Patent ID: 6248598
Filing Date: 2001-06-19
Classification: B01L,G01N,Y10S

Abstract:
A method for detecting at least one analyte in the saliva of a subject suspected of containing said analyte using a device that provides for both the collection of saliva and the detection of at least one analyte contained therein, comprising the following steps:(i) collecting saliva in a device that provides for the simultaneous collection of saliva and detection of an analyte in said saliva wherein said device comprises the following:(a) at least a portion (a) for saliva collection comprised of an absorbent material that when placed in the mouth provides for saliva absorption and flow onto a second portion (b) with which (a) is in contact,(b) at least one portion (b) that comprises a solid support constituted of an absorbent material that provides for the immunochromatographic assay of saliva, which comprises a visual read area on which visual detection of the presence or absence of an analyte can be seen after the assay is complete, on which visual reading area is directly or indirectly bound,(1) at least one ligand that specifically binds the analyte that is to be detected;(2) at least one tracer that is comprised of the analyte labeled with a visually detectable particulate label without the need for any other visual detection device;(3) an area within the visual read area that contains a line or other visually detectable area indicative of the presence or absence of the analyte being detected and optionally a control area that contains a line or other visually detectable area that indicates that the assay is completed;(c) at least one area (c) that is in contact with (b) at least at one end, which is comprised of an absorbent material tat provides for the flow of saliva from (b) toward the end of the device opposite the end at which saliva collection occurs and;(d) a holder that contains the area (b) and (c), and which comprises at least one cut-out portion that provides for visual detection of the visual read area contained in (b) after assay has been completed; andwherein said collection of saliva is effected by placing the saliva collection end of said device in the mouth of said subject for about 10 to 120 seconds resulting in a sufficient amount of saliva being absorbed by said device to enable analyte detection;(ii) removal of said device from the mouth; and(iii) visually detecting about one to sixty minutes after saliva collection whether said at least one analyte is present or absent by visually analyzing the visual read area on said solid support area (b) of said device.