Abstract: The invention is an electronically processed single-step test device for detecting the presence of a preselected analyte in a fluid. The device includes a hollow rectangular outer casing, disposed within co-joined upper and lower sections of the casing are assay material, an electronic processing system, and a LCD display. The LCD display is observable through a viewing window. The assay material is a sorptive material including a fluid sample application region in the form of a sample wick in fluid communication with a test strip. The test strip includes an analyte capture region adjacent to a light shield. The electronic processing system includes red and green LEDs which are alternately pulsed or energized over predetermined periods of time to determine if fluid test results show a marker or markers in the capture region indicative of the presence of a preselected analyte in the fluid. If so, Yes+ is displayed on the LCD. If not, No? is displayed on the LCD.

Abstract: The invention is an improved single-step test device for detecting the presence of a pre-selected analyte in a urine stream. The device includes a hollow rectangular outer casing and an assay material disposed within co-joined upper and lower sections of the casing. The outer casing includes a urine inlet port; a viewing window in the upper section; at least the upper section consisting of transparent material; and may also include at least one drainage vent spaced about the urine inlet port. The assay material is a sorptive material including: a urine sample application region adjacent to, and in fluid communication with the urine inlet port; a capture region adjacent to the viewing window; and a fluid flow path for transporting a liquid sample between the urine sample application region and the analyte capture region. The flow of urine in the fluid path is observable through the transparent upper section for confirming a test is operative.

Abstract: The invention is an improved single-step test device for detecting the presence of a pre-selected analyte in a urine stream. The device includes a hollow rectangular outer casing and an assay material disposed within co-joined upper and lower sections of the casing. The outer casing includes a urine inlet port; a viewing window in the upper section; at least the upper section consisting of transparent material; and may also include at least one drainage vent spaced about the urine inlet port. The assay material is a sorptive material including: a urine sample application region adjacent to, and in fluid communication with the urine inlet port; a capture region adjacent to the viewing window; and a fluid flow path for transporting a liquid sample between the urine sample application region and the analyte capture region. The flow of urine in the fluid path is observable through the transparent upper section for confirming a test is operative.

Abstract: The invention relates to a method of making a laminated substrate for use in an immunodiagnostic device and a machine or apparatus for marking the substrate with reagent. The method of forming the laminated substrate creates a rollable chromatographic medium. The chromatographic medium can be biphasic or multiphasic. The biphasic chromatographic medium comprises a capture medium precast onto a plastic backing and a release medium. The release and capture media are bonded to a liner material such as a plastic film. The multiphasic chromatographic medium comprises a capture medium precast onto a plastic backing, a release medium, and a sample absorbent medium. The capture medium, the release medium and the sample absorbent medium are disposed on a liner material such as a plastic film. The biphasic and multiphasic laminates are prepared for use as immunoassays by a specially adapted machine or apparatus.