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A KIDNEY FUNCTION TRACKING URINE DIPSTICK

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A KIDNEY FUNCTION TRACKING URINE DIPSTICK

ORDINARY APPLICATION

Published

date

Filed on 7 November 2024

Abstract

The present invention discloses a kidney function tracking urine dipstick (100) configured for non-invasive monitoring of renal biomarkers, including albumin, creatinine, protein levels, pH, and specific gravity. It features a test strip (10) integrated with colorimetric reagents (20) for biomarker detection and a quantitative reading indicator (30) for user interpretation. The dipstick (100) includes optional smartphone compatibility for precise digital readings and trend tracking, enabling users to proactively manage kidney health and facilitating remote healthcare monitoring through data-sharing capabilities.

Patent Information

Application ID202411085266
Invention FieldBIO-MEDICAL ENGINEERING
Date of Application07/11/2024
Publication Number47/2024

Inventors

NameAddressCountryNationality
Dr. AKSHAYA UPASHYAYDepartment of Urology, Graphic Era Institute of Medical Sciences, Graphic Era deemed to be University, Dehradun.IndiaIndia
Dr. PRIYANK VYASDepartment of Biotechnology, Graphic Era deemed to be University, Dehradun.IndiaIndia

Applicants

NameAddressCountryNationality
GRAPHIC ERA DEEMED TO BE UNIVERSITY566/6, Bell Road, Society Area, Clement Town, Dehradun – 248002, Uttarakhand, India.IndiaIndia

Specification

Description:FIELD OF THE INVENTION:
The field of the present invention relates to medical diagnostic tools, specifically urine-based testing devices for kidney function monitoring. It involves a disposable dipstick designed to track essential biomarkers indicative of kidney health, offering a convenient, non-invasive solution for real-time kidney function assessment.

BACKGROUD OF THE INVENTION:
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.
Kidney health is a critical aspect of overall wellness, as kidneys perform essential functions that include filtering waste from the blood, balancing bodily fluids, regulating blood pressure, and managing electrolyte levels. Impaired kidney function can lead to an accumulation of waste in the bloodstream, potentially resulting in severe health complications, including chronic kidney disease (CKD), kidney failure, cardiovascular issues, and even life-threatening situations. Early detection and consistent monitoring of kidney function are crucial in preventing the progression of kidney-related ailments. However, standard testing methods often require complex equipment, laboratory conditions, or specialized healthcare professionals. This creates a need for a more accessible and user-friendly solution for monitoring kidney health, especially for patients who are at risk of kidney disease or those with pre-existing conditions that may affect kidney function.
The global burden of kidney disease has increased substantially over the years. Chronic kidney disease alone affects millions worldwide, and a large portion of these cases remains undiagnosed until later stages. The conventional methods for assessing kidney function often involve blood tests measuring serum creatinine levels or comprehensive urine analysis requiring laboratory infrastructure. While these methods are accurate, they are not practical for regular monitoring at home. As a result, patients may miss the critical early detection window, where interventions could potentially slow disease progression. Furthermore, certain populations, such as elderly patients and those in remote areas, may face additional barriers to regular testing, which adds to the importance of an accessible, easy-to-use diagnostic tool.
Recent advancements in diagnostic technology have emphasized the need for non-invasive, real-time monitoring devices that empower patients to take charge of their health. Portable devices like blood glucose meters and at-home blood pressure monitors have shown how accessible tools can revolutionize patient management and outcomes. A similar approach to kidney health, such as a urine dipstick for kidney function tracking, would be a significant advancement. Unlike blood testing, urine tests are inherently less invasive, involve minimal discomfort, and are easier to administer. They are particularly suited for tracking biomarkers that indicate kidney function, such as albumin, creatinine, protein levels, and pH, making urine dipsticks a promising solution for kidney health monitoring.
Urine dipsticks have been widely used in clinical settings for various tests, primarily for screening urinary tract infections, proteinuria, glucose levels, and ketones. However, the design and functionality of most existing dipsticks do not support comprehensive kidney function monitoring. Traditional urine dipsticks generally focus on single indicators and lack the integration of multiple biomarkers relevant to kidney health. Additionally, they often provide qualitative rather than quantitative results, limiting their utility for ongoing tracking of subtle changes in kidney function over time. Therefore, an enhanced urine dipstick that can track multiple biomarkers in a quantitative manner would address a significant gap in current diagnostic solutions. This would not only benefit individuals with existing kidney conditions but also provide a preventive measure for those at risk.
One of the essential aspects of kidney health monitoring involves the detection of albumin and creatinine levels in urine. Albumin, a protein normally retained in the blood, can leak into the urine when the kidneys are damaged or diseased. Elevated urine albumin levels, known as albuminuria, are often an early sign of kidney damage and can indicate the presence of CKD or other renal complications. Similarly, the creatinine concentration in urine serves as an indicator of kidney function, especially when analyzed alongside albumin levels. The albumin-to-creatinine ratio (ACR) is a critical measure, commonly used in medical evaluations to detect early-stage kidney disease. A urine dipstick capable of accurately measuring albumin and creatinine levels, and calculating ACR, would provide a powerful tool for early kidney disease detection and ongoing monitoring.
In addition to albumin and creatinine, other biomarkers such as pH, specific gravity, and protein levels also provide valuable information about kidney function and overall urinary health. For instance, changes in urine pH can reflect issues in kidney function or imbalances in body chemistry, while abnormal specific gravity readings may indicate issues with kidney filtration capabilities. Protein levels in the urine are another crucial marker, as excessive protein (proteinuria) is often associated with kidney disease. By incorporating the measurement of these markers, a dipstick designed for kidney function tracking would give a more comprehensive view of renal health than conventional single-indicator dipsticks.
Developing a urine dipstick for kidney function tracking presents some technical challenges, particularly in ensuring accuracy, sensitivity, and ease of interpretation. To address these challenges, the dipstick could employ colorimetric reagents that change color based on specific concentrations of biomarkers. These reagents would react proportionally to the presence of albumin, creatinine, protein, and other indicators, allowing the user to visually interpret the results based on color intensity or shade. For greater precision, this dipstick could be paired with a smartphone app that reads the colors via image analysis, translating them into quantitative data for more reliable tracking over time. Such an approach would not only enhance the ease of use but also improve accuracy by minimizing the subjectivity of manual color comparisons.
A smartphone-compatible kidney function dipstick would also provide opportunities for data tracking and long-term health monitoring. By storing historical data, the app could alert users to trends or changes in their kidney function that might indicate the need for medical consultation. This feature would be especially beneficial for individuals with conditions such as diabetes, hypertension, or cardiovascular disease, where kidney health can be impacted over time. It would empower users to make informed decisions about their health and seek medical intervention before the onset of advanced symptoms. Moreover, data aggregation on a population scale could offer valuable insights for healthcare providers, potentially aiding in broader public health efforts to combat kidney disease.
A further advantage of a urine dipstick for kidney function is its potential to reach underserved populations. Individuals in low-resource areas often face barriers to regular healthcare, including limited access to diagnostic facilities and trained professionals. A portable, disposable kidney function dipstick could bring an affordable, reliable diagnostic option directly to these communities. In rural and remote areas, this innovation could serve as a first line of detection, helping to identify individuals at risk of kidney disease early on and facilitating timely intervention through healthcare networks.
Therefore, a kidney function tracking urine dipstick offers a promising solution to a growing healthcare need. By enabling non-invasive, real-time monitoring of critical biomarkers, this invention could bridge a significant gap in kidney health management, especially for those who lack access to regular laboratory testing. The development of such a device would align with trends in personalized healthcare, empowering individuals to take control of their health while providing valuable data for the medical community. With the ability to detect early signs of kidney dysfunction, this dipstick could ultimately improve patient outcomes, reduce the burden on healthcare systems, and contribute to more proactive kidney disease management on a global scale.

OBJECTS OF THE INVENTION:
The prime object of the invention is to provide a convenient, non-invasive urine dipstick that enables users to monitor key biomarkers associated with kidney function. This device is designed for at-home use, allowing individuals to regularly assess their kidney health without requiring specialized laboratory equipment or trained medical professionals. The aim is to create a self-monitoring tool that is easy to use, thus facilitating early detection of potential kidney-related issues.
Another object of the invention is to incorporate multiple biomarkers into a single dipstick for a comprehensive analysis of kidney function. By including indicators such as albumin, creatinine, pH, protein levels, and specific gravity, the dipstick offers a more holistic view of renal health than traditional single-function urine dipsticks. This multi-indicator capability allows users to track a range of kidney function markers simultaneously, giving them a better understanding of their overall urinary health.
Yet another object of the invention is to provide an accurate and easy-to-interpret diagnostic tool that minimizes user error in reading results. This invention aims to employ colorimetric reagents that react proportionally to biomarker concentrations, with color changes indicating specific levels of each marker. To enhance accuracy, the dipstick could be paired with a smartphone app, which reads the color changes through image processing and converts them into quantitative data. This approach reduces subjective interpretation and allows for more precise tracking over time.
Still another object of the invention is to enable long-term monitoring and data tracking for patients at risk of kidney disease. The smartphone app accompanying the dipstick could store historical data, enabling users to monitor trends and changes in their kidney health over time. This feature can provide insights into the progression or stabilization of kidney function, alerting users to consult medical professionals when significant changes occur. It would be particularly beneficial for those with conditions like diabetes or hypertension, where regular monitoring of kidney health is crucial.
A further object of the invention is to make kidney function monitoring accessible to underserved populations, particularly in rural and low-resource areas. The dipstick is designed to be affordable and disposable, making it a practical option for individuals who may not have regular access to healthcare facilities. By providing a reliable, cost-effective diagnostic tool, this invention addresses disparities in healthcare accessibility, empowering more people to take charge of their kidney health.
Another object of the invention is to enhance public health data collection on kidney health trends across diverse populations. Aggregated data from app-compatible dipsticks could provide valuable information for healthcare providers and public health organizations, offering insights into population-level trends in kidney function. This capability could help inform targeted interventions, improve patient outcomes, and contribute to the broader understanding and management of kidney disease on a global scale.

SUMMARY OF THE INVENTION:
The present invention introduces a kidney function tracking urine dipstick designed to facilitate at-home monitoring of key renal biomarkers. This dipstick offers a comprehensive, non-invasive solution for individuals needing regular kidney health assessments, especially those with predisposing conditions such as diabetes or hypertension. By incorporating multiple biomarkers relevant to kidney health, the dipstick aims to provide users with a more detailed understanding of their renal status, aiding in early detection and potentially reducing the risk of chronic kidney disease progression.
An inventive aspect of the invention is to provide a urine dipstick that combines multiple renal biomarkers, including albumin, creatinine, protein levels, specific gravity, and pH, within a single test strip. This multi-biomarker integration enhances the dipstick's utility, allowing users to assess a variety of kidney function indicators in one test. The ability to detect albumin and creatinine levels, among other markers, offers users a reliable indication of kidney function changes, particularly through the albumin-to-creatinine ratio (ACR), a critical measure in early kidney disease detection.
Another inventive aspect of the invention is to provide a colorimetric detection system that allows for quick and easy interpretation of results. The dipstick utilizes specialized reagents that produce color changes in response to the concentration of each biomarker, enabling users to visually interpret their test results based on color intensity. For improved accuracy, this colorimetric data can be read and analyzed through a smartphone app, which captures the dipstick image and processes it using image analysis software to provide quantitative readings. This app compatibility minimizes the potential for user error and allows for consistent, precise readings across multiple uses.
Yet another inventive aspect of the invention is to offer a dipstick with data storage and trend analysis capabilities through its smartphone app integration. The app not only assists with accurate reading but also stores historical data, enabling users to track changes in their kidney function over time. This trend analysis capability is particularly useful for individuals managing chronic conditions, as it allows them to identify any significant shifts in renal health that might warrant medical intervention. This feature promotes proactive health management and supports informed decision-making regarding kidney care.
Still another inventive aspect of the invention is to provide an accessible and affordable diagnostic tool that can be widely used, even in underserved or remote areas. The dipstick is designed to be disposable and cost-effective, making it an accessible option for individuals who lack regular access to healthcare facilities. Its ease of use and affordability broaden the reach of kidney health monitoring, empowering users from various backgrounds to regularly assess their kidney function and seek timely medical support when necessary.
A further inventive aspect of the invention is the potential for aggregating anonymized data to support population-level health studies. Through the smartphone app, anonymized data collected from users can contribute to a broader understanding of kidney health trends across different demographics and regions. This aggregated data could provide valuable insights for healthcare providers, researchers, and public health organizations, enabling them to identify patterns in kidney function changes and target interventions accordingly. The invention, therefore, not only benefits individual users but also contributes to a larger public health initiative aimed at combating kidney disease.
The kidney function tracking urine dipstick offers an innovative approach to renal health monitoring, addressing a significant gap in accessible, non-invasive diagnostic tools. By integrating multiple biomarkers, enhancing accuracy through app-based reading, enabling trend analysis, and providing an affordable solution, this invention represents a meaningful advancement in kidney care. It empowers users to take control of their kidney health, potentially improving outcomes through early detection and consistent monitoring.

BRIEF DESCRIPTION OF DRAWINGS:
The accompanying drawings illustrate various embodiments of "A Kidney Function Tracking Urine Dipstick," highlighting key aspects of its components and operation. These figures are intended for illustrative purposes to aid in understanding the invention and are not meant to limit its scope.
FIG. 1 depicts a block diagram of a kidney function tracking urine dipstick, showing its structure and composition, according to an embodiment of the present invention.
The drawings provided will be further described in detail in the following sections. They offer a visual representation of the urine dipstick's design, biomarker detection process, and data interpretation, helping to clarify and support the detailed description of the invention.

DETAILED DESCRIPTION OF THE INVENTION:
In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural and logical changes may be made without departing from the spirit and scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims and their equivalents.
The present invention is described in brief with reference to the accompanying drawings. Now, refer in more detail to the exemplary drawings for the purposes of illustrating non-limiting embodiments of the present invention.
As used herein, the term "comprising" and its derivatives including "comprises" and "comprise" include each of the stated integers or elements but does not exclude the inclusion of one or more further integers or elements.
As used herein, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. For example, reference to "a device" encompasses a single device as well as two or more devices, and the like.
As used herein, the terms "for example", "like", "such as", or "including" are meant to introduce examples that further clarify more general subject matter. Unless otherwise specified, these examples are provided only as an aid for understanding the applications illustrated in the present disclosure, and are not meant to be limiting in any fashion.
As used herein, the terms ""may", "can", "could", or "might" be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.
Exemplary embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplary embodiments are shown. These exemplary embodiments are provided only for illustrative purposes and so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those of ordinary skill in the art. The invention disclosed may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.
Various modifications will be readily apparent to persons skilled in the art. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Moreover, all statements herein reciting embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (i.e., any elements developed that perform the same function, regardless of structure). Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. For purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention.
Each of the appended claims defines a separate invention, which for infringement purposes is recognized as including equivalents to the various elements or limitations specified in the claims. Depending on the context, all references below to the "invention" may in some cases refer to certain specific embodiments only. In other cases, it will be recognized that references to the "invention" will refer to subject matter recited in one or more, but not necessarily all, of the claims.
All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "such as") provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.
Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition and persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.
Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all groups used in the appended claims.
With reference to FIG. 1, in an embodiment of the present invention, the present invention introduces a kidney function tracking urine dipstick (100), providing a convenient, non-invasive solution for assessing kidney health through regular monitoring of critical biomarkers. The dipstick (100) is designed specifically for individuals requiring consistent kidney health monitoring, especially those with underlying health conditions such as diabetes or hypertension, who are at a higher risk of kidney impairment. By detecting multiple biomarkers within a single test, the dipstick (100) enables users to obtain a more comprehensive understanding of their renal status without needing specialized laboratory equipment or trained medical professionals. This enhanced accessibility facilitates early detection of potential kidney-related issues, potentially preventing the progression of chronic kidney disease and improving overall health outcomes.
The test strip (10) within the dipstick (100) is embedded with colorimetric reagents (20) that are highly sensitive to specific biomarkers associated with kidney health, including albumin, creatinine, protein levels, pH, and specific gravity. These biomarkers are essential indicators of kidney function, as they reflect the ability of the kidneys to filter and balance bodily fluids. The colorimetric reagents (20) interact with each biomarker and produce color changes proportional to the biomarker's concentration, providing an intuitive, visual response that the user can interpret directly. The albumin and creatinine levels are particularly important, as an abnormal albumin-to-creatinine ratio (ACR) is an early indicator of kidney dysfunction, especially in the case of chronic kidney disease. By integrating this ratio calculation capability, the dipstick (100) supports users in identifying early signs of kidney issues.
A quantitative reading indicator (30) is included on the dipstick (100) to further assist users in interpreting the test results. This indicator (30) provides a reference for the color changes produced by the colorimetric reagents (20), allowing users to estimate biomarker levels based on the intensity or shade of the colors visible on the test strip (10). For example, a higher concentration of protein or albumin would produce a darker color on the respective test areas, while lower levels would be indicated by lighter colors. This user-friendly visual scale makes the dipstick (100) accessible to individuals with minimal medical training, enabling them to monitor their kidney function independently at home.
The dipstick (100) is designed to be disposable, ensuring a single-use format that prevents contamination from previous tests. This disposable nature is crucial for maintaining result accuracy, as it eliminates the risk of cross-contamination, which can distort biomarker readings. By providing a fresh test strip (10) with each use, the dipstick (100) supports consistent and reliable results, making it a dependable option for routine kidney function monitoring. Additionally, the disposable format of the dipstick (100) allows it to be economically viable, contributing to its affordability for regular, at-home use. This cost-effective design makes it a practical choice for a broader range of users, including those in low-resource areas or those who may lack access to regular healthcare facilities.
In an innovative extension, the kidney function tracking urine dipstick (100) includes compatibility with a smartphone-based interface. This interface captures an image of the dipstick (100) after testing and uses image analysis technology to process and interpret the color changes produced by the colorimetric reagents (20). Through this digital analysis, the smartphone interface can translate the color intensity into quantitative data, offering a more accurate and objective reading of biomarker levels compared to manual interpretation. This feature minimizes human error in reading the results, ensuring greater precision and reliability, especially for users who may struggle with interpreting color gradients.
The smartphone-compatible interface is further designed to store historical data from multiple tests, enabling users to track trends and changes in their kidney function over time. This trend analysis capability is particularly beneficial for individuals with chronic conditions requiring long-term kidney monitoring, as it allows them to detect gradual changes that might indicate an emerging issue. For example, an upward trend in protein or albumin levels over time could signal declining kidney function, prompting the user to seek medical consultation before the condition worsens. By storing historical data and supporting trend analysis, the smartphone interface encourages proactive kidney health management, empowering users to take an active role in their well-being.
In addition to data storage, the smartphone-compatible interface allows for remote sharing of test results with healthcare providers. Users can share their data with medical professionals, facilitating remote patient monitoring and enabling early intervention based on observed kidney function trends. This feature is especially valuable for patients living in remote or underserved areas who may have limited access to in-person medical care. By providing an easy way to communicate test results with healthcare providers, the dipstick (100) supports a collaborative approach to kidney health management, allowing professionals to offer timely advice and adjust treatment plans based on real-time data.
The dipstick's composition is formulated with cost-effective materials, making it a financially accessible option for regular monitoring without the need for expensive laboratory procedures. By maintaining affordability, the dipstick (100) addresses the growing demand for accessible diagnostic tools, particularly in regions with limited healthcare infrastructure. Its low-cost design ensures that users can monitor their kidney health frequently, detecting potential issues early on and reducing the burden on healthcare systems by minimizing the need for emergency interventions. This affordability and accessibility make the dipstick (100) suitable for widespread use, supporting public health initiatives focused on early disease detection and prevention.
Moreover, the design of the dipstick (100) includes a user-friendly visual scale printed directly on the test strip (10) to simplify result interpretation. This scale provides reference colors corresponding to various biomarker levels, enabling users to quickly assess their kidney function without the need for complex instructions. For example, a simple color scale might indicate low, moderate, and high levels for each biomarker, allowing users to easily compare the color change on the test strip (10) to the printed scale. This feature is particularly useful for individuals who may lack technical or medical knowledge, making the dipstick (100) an inclusive tool for users across diverse demographics.
The quantitative reading indicator (30), combined with the smartphone interface, further enhances the dipstick's usability by reducing interpretation ambiguity. While the visual scale provides a quick reference, the digital reading through the smartphone app offers a more precise analysis of biomarker levels. This dual interpretation option-visual and digital-makes the dipstick (100) versatile, catering to users with varying preferences and comfort levels with technology. By offering both manual and app-based interpretations, the dipstick (100) ensures that users have access to accurate readings regardless of their preferred method.
The kidney function tracking urine dipstick (100) represents an advancement in diagnostic technology, combining multi-biomarker detection, colorimetric analysis, smartphone compatibility, and cost-effective design into a single device. By integrating these features, the dipstick (100) empowers users to proactively monitor their kidney health, reducing dependency on frequent clinical visits and promoting early intervention. Its ease of use, affordability, and compatibility with digital health tools align with the growing emphasis on patient-centered healthcare, where individuals are encouraged to take an active role in managing their health.
The smartphone interface not only enhances accuracy but also facilitates data aggregation on a larger scale. Anonymized data collected from users can contribute to public health studies on kidney function trends, offering valuable insights into the prevalence and progression of kidney disease across different populations. This data could inform healthcare providers and policymakers in developing targeted interventions, resource allocation, and awareness campaigns to address kidney disease at the community and national levels. Thus, the dipstick (100) serves not only as an individual diagnostic tool but also as a potential contributor to broader kidney health research and public health efforts.
Overall, the kidney function tracking urine dipstick (100) provides an innovative approach to renal health management, bridging the gap between traditional laboratory testing and home-based monitoring. Its integration of multiple biomarkers, disposable design, user-friendly indicators, and smartphone compatibility make it a comprehensive solution for individuals seeking accessible, reliable kidney function assessments. By offering a non-invasive, cost-effective method for kidney health tracking, the dipstick (100) supports proactive health management and fosters early detection, ultimately contributing to better health outcomes and reducing the impact of kidney disease on individuals and healthcare systems alike.

The working of the kidney function tracking urine dipstick (100) involves a straightforward process that allows users to monitor critical biomarkers related to kidney health in a non-invasive and user-friendly manner. The dipstick (100) is equipped with a test strip (10) integrated with colorimetric reagents (20) and a quantitative reading indicator (30), enabling the detection and interpretation of specific biomarkers, including albumin, creatinine, protein levels, pH, and specific gravity. Here is a step-by-step outline of how the dipstick (100) functions:
1. Preparation and Urine Collection: The user begins by collecting a small urine sample in a sterile container. The dipstick (100) is then dipped into the urine sample, ensuring the test strip (10) is fully submerged for a few seconds to allow contact with the urine. This step is crucial for the colorimetric reagents (20) embedded on the test strip (10) to interact with the biomarkers present in the urine.
2. Biomarker Detection through Colorimetric Reaction: Once the dipstick (100) comes in contact with the urine, the colorimetric reagents (20) on the test strip (10) begin to react with the specific biomarkers. Each reagent is formulated to change color in response to a particular biomarker concentration. For instance:
a) Albumin and Creatinine: The reagents produce color changes that vary in intensity based on the concentration of albumin and creatinine, essential indicators for calculating the albumin-to-creatinine ratio (ACR).
b) Protein Levels: Elevated protein levels lead to a distinct color response, enabling detection of proteinuria, a sign of potential kidney dysfunction.
c) pH and Specific Gravity: Reagents also react to detect pH levels and specific gravity, providing additional insights into the urine's chemical and physical characteristics that relate to kidney function.
Each biomarker produces a unique color change, which intensifies based on its concentration. The colorimetric reaction is immediate, and the user can observe the results on the test strip (10) within seconds.
3. Visual Interpretation Using Quantitative Reading Indicator: The quantitative reading indicator (30) on the dipstick (100) serves as a visual scale, allowing the user to interpret the biomarker levels by comparing the color changes on the test strip (10) against the indicator's reference colors. The indicator (30) provides a visual gradient, with each color corresponding to a specific range of biomarker concentrations. This feature allows users to obtain an approximate reading of each biomarker level directly on the dipstick (100), providing an accessible and intuitive way to assess kidney health.
4. Smartphone-Compatible Digital Reading (Optional): For enhanced accuracy and digital tracking, the user has the option of capturing an image of the dipstick (100) using a smartphone application compatible with the device. The app is programmed to perform image analysis on the test strip (10) colors, converting color intensities into precise quantitative values for each biomarker. By reducing subjective interpretation, this digital reading method provides an objective analysis of the biomarker levels, making it especially beneficial for users seeking reliable, trackable results.
5. Data Storage and Trend Analysis: If the smartphone-compatible interface is used, the app can store the results, allowing users to track their kidney health over time. Each test result is saved, creating a historical log of biomarker levels. This trend analysis capability enables users to identify gradual changes in kidney function, such as rising protein or albumin levels, which may indicate an early decline in kidney health. The ability to observe trends empowers users to make informed decisions about their kidney health and seek medical advice if significant changes are detected.
6. Data Sharing with Healthcare Providers (Optional): To facilitate remote healthcare monitoring, users can share their stored test results with healthcare providers through the smartphone app. This data-sharing capability is particularly beneficial for individuals with chronic kidney disease or other conditions requiring regular monitoring, as it allows healthcare providers to review kidney function trends remotely and provide timely recommendations or interventions as needed.
7. Disposal of the Dipstick: After the test is complete, the dipstick (100) is disposed of as a single-use item. This disposable nature prevents contamination and ensures that each test is conducted on a fresh, uncontaminated strip, thereby maintaining the accuracy of the results. The cost-effective design supports frequent testing without significant financial burden, making it accessible for routine kidney function monitoring.
Therefore, the kidney function tracking urine dipstick (100) functions through a series of steps that combine chemical reactions, visual interpretation, optional digital analysis, and data tracking. These features allow users to gain insights into their kidney health in a convenient, non-invasive manner. The integration of colorimetric reagents (20), a visual reading indicator (30), and smartphone compatibility makes the dipstick (100) a versatile tool for both immediate assessment and long-term kidney health monitoring. Through this comprehensive approach, the dipstick (100) empowers users to take control of their kidney health, supports early detection of kidney issues, and facilitates proactive health management.

ADVANTAGES OF THE INVENTION:
The prime advantage of the invention is to provide a convenient, non-invasive method for monitoring kidney health, allowing individuals to assess their kidney function regularly without requiring laboratory visits or medical expertise.
Another advantage of the invention is its multi-biomarker detection capability, which provides a comprehensive assessment of kidney health by analyzing key indicators like albumin, creatinine, protein levels, pH, and specific gravity in a single test.
Yet another advantage of the invention is the intuitive colorimetric reading system, enabling users to interpret results visually with ease, making the dipstick accessible to individuals with minimal technical or medical knowledge.
Still another advantage of the invention is its compatibility with smartphone-based analysis, enhancing reading accuracy by using digital image processing, thereby reducing human error and providing precise, reliable results for users.
A further advantage of the invention is the data storage and trend analysis feature, allowing users to track kidney health changes over time, which supports early intervention and proactive management of potential kidney issues.
Another advantage of the invention is its disposable, single-use format, which prevents contamination between tests, ensuring result accuracy and promoting hygienic testing practices for consistent and dependable readings.
Yet another advantage of the invention is its affordability, making it a cost-effective solution for regular kidney health monitoring, particularly beneficial for individuals with limited access to frequent healthcare services.
Still another advantage of the invention is its data-sharing capability, enabling remote health monitoring by allowing users to share test results with healthcare providers, which supports timely medical intervention and tailored treatment recommendations.
A further advantage of the invention is its potential to support public health efforts by aggregating anonymized data on kidney health trends, providing valuable insights for healthcare providers and researchers to better understand and manage kidney disease.
, Claims:CLAIM(S):
We Claim:
1. A kidney function tracking urine dipstick (100), comprising:
a. a test strip (10) integrated with colorimetric reagents (20) to detect multiple biomarkers, including albumin, creatinine, protein levels, pH, and specific gravity; and
b. a quantitative reading indicator (30) that provides a visual response based on biomarker concentration to enable user interpretation.
2. The kidney function tracking urine dipstick of claim 1, wherein the colorimetric reagents produce color changes proportionally corresponding to the biomarker levels, allowing for visual assessment of kidney health.
3. The kidney function tracking urine dipstick of claim 1, further comprising a smartphone-compatible interface that captures, processes, and interprets the color changes to generate quantitative data for precise analysis of kidney function.
4. The kidney function tracking urine dipstick of claim 3, wherein the smartphone-compatible interface is configured to store historical data from multiple tests, enabling trend analysis for ongoing kidney function monitoring.
5. The kidney function tracking urine dipstick of claim 1, wherein the dipstick is disposable, making it suitable for single use to provide reliable results without contamination from previous tests.
6. The kidney function tracking urine dipstick of claim 1, wherein the albumin-to-creatinine ratio (ACR) is calculated from the biomarker readings to assess early signs of kidney dysfunction.
7. The kidney function tracking urine dipstick of claim 1, further comprising a user-friendly visual scale printed on the dipstick for easy interpretation of color intensity changes related to biomarker levels.
8. The kidney function tracking urine dipstick of claim 3, wherein the smartphone-compatible interface uses image analysis to reduce human error in reading the dipstick results, enhancing diagnostic accuracy.
9. The kidney function tracking urine dipstick of claim 1, wherein the dipstick's composition is formulated to be cost-effective, making it accessible for regular home-based monitoring by individuals without requiring laboratory support.
10. The kidney function tracking urine dipstick of claim 3, wherein the smartphone-compatible interface supports data sharing with healthcare providers to facilitate remote patient monitoring and early intervention based on kidney function trends.

Documents

NameDate
202411085266-COMPLETE SPECIFICATION [07-11-2024(online)].pdf07/11/2024
202411085266-DECLARATION OF INVENTORSHIP (FORM 5) [07-11-2024(online)].pdf07/11/2024
202411085266-DRAWINGS [07-11-2024(online)].pdf07/11/2024
202411085266-EDUCATIONAL INSTITUTION(S) [07-11-2024(online)].pdf07/11/2024
202411085266-EVIDENCE FOR REGISTRATION UNDER SSI [07-11-2024(online)].pdf07/11/2024
202411085266-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [07-11-2024(online)].pdf07/11/2024
202411085266-FIGURE OF ABSTRACT [07-11-2024(online)].pdf07/11/2024
202411085266-FORM 1 [07-11-2024(online)].pdf07/11/2024
202411085266-FORM FOR SMALL ENTITY(FORM-28) [07-11-2024(online)].pdf07/11/2024
202411085266-FORM-9 [07-11-2024(online)].pdf07/11/2024
202411085266-POWER OF AUTHORITY [07-11-2024(online)].pdf07/11/2024
202411085266-PROOF OF RIGHT [07-11-2024(online)].pdf07/11/2024
202411085266-REQUEST FOR EARLY PUBLICATION(FORM-9) [07-11-2024(online)].pdf07/11/2024

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