Abstract: The invention relates to a direct sample collection pad for assay diagnosis of a sample without introducing an additional sampling device into the assay method. This simplifies the system and method of sample collection and assay diagnosis, thus reducing waste and potential for patient irritation or injury during diagnosis.

Abstract: Disclosed herein are assay methods, lateral flow assay test strips, and devices for improved analyte detection. Analyte binding to target is performed both in solution phase and with a target immobilized on a surface, resulting in improved analyte detection.

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 uses thereof in monitoring adherence to pre-exposure prophylaxis. Such reagents comprise NRTI derivatives, analogs, NRTI derivatives conjugates, along with antibodies directed to same, which are useful for antibody-based methods, such as a lateral flow immunoassay and other point of care devices.

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 antibody-based methods, such as a lateral flow immunoassay and other point of care devices.

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 method of preparing a cryo-surgical system for treatment includes accessing 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 further includes a plurality of flexible finger portions disposed proximate the second end of the delivery tube opposite the first end. A porous applicator bud is disposed proximate the second end of the delivery tube. The porous applicator bud includes a body portion disposed between the plurality of flexible finger portions and a contact surface extending from the plurality of flexible finger portions. An adjustment ring disposed along the delivery tube adjacent to the plurality of flexible finger portions can be used to adjust the size of the contact surface of the porous applicator bud.

Abstract: A method of preparing a cryo-surgical system for treatment includes accessing 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 further includes a plurality of flexible finger portions disposed proximate the second end of the delivery tube opposite the first end. A porous applicator bud is disposed proximate the second end of the delivery tube. The porous applicator bud includes a body portion disposed between the plurality of flexible finger portions and a contact surface extending from the plurality of flexible finger portions. An adjustment ring disposed along the delivery tube adjacent to the plurality of flexible finger portions can be used to adjust the size of the contact surface of the porous applicator bud.

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 collection kit includes a sample collector, a polycarbonate container, and a preservative solution. The sample collector includes an absorbent pad with a collecting element that receives a sample of oral fluid. The absorbent pad also includes an interior portion that extends into a handle. The handle includes an upper casing and a lower casing. The collecting element can be treated with a surfactant to optimize recovery of analytes from the oral sample and/or their absorbance onto the absorbent pad. A polycarbonate container receives the absorbent pad or the sample collector and stores it for testing of analytes. A dextran sulfate preservative solution is included in the polycarbonate container that inhibits enzymatic activity on a collected sample.

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 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.

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.