Abstract: The invention provides a developer solution vial and methods of its use to diagnose diseases using a sampling and/or assay device, for example, for use with a lateral flow assay (LFA) device. The developer solution vial may include any container that is capable of holding developer solution. The developer solution vial is keyed to the sampling and/or assay device. The developer solution vial minimizes the amount of developer solution required for accurate fluid flow assay testing.

Abstract: The invention provides novel compounds, reagents, systems, and methods for detecting a metabolite related to a NRTI in a biological sample, and use thereof in monitoring adherence to pre-exposure prophylaxis or anti-retroviral treatment. Such reagents comprise NRTI derivatives, analogs, NRTI derivatives conjugates, along with antibodies directed to same, which are useful for anti-body-based methods, such as a lateral flow immunoassay and other point of care devices.

Abstract: A cryo-surgical system may comprise a container containing a refrigerant, a delivery tube having a first end configured to be in flow communication with the container and a second end opposite the first end. The system may further include a plurality of flexible finger portions disposed proximate a second end of the delivery tube opposite the first end, an applicator bud having a body portion disposed within the plurality of flexible finger portions and a contact surface extending from the plurality of flexible finger portions. An adjustment ring may be disposed along the delivery tube adjacent to the plurality of flexible finger portions. The contact surface of the bud may be changeable by adjustment of the adjustment ring.

Abstract: A sample collector and test device is disclosed. The sample collector and test device may be used together as a diagnostic tool for collecting and assay of analytes contained in a sample. A sample collector is also disclosed which may be used with existing sample containers and or test devices. The sample collector may indicate sample adequacy when a sufficient volume of sample has been collected for assay and may also include a sample retaining feature which retains a portion of expressed sample for confirmatory testing, if desirable. The sample collector may also include a mechanism for expressing sample in a sample collector and/or test device. A test device is also disclosed for retaining and assay of an expressed sample. The disclosed test device may be used with existing sample collectors. In a preferred embodiment, test device is used with a preferred sample collector.

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.

Abstract: A cryosurgery device for dispensing a liquid refrigerant from a container having a valve stem extending outwardly therefrom. The device includes an actuator adapted to seat on the valve stem of the container in order to depress the valve stem to release the refrigerant from the container. The actuator includes an inner passageway having opposed ends disposed therein, one of the ends of the passageway being in fluid communication with the valve stem. An applicator tube is mounted to the actuator at the other end of the inner passageway. A cap is disposed on the top of the container. The actuator is movably positioned on the cap and a shield is attached to the cap to completely receiving the applicator tube. Liquid refrigerant can only be dispensed when the actuator is positioned properly and the applicator tube is disposed within the shield means.

Abstract: A container is configured to provide sequential access to contents therein, and includes an upper portion and a lower portion connected to the upper portion by a hinged portion, the lower portion defining an interior space bearing a moveable tray and an opening through which the moveable tray may move, the moveable tray defining an interior volume configured to receive at least one device therewithin. The container also includes at least one device borne by the moveable tray, at least one cavity for receiving the at least one device disposed in the upper portion and at least one insert located between the upper and lower portions, the at least one insert comprising at least written indicia thereon.

Abstract: A sample collector and test device is disclosed. The sample collector and test device may be used together as a diagnostic tool for collecting and assay of analytes contained in a sample. A sample collector is also disclosed which may be used with existing sample containers and or test devices. The sample collector may indicate sample adequacy when a sufficient volume of sample has been collected for assay and may also include a sample retaining feature which retains a portion of expressed sample for confirmatory testing, if desirable. The sample collector may also include a mechanism for expressing sample in a sample collector and/or test device. A test device is also disclosed for retaining and assay of an expressed sample. The disclosed test device may be used with existing sample collectors. In a preferred embodiment, test device is used with a preferred sample collector.

Abstract: A lateral flow test strip for the analysis of a sample featuring numerous capture zones arranged in an array such that each capture zone is substantially equidistant from the sample containing area. The sample does not pass through another capture zone to reach any one of the other capture zones. The capture zones are preferably arranged in a linear array perpendicular to the flow of the sample through the lateral flow test strip. The lateral flow test strip allows for an increased number of simultaneous analyses of numerous analytes from one sample to occur on one lateral flow test strip.

Abstract: An apparatus and process for transporting aqueous fluid from the oral cavity to a lateral chromatographic strip for test is disclosed. A lateral chromatographic strip is placed within a cavity defined in a housing. The lateral chromatography strip extends within the cavity and is disposed along the housing to an inspection site. At least one inspection site to the lateral chromate phic strip is provided to enable inspection of selected sites on the lateral chromatographic strip for test results. A porous wick material protrudes from the housing to a collection site exterior of the housing at one end and communicates to the lateral chromatographic strip at the other end. This porous wick material has particulate construction, the particles adsorbing aqueous oral fluid to transport the fluid from the mouth to the lateral chromatographic strip without substantial absorption.

Abstract: A device for collecting and transporting aqueous fluid from the oral cavity to a lateral chromatographic strip for test is disclosed. The lateral chromatographic strip is placed within and extend along a cavity defined in a housing. At least one inspection site to the lateral chromatographic strip is provided to enable inspection of selected sites on the lateral chromatographic strip for test results. A porous wick material protrudes from the housing to a collection site exterior of the housing at one end and communicates to the lateral chromatographic strip at the other end. The porous wick material has particulate construction, the particles adsorbing aqueous oral fluid to transport the fluid from the mouth to the lateral chromatographic strip without substantial absorption. The particles of the porous wick material are bound together to define a continuous interstitial volume for the flow of oral fluid to be transported and are treated to be hydrophilic to the adsorbed oral fluids.

Abstract: This invention provides for a rapid and convenient method of simultaneous collection of both genomic and diagnostic information from a single sample on a bibulous pad by differential extraction of the diagnostic information from the genomic information. It is a surprising discovery of this invention that a PCR assay on the contents of the bibulous pad provides results comparable in reliability, specificity, and sensitivity to the best available serum (blood) based assays. The assays of this invention can be used to confirm each other, either by detecting the genomic information leading to the diagnostic information, or by detecting in the genomic information, a predisposition to a disease and confirming the presence of the disease through diagnostic testing.

Abstract: A device for collecting and transporting aqueous fluid from the oral cavity to a lateral chromatographic strip for test is disclosed. The lateral chromatographic strip is placed within and extend along a cavity defined in a housing. At least one inspection site to the lateral chromatographic strip is provided to enable inspection of selected sites on the lateral chromatographic strip for test results. A porous wick material protrudes from the housing to a collection site exterior of the housing at one end and communicates to the lateral chromatographic strip at the other end. The porous wick material has particulate construction, the particles adsorbing aqueous oral fluid to transport the fluid from the mouth to the lateral chromatographic strip without substantial absorption. The particles of the porous wick material are bound together to define a continuous interstitial volume for the flow of oral fluid to be transported and are treated to be hydrophilic to the adsorbed oral fluids.

Abstract: A container is configured to provide sequential access to contents therein, and includes an upper portion and a lower portion connected to the upper portion by a hinged portion, the lower portion defining an interior space bearing a moveable tray and an opening through which the moveable tray may move, the moveable tray defining an interior volume configured to receive at least one device therewithin. The container also includes at least one device borne by the moveable tray, at least one cavity for receiving the at least one device disposed in the upper portion and at least one insert located between the upper and lower portions, the at least one insert comprising at least written indicia thereon.

Abstract: A lateral flow test strip for the analysis of a sample featuring numerous capture zones arranged in an array such that each capture zone is substantially equidistant from the sample containing area. The sample does not pass through another capture zone to reach any one of the other capture zones. The capture zones are preferably arranged in a linear array perpendicular to the flow of the sample through the lateral flow test strip. The lateral flow test strip allows for an increased number of simultaneous analyses of numerous analytes from one sample to occur on one lateral flow test strip.

Abstract: A device for collecting and transporting aqueous fluid from the oral cavity to a lateral chromatographic strip for test is disclosed. The lateral chromatographic strip is placed within and extend along a cavity defined in a housing. At least one inspection site to the lateral chromatographic strip is provided to enable inspection of selected sites on the lateral chromatographic strip for test results. A porous wick material protrudes from the housing to a collection site exterior of the housing at one end and communicates to the lateral chromatographic strip at the other end. The porous wick material has particulate construction, the particles adsorbing aqueous oral fluid to transport the fluid from the mouth to the lateral chromatographic strip without substantial absorption. The particles of the porous wick material are bound together to define a continuous interstitial volume for the flow of oral fluid to be transported and are treated to be hydrophilic to the adsorbed oral fluids.