Siemens Healthcare Diagnostics Gmbh

Bayer Healthcare LLC

Gary H Krauth

David Ledden

David A Brock

Jack L Zuidema

David L Boger

David J Ledden

Donald R Hesser

Kevin J Sheldrake

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.

Native analyte as a reference in lateral flow assays

Apparatus and methods are disclosed for verifying one or more operational conditions of an optical inspection machine. A row of grooves (-) 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 (-), each with different geometry, configured on an insertable device (). The insertable device () can be positioned so that the row of grooves (-) 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 (-) is indicated.

Verification apparatus and methods for optical inspection machine

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.

Tray assembly for optical inspection apparatus

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Hopedale, MA, United States of America

Gary H Krauth