AN ENHANCED DISPOSABLE TEST STRIP FOR DIGESTIVE HEALTH MONITORING

Abstract

The present invention discloses a disposable test strip for digestive health monitoring, configured to detect biomarkers such as pH levels, enzymes, and bile acids in biological samples like saliva or stool. The multilayer structure includes an absorbent layer, colorimetric reagent layer, PVA protective film, adhesive base, and hydrophobic barrier. It delivers real-time, visible color changes for easy result interpretation, promoting non-invasive, rapid, and cost-effective digestive health assessment suitable for at-home use, enhancing preventive healthcare and early intervention.

Specification

Description:FIELD OF THE INVENTION:
The field of this invention pertains to digestive health diagnostics, specifically focusing on disposable, at-home test strips configured for non-invasive monitoring of gastrointestinal biomarkers. It falls within the domain of medical diagnostics and home healthcare, offering quick, convenient assessment of digestive function and potential imbalances.

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.
Digestive health is a vital aspect of overall well-being, as it affects nutrient absorption, immune function, and the body's ability to manage waste. Common gastrointestinal issues, such as irritable bowel syndrome, acid reflux, and dysbiosis, can lead to a range of symptoms, including abdominal pain, bloating, and changes in bowel habits. These conditions often require timely identification to prevent progression and complications. However, monitoring digestive health typically involves complex laboratory tests that can be invasive, time-consuming, and costly. As a result, many individuals either delay seeking medical attention or overlook mild symptoms that may be indicative of more significant issues.
There is a growing demand for convenient, at-home diagnostic tools that can provide early insights into digestive health without the need for frequent doctor visits. At-home tests allow users to assess their health conditions and make informed decisions about diet, medication, or seeking professional advice. The development of disposable test strips that can monitor digestive markers is an innovation aimed at addressing this demand. These strips are simple to use, require minimal sample collection, and offer real-time results that are easy to interpret. They can be a beneficial addition to the field of home healthcare by empowering users to take proactive measures for their digestive well-being.
The concept of using disposable test strips in medical diagnostics is not new, as they have been widely utilized for detecting glucose levels, pregnancy hormones, and infectious diseases. However, adapting this technology to digestive health monitoring presents unique challenges. Digestive biomarkers, including enzymes, bile acids, and inflammation indicators, are more complex than those commonly tested in other applications. These biomarkers require specific reagents that can react accurately with the samples, often involving more sophisticated chemical formulations to ensure accurate results.
Traditional digestive health tests generally require stool or saliva samples to be sent to a laboratory, where complex biochemical assays are performed to analyze the presence of markers such as digestive enzymes or bile acids. This process can be time-consuming, often taking several days to provide results, which delays intervention and treatment. Additionally, these methods may not be accessible in remote or underdeveloped regions due to the lack of laboratory facilities and healthcare resources. The invention of an enhanced disposable test strip for digestive health monitoring aims to fill this gap by providing a more accessible and user-friendly alternative.
The disposable test strip is configured to be compact and cost-effective, making it suitable for widespread use. It incorporates a multilayered structure, each layer having a distinct function. The top layer is a protective barrier that prevents contamination while allowing the sample to pass through. Beneath this is an absorbent layer that draws the sample into the test strip, ensuring rapid interaction with the reagents. The central layer contains colorimetric reagents specifically formulated to react with digestive biomarkers, producing distinct color changes based on the concentration of each marker. The bottom layer of the strip serves as a support structure, keeping the strip intact during testing and handling. This design ensures that the test strip remains simple and user-friendly while maintaining the accuracy of results.
The test strip's design also emphasizes versatility, allowing it to detect multiple digestive health markers simultaneously. It can analyze pH levels to provide an indication of stomach acidity, which is crucial for diagnosing conditions like acid reflux and peptic ulcers. The test strip can also detect bile acids, which play a significant role in fat digestion and can indicate liver or gallbladder function. By integrating various reagents that respond to different biomarkers, the strip can offer a comprehensive assessment of the digestive system in a single test, making it a valuable tool for users managing chronic digestive conditions or monitoring recovery after treatment.
One of the key advantages of this enhanced disposable test strip is its rapid response time. Users can obtain results within minutes, allowing for immediate assessment of digestive health status. This quick turnaround is especially important in cases where symptoms fluctuate rapidly, such as during an acute digestive upset. Early detection can lead to prompt dietary adjustments or medical intervention, reducing the risk of severe complications. Moreover, the test strip's simplicity ensures that it can be used by individuals with minimal technical knowledge, making it particularly useful for elderly users or those with limited access to healthcare facilities.
The test strip also offers potential applications in preventive healthcare. By providing regular feedback on digestive markers, users can monitor their gut health over time and make informed lifestyle changes. For instance, if the strip detects an abnormal pH level or the presence of certain enzymes, users might consider modifying their diet, increasing fiber intake, or consulting a healthcare professional for further advice. This proactive approach aligns with the broader trend of personalized medicine, where individuals play an active role in managing their health.
Another significant aspect of this invention is its potential to reduce healthcare costs. Regular use of the disposable test strip can reduce the need for expensive laboratory tests and frequent doctor visits, making it an economical option for managing digestive health. Additionally, the test strip's disposable nature ensures hygiene and safety, as it minimizes the risk of cross-contamination that can occur with reusable diagnostic tools. This feature makes it suitable for both individual and family use, further broadening its appeal.
The development of the enhanced disposable test strip for digestive health monitoring represents a step forward in making healthcare more accessible and user-centric. By focusing on simplicity, accuracy, and cost-effectiveness, this invention has the potential to improve digestive health outcomes across various demographics. It caters to the increasing demand for at-home diagnostic solutions that are not only easy to use but also reliable in delivering results that can guide health management decisions. As awareness of the importance of digestive health continues to grow, this test strip can play a crucial role in promoting a preventive approach to healthcare, ultimately contributing to improved quality of life.

OBJECTS OF THE INVENTION:
The prime object of the invention is to provide a disposable test strip for digestive health monitoring that enables users to assess key gastrointestinal biomarkers in a non-invasive and convenient manner. By simplifying the diagnostic process, this test strip aims to deliver real-time results, making it easier for users to identify potential digestive issues without requiring laboratory tests or professional assistance.
Another object of the invention is to offer a cost-effective solution for digestive health monitoring. The test strip is configured to be affordable and accessible, allowing for frequent usage without financial strain. This affordability ensures that individuals from various socio-economic backgrounds can monitor their digestive health regularly and take necessary preventive measures when required.
Yet another object of the invention is to incorporate a multi-sensor system within the test strip. The inclusion of distinct sensing regions allows for simultaneous detection of different digestive markers, such as enzymes, pH levels, and bile acids. This comprehensive analysis provides a broader overview of digestive health in a single test, making it a more versatile diagnostic tool.
Still another object of the invention is to ensure rapid response and result interpretation. The test strip is formulated to produce visible color changes within minutes of sample application, enabling users to obtain immediate feedback on their digestive health status. This quick turnaround is particularly beneficial for individuals experiencing acute digestive symptoms, as it allows for timely dietary adjustments or medical intervention.
An additional object of the invention is to promote preventive healthcare by allowing users to regularly monitor their digestive health. By offering a convenient at-home diagnostic tool, the test strip encourages individuals to take proactive measures, such as dietary modifications or seeking medical advice based on test results. This aligns with the broader aim of personalized healthcare, where individuals play an active role in managing their well-being.
A further object of the invention is to ensure safety and hygiene through the use of disposable materials. The single-use nature of the test strip minimizes the risk of cross-contamination, making it suitable for personal and family use. The disposable design also aligns with current healthcare trends that prioritize safety and infection control.
Yet a further object of the invention is to provide a test strip that is easy to use, even for individuals with minimal technical knowledge. The strip's simple design and clear instructions make it accessible to users of all age groups, including the elderly and those with limited healthcare literacy. This ease of use enhances its applicability and broadens its reach, especially in regions with limited access to healthcare facilities.
Another significant object of the invention is to offer a reliable diagnostic tool that maintains accuracy across different sample types, such as saliva or stool. This versatility ensures that users can choose the most suitable sample type for their specific condition, increasing the strip's effectiveness in detecting a range of digestive health markers.

SUMMARY OF THE INVENTION:
The invention titled an enhanced disposable test strip for digestive health monitoring is configured to offer an easy-to-use, rapid, and non-invasive method for analyzing digestive biomarkers. This test strip incorporates a multilayer structure with specific reagents formulated to detect various gastrointestinal markers such as digestive enzymes, pH levels, and bile acids. It is made from materials that ensure safety, accuracy, and hygiene, making it suitable for at-home use.
The test strip comprises several chemical reagents and materials, each carefully chosen for its role in the detection process. Below is a detailed breakdown of the ingredients and their approximate percentage composition:
1. Absorbent Layer (35%):
i. This layer is composed of cellulose fibers and polyacrylate, which ensures rapid absorption of the sample.
ii. It allows the sample to pass through to the reagent layer without causing any diffusion errors.
2. Colorimetric Reagent Layer (25%):
i. The reagent layer contains a mix of pH indicators, enzyme-specific substrates, and bile acid-sensitive compounds.
ii. The primary reagents include methyl orange (0.5-1%), bromothymol blue (0.5-1%), and phenolphthalein (0.2-0.5%), each of which provides a visible color change upon interaction with specific biomarkers.
3. Polyvinyl Alcohol (PVA) Film (10%):
i. This layer acts as a protective coating, preventing contamination while allowing easy handling.
ii. PVA ensures sample integrity and preserves the reagents' effectiveness during testing.
4. Adhesive Base Layer (20%):
i. Composed of silicone-based adhesive, this layer holds the test strip components together, ensuring structural stability during testing.
ii. It provides a strong, non-reactive binding to avoid interference with the detection process.
5. Hydrophobic Barrier Layer (10%):
i. Made from polyethylene, this layer prevents external moisture from affecting the results, ensuring consistent performance.
Inventive features of the invention are as follows:
An inventive aspect of the invention is to provide a comprehensive diagnostic tool capable of detecting multiple digestive biomarkers simultaneously. The multilayer design of the test strip, with each layer dedicated to a specific function, ensures that users can monitor different parameters, such as pH balance, bile acid presence, and enzyme activity, within a single test. This innovation improves the accuracy and scope of digestive health assessment, making it more versatile than traditional single-parameter test strips.
Another inventive aspect of the invention is to ensure rapid sample absorption and reaction, enabling real-time result visualization. The combination of cellulose and polyacrylate in the absorbent layer facilitates quick sample uptake, while the optimized reagent composition ensures visible color changes within minutes. This fast response time allows users to assess their digestive health promptly, reducing anxiety and enabling quicker decision-making regarding dietary or medical interventions.
Yet another inventive aspect of the invention is to enhance safety and hygiene by using disposable, non-toxic materials. The inclusion of polyvinyl alcohol film as a protective barrier ensures that the test strip remains uncontaminated, while the hydrophobic barrier prevents moisture interference. This safety-focused design minimizes cross-contamination risks, making the strip suitable for personal and family use, particularly in environments with limited healthcare resources.
Still another inventive aspect of the invention is to offer a cost-effective solution for regular digestive health monitoring. The ingredients and materials used in the test strip are readily available and low-cost, which helps maintain affordability without compromising performance. This aspect makes it feasible for widespread use, supporting preventive healthcare approaches and promoting accessibility to diagnostic tools.
An additional inventive aspect of the invention is the incorporation of a highly visible colorimetric indicator system that provides clear, easy-to-interpret results. The test strip uses distinct colors to represent various digestive health markers, reducing the possibility of misinterpretation. This feature ensures that users of all age groups, including the elderly and individuals with minimal technical knowledge, can use the strip effectively.
A further inventive aspect of the invention is the strip's compatibility with various sample types, such as saliva and stool, expanding its diagnostic utility. The reagents and materials used in the test strip are configured to maintain consistent performance across different sample types, making it suitable for a range of digestive health assessments. This versatility aligns with the goal of personalized healthcare, allowing users to choose the sample type that best suits their condition or comfort level.

BRIEF DESCRIPTION OF DRAWINGS:
The accompanying drawings illustrate various embodiments of "An Enhanced Disposable Test Strip for Digestive Health Monitoring," highlighting key aspects of its structure and functionality. 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 an enhanced disposable test strip for digestive health monitoring, showing its multilayer 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 test strip's structure, reagent layers, and protective features, 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 disposable test strip for digestive health monitoring is formulated with a multilayer structure and specific reagents to detect a range of digestive biomarkers. The composition of the test strip includes an absorbent layer, a colorimetric reagent layer, a protective film, an adhesive base layer, and a hydrophobic barrier. Each layer is optimized for functionality, ensuring accurate, reliable, and safe results. The test strip's formulation is configured to provide rapid, non-invasive monitoring while being compatible with various biological samples such as saliva and stool.
The test strip's ingredients and their respective percentage compositions are detailed below, reflecting their role in the overall function of the invention:
1. Absorbent Layer (35% of total composition):
a) The absorbent layer is primarily composed of cellulose fibers and polyacrylate.
b) Cellulose fibers (20-25%): These fibers serve as the primary absorbent material, ensuring quick uptake and distribution of the sample throughout the layer.
c) Polyacrylate (10-15%): It acts as a superabsorbent polymer, further enhancing the capacity to draw in moisture rapidly. The combination of cellulose and polyacrylate maintains the structural integrity of the layer, preventing leakage and ensuring maximum interaction with the reagent layer.
2. Colorimetric Reagent Layer (25% of total composition):
a) The reagent layer contains a blend of pH indicators, enzyme-specific substrates, and bile acid-sensitive compounds. The formulation includes:
i. Methyl Orange (0.5-1%): Used for pH detection, it produces a color change ranging from red to orange, indicating shifts in acidity levels.
ii. Bromothymol Blue (0.5-1%): This compound responds to bile acid presence, showing a color shift from yellow to blue, reflecting bile acid concentrations in the sample.
iii. Phenolphthalein (0.2-0.5%): It indicates enzyme activity, with a color change from colorless to pink when specific digestive enzymes are present.
b) The rest of the reagent layer consists of inert carriers (15-18%) that stabilize the active components, ensuring consistent reagent distribution and performance.
3. Polyvinyl Alcohol (PVA) Protective Film Layer (10% of total composition):
a) Polyvinyl Alcohol (10%): This transparent, water-resistant film prevents contamination, maintaining sample integrity and ensuring clear visibility of colorimetric reactions. It acts as a barrier against environmental interference, ensuring the reagents remain stable throughout the testing process.
4. Adhesive Base Layer (20% of total composition):
a) Silicone-Based Adhesive (20%): The adhesive layer secures the strip's components, providing structural stability and ensuring that the layers remain intact during testing. The silicone adhesive is non-reactive, ensuring that it does not interfere with the chemical reactions of the reagent layer.
5. Hydrophobic Barrier Layer (10% of total composition):
a) Polyethylene (10%): This barrier prevents moisture interference, ensuring consistent results by repelling external water sources. The hydrophobic layer helps maintain the test's accuracy, making the strip suitable for use in humid environments.
The multilayer structure of the test strip ensures that each component plays a specific role in enhancing the detection and analysis of digestive biomarkers. The absorbent layer, comprising cellulose fibers and polyacrylate, rapidly draws the biological sample into the strip, facilitating even distribution. This layer ensures the sample reaches the reagent layer efficiently, enabling accurate chemical interactions that are crucial for determining digestive health.
An inventive aspect of the test strip is the design of the colorimetric reagent layer, which contains pH-sensitive compounds, enzyme-specific substrates, and bile acid-sensitive agents. The inclusion of methyl orange, bromothymol blue, and phenolphthalein as colorimetric indicators ensures that each digestive biomarker can be detected through visible color changes. For instance, the presence of high bile acid levels will trigger a blue shift in bromothymol blue, while changes in acidity will be reflected by color shifts in methyl orange. These clear, distinct color changes make it easy for users to interpret the results without the need for technical knowledge or equipment.
Another inventive aspect of the test strip is the PVA protective film layer, which maintains the integrity of the sample and prevents contamination. The PVA film is not only transparent but also water-resistant, allowing users to observe the colorimetric changes without interference. This protective layer enhances the reliability of the test results, ensuring that environmental factors such as dust, moisture, or foreign particles do not affect the accuracy of the readings.
Yet another inventive aspect is the inclusion of a silicone-based adhesive base layer, which ensures the structural cohesion of the test strip. The adhesive holds the layers together securely, allowing users to handle the strip easily without compromising its performance. The adhesive's non-reactive nature ensures that it does not interfere with the chemical reactions occurring in the reagent layer, maintaining the accuracy and consistency of the test results.
Still another inventive aspect is the incorporation of a hydrophobic barrier layer, which prevents external moisture from affecting the test's performance. The polyethylene material used in this layer repels water, ensuring that the sample and reagents remain stable throughout the testing process. This barrier makes the test strip suitable for use in various climates, including humid environments, where moisture could otherwise alter the test results.
The test strip also incorporates multiple distinct sensor regions within the colorimetric reagent layer, allowing for simultaneous analysis of various digestive biomarkers. Each sensor region is dedicated to detecting specific markers, such as pH levels, enzyme activity, and bile acid concentrations. This multi-sensor design enables a comprehensive assessment of digestive health in a single test, providing users with a broader overview of their gastrointestinal status. The presence of multiple sensor regions also facilitates a more detailed analysis, allowing users to identify potential imbalances or abnormalities in their digestive system.
The versatility of the test strip is evident in its compatibility with different biological samples, such as saliva and stool. The reagents and materials used in the strip are formulated to maintain consistent performance across these sample types, making it suitable for a wide range of digestive health assessments. Whether users are monitoring acidity levels, detecting bile acids, or assessing enzyme activity, the test strip provides a flexible, reliable tool for digestive health monitoring.
The colorimetric reagents in the test strip are specifically configured to produce distinct color changes that correspond to specific concentrations of digestive biomarkers. This feature allows for easy interpretation of the results, as each color change is associated with a particular marker level, helping users quickly identify potential issues. The test strip provides a straightforward color chart that users can compare with the observed results, promoting proactive health management. By facilitating the early detection of abnormalities, users can make informed decisions regarding dietary adjustments, lifestyle changes, or further medical consultation.
The disposable nature of the test strip is a significant feature that minimizes the risk of cross-contamination. Configured for single use, the strip can be safely discarded after testing, ensuring that subsequent tests remain uncontaminated. This disposable design aligns with current hygiene standards in medical diagnostics, making it particularly suitable for personal use in homes or in environments with limited healthcare facilities. The single-use design not only reduces the risk of infection but also promotes safety, making the test strip an ideal option for frequent monitoring of digestive health.
Therefore, the enhanced disposable test strip for digestive health monitoring offers a comprehensive, convenient, and cost-effective solution for assessing gastrointestinal function. Its multilayer structure, coupled with specific reagents and protective features, ensures reliable performance across different conditions and sample types. The test strip is configured to provide real-time results that facilitate early detection and management of digestive issues, promoting preventive healthcare. By integrating safety, versatility, and ease of use, the invention empowers users to take an active role in managing their digestive health. Its affordable design ensures accessibility, making it a valuable tool for users across diverse demographics, including those in remote or underdeveloped regions.

Working of the invention: The working of the enhanced disposable test strip for digestive health monitoring is centered around a multilayer design, where each layer plays a specific role in facilitating the detection of digestive biomarkers. The strip operates in a sequential manner, beginning with the sample application and progressing through various interactions that lead to the final result interpretation. The process is rapid, typically taking only a few minutes to complete, making it convenient for users seeking immediate feedback on their digestive health.
The first step in the working of the test strip involves sample application. The user applies a small amount of biological sample, such as saliva or stool, onto the absorbent layer of the strip. This layer, composed of cellulose fibers and polyacrylate, is configured to rapidly absorb the sample, distributing it evenly across the surface. The absorbent layer ensures efficient sample intake, allowing the biological components to reach the underlying colorimetric reagent layer quickly. This fast absorption is crucial for initiating the chemical reactions needed for biomarker detection.
Once the sample reaches the colorimetric reagent layer, the detection process begins. This layer contains a set of specific reagents that are sensitive to various digestive biomarkers, such as pH levels, enzyme activity, and bile acids. As the sample interacts with the reagents, chemical reactions occur, leading to visible color changes. For example, if the pH of the sample indicates increased acidity, the reagent methyl orange will change from orange to red. Similarly, the presence of bile acids will trigger a color shift from yellow to blue in the bromothymol blue indicator, while enzyme activity will cause phenolphthalein to change from colorless to pink. These color changes are configured to be distinct and easy to interpret, allowing users to visually assess the presence and concentration of specific biomarkers.
The polyvinyl alcohol (PVA) protective film layer plays a critical role during the reaction process. It prevents contamination and external interference, maintaining the integrity of the sample and reagents throughout the test. The transparency of the PVA film allows users to observe the color changes clearly, ensuring accurate result interpretation. Additionally, the water-resistant nature of the PVA layer prevents any external moisture from affecting the chemical reactions, enhancing the reliability of the test results. This protective feature is particularly beneficial in environments where humidity or other contaminants could compromise the accuracy of the readings.
The adhesive base layer contributes to the stability of the test strip during the entire testing process. Composed of a silicone-based adhesive, this layer holds all components together, ensuring that the strip remains intact and easy to handle. The adhesive is non-reactive, meaning it does not interfere with the reagent reactions, thus maintaining the accuracy of the test results. This structural cohesion ensures that the test strip can withstand normal handling without compromising its performance, providing users with a durable and reliable diagnostic tool.
The hydrophobic barrier layer, located at the bottom of the test strip, serves to prevent moisture from entering the strip from the external environment. Made of polyethylene, this layer ensures that the reagents and the sample remain unaffected by external humidity or water exposure. By repelling moisture, the hydrophobic barrier maintains consistent test performance, even in humid conditions. This feature is essential for maintaining the stability and reliability of the results, making the test strip suitable for use in a variety of environmental settings.
As the colorimetric reactions take place within the reagent layer, the user can observe the color changes directly through the transparent PVA film. Each color change corresponds to a specific biomarker level, allowing for straightforward interpretation. The test strip typically comes with a color chart that users can use to compare the observed colors and determine the results. For example, a deep red color may indicate high acidity, while a vivid blue could suggest elevated bile acid levels. The color chart is configured to be easy to understand, even for individuals with minimal technical knowledge, enabling quick and accurate assessment of digestive health.
The versatility of the test strip allows it to work effectively with different sample types, such as saliva and stool, which contain distinct sets of digestive biomarkers. The reagents are formulated to interact consistently with these sample types, making the strip adaptable for various digestive health assessments. This adaptability enhances the diagnostic capabilities of the test strip, allowing users to select the sample type that best suits their specific needs and conditions.
The disposable nature of the test strip ensures that it is safe and hygienic for single use. After testing, users can easily discard the strip, minimizing the risk of cross-contamination. The disposable design aligns with modern hygiene standards in medical diagnostics, making it particularly suitable for personal, at-home use. It also promotes frequent monitoring of digestive health, as users can perform the test regularly without the risk of contaminating subsequent tests. This aspect of the invention supports preventive healthcare by encouraging users to monitor their digestive health over time and identify potential issues early.
Therefore, the working of the enhanced disposable test strip for digestive health monitoring is based on a step-by-step interaction between the sample and the multilayer components. Each layer performs a specific function that contributes to the overall accuracy, reliability, and ease of use of the test. From rapid sample absorption to visible colorimetric reactions and protective features, the test strip provides a comprehensive and user-friendly approach to digestive health monitoring, empowering individuals to take proactive measures in managing their gastrointestinal well-being.

ADVANTAGES OF THE INVENTION:
The prime advantage of the invention is to provide a rapid, non-invasive tool for digestive health monitoring, enabling users to detect biomarkers easily and obtain real-time results, facilitating early detection and intervention for gastrointestinal issues.
Another advantage of the invention is its user-friendly design, making it accessible to individuals with minimal technical knowledge. The clear colorimetric changes allow users to interpret results without specialized equipment or professional assistance.
Yet another advantage of the invention is its compatibility with various biological samples, such as saliva and stool. This versatility enhances the diagnostic scope, enabling broader assessments of digestive health through a single test strip.
Still another advantage of the invention is the disposable, single-use nature of the test strip, which minimizes cross-contamination risks. This feature promotes hygiene and safety, making it suitable for frequent, at-home use.
An additional advantage of the invention is its cost-effectiveness. The test strip's affordable design allows for regular monitoring, encouraging preventive healthcare and making it accessible to diverse socio-economic groups.
A further advantage of the invention is its multilayer structure, ensuring accurate sample absorption, reagent reaction, and moisture protection. This design provides consistent performance across different conditions, improving the reliability of the test results.
Yet a further advantage of the invention is the quick response time, as results can be obtained within minutes. This rapid feedback helps users make timely dietary adjustments or seek medical advice when needed.
, Claims:CLAIM(S):
We Claim:
1. A disposable test strip for digestive health monitoring, comprising:
a. An absorbent layer configured to quickly absorb a biological sample, facilitating interaction with subsequent layers,
b. A colorimetric reagent layer that contains specific reagents capable of detecting digestive biomarkers, producing visible color changes upon reaction,
c. A polyvinyl alcohol (PVA) protective film layer that prevents contamination while maintaining sample integrity,
d. An adhesive base layer that secures the layers together, providing structural stability and non-reactivity, and
e. A hydrophobic barrier layer to prevent moisture interference and ensure consistent performance.
2. The test strip according to claim 1, wherein the colorimetric reagent layer includes:
a. pH-sensitive compounds, enzyme-specific substrates, and bile acid-sensitive compounds, with reagents selected from the group consisting of methyl orange, bromothymol blue, and phenolphthalein.
3. The test strip according to claim 1, wherein the absorbent layer is composed of a combination of cellulose fibers and polyacrylate, facilitating rapid sample absorption and accurate reagent interaction.
4. The test strip according to claim 1, wherein the polyvinyl alcohol protective film layer is configured to be transparent and water-resistant, ensuring clear visibility of color changes while protecting the underlying reagents from contamination.
5. The test strip according to claim 1, wherein the adhesive base layer is composed of silicone-based adhesive, providing secure bonding of the layers without interfering with the colorimetric reactions.
6. The test strip according to claim 1, wherein the hydrophobic barrier layer is made of polyethylene, preventing external moisture from affecting the test strip's performance and maintaining the integrity of the results.
7. The test strip according to claim 1, further comprising:
a. Multiple distinct sensor regions within the colorimetric reagent layer, each dedicated to detecting a specific digestive biomarker, allowing for simultaneous analysis of pH, enzyme levels, and bile acids in a single test.
8. The test strip according to claim 1, wherein the test strip is configured for use with various biological samples, including saliva and stool, enabling a broad application for digestive health monitoring.
9. The test strip according to claim 1, wherein the colorimetric reagents produce distinct color changes corresponding to specific concentrations of digestive biomarkers, allowing for easy interpretation of results by users.
10. The test strip according to claim 1, wherein the disposable design minimizes cross-contamination risk, making the test strip suitable for personal, at-home use and frequent monitoring of digestive health.

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