Description:RAPID IMMUNOASSAY KITS FOR EARLY DETECTION OF INFECTIOUS DISEASES IN CLINICAL SETTINGS
Field of the Invention
[0001] The disclosed subject matter pertains to diagnostic assay kits, particularly rapid immunoassay devices configured for early clinical detection of infectious diseases.
Background
[0002] The background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
[0003] Infectious diseases remain one of the foremost challenges in global healthcare systems, necessitating prompt identification and intervention to prevent morbidity, mortality, and community transmission. Traditional diagnostic modalities, including enzyme-linked immunosorbent assays (ELISA), culture-based techniques, and nucleic acid amplification tests (NAAT), offer high sensitivity and specificity but are often constrained by extended turnaround times, reliance on specialized laboratory equipment, and the requirement for trained personnel. These limitations hinder deployment in decentralized or point-of-care settings, especially in under-resourced clinics or during outbreak situations. Lateral flow immunoassays (LFIAs) have emerged as practical alternatives due to their low cost, portability, and ease of use. However, current commercial LFIA formats often exhibit reduced sensitivity for early-stage infections, limited multiplexing capabilities, and variable visual readout clarity. Moreover, most devices are configured for single-target detection, resulting in a fragmented testing process in cases of differential diagnosis. There remains a pressing need for enhanced rapid immunoassay systems capable of detecting multiple infectious agents concurrently with higher reliability, improved sample compatibility, and integration-ready digital interface for clinical data management. The present disclosure addresses these unmet needs by proposing a structurally refined, functionally integrated, and clinically compatible rapid immunoassay kit suitable for scalable deployment in primary and tertiary healthcare settings.
[0004]
[0005] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.
[0006] It also shall be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. This invention can be achieved by means of hardware including several different elements or by means of a suitably programmed computer. In the unit claims that list several means, several ones among these means can be specifically embodied in the same hardware item. The use of such words as first, second, third does not represent any order, which can be simply explained as names.
Summary
[0007] Various objects, features, and advantages of the disclosed subject matter can be more fully appreciated with reference to the following detailed description of the disclosed subject matter when considered in connection with the following drawings, in which like reference numerals identify like elements.
[0008] The disclosed subject matter pertains to diagnostic assay kits, particularly rapid immunoassay devices configured for early clinical detection of infectious diseases.
[0009] The disclosed system comprises a rapid immunoassay kit tailored for timely identification of infectious disease markers in patient samples collected in clinical settings. The kit includes a sequential arrangement of functional substrates encapsulated within a compact, disposable housing. A sample application pad receives the biological specimen and initiates migration through a conjugate release matrix embedded with visually traceable, antibody-linked detection probes. These probes selectively bind to target antigens present in the specimen. The reaction mixture flows over a nitrocellulose membrane containing a test line and a control line. The test line immobilizes capture antibodies that selectively retain the antigen-detection probe complexes, resulting in visible signal development when the target antigen is present. The control line validates assay integrity by capturing unbound detection probes. An absorbent pad maintains unidirectional capillary flow to drive complete sample migration. The sealed housing includes a viewing window that enables direct observation of the test outcome. Additional features include particle-conjugated detection reagents for enhanced contrast, pre-filtration of complex biological samples, and a stabilizer-enriched buffer matrix to ensure consistent reactivity. Certain variants incorporate multiplexed test lines, optically enhanced windows, and QR codes for digital result capture. The disclosed kit architecture addresses clinical demands for rapid, reliable, and multi-target infectious disease diagnostics using a simple operational workflow.
Brief Description of the Drawings
[00010] The features and advantages of the present disclosure would be more clearly understood from the following description taken in conjunction with the accompanying drawings in which:
[00011] FIG. 1 illustrates a system architecture diagram of the rapid immunoassay kit showing the physical arrangement and sequential interconnection of functional substrates within the sealed housing including the sample pad, conjugate matrix, membrane, and absorbent pad.
[00012] FIG. 2 illustrates a method flow diagram of the diagnostic sequence beginning with biological sample application, followed by interaction with labeled antibodies, antigen-capture at the test line, control validation, and final visual interpretation through the viewing window.
[00013] FIG. 3 illustrates a data flow diagram showing optional integration with a digital result management platform via a QR code, enabling capture, logging, analysis, and transmission of test results to a clinical data management system.
Detailed Description
[00014] The following is a detailed description of exemplary embodiments to illustrate the principles of the invention. The embodiments are provided to illustrate aspects of the invention, but the invention is not limited to any embodiment. The scope of the invention encompasses numerous alternatives, modifications and equivalent; it is limited only by the claims.
[00015] In view of the many possible embodiments to which the principles of the present discussion may be applied, it should be recognized that the embodiments described herein with respect to the drawing figures are meant to be illustrative only and should not be taken as limiting the scope of the claims. Therefore, the techniques as described herein contemplate all such embodiments as may come within the scope of the following claims and equivalents thereof.
[00016] Throughout the present disclosure, the term “network” relates to an arrangement of interconnected programmable and/or non-programmable components that are configured to facilitate data communication between one or more electronic devices and/or databases, whether available or known at the time of filing or as later developed. Furthermore, the network may include, but is not limited to, one or more peer-to-peer network, a hybrid peer-to-peer network, local area networks (LANs), radio access networks (RANs), metropolitan area networks (MANS), wide area networks (WANs), all or a portion of a public network such as the global computer network known as the Internet, a private network, a cellular network and any other communication system or systems at one or more locations.
[00017] Throughout the present disclosure, the term “process”* relates to any collection or set of instructions executable by a computer or other digital system so as to configure the computer or the digital system to perform a task that is the intent of the process.
[00018] Throughout the present disclosure, the term ‘Artificial intelligence (AI)’ as used herein relates to any mechanism or computationally intelligent system that combines knowledge, techniques, and methodologies for controlling a bot or other element within a computing environment. Furthermore, the artificial intelligence (AI) is configured to apply knowledge and that can adapt it-self and learn to do better in changing environments. Additionally, employing any computationally intelligent technique, the artificial intelligence (AI) is operable to adapt to unknown or changing environment for better performance. The artificial intelligence (AI) includes fuzzy logic engines, decision-making engines, preset targeting accuracy levels, and/or programmatically intelligent software.
[00019] The detailed description is described with reference to the accompanying figures. In the figures, the left-most digit(s) of a reference number identifies the figure in which the reference number first appears. The use of the same reference numbers in different instances in the description and the figures may indicate similar or identical items.
[00020] Pursuant to the "Detailed Description" section herein, whenever an element is explicitly associated with a specific numeral for the first time, such association shall be deemed consistent and applicable throughout the entirety of the "Detailed Description" section, unless otherwise expressly stated or contradicted by the context.
[00021] The disclosed subject matter pertains to diagnostic assay kits, particularly rapid immunoassay devices configured for early clinical detection of infectious diseases.
[00022] Pursuant to the "Detailed Description" section herein, whenever an element is explicitly associated with a specific numeral for the first time, such association shall be deemed consistent and applicable throughout the entirety of the "Detailed Description" section, unless otherwise expressly stated or contradicted by the context.
[00023] FIG. 1 illustrates the system architecture of the disclosed rapid immunoassay kit comprising sequentially arranged internal components enclosed within a sealed disposable housing. The sample application pad is positioned at a first terminal end of the housing and is configured to receive a patient-derived biological specimen. The sample pad is operatively coupled downstream to a conjugate release matrix. This matrix is embedded with detection antibodies conjugated to visual marker particles. Upon wetting by the biological sample, the matrix facilitates the controlled release of conjugates into the migrating fluid stream. Aligned further downstream is a nitrocellulose membrane that comprises at least one test line and one control line. The test line immobilizes specific capture antibodies reactive to target antigens present in the sample, and the control line immobilizes anti-species antibodies that bind unreacted detection conjugates. At the distal end of the membrane lies an absorbent pad configured to wick fluid away from the membrane and maintain unidirectional capillary flow. An optically clear viewing window is provided above the test and control lines to enable user-readable result interpretation. The entire arrangement is contained within a unibody housing that may include a sealing layer and application port, maintaining sample integrity and biohazard containment. This configuration enables the immunochemical reaction to occur in a self-contained manner without external intervention, optimizing workflow efficiency in clinical point-of-care settings. The present disclosure pertains to a rapid immunoassay kit constructed to detect infectious disease markers in patient-derived biological fluids. The system comprises multiple layers of reactive substrates arranged within a unified disposable housing. At the initial stage, the biological specimen, which may include blood, serum, plasma, saliva, or nasal secretions, is applied to a sample application pad configured to initiate lateral fluid migration. Said sample application pad optionally integrates a microfiltration interface that separates erythrocytes or mucosal debris from the fluidic phase, enabling uninterrupted downstream flow. Positioned downstream, a conjugate release matrix contains lyophilized antibodies conjugated to visible particles such as colloidal gold, latex beads, or fluorescent nanospheres. Upon rehydration with the sample fluid, the conjugates are released into solution and interact with any target antigen present.
[00024] The sample and conjugate mixture then traverses a nitrocellulose membrane in which spatially segregated test lines are embedded. Each test line contains immobilized capture antibodies selected for high-affinity binding to specific pathogen-derived antigens. One or more such test lines may be included to permit multiplexed detection of various infectious agents. Adjacent to the test lines, a control line is embedded with anti-species immunoglobulins that bind the detection probe irrespective of antigen presence, serving as a procedural control. Upon antigen–antibody binding, the probe accumulates at the respective test line, forming a visible line or color change discernible to the naked eye through a transparent viewing window in the housing. This viewing window may include an anti-glare polymeric material to aid low-light observation.
[00025] The terminal segment of the membrane is aligned with an absorbent pad configured from a cellulose composite or synthetic matrix. This pad sustains the unidirectional capillary action, preventing stagnation and reducing assay time. The sealed housing that contains all the components is designed to permit single-sample entry via a designated port, which may be secured by a breakable foil seal. In certain embodiments, the housing features a QR code linked to a software platform that supports result archiving, decision support algorithms, or clinical data logging. The total assay time is calibrated to be under ten minutes, ensuring compatibility with emergency and outpatient clinical workflows.
[00026] In an alternative embodiment, the nitrocellulose membrane includes three distinct test lines corresponding to dengue, SARS-CoV-2, and influenza antigens, respectively. The conjugate pad in this embodiment is impregnated with a mixture of colloidal gold-labeled monoclonal antibodies against all three pathogens, allowing differential visualization depending on the target present. The membrane is pre-blocked with non-reactive proteins to prevent nonspecific binding, and a stabilizing buffer within the conjugate pad ensures that rehydration is not affected by minor variations in sample pH or ionic strength.
[00027] In another embodiment, the sample application pad is designed with dual-layered filtration comprising a glass fiber prefilter and a membrane interface for use with whole blood. This configuration allows the kit to be deployed in resource-limited clinics without laboratory centrifugation. The test result remains interpretable within seven minutes, and high-intensity color contrast is maintained through the use of blue latex beads as the conjugate carrier.
[00028] In a third embodiment, the kit is enclosed in a modular cassette form factor that permits insertion into a digital reader. The reader contains an image sensor and analysis software capable of quantifying line intensities and generating semi-quantitative results. This version is intended for hospital use where result traceability and clinical integration are critical. The housing is barcoded, and output data can be transmitted to a local electronic health record system.
[00029] Operationally, the disclosed system reduces interpretation error by enabling rapid differentiation between infected and non-infected states based on the presence or absence of a single or multiple test lines. The use of capillary action without external pumps makes the system self-contained and mechanically robust. The integration of digitally accessible identifiers allows clinicians to integrate patient records with assay outcomes. In various usage contexts such as rural health centers, mobile diagnostics vans, or intensive care triage zones, the disclosed system maintains performance consistency due to its buffer stabilization and physical integration. Variants of the kit may also be adapted to detect bacterial, fungal, or parasitic markers by substituting antibody reagents while maintaining the overall system architecture.
[00030] Thus, the rapid immunoassay kit described herein serves as a scalable, reliable, and cost-effective diagnostic platform capable of addressing diverse infectious disease surveillance needs across decentralized clinical environments.
[00031] FIG. 2 shows a method flow diagram representing the operational sequence of the rapid immunoassay kit. The process begins with the application of a biological sample onto the sample pad. This initial step triggers migration through capillary action toward the conjugate release matrix. In the matrix, labeled antibodies rehydrate and bind any target antigens present in the sample. The antigen-antibody complexes continue to migrate and encounter the test line where immobilized capture antibodies selectively retain the complex. This retention results in visible signal development at the test line region. Concurrently, excess or unbound labeled antibodies progress further and are captured at the control line to validate assay integrity. Migration then proceeds to the absorbent pad, which sustains flow and prevents back diffusion. The viewing window above the membrane facilitates real-time observation of the visual result. This procedural sequence, conducted within ten minutes, allows rapid determination of infection status. The method avoids the need for instrumentation, making it accessible for bedside, outpatient, and field applications.
[00032] FIG. 3 provides a data flow diagram illustrating the optional digital data pathway linked with the immunoassay kit. The sealed housing includes a QR code affixed to its external surface, which, when scanned by a mobile device, links to a cloud-based or locally hosted digital interface. The interface provides a guided interpretation framework and logging module. Upon visual result interpretation by the user, the selected result (positive, negative, or invalid) is logged into the digital platform along with a timestamp and patient identifier. The system optionally supports image capture of the test strip, enabling software-based validation using embedded visual pattern recognition algorithms. Subsequently, the result data may be encrypted and transmitted to an electronic health record (EHR) system or disease surveillance database. This data flow supports diagnostic traceability, real-time clinical decision-making, and centralized epidemiological reporting without altering the underlying mechanical assay structure. Such integration strengthens the utility of the disclosed kit in public health infrastructure.
[00033] The above description is intended to be illustrative, and not restrictive. Although the present disclosure has been described with references to specific illustrative examples and implementations, it will be recognized that the present disclosure is not limited to the examples and implementations described. The scope of the disclosure should be determined with reference to the following claims, along with the full scope of equivalents to which the claims are entitled.
[00034] Modifications, additions, or omissions may be made to the systems and apparatuses described herein without departing from the scope of the disclosure. The components of the systems and apparatuses may be integrated or separated. Moreover, the operations of the systems and apparatuses may be performed by more, fewer, or other components. Additionally, operations of the systems and apparatuses may be performed using any suitable logic comprising software, hardware, and/or other logic. As used in this document, “each” refers to each member of a set or each member of a subset of a set.
[00035] The term “memory,” as used herein relates to a volatile or persistent medium, such as a magnetic disk, or optical disk, in which a computer can store data or software for any duration. Optionally, the memory is non-volatile mass storage such as physical storage media. Furthermore, a single memory may encompass and in a scenario wherein computing system is distributed, the processing, memory and/or storage capability may be distributed as well.
[00036] Throughout the present disclosure, the term ‘server’ relates to a structure and/or module that include programmable and/or non-programmable components configured to store, process and/or share information. Optionally, the server includes any arrangement of physical or virtual computational entities capable of enhancing information to perform various computational tasks.

12

Claims
I/We Claim:
CLAIM 1
A rapid immunoassay kit for early detection of infectious diseases in clinical settings, comprising:
a sample application pad configured to receive a biological specimen selected from the group consisting of blood, serum, plasma, saliva, or nasal exudate;
a conjugate release matrix disposed downstream of the sample application pad, said conjugate release matrix embedded with labeled antibodies specific to one or more target antigens associated with infectious pathogens;
a nitrocellulose membrane comprising a test line and a control line, said test line coated with immobilized capture antibodies reactive to said target antigens, and said control line coated with anti-species antibodies reactive to said labeled antibodies;
an absorbent pad configured to receive migrated fluid and maintain capillary flow along said nitrocellulose membrane;
and a sealed housing enclosing said components in a linear arrangement, said sealed housing including a viewing window aligned with said test line and said control line to enable visual interpretation of assay results.
CLAIM 2
The rapid immunoassay kit of claim 1, wherein said labeled antibodies comprise colloidal gold, fluorescent particles, or latex beads conjugated to monoclonal or polyclonal antibodies to enhance visibility and detection sensitivity.
CLAIM 3
The rapid immunoassay kit of claim 1, wherein said test line includes two or more spatially separated regions, each containing capture antibodies specific to distinct infectious agents selected from the group consisting of dengue virus, chikungunya virus, SARS-CoV-2, and influenza virus.
CLAIM 4
The rapid immunoassay kit of claim 1, wherein said sample application pad includes a built-in filtration membrane configured to remove interfering particulates and cellular debris from the applied biological sample prior to fluid migration.
CLAIM 5
The rapid immunoassay kit of claim 1, wherein said conjugate release matrix is impregnated with a buffer formulation comprising stabilizers, surfactants, and pH-adjusting agents to facilitate uniform rehydration and release of the labeled antibodies upon contact with the sample.
CLAIM 6
The rapid immunoassay kit of claim 1, wherein said sealed housing comprises a breakable foil or polymer film sealing an inlet port, said inlet port operable to receive a dropper-dispenser for controlled application of the biological sample.
CLAIM 7
The rapid immunoassay kit of claim 1, wherein said viewing window comprises an optically clear polymeric material with anti-reflective coating to enhance contrast and visual clarity of said test and control lines under ambient lighting.
CLAIM 8
The rapid immunoassay kit of claim 1, wherein said absorbent pad comprises a multi-layered cellulose composite structure adapted to maintain consistent wicking rate and prevent backflow of assay fluid during operation.
CLAIM 9
The rapid immunoassay kit of claim 1, wherein said test line produces a qualitative signal response within a reaction time of less than ten minutes following application of the biological sample.
CLAIM 10
The rapid immunoassay kit of claim 1, wherein said housing further includes an integrated QR code affixed to an outer surface, said QR code linked to a digital platform for result logging, interpretation assistance, and data transmission to clinical information systems.

RAPID IMMUNOASSAY KITS FOR EARLY DETECTION OF INFECTIOUS DISEASES IN CLINICAL SETTINGS
Abstract
A rapid immunoassay kit is disclosed for early-stage clinical detection of infectious diseases. The kit includes a sample application pad, a conjugate release matrix with labeled antibodies, a nitrocellulose membrane featuring a test line and control line, and an absorbent pad to drive capillary flow. The components are enclosed in a sealed housing with a viewing window for result interpretation. The assay supports detection of multiple infectious agents with improved visibility, enhanced sample compatibility, and rapid qualitative output. Integration with digital platforms is facilitated through a QR code interface. , Claims:Claims
I/We Claim:
CLAIM 1
A rapid immunoassay kit for early detection of infectious diseases in clinical settings, comprising:
a sample application pad configured to receive a biological specimen selected from the group consisting of blood, serum, plasma, saliva, or nasal exudate;
a conjugate release matrix disposed downstream of the sample application pad, said conjugate release matrix embedded with labeled antibodies specific to one or more target antigens associated with infectious pathogens;
a nitrocellulose membrane comprising a test line and a control line, said test line coated with immobilized capture antibodies reactive to said target antigens, and said control line coated with anti-species antibodies reactive to said labeled antibodies;
an absorbent pad configured to receive migrated fluid and maintain capillary flow along said nitrocellulose membrane;
and a sealed housing enclosing said components in a linear arrangement, said sealed housing including a viewing window aligned with said test line and said control line to enable visual interpretation of assay results.
CLAIM 2
The rapid immunoassay kit of claim 1, wherein said labeled antibodies comprise colloidal gold, fluorescent particles, or latex beads conjugated to monoclonal or polyclonal antibodies to enhance visibility and detection sensitivity.
CLAIM 3
The rapid immunoassay kit of claim 1, wherein said test line includes two or more spatially separated regions, each containing capture antibodies specific to distinct infectious agents selected from the group consisting of dengue virus, chikungunya virus, SARS-CoV-2, and influenza virus.
CLAIM 4
The rapid immunoassay kit of claim 1, wherein said sample application pad includes a built-in filtration membrane configured to remove interfering particulates and cellular debris from the applied biological sample prior to fluid migration.
CLAIM 5
The rapid immunoassay kit of claim 1, wherein said conjugate release matrix is impregnated with a buffer formulation comprising stabilizers, surfactants, and pH-adjusting agents to facilitate uniform rehydration and release of the labeled antibodies upon contact with the sample.
CLAIM 6
The rapid immunoassay kit of claim 1, wherein said sealed housing comprises a breakable foil or polymer film sealing an inlet port, said inlet port operable to receive a dropper-dispenser for controlled application of the biological sample.
CLAIM 7
The rapid immunoassay kit of claim 1, wherein said viewing window comprises an optically clear polymeric material with anti-reflective coating to enhance contrast and visual clarity of said test and control lines under ambient lighting.
CLAIM 8
The rapid immunoassay kit of claim 1, wherein said absorbent pad comprises a multi-layered cellulose composite structure adapted to maintain consistent wicking rate and prevent backflow of assay fluid during operation.
CLAIM 9
The rapid immunoassay kit of claim 1, wherein said test line produces a qualitative signal response within a reaction time of less than ten minutes following application of the biological sample.
CLAIM 10
The rapid immunoassay kit of claim 1, wherein said housing further includes an integrated QR code affixed to an outer surface, said QR code linked to a digital platform for result logging, interpretation assistance, and data transmission to clinical information systems.