Universal testing system for quantitative analysis

Inventors

Piasio, Roger • Wheeler, Andrew • Cowperthwaite, Wesley

Assignees

Optimum Imaging Diagnostics LLC

Abstract

A cassette is disclosed that permits, with an instrument, quantitative analysis to be performed at the moment of sample testing without additional steps to the end user. The cassette includes a calibration strip and a sample strip. The calibration strip contains known quantities of analyte, from which a calibration curve can be created and applied to the analysis of the sample strip. The disclosed cassette can utilize light transmission or light reflectance techniques. The cassette may include a separate wash port for rapid washing of a high background sample. The disclosed cassette may perform diagnostic tests for humans, animals, environmental sample, and/or food samples. In some cases, the disclosed devices and techniques may be used to monitor efficacy of drug therapy and patient compliance with respect to physician-prescribed medication in a point of care setting.

Core Innovation

The invention describes a universal quantitative point-of-care lateral-flow cassette configured to measure an analyte of interest using an on-board calibrator. The cassette includes a calibration strip having a first region and a second region with first and second concentrations of the analyte, wherein the first concentration is different from the second concentration. A calibration marker approach based on different analyte concentrations in multiple regions is positioned in the same cassette as the measurement pathway.

The cassette further includes a sample strip positioned parallel to the calibration strip. A sample port is formed to be in fluid communication with the sample strip but not in fluid communication with the calibration strip, while a fluid port is in fluid communication with both the calibration strip and the sample strip. Shared fluid and chase flow runs concurrently through both strips to reconstitute detector conjugates and generate signals that support creating a calibration curve for concurrent quantitative analysis using optical readout.

The housing and strip architecture are configured to support comparable lateral flow and reliable signal generation. The disclosed architectures include porous membrane layers supporting lateral flow, such as backing, capillary substrate, conjugate pad, sample pad, and absorbent pad, and include calibration marker regions with zero and non-zero analyte concentration regions. The cassette is described with dedicated ports and housing features including a sample port, an optional wash port to reduce high background, and housing elements such as pressure points and clamping regions to ensure uniform strip migration and comparable sensing.

Claims Coverage

The partial content provides two independent claims (clm-00001 and clm-00014). Across these independent claims, the key inventive features focus on a cassette having an on-board calibration strip with different analyte concentration regions positioned parallel to a sample strip, and on separate fluid paths that keep the sample port non-communicating with the calibration strip while a common fluid port interfaces with both strips. Additional claim sets refine quantitative relationships for calibration concentrations and define further housing contact and port structures.

Overall claim coverage centers on a cassette architecture that combines an on-board calibration strip with distinct analyte concentration regions and a parallel sample strip, together with fluid-path separation using a sample port that does not communicate with the calibration strip and a fluid port that communicates with both strips, all retained within a housing that supports fixed strip placement.

Stated Advantages

Documented Applications

No documented applications found