Abstract: A lateral flow immunoassay system is provided that includes a housing having a base portion forming a first chamber therein and a body portion formed with three openings in fluid communication with the first chamber, a vial containing a buffer agent, and a sample collector for introducing a sample fluid into the first chamber via the second opening. The vial is mounted to the housing such that a dispensing side extends into the first opening for dispensing the buffer agent therefrom into the first chamber. The housing allows the buffer agent and sample fluid to be mixed within a reaction well formed within the first chamber to form a test sample mixture. The body portion is configured to receive a receiving end of an elongated holder in the third opening and allow a test strip secured in the holder to be brought into communication with the text sample mixture.

Abstract: A lateral flow immunoassay system is provided that includes a housing having a base portion forming a first chamber therein and a body portion formed with three openings in fluid communication with the first chamber, a vial containing a buffer agent, and a sample collector for introducing a sample fluid into the first chamber via the second opening. The vial is mounted to the housing such that a dispensing side extends into the first opening for dispensing the buffer agent therefrom into the first chamber. The housing allows the buffer agent and sample fluid to be mixed within a reaction well formed within the first chamber to form a test sample mixture. The body portion is configured to receive a receiving end of an elongated holder in the third opening and allow a test strip secured in the holder to be brought into communication with the text sample mixture.

Abstract: Devices and methods for testing a biological sample for an analyte of interest are provided that make use of a reaction chamber for receiving a reaction mixture, a housing positioned below the reaction chamber for receiving a test cassette, and a door that is positioned in the top portion of the housing. The door includes a ramp that extends downwardly into the housing such that biasing the ramp upwards opens the door into the cavity of the reaction chamber and places the reaction chamber in fluid communication with the insertion area to thereby allow the reaction mixture to flow onto a test cassette and allow for the determination of an amount of an analyte of interest.

Abstract: An extraction method and apparatus is provided for obtaining quick, safe and highly sensitive testing of a variety of body fluids including saliva, blood, urine or other fluids for drugs of abuse or other analytes. The apparatus includes a latchable extraction wand for obtaining body fluid samples from a subject which is adapted to maximize the portion of the body fluid sample that will go into a graduated bottle containing a buffer solution, and a testing device wherein the sample will be received and into which test strips can be inserted to determine levels of drugs of abuse or other analyte in the sample. In one of the methods of the invention, energy is imparted to the sample and buffer solution, such as by shaking, and this facilitates reduction of sample viscosity, such as by promoting the breakdown of mucins when the sample is saliva.

Abstract: A method and device are provided for stimulating and increasing the production of saliva during immunoassay tests for drugs or other analytes wherein a scent or odor capable of stimulating saliva production is incorporated into a device for obtaining an oral sample from a test subject. The scent or odor may be impregnated into the oral sample collection device or may be part of an attachment to such a device, and the scent or odor is disposed in such a manner so as to maximize the exposure of the scent to the test subject and thus stimulate the production of saliva. The method and device of the invention are advantageous because the increased production of saliva will facilitate the testing of an oral sample for drugs or other analytes and will increase the likelihood of obtaining a complete and accurate result.

Abstract: An assay device for testing of liquid samples for drugs of abuse has a transparent container for retaining a liquid sample. A backing member is within the container and is curved so that its front surface corresponds to the curvature of the container wall. Immunoassay test strips are on the front face of the backing and are visible through the container wall. Each test strip is enclosed in a transparent pocket which has a bottom opening through which the bottom portion of the test strip protrudes to contact the liquid sample within the container. The liquid then flows upwardly through the test strip to react with reagents within the test strip.

Abstract: A lateral flow immunoassay test device is provided that includes a housing with an elongated slot for holding a test sample collector; an elongated holder member for securing at least one immunoassay test strip therein; a first chamber for storing a first, pre-treatment reagent; and a second chamber for storing a second reagent. Methods of conducting lateral flow immunoassays are also provided. The device and methods of conducting lateral flow immunoassays as provided herein are advantageous in that they allow pre-treatment and pre-incubation of the test sample so that the sample flows onto the test strip more easily and provide for increases in the sensitivity of the assay.

Abstract: An extraction method and apparatus is provided for obtaining quick, safe and highly sensitive testing of any of a variety of body fluids including saliva, blood, urine or other fluids for drugs of abuse or other analytes. The apparatus includes a latchable extraction wand for obtaining body fluid samples from a subject which is adapted to maximize the portion of the body fluid sample that will go into a graduated bottle containing a buffer solution, and a testing device wherein the sample will be received and into which test strips can be inserted to determine levels of drugs of abuse or other analyte in the sample. In one of the methods of the invention, energy is imparted to the sample and buffer solution, such as by shaking, and this facilitates the reduction of sample viscosity, such as by promoting the breakdown of mucins when the sample is saliva.

Abstract: A method and device are provided for stimulating and increasing the production of saliva during immunoassay tests for drugs or other analytes wherein a scent or odor capable of stimulating saliva production is incorporated into a device for obtaining an oral sample from a test subject. The scent or odor may be impregnated into the oral sample collection device or may be part of an attachment to such a device, and the scent or odor is disposed in such a manner so as to maximize the exposure of the scent to the test subject and thus stimulate the production of saliva. The method and device of the invention are advantageous because the increased production of saliva will facilitate the testing of an oral sample for drugs or other analytes and will increase the likelihood of obtaining a complete and accurate result.

Abstract: A lateral flow immunoassay test device that includes a housing with an elongated slot for holding a test sample collector; an elongated holder member for securing at least one immunoassay test strip therein; a first chamber for storing a first, pre-treatment reagent; and a second chamber for storing a second reagent. The pre-treatment reagent is contained within a rupturable enclosure. A piercing member is located within the housing that is used to rupture the enclosure in order to release the pre-treatment reagent so that the sample and pre-treatment reagent form a mixture. The second reagent may then be introduced to the mixture which is allowed to react with the second reagent for a period of time. The mixture and second reagent combination is then contacted with the immunoassay test strip.

Abstract: A container for retaining a liquid sample to be tested is closed by a removable closure cap having a slot therein to receive a flat rectangular panel test card member inserted through the slot into the container. A flexible resilient member is mounted adjoining to the closure cap slot and has a slit therein with abutting edges through which the test card is passed. After the test card has been withdrawn, the abutting edges contract to their normally closed position to prevent the leakage of any liquid through the slot when the container is being handled. During withdrawal of the test card through the slot the abutting edges wipe excess liquid sample from the test card.

Abstract: A test card for drugs of abuse has a thin flat member having the size and shape of a business card. A plurality of immunoassay test strips extend longitudinally from top to bottom at the card and are fastened side by side in parallel on one or both sides of the test card within the outline of the card. Each test strip is reactive to provide a visual indication in response to a particular drug of abuse. The test card thus provides for the simultaneous detection of multiple analytes. Processes are also disclosed for making the drug test card with test strips on one and both sides of the card.

Abstract: A drug abuse test kit has a transparent cup-like container for retaining a fluid sample to be tested and the open top end of the container is closed by a closure cap seated upon the open end. There is a slit in the closure cap to receive a multiple drug test card having a plurality of immunoassay test strips thereon with visual endpoints to indicate presence or absence of a particular drug. The container is provided with a second cover which is solid and unslit to close and seal the container when a sample therein is to be transported.