Multiplex lateral flow immunoassay device and method for contextual immune profiling

A multiplex lateral flow immunoassay device simultaneously detects granulysin and a secondary biomarker to address the challenge of rapid, decentralized diagnostics for immune-mediated conditions, enhancing diagnostic specificity and speed.

WO2026178568A1 Publication Date: 2026-08-27BROWN GABRIEL
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Patent Information

Application Number
PCT/US2026/016511
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2025-02-24
Filing Date
2026-02-24
Publication Date
2026-08-27

AI Technical Summary

Technical Problem

Current diagnostic methods for immune-mediated conditions, such as organ transplant rejection, rely on centralized laboratory platforms and require specialized infrastructure, taking too long for rapid clinical decision-making and cannot simultaneously detect cytotoxic immune activation and tissue-specific immune injury in a single biological sample.

Method used

A multiplex lateral flow immunoassay device that simultaneously detects granulysin (GNLY) as a cytotoxic immune effector biomarker and at least one secondary biomarker indicative of tissue-specific immune injury, using a multiplex lateral flow immunoassay system with spatially distinct capture zones and labeled detection antibodies, enabling rapid point-of-care diagnostics.

Benefits of technology

Enables rapid, decentralized detection of cytotoxic immune activation and tissue-specific injury, providing contextual interpretation of immune activation states without the need for centralized laboratories, improving diagnostic specificity and speed.

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Abstract

The present invention relates to multiplex lateral flow immunochromatographic diagnostic devices configured to detect immune activity biomarkers in biological samples. The device is configured to detect granulysin as a biomarker indicative of cytotoxic immune effector activity and at least one secondary biomarker indicative of tissue-associated immune injury. In certain embodiments, the device comprises a sample pad, a conjugate pad containing labeled detection antibodies, a porous membrane comprising spatially distinct capture zones corresponding to granulysin and the secondary biomarker, a control zone, and an absorbent pad configured to facilitate capillary flow. Detection of granulysin and the secondary biomarker within a single multiplex device enables determination of immune activation state and tissue-associated immune context from a single biological sample. The device is suitable for rapid diagnostic use, including point-of-care and laboratory environments, using whole blood, plasma, serum, or related biological fluids.
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