Lateral flow assay system and methods for its use
Inventors
Kabir, Mazbahul • Raychaudhuri, Syamal • Needham, James William • Morkowski, Stanislaw
Assignees
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Publication Number
US-8399261-B2
Publication Date
2013-03-19
Expiration Date
Abstract
A lateral flow test system together with methods for its use in the detection of one or more analytes, or components, of interest within a sample, such as a biological sample, is provided. The system comprises a liquid formulation of a gold conjugate and a lateral flow assay device that does not include a conjugate pad having conjugate dried thereon.
Core Innovation
The invention relates to a system for detecting a presence of a component of interest in a test sample using a liquid formulation of an indicator conjugate. The indicator conjugate is a gold conjugate that includes a first member of a binding pair, and detection is performed using a lateral flow assay device with a sample receiving region and a capture membrane positioned downstream.
The capture membrane comprises a test region with an immobilized detection agent specific for the component of interest, and a control region with an immobilized second member of the binding pair. The detection agent is selected from Leishmania antigens, T. cruzi antigens, and cardiolipin micelle, and the device omits a conjugate pad.
A method is also provided for detecting the component of interest in a liquid test sample by applying the test sample together with a liquid formulation of the indicator conjugate and a chase buffer to the sample receiving region. A component-indicator conjugate complex migrates through the capture membrane to the test region, contacts the detection agent, and becomes immobilized to form a detectable signal.
Claims Coverage
The document provides two independent claims, one system claim and one method claim. Across these claims, the main inventive features include a liquid-formulated gold indicator conjugate, a lateral flow capture membrane with immobilized test and control regions defined by a binding pair, and an assay format that omits a conjugate pad while using chase buffer during sample application.
Liquid formulation of a gold indicator conjugate with a first member of a binding pair
A liquid formulation of an indicator conjugate including a first member of a binding pair, wherein the indicator conjugate is a gold conjugate.
Lateral flow assay device with sample receiving region and capture membrane having immobilized test and control regions
A lateral flow assay device comprising a sample receiving region and a capture membrane comprising a test region with an immobilized detection agent specific for the component of interest, and a control region comprising an immobilized second member of the binding pair.
Detection agent selection for immobilized test region
The detection agent is selected from Leishmania antigens, T. cruzi antigens, and cardiolipin micelle.
Applying liquid gold indicator conjugate with chase buffer to sample receiving region
Applying the test sample, a liquid formulation of an indicator conjugate and a chase buffer to the sample receiving region, wherein the indicator conjugate is a gold conjugate.
Migration and immobilization to form a detectable signal in test region
Allowing a component-indicator conjugate complex to migrate through the capture membrane to the test region and contact the detection agent thereby immobilizing the component-indicator conjugate complex and forming a detectable signal, wherein the presence of the component of interest in the test sample is indicated by the signal.
Overall claim coverage centers on detecting a component of interest using a lateral flow assay where a liquid-formulated gold indicator conjugate migrates through a capture membrane containing immobilized test and control regions. The test region uses an immobilized detection agent selected from Leishmania antigens, T. cruzi antigens, and cardiolipin micelle, and the method applies chase buffer to enable formation of a detectable signal at the test region.
Stated Advantages
Improved sensitivity versus conventional dried-gold conjugate-pad systems for visceral leishmaniasis (k39), Chagas disease (T. cruzi ITC.8.2), and syphilis (cardiolipin micelle).
Documented Applications
Detection for visceral leishmaniasis using k39 recombinant antigen.
Detection for Chagas disease using T. cruzi ITC.8.2.
Detection for syphilis using cardiolipin micelle.
Use of kit packaging/instructions for the disclosed system.
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