Abstract: A device for collecting oral liquids includes a lateral flow chromatography strip having a collection pad for insertion into the mouth. The collection pad is separated from the remainder of the chromatography strip by a liquid impermeable removable barrier which prevents liquid in the collection pad from entering the chromatography strip. Once adequate oral liquid has been collected (as indicated by a sample sufficiency indicator), the device is withdrawn from the mouth and the barrier is removed to allow oral liquids to flow through the strip. The liquids interact with binding partners in the strip to provide test results, such as an indication that an analyte of interest is present in the liquid. The strip may be contained in a housing with an access opening through which the removable barrier may be manipulated, and windows through which test results may be viewed. This device avoids reflux of reagents from the strip into the mouth of a test subject during use.

Abstract: Methods and devices for the detection and/or quantification of an analyte in a sample are provided. These are positive detection methods and devices, in that the more analyte is present in the sample, the stronger the signal that is provided. Devices of the invention include a mobilization zone including a mobile or mobilizable detectable analyte analog, a sample application area, primary and secondary capture areas each including an immobilized binding partner having a binding affinity for the analyte being tested for a detectable analyte analog. The mobilization zone, sample application area, primary and secondary capture area are in fluid continuous contact with each other. In these devices, the first immobilized binding partner has an equal or lower apparent affinity for the analyte than it has for the detectable analyte analog.

Abstract: A device for collecting oral liquids includes a lateral flow chromatography strip having a collection pad for insertion into the mouth. The collection pad is separated from the remainder of the chromatography strip by a liquid impermeable removable barrier which prevents liquid in the collection pad from entering the chromatography strip. Once adequate oral liquid has been collected (as indicated by a sample sufficiency indicator), the device is withdrawn from the mouth and the barrier is removed to allow oral liquids to flow through the strip. The liquids interact with binding partners in the strip to provide test results, such as an indication that an analyte of interest is present in the liquid. The strip may be contained in a housing with an access opening through which the removable barrier may be manipulated, and windows through which test results may be viewed. This device avoids reflux of reagents from the strip into the mouth of a test subject during use.

Abstract: Microporous solid phase materials that are suitable for lateral flow and other assays for detecting the presence of analytes in test samples, that are stable under variations in humidity and, even after storage for extended periods of time, can form stable covalent bonds with molecules containing a free primary or secondary amine group or sulfhydryl group are described. The invention further concerns chemically derivatized solid phase materials, and conjugates comprising such materials. Examples of lateral flow devices for the quantitative or semi-quantitative determination of an analyte in a biological sample are described.

Abstract: Lateral flow device and method are provided for performing semi-quantitative visual or instrument-based detection in a test sample of a large molecule analyte that contains two binding domains, &agr; and &bgr;. The device contains two reagents, a contrast reagent and an indicator reagent, and an analyte test zone (ATZ) that contains a fixed number of immobilized &agr;-domain-specific binding sites. The contrast and indicator reagents each contain signal generators such that the two reagents contrast each other in different regions of a visual, spectrophotometric, calorimetric or fluorometric spectrum. The contrast reagent is prebound to an &agr;-region-fragment of the analyte of interest and, therefore, does not react with the analyte of interest in the test sample. The indicator reagent is attached to a binding ligand specific for the &bgr;-domain of the analyte of interest.

Abstract: There is provided a biodegradable feminine hygienic interlabia pad which includes a biodegradable inner absorbent sliver made of cotton or rayon and a biodegradable outer cover also made of cotton or rayon. The edges of the outer cover are sewn together to form a hollow cylinder. There is also provided a method and apparatus for manufacturing the pads. A rope of absorbent material and a web of the outer covering are brought together in a die. The die in the form of a hollow tube and a tapered guide which causes the outer covering to enclose the absorbent material with the seam for the outer covering being on the inside of the pad. The die includes an opening for exposing the adjacent edges of the web so that the edges may be sewn together. Also adjacent panels are formed by sewing the pad itself.

Abstract: There is provided a method and apparatus for collecting vaginal fluid and exfoliated vaginal cells for medical diagnostic purposes. An absorbent media is placed interlabially or intravaginally. Fluid is collected within the absorbent media. The absorbent media is removed, and the fluid is extracted therefrom. For intravaginal collection, the absorbent media may be placed in a housing having fluid receiving apertures therein. Medical diagnostic testing is performed on the extracted fluid.

Abstract: There is provided a method and apparatus for collecting vaginal fluid and exfoliated vaginal cells for medical diagnostic purposes. An absorbent media is placed interlabially or intravaginally. Fluid is collected within the absorbent media. The absorbent media is removed, and the fluid is extracted therefrom. For intravaginal collection, the absorbent media may be placed in a housing having fluid receiving apertures therein. Medical diagnostic testing is performed on the extracted fluid.

Abstract: There is provided a method and apparatus for collecting vaginal fluid and exfoliated vaginal cells for medical diagnostic purposes. An absorbent media is placed interlabially or intravaginally. Fluid is collected within the absorbent media. The absorbent media is removed, and the fluid is extracted therefrom. For intravaginal collection, the absorbent media may be placed in a housing having fluid receiving apertures therein. Medical diagnostic testing is performed on the extracted fluid.