Immunoassay methods and compositions for detecting infection involving use of test antigens as cross-reactive control antigens
Inventors
Needham, James William • Raychaudhuri, Syamal
Assignees
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Publication Number
US-11913953-B2
Publication Date
2024-02-27
Expiration Date
Abstract
The present invention relates to compositions and methods involving diagnostic tests with multiple test antigens. The present invention involves the expanded use of test antigens as cross-reactive control antigens (CCAs). The invention advantageously provides for enhanced test results analysis by simultaneously providing both test antigen and CCA signal results. These results, in turn, allow useful sample comparison and cross-reference between samples to more accurately identify and verify the fidelity of test results obtained for multiple infective agents at once. The present invention may include compositions and methods for detecting infection by Zika virus or another flavivirus, and may distinguish between infections caused by genetically similar agents.
Core Innovation
The disclosed invention provides immunoassay compositions and methods that distinguish between related infective agents in vitro by using at least two different test antigens and generating detectable signals. Each test antigen is used as a cross-reactive control antigen, and the assay provides both a test antigen signal and a cross-reactive control antigen signal simultaneously.
The method uses test antigens derived from different species within a shared viral genus, where the shared viral genus is the flavivirus genus. Each test antigen binds to a common bound component and a common test antigen conjugate, and each different test antigen indicates the presence or absence of a particular bound component.
The assay includes definition and interpretation concepts for signal outputs, including immune status ratios, cutoffs, and interpretation tables. Reported performance on clinical and control sera is described in terms of specificity, cross-reactivity, percent agreement, and interference testing, and expanded panels include Zika, dengue, West Nile, and optionally chikungunya antigens.
Claims Coverage
The independent claim covers an in vitro distinguishing method based on simultaneous, antigen-specific detectable signals using test antigens that also serve as cross-reactive control antigens within the flavivirus genus. The coverage is anchored by three main inventive elements.
Simultaneous signals from test antigen and cross-reactive control antigen
providing both test antigen and cross-reactive control antigen signal results simultaneously.
Test antigens used as cross-reactive control antigens with common binding components
using each of the at least two different test antigens as a cross-reactive control antigen; wherein each test antigen binds to each of a common bound component and a common test antigen conjugate; wherein each of the different test antigens indicates the presence or absence of a particular bound component.
Different species flavivirus genus test antigens
the different test antigens are derived from different species within a shared viral genus, wherein the shared viral genus is the flavivirus genus.
Across the independent claim, distinguishing related infective agents in vitro is achieved by using at least two different test antigens that act as cross-reactive control antigens, binding a common bound component and conjugate, and producing simultaneous test and cross-reactive control antigen signal results; the antigens are derived from different species within the flavivirus genus.
Stated Advantages
Distinguishes between related infective agents in vitro.
Provides simultaneous test antigen and cross-reactive control antigen signal results.
Reduces cross-reactivity by using multiple test antigens and immune status ratios with cutoffs.
Documented Applications
Immunoassay panels for flaviviruses including Zika, dengue, and West Nile, with optional inclusion of alphavirus chikungunya antigens, using measured immune status ratios and interpretation tables.
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