivery to the assay strip; a collection strip in fluid communication with the lateral flow assay strip; and a blocking strip coupled between and in flow communication with the lateral flow assay strip and the collection strip. The channel is defined by a narrow part proximal to the assay portion and a part which receives oral fluid and has a substantially wider channel width. The collection strip has a first portion disposed within the channel and a second portion protruding outwardly from the neck opening.

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 a 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 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.