Abstract: This invention is directed to a lateral flow assay for detecting the presence of an analyte in a liquid test sample. The lateral flow assay represents an improvement in the ability to accurately and with high fidelity to detect the presence or absence of a target analyte in a liquid sample, in part, by encompassing a reference region of immobilized, non-diffusible analyte that allows for detection of any factors that interfere with the interaction and binding of the analyte to the labeled capture reagent. Any influences on the interaction and binding of the analyte that is free in solution in the liquid test sample to its complementary labeled reagent will be encountered in parallel in the binding between the immobilized analyte in reference region to the labeled reagent as it diffuses through the reference region. In one embodiment, the lateral flow assay of the invention is a urine-based human Chorionic Gonadotropin (hCG) assay.

Abstract: Apparatus and methods are disclosed for verifying one or more operational conditions of an optical inspection machine. A row of grooves (1-5) that simulate a reagent pad containing a specific type of analytes at known concentrations can be used for verification of the operation of the machine. Apparatus can include a row of grooves (1-5), each with different geometry, configured on an insertable device (20). The insertable device (20) can be positioned so that the row of grooves (1-5) can be illuminated by the readhead of the machine. If the optical inspection machine provides results corresponding to the known type(s) and concentrations of analyte(s), proper operation of the optical inspection machine is indicated. If the simulated type and concentration of specified reagen is not indicated, improper operation is indicated. Measurement error due to non-machine error is indicated when the known type and concentration of the analyte simulated by the rows (1-5) is indicated.

Abstract: Apparatus and methods are disclosed for verifying one or more operational conditions of an optical inspection machine. A row of grooves (1-5) that simulate a reagent pad containing a specific type of analytes at known concentrations can be used for verification of the operation of the machine. Apparatus can include a row of grooves (1-5), each with different geometry, configured on an insertable device (20). The insertable device (20) can be positioned so that the row of grooves (1-5) can be illuminated by the readhead of the machine. If the optical inspection machine provides results corresponding to the known type(s) and concentrations of analyte(s), proper operation of the optical inspection machine is indicated. If the simulated type and concentration of specified reagen is not indicated, improper operation is indicated. Measurement error due to non-machine error is indicated when the known type and concentration of the analyte simulated by the rows (1-5) is indicated.

Abstract: A tray assembly for use with an apparatus adapted to inspect a liquid sample, including a support tray insertable within an inspection location within the liquid sample inspection apparatus so that a light source of the apparatus illuminates a liquid sample carried on the support tray and a detector of the apparatus receives light from the liquid sample when the support tray is positioned at the inspection location, and an insert supported within the support tray and having a first surface adapted to receive a first type of liquid carrier and a second surface adapted to receive a second type of liquid carrier different from the first type of liquid carrier.

Abstract: A tray assembly for use with an apparatus adapted to inspect a liquid sample, including a support tray insertable within an inspection location within the liquid sample inspection apparatus so that a light source of the apparatus illuminates a liquid sample carried on the support tray and a detector of the apparatus receives light from the liquid sample when the support tray is positioned at the inspection location, and an insert supported within the support tray and having a first surface adapted to receive a first type of liquid carrier and a second surface adapted to receive a second type of liquid carrier different from the first type of liquid carrier.

Abstract: The method of the present invention employs an enzyme immunoassay for measuring the concentration of an analyte in a sample by indirect colorimetric detection. An incident light beam at a plurality of wavelengths is directed into a liquid solution containing an analyte of interest. The solution is capable of attenuating the amount of light at a first wavelength received from this solution as a function of the increasing concentration of the analyte present. A light signal from the solution at the first wavelength is detected, and light at a second wavelength, at which substantially no attenuation of light signal occurs as the concentration of the analyte increases, is also detected. The ratio of the two respective wavelengths is formed and that ratio is compared with ratios of known amounts of the analyte to determine the amount of the analyte in the sample.

Abstract: Assay for a hapten or antigen wherein supported hapten or antigen is used to separate "bound" and "free" fractions. The sensitivity of the assay is increased.