System and method for processing test fluid
Patent Information
- Application Number
- CA3323047
- Authority / Receiving Office
- CA · CA
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-04-04
- Filing Date
- 2025-04-01
- Publication Date
- 2025-10-09
AI Technical Summary
Existing diagnostic methods struggle with processing viscous sample fluids, leading to inaccurate and complex results due to the need for manual dilution and variable fluid viscosity, which can cause errors and clogging in rapid tests.
A test apparatus with a pre-installed viscosity modifying reagent in a dried format within the pool, which interacts with the test fluid to reduce viscosity, ensuring consistent fluid flow and accurate results without manual dilution, using a glycoprotein-specific precipitation method to target mucins without affecting other proteins.
The system provides reliable, rapid, and accurate diagnostic results by maintaining consistent fluid flow, preventing clogging, and ensuring reproducible outcomes across varying viscosities without manual intervention, enhancing diagnostic reliability and usability.
Abstract
Description
[0001] SYSTEM AND METHOD FOR. PROCESSING TEST FLUID
[0002] TECHNICAL FIELD
[0003] The present disclosure relates to a system used in a field of diagnostic fluid processing. Moreover, the present disclosure relates to a method for using the system.
[0004] BACKGROUND
[0005] Diagnostic tests, like immunochromatographic tests, have witnessed significant growth, as they are currently driven by technological advancements, data analytics, and integration of technology with healthcare and well-being systems. The immunochromatographic tests are commonly used for various purposes in healthcare diagnostics, such as detecting infectious diseases, monitoring chronic conditions, or conducting rapid screenings. The immunochromatographic tests are rapid tests that are essential for providing quick and on-the-spot results, thereby facilitating decision-making to improve the health of an individual. Nowadays, non-invasive sample collection in healthcare diagnostics is being preferred, which is pain-free, and can produce decent results which can be used for decision-making.
[0006] However, existing methods utilized for diagnostic testing of healthcare and well-being systems are associated with several limitations. Firstly, existing methods are unable to process viscous sample fluids and produce incorrect and unusable results. Secondly, in order to process such viscous sample fluids, additional fluid is added into the viscous sample fluids to dilute said viscous sample fluids. However, such additions increase complexity while conducting the rapid test, and has chances of committing an error if the viscous sample fluids are diluted more than what is required while conducting the rapid test. Thirdly, the rapid tests which are complex in nature cannot be carried out in an accurate manner due to the variable nature of the viscous sample fluids.
[0007] Therefore, in light of the foregoing discussion, there is a comprehensive need to overcome the aforementioned limitations to enhance diagnostic reliability and usability.
[0008] SUMMARY
[0009] The aim of the present disclosure is to provide a system and a method for using the system to reduce a viscosity of a test fluid. The aim of the present disclosure is achieved by a system and a method for processing a test fluid as defined in the appended independent claims to which reference is made to. Advantageous features are set out in the appended dependent claims.
[0010] Throughout the description and claims of this specification, the words "comprise" , "include", "have", and "contain" and variations of these words, for example "comprising" and "comprises" , mean "including but not limited to", and do not exclude other components, items, integers or steps not explicitly disclosed also to be present. Moreover, the singular encompasses the plural unless the context otherwise requires. In particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.
[0011] BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 shows a schematic illustration of a system, in accordance with an embodiment of the present disclosure;
[0013] FIGs. 2A, 2B, 2C, 2D, 2E, and 2F collectively, illustrate an exemplary implementation of processing a test fluid using the system, in accordance with an embodiment of the present disclosure; FIG. 3 is an illustration of a protrusion in a test apparatus of FIG. 1, in accordance with an embodiment of the present disclosure;
[0014] FIG. 4 illustrates steps of a method for processing a test fluid, in accordance with an embodiment of the present disclosure;
[0015] FIGs. 5A, and 5B illustrate perspective views of a test apparatus implemented as a cassette-type test device, in accordance with an embodiment of the present disclosure; and
[0016] FIGs. 6A, 6B, 6C and 6D illustrate graphical illustrations for analysis of viscosity of a test fluid, when a test apparatus is in use, in accordance with an embodiment of the present disclosure.
[0017] DETAILED DESCRIPTION OF EMBODIMENTS
[0018] The following detailed description illustrates embodiments of the present disclosure and ways in which they can be implemented. Although some modes of carrying out the present disclosure have been disclosed, those skilled in the art would recognize that other embodiments for carrying out or practising the present disclosure are also possible.
[0019] In a first aspect, the present disclosure provides a test system comprising:
[0020] A test apparatus having: a pool having a volume, and an inlet for filling the volume of the pool through the inlet with a test fluid, wherein an inner surface of the pool comprises an amount of a viscosity modifying reagent in a dried format, an immunochromatography assay strip, wherein the viscosity modifying reagent comprises a viscosity-removing salt that is used to precipitate a viscosity-causing substance present in the test fluid, and wherein the immunochromatography assay strip is to be entered through the inlet to be in contact with the test fluid, when in use.
[0021] The present disclosure provides an aforementioned system that processes the test fluid for use in rapid tests (for example, such as rapid immunochromatographic assays). The test fluid could be understood to be a test sample of a fluid. Beneficially, the test fluid can be of varying viscosities, which is then treated for use in the rapid tests. Moreover, the presence of the viscosity modifying reagent in the dried format streamlines the overall process as an integrity of the viscosity modifying reagent is maintained till the time the rapid testing is to be performed when the test fluid is received. The viscosity modifying reagent is preinstalled in the test apparatus, which reduces a viscosity of the test fluid and makes the rapid tests work consistently and in an unobstructed manner despite variability in the viscosity of different test fluids. Hence, a need for manually providing the viscosity modifying reagent is eliminated, which reduces any chances of error when adjusting the viscosity of the test fluid. Moreover, there is no need to dilute the test fluid, or to add any fluids externally, as flow properties of the test fluid is consistent. Subsequently, such test apparatuses where the application of the viscosity modifying reagent is in the dried format ensures longevity of said test apparatus, as said test apparatus remains effective and reliable even after extended periods of storage and time. Furthermore, the viscosity modifying reagent is applied in the dried format while manufacturing the test apparatus, which facilitates rapid testing on-site, thereby contributing to a versatility and applicability of the test apparatus in various healthcare systems. In this regard, the viscosity modifying reagent could initially be in a liquid format, from which moisture is removed to convert said viscosity modifying reagent in the dried format.
[0022] In a second aspect, the present disclosure provides a method for for using a system, the method comprising: dispensing a test fluid into the test-fluid receiving volume, exposing the test fluid to be in contact with the viscosity modifying reagent for a predefined period of time; disposing an immunochromatography assay strip with the test fluid to allow absorption; and detecting a test result from the immunochromatography assay strip.
[0023] The present disclosure provides an aforementioned method for processing the test fluid. Herein, the solution is dispensed in a controlled manner that allows to flexibly adjust the amount of the viscosity modifying reagent based on a testing requirement. Subsequently, the solution can be prepared with a particular concentration of the viscosity modifying reagent. Herein, by using the viscosity modifying reagent, a glycoprotein-specific precipitation method is employed that targets mucins without affecting other proteins of interest (for example, such as immunoglobulins). Moreover, the viscosity causing substance is removed from the test fluid prior to coming in contact with the immunochromatography assay strip, thus preventing clogging of porous membranes of the immunochromatography assay strip. Hence, the test apparatus can be customized based on specific testing requirements, thus enabling the method to be adaptable to different types of test fluids. Furthermore, the rapid testing can be performed in a time-efficient manner, as the viscosity modifying reagent is already dispensed and dried on the inner surface of the pool.
[0024] Throughout the present disclosure, the term "test apparatus" refers to an equipment that is designed for conducting tests or analyses, particularly in a field of scientific experimentation or diagnostic testing. In this regard, the test apparatus could be implemented for conducting rapid immuno- chromatographic tests.
[0025] Optionally, the test apparatus is one of: a test tube, a petri dish, a microtiter plate, a cassette-type test device, an automatic test device. In this regard, the test tube is a cylindrical vessel which is designed to hold, and mix liquids. The test is typically made of a glass material or a plastic material. Moreover, the petri dish is a shallow, circular dish with optionally a lid. The microtiter plate is a flat plate with multiple wells, arranged in a grid format. Microtiter plates are widely employed for conducting multiple tests simultaneously, often in biological or chemical assays.
[0026] The cassette-type test device is a compact and portable test apparatus that is designed in a cassette format. The cassette-type test device is small and lightweight which facilitates ease of use and transport, allowing for on-site testing in various scenarios. The cassette-type test device typically comprises various components which are necessary for conducting specific tests, providing a user-friendly approach for point-of- care diagnostics. Beneficially, the cassette-type test device comprises well-defined channels and compartments for precise control of the test fluid. This is advantageous for ensuring an accurate and controlled dispensing of the viscosity modifying reagent on the inner surfaces of the pool.
[0027] Furthermore, the automatic test device is a diagnostic apparatus that is capable of performing tests without manual intervention. Optionally, the test device further comprises at least one sensor and a processor, wherein the processor is configured to: process sensor data, collected by the at least one sensor, to determine at least one characteristic of the test fluid; and send a test output indicative of the at least one characteristic of the test fluid, to a user device.
[0028] Examples of the at least one characteristic of the test fluid may include, but are not limited to, a viscosity, a concentration, a volume, etc. of the test fluid. Examples of the user device may include, but are not limited to, a smartphone, a tablet, and a computer. The test output that is sent to the user device, enables the user associated with the user device to receive real-time information about the test results of the test fluid. Beneficially, the test apparatus's adaptability to different formats enhances its versatility hence making it suitable for various testing situations.
[0029] The test apparatus has the base portion, wherein the term "base portion" refers to that part of said test apparatus that is in direct contact with a surface. Moreover, the term "wall portion" refers to a vertical side of the test apparatus that extends upwardly from an outer edge of the base portion. In this regard, the wall portion determines an overall shape of the test apparatus. Therefore, the wall portion could be designed in various shapes, for example, such as a cylindrical shape, a rectangular shape, a hemispherical shape. A combination of the base portion and the wall portion comprise the inner surface that encloses the test-fluid receiving volume of the test apparatus, wherein said test-fluid receiving volume is to carry out chemical reactions involving at least the test fluid. In this regard, the inner surface is pre-coated with the viscositymodifying reagent in the dried format, wherein mucins (i.e., glycoproteins) are removed from the test fluid prior to using the immunochromatographic assay strip.
[0030] Throughout the present disclosure, the term "pool" refers to a depression or a pit formed within the test apparatus that has a particular volume which is defined by the base portion and the wall portion. The wall also defines at least one of: a boundary, a shape, of the pool. In an example, the pool may have a single continuous wall such as with a circular or similar cross-section, or may have multiple walls joined together to define the pool. Herein, the pool is a designated space wherein the test fluid is introduced through the inlet for the purpose of conducting tests or analyses. Herein, the term "inlet" refers to an opening which allows the test fluid to be introduced into the volume of the pool. The inlet is strategically positioned on the test apparatus in such a manner that it facilitates the filling of the test fluid in the pool in a controlled manner. For example, in a medical diagnostic test apparatus, the test apparatus may be a cuvette designed to hold a blood sample in a volume of the cuvette.
[0031] Moreover, the pool may be implemented as a reaction vessel which is used to study chemical changes occurring in the test fluid. Herein, the term "test fluid" refers to a sample fluid from body of a user having a particular viscosity, wherein the test fluid is subjected to analysis or testing by the test apparatus. Examples of the test fluid may include, but are not limited to, saliva, blood, sweat, and urine. When the test fluid is the saliva, said test fluid contains viscosity-causing substances like glycoproteins (for example, such as mucin) which are secreted to the test fluid from salivary glands, which affects a time taken for conducting the rapid tests using conventional test kits. In a first example, when the test apparatus may the cassette-type test device, an area of the pool may be 70 millimeter square (mm2)and an area of the pool having the volume, with the wall defining the volume may be 140 mm2. jn asecond example, when the test apparatus may be a microtiter plate, an area of the pool may be 270 mm2. Moreover, a dimension of the pool may be 7 millimeters by 11 millimeters. In a third example, when the test apparatus may be a 1.5 millilitres (mL) microtube, an area of the pool may be 620 mm2.
[0032] Through the present disclosure, the term "viscosity modifying reagent" refers to a compound that is designed to reduce the viscosity of the test fluid, to make the test fluid compatible for immunochromatographic tests. Notably, the amount of the viscosity modifying reagent is indicative of a quantity of the viscosity modifying reagent that is present within the test apparatus. A unit of measurement of the viscosity modifying reagent may be millimoles (mmol) per square meter, wherein said unit indicates the amount of substance of the viscosity modifying reagent relative to a surface area of the inner surface within the test apparatus. The viscosity modifying reagent is pre-installed in the pool during manufacturing of the test apparatus in a liquid format and dried during manufacturing process. Optionally, the viscosity modifying reagent is pre-installed in the pool in a dried format during manufacturing of the test apparatus. Moreover, the viscosity modifying reagent comprises the viscosity-removing salt that chemically interacts with certain components in the test fluid that cause high viscosity. The drying time can vary depending on factors such as air humidity and temperature, and may take several hours to dry. For drying the viscosity modifying reagent at a faster rate, lyophilization method is employed. The lyophilization method involves freezing the pool and then removing ice (formed due to sublimation of the viscosity modifying reagent) under vacuum conditions. Advantageously, lyophilization method reduces drying time and preserves the integrity of the viscosity modifying reagent. Throughout the drying process, quality control measures are implemented to verify that the viscosity modifying reagent is dried uniformly and adheres properly to the inner surface of the pool. Herein, the viscosity modifying reagent can be dried by using a common method, for example, such as conventional air-drying.
[0033] Moreover, a technical effect of the viscosity modifying reagent and it comprising the viscosity-removing salt is that they enhance properties of the test fluid for selective precipitation of the viscosity causing substance in the test fluid. The viscosity-removing salt is used to selectively precipitate the viscosity causing substance, such as proteins or mucins, present in the test fluid. This selective precipitation process improves an overall fluid dynamic of the test fluid within the test apparatus, preventing potential blockages or interference in downstream processes, for example, such as during test fluid analysis. Herein, by reducing the viscosity of the test fluid through precipitation, the viscosity modifying reagent contributes to an efficient and controlled test, improving the accuracy and reliability of the analysis by maintaining a consistent and optimal flow rate of the test fluid through the test apparatus, without comprising an integrity of the test fluid. Beneficially, the selective precipitation process is performed outside the immunochromatography assay strip, thus preventing resulting viscosity causing substance (for example, such as sediments) from clogging porous membrane of said immunochromatography assay strip.
[0034] Throughout the present disclosure, the term "immunochromatography assay strip" refers to a diagnostic tool used in lateral flow assays to detect specific analytes in the test fluid. The immunochromatography assay strip is designed to come into contact with the test fluid for absorption, after the test fluid has reacted with the viscosity modifying reagent. Herein, the immunochromatography assay strip is positioned within the test apparatus such that it interacts with the test fluid after said test fluid has mixed with the viscosity modifying reagent. A reduced viscosity of the test fluid allows said test fluid to flow uniformly through the immunochromatography assay strip, thus improving a detection of target analytes. For example, the test fluid may be saliva, which comprises mucins that may increase viscosity. When the saliva may be introduced into the test apparatus, it mixes with the viscosity modifying reagent on the inner surface. The viscosity-removing salt may precipitate the mucins, thus reducing a viscosity of the saliva. This may allow the immunochromatography assay strip to absorb the saliva effectively, thus ensuring an accurate detection of biomarkers in the saliva.
[0035] In this regard, a droplet of the viscosity modifying reagent is dispensed during manufacturing of the test apparatus into the volume of the pool, which is then allowed to dry. Herein, drying the viscosity modifying reagent involves removal of liquid component from the viscosity modifying reagent, using drying methods. Examples of such drying methods may include, but are not limited to, conventional air-drying (depending on air humidity and ambient temperature), lyophilization in cold under vacuum, evaporation, spray drying, freeze drying, and desiccation. Subsequently, the viscosity modifying reagent is in a dried format in the inner surface of the pool, where the test fluid will come into contact when using the test apparatus. Furthermore, applying the viscosity modifying reagent directly on the inner surface of the pool allows for a controlled interaction between the viscosity modifying reagent and the test fluid. This controlled interaction is essential for achieving consistent and reliable viscosity modification. Advantageously, applying the viscosity modifying reagent in the dried format minimizes dilution of the test fluid.
[0036] Optionally, the amount of the viscosity modifying reagent is in range of 0.001 millimol (mmol) per square meter to 1.00 mmol per square meter. The range of the viscosity modifying reagent may for example lie from 0.001, 0.002, 0.003,0.005, 0.10, 0.20, 0.50, 0.10, or 0.5 mmol per square meter to 0.004, 0.009, 0.04, 0.09, 0.6, 0.8, 0.9, or 1.00 mmol per square meter. Herein, the amount of the viscosity modifying reagent depends on an amount of the test fluid that the test apparatus can accommodate. For example, for every 1.5 millilitre (mL) of the test fluid, the amount of the viscosity modifying reagent may be 0.03 mmol per square meter. Notably, the test cassette is configured to receive a volume of saliva with the suggested volume ranging from a minimum of 60 microlitres, an optimum of 100 microlitres, up to a maximum of 140 microlitres.
[0037] Herein, the amount of the viscosity modifying reagent that is applied on the inner surface of the pool is sufficient for effective adjustment of viscosity of the test fluid. However, if the amount of the viscosity modifying reagent is too low, the viscosity modification may not be adequate hence leading to potential issues in subsequent testing. Conversely, if the amount of the viscosity modifying reagent is too high, it may negatively affect the biological components (for example, antibodies or other molecules of interest in the test fluid), hence impacting the integrity of the test fluid and requires more pH-adjusting reagent. Subsequently, maintaining the amount of the viscosity modifying reagent within the range ensures consistency in viscosity across various test fluids. This consistency is essential for obtaining reproducible and comparable results. A technical effect of providing the range for the viscosity modifying reagent is that it ensures optimal adjustment of viscosity of the test fluid.
[0038] Continuing in reference with the first example, the amount of the viscosity modifying reagent received at the inner surface of the pool, in dried format, may be 0.29 millimol mmol per square meter. Moreover, the amount of the viscosity modifying reagent received at the inner surface of the pool and the wall portion, in dried format, may be 0.14 mmol per square meter. Continuing in reference with the second example, the amount of the viscosity modifying reagent received at the inner surface of the microtiter plate may be 0.07 mmol per square meter. Continuing in reference with the third example, the amount of the viscosity modifying reagent received at the inner surface of the microtube may be 0.03 mmol per square meter.
[0039] Optionally, a first distance of the viscosity modifying reagent from the inlet lies in a range of 0.05 millimetres (mm) - 10 mm. In this regard, the term "first distance" refers to the separation between the inlet and the viscosity modifying reagent within the test apparatus. The first distance may, for example, lie in a range from 0.05, 0.06, 0.07, 0.10, 0.50, 1.00, 2.00, 5.00, or 9.00 mm up to 0.10, 0.15, 0.80, 1.50, 6.00, 8.00, 9.50, 9.80 or 10 mm. Herein, the range allows for controlled placement of the viscosity modifying reagent in relation to the inlet. The first distance is essential to manage interaction of the test fluid with the viscosity modifying. Moreover, different diagnostic tests may require different reaction times or conditions. Thereby, the first distance provides flexibility to customize the test apparatus based on requirements, thus accommodating variations in the types of the test fluid. Furthermore, placing the viscosity modifying reagent within at the first distance prevents premature interaction with the test fluid. This is particularly essential for maintaining the stability of the viscosity modifying reagents in the dried format and ensuring that they are activated at the right moment. A technical effect of defining the first distance within the specified range is to provide the test apparatus with the flexibility and adaptability necessary to achieve controlled and optimized reactions based on the unique requirements of different testing processes.
[0040] As an example, for a rapid point-of-care test where quick results are required, the first distance may be 0.05 mm. As another example, for laboratory-based assaying where precision is paramount, the first distance may be 10 mm which may facilitate a controlled and gradual reaction.
[0041] Optionally, a volume of the viscosity modifying reagent lies in a range of 1 microlitre (pL) to 2000 pL. The range of the volume of the viscosity modifying reagent may, for example, lie in a range from 1, 5, 10, 20, 50, 150, 250, 450, 950, or 1650 microlitres up to 100, 500, 1200, 1600, 1800, 1900, 1970, 1990, or 2000 microlitres. In this regard, the volume of the viscosity modifying reagent indicates a physical space occupied by the viscosity modifying reagent within the test apparatus and may be expressed in units, for example, such as litres, millilitres, cubic centimetres, etc. Notably, this range enables flexibility to adapt to different test fluid volumes, wherein small test fluids may require less volume of the viscosity modifying reagent while larger test fluids may benefit from higher volume of the viscosity modifying reagent. It will be appreciated that the volume of the viscosity modifying reagent depends on a type of the rapid test or a characteristic of the test fluid. A technical effect of providing the range of the volume of the viscosity modifying reagent ensures that said viscosity modifying reagent is utilized efficiently with respect to the test fluid used when using the test apparatus.
[0042] As an example, two tests (namely, Test A and Test B) may be conducted, wherein the Test A requires precise changes in viscosity of a test fluid, and Test B may be a complex text to be performed on the test fluid. Hence, a volume of the viscosity modifying reagent for Test A may be 30 pL, while for Test B may be 2000 pL.
[0043] Optionally, the viscosity modifying reagent is an aluminum-derived reagent. The aluminum-derived reagent alters the viscosity of the test fluid by forming a complex with the test fluid, which affects a flow behaviour of the test fluid. A technical effect of the viscosity modifying reagent being at least one of: the aluminum-derived reagent, the quaternary ammonium-derived reagent providing flexibility and adaptability to reduce the viscosity of the test fluid, based on a type of the test fluid.
[0044] Optionally, the viscosity-removing salt is dissolved in water or in an organic solvent, and wherein a concentration of the viscosity modifying reagent, prior to drying, is at least 10 millimoles (mmol) per liter. Herein, the viscosity-removing salt is an ionic compound. The viscosity-removing salt is used to precipitate viscosity-causing substance present in the test fluid, for example, precipitating glycoprotein when the test fluid is saliva. When the viscosity modifying reagent is the aluminum-derived reagent, the viscosity-removing salt is any one of: aluminum chloride (AlCh), aluminum potassium sulphate (AIK SCMh). Herein, the organic solvent can be one of: ethanol, chloroform, dichloromethane, diethyl ether, benzene.
[0045] Moreover, the viscosity-removing salt is dissolved in water or the organic solvent to produce an aqueous solution which is easier to handle, and ensures uniform distribution of the viscosity modifying reagent throughout the aqueous solution. Thereby, this aqueous solution is applied to the test apparatus to reduce the viscosity of the test fluid when the system is in use. Herein, using the aqueous solution simplifies the production of the viscosity modifying reagent and its integration into the test apparatus. Typically, the use of water as a solvent, particularly with the viscosity-removing salt enhances the stability and solubility of the viscosity modifying reagent. This is essential for maintaining the effectiveness of the viscosity modifying reagent during the storage and usage of the test apparatus. In an instance, a temperature of the water may be ambient temperature when the concentration of the viscosity modifying reagent is at least 1 mM after dissolved in the sample liquid. In another instance, the temperature of the water may be greater than the ambient temperature, to dissolve the viscosity-removing reagent in the water in an expedited manner. Notably, the concentration of the at least 1 mM ensures an adequate amount of the viscosity modifying reagent is present, to effectively reduce the viscosity of the test fluid. Furthermore, such concentration ensures consistency in performance of the viscosity modifying reagent across different test fluids. This helps in achieving reliable and reproducible results, essential for diagnostic accuracy. As an example, the concentration of the viscosity modifying reagent may be below 8 mM after dissolving to the test fluid, which may be insufficient to reduce the viscosity of the test fluid. As another example, the concentration of the viscosity modifying reagent may be 12 mM after dissolving to the test fluid, which may be insufficient to reduce the viscosity of the test fluid. A technical effect of composing the viscosity modifying reagent in such a manner is that it improves the flowability of the test fluid, when the sample comes in contact with the viscosity modifying reagent, thus providing results rapidly when the test apparatus is in use.
[0046] Optionally, the viscosity modifying reagent, prior to drying, further comprises a sucrose solution, the sucrose solution comprising sucrose dissolved in water, wherein a concentration that lies in a range of 0.1 percent (%) to 30 percent of a total volume of water. In this regard, the sucrose solution refers to a liquid mixture composed of sucrose (for example, such as a disaccharide sugar) dissolved in water. Notably, sucrose solution acts as a stabilizing agent, wherein the sucrose solution keeps the droplet of the viscosity modifying reagent in place, in the inner surface of the pool. For example, the concentration of the sucrose dissolved in water may, for example, lie in a range from 0.1%, 0.2%, 0.3%, 0.5%, 1.0%, 5%, 15%, or 25% of the total volume of water up to 0.70%, 10%, 20%, 25%, 28%, or 30% of the total volume of water. When the concentration of the sucrose dissolved in water lies outside the aforementioned range, it could lead to issues such as at least one of: incomplete solubility, undesired interactions, of the viscosity modifying reagent with the test fluid. A technical effect of adding the sucrose solution in the viscosity modifying reagent is that a solubility and a stability of said viscosity modifying reagent is improved.
[0047] Throughout the present disclosure, the term "test fluid-receiving volume" refers to a space within the test apparatus that is intended to receive and accommodate the test fluid and the viscosity modifying reagent. Furthermore, an improvement in fluidity of the test fluid is achieved after the test fluid comes in contact with the viscosity modifying reagent which is present within the test-sample receiving volume. Herein, the test fluid with the improved fluidity ensures uniform and thorough interactions with the viscosity modifying reagent which leads to procuring results of the rapid tests quickly. For example, the test fluid may be saliva, wherein the saliva comprises glycoproteins which affects the viscosity of the saliva. The saliva is received in the designated test fluid-receiving volume and may come in contact with the viscosity modifying reagent which reduces the viscosity of the saliva, thus making it more suitable for immunochromatographic assays and speeding up a time taken when conducting the rapid tests. Optionally, an amount of a pH-adjusting reagent in a pre-dried format is applied on the inner surface of the pool. Herein, the "pH-adjusting reagent" refers to a compound that is capable of modifying acidity or alkalinity (namely, pH) of the test fluid. In this regard, a droplet of the pH-adjusting reagent is dispensed in the inner surface of the pool of the test apparatus, which is then allowed to dry. Such drying of the pH- adjusting reagent is performed using the drying methods as previously mentioned. Herein, an objective of adding the pH-adjusting reagent is to control a pH level of the test fluid when the test apparatus is in use, to maintain a standard condition within the test apparatus. Optionally, the pH-adjusting reagent is deposited as a layer on top of a layer of the viscosity modifying reagent. Examples of the pH-adjusting reagent may include, but are not limited to, Tris(hydroxymethyl)aminomethane, and sodium hydroxide. A technical effect of applying the pH-adjusting reactant in a dried format is that it enhances stability, controlled activation, and overall reliability of the test apparatus, contributing to the effectiveness of the test apparatus.
[0048] Moreover, the pre-dried format of the pH-adjusting reagent on the inner surface of the pool enhances its stability and durability. In the dried format, the pH-adjusting reagent remains in a stable and inert state until it comes into contact with the test fluid, hence ensuring that the pH- adjusting reagent retains its effectiveness over an extended period of time. The extended period of time is between 1 month to 60 months. Optionally, the extended period of time is in a range of 1, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, or 55 months up to 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55 or 60 months. Furthermore, the pre-dried format of the pH- adjusting reagent enables for controlled activation of the pH-adjusting reagent upon contact with the test fluid, thereby ensuring that the pH adjustment of the test fluid occurs precisely when needed, providing optimal conditions for subsequent reactions. Additionally, the pre-dried format of the pH-adjusting reagent ensures uniform application of the pH-adjusting reagent on the inner surface of the pool. This uniformity enhances the reproducibility of results across multiple tests, reducing variability and increasing the reliability of results achieved when using the test apparatus.
[0049] Herein, when the viscosity modifying reagent is the aluminum-derived reagent. The aluminum-derived reagent reacts with water producing aluminum hydroxide. The reaction releases hydrogen ions, which makes the solution acidic. These hydrogen ions are counteracted with the pH- adjusting reagent. The aluminum-derived reagent is dissolved in water, i.e., any one of: AlCh, AIK(SO4)2 to produce aluminum hydroxide. This helps to neutralize acidity of the solution that are precipitated out from the test fluid, as the pH-adjusting reagent acts as a base. Specifically, production of the aluminum hydroxide co-precipitates glycoproteins. The solution becomes acidic because of the aluminum hydroxide formation reaction.
[0050] Moreover, an optimum pH for immunoassay reaction depends on the type of test fluid used. In some instances, a physiological pH of 7.4 could be considered close to a predefined pH level (of a normal human body with no disease), which aligns with production conditions of antibodies commonly used in immunoassay reactions. For example, in a rapid test conducted using the test apparatus, there may be antibodies which may be used in an immunoassay test which exhibits optimal reactivity at a physiological pH of 7.4. The dried pH-adjusting reagent then applied on the inner surface of the pool ensures that the pH of the test fluid may be adjusted to the pH of 7.4, thereby maximizing an efficiency and an accuracy of the rapid test.
[0051] Optionally, a second distance between the viscosity modifying reagent and the pH-adjusting reagent is at least 0.1 millimeters. In this regard, the "second distance" refers to the separation between the viscosity modifying reagent and the pH-adjusting reagent within the test apparatus. Herein, the second distance prevents pre-mature mixing and cross-contamination between the viscosity modifying reagent and the pH- adjusting reagent when the test apparatus is not in use. Hence, this reduces a risk of unintended interactions or mixing between the viscosity modifying reagent and the pH-adjusting reagent. Furthermore, the second distance allows for controlled timing of reactions involving the viscosity modifying reagent and the pH-adjusting reagent. This control over the timing of reactions ensures that the viscosity modifying reagent and the pH-adjusting reagent reacts in a required (or a standard manner) with the test fluid, thereby contributing to accurate and reliable results when the test apparatus is in use. A technical effect of dispensing the viscosity modifying reagent and the pH-adjusting reagent in such a manner is that it ensures that they mix with the test fluid.
[0052] Optionally, the inner surface of the pool comprises a protrusion, the protrusion that provides a fluidic separation between the viscosity modifying reagent and the pH-adjusting reagent. In this regard, the term "protrusion" refers to a raised or elevated structure on the inner surface of the pool within the test apparatus. Notably, by having the protrusion on the inner surface of the pool, a physical barrier or a separation is created between the viscosity modifying reagent and the pH-adjusting reagent. Hence, such protrusions prevent the viscosity modifying reagent and the pH-adjusting reagent from coming into direct contact with each other or mixing prematurely. This fluidic separation is essential for maintaining the integrity and the stability of the viscosity modifying reagent and the pH-adjusting reagent which contributes to the accuracy and reliability of the test results. Optionally, a height of the protrusion is such that (i.e., as low as possible) it does not affect a flow of the test fluid, when the test apparatus is in use. Optionally, a shape of a top surface of the protrusion is one of: a polygon, an oval, a triangle, a corner snippet, a rounded-corner polygon. For example, in a diagnostic assay, a test fluid may need to be in contact with the viscosity modifying reagent first and then come in contact with the pH-adjusting reagent. The protrusion may be provided in such a manner that the test fluid comes in contact with the viscosity modifying reagent and then the pH-adjusting reagent. A technical effect of providing the protrusion between the viscosity modifying reagent and the pH- adjusting reagent is that it ensures controlled interactions of the viscosity modifying reagent and the pH-adjusting reagent with each other and / or with the test fluid.
[0053] Optionally, the test apparatus further comprises a detergent-dispensing element that is configured to dispense a detergent solution into the testfluid receiving volume, wherein the detergent solution comprises a detergent reagent lying in a range of 0.01 percent (%) to 50 percent of a total volume of water, and wherein a volume of the detergent reagent lies in a range of 1 microlitres (pL) - 50 pL. In this regard, the term "detergent-dispensing element" refers to a component within the test apparatus that is designed to dispense the detergent solution into the pool. The term "detergent solution" refers to a liquid mixture composed of the detergent reagent dissolved in water. Moreover, the detergent solution acts as a surfactant, reducing the resistance to liquid contact on hydrophobic surfaces. This, in turn facilitates more effective and uniform fluid channelling through the features of the test apparatus.
[0054] The term "detergent reagent" refers to a chemical compound or substance incorporated into the detergent solution, for example, such as Tween20. The detergent solution is used to channel the test fluid to the test fluid-receiving volume of the pool more effectively as it reduces hydrophobic barriers on the inner surface that resist contact with the test fluid. Herein, the detergent reagent is an active ingredient responsible for reducing surface tension, overcoming the hydrophobic barriers, and improving wetting properties of the test fluid within the test apparatus. The hydrophobic barriers could be inherent in material used for constructing the test apparatus or may develop during the manufacturing process of the test apparatus. The detergent reagent in the detergent solution may, for example, lie in range from 0.01%, 0.02%, 0.05%, 0.10%, 0.5%, 01.0%, 10%, 25% or 40% of the total volume of water up to 0.06%, 0.7%, 5%, 20%, 25%, 45%, 49% or 50% of the total volume of water. The volume of the detergent reagent may, for example, lie in a range from 1, 2, 4, 6, 10, 14, 20, 26, 36, or 46 microlitres up to 5, 10, 15, 25, 35, or 50 microlitres. This precision is essential for avoiding excess detergent that could adversely impact the test performance within the test apparatus. A technical effect of dispensing the detergent solution involves addressing surface tension, fluid flow dynamics, and hydrophobic barriers, thereby enhancing the overall performance and accuracy of the test output when the test apparatus is in use.
[0055] In an exemplary practical use case scenario, the test apparatus may be the cassette-type test device. The cassette-type test device may comprise the test-sample-receiving volume, an immunochromatographic assay strip, a wettable sample collection strip, an activation button, a latching mechanism, and a read-out window. A wettable sample absorption pad may be inserted in a test fluid collection tube or directly into mouth of an individual, wherein the test fluid may be saliva. Then, the wettable sample collection strip is pulled through an assembly of a cassette to introduce the test fluid into the test-sample-receiving volume in the cassette. Then, the activation button may be pressed to bend the immunochromatographic assay strip to contact with the test fluid in the test-sample-receiving volume wherein the latching mechanism keeps the bent strip orientation. The test fluid may be mixed with the viscosity modifying reagent in the test-sample-receiving volume. After a predefined period of time from 1 minutes to 15 minutes, test output can be read on the readout window or sent to a cloud service for remote analysis. The present disclosure also relates to the method for using the test system as described above. Various embodiments and variants disclosed above, with respect to the aforementioned test system, apply mutatis mutandis to the present method for processing the test fluid as described hereinafter.
[0056] The test fluid is introduced into the test-fluid receiving volume within the test apparatus. The inner surface of the test apparatus is already coated with the viscosity-modifying reagent, which has been pre-dried before the test fluid is dispensed. Such pre-drying of the viscosity-modifying reagent ensures that said viscosity-modifying reagent remains stable until it comes into contact with the test fluid. The test fluid is dispensed in a uniform and a precise manner to provide standard condition inside the test apparatus for accurate testing. Typically, various techniques can be employed for dispensing the solution including pipetting, automated dispensers, or other methods that allow for accurate and controlled process of the solution onto the inner surface of the pool. Herein, the volume of the test fluid dispensed is carefully controlled to ensure consistency across different tests. The viscosity modifying reagent is dispensed in such a manner that the test fluid comes in contact with said viscosity modifying reagent when the test apparatus is in use.
[0057] Subsequently, once the test fluid is dispensed, said test fluid is allowed to interact with the viscosity modifying reagent for the predefined period of time, wherein the predefined period of time from 1 minutes to 15 minutes ensures sufficient time for the viscosity-modifying reagent to dissolve and modify the viscosity of the test fluid. Optionally the predefined period of time is in a range of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 or 14 minutes up to 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 minutes. After the interaction of the test fluid with the viscosity modifying reagent, the immunochromatography assay strip is introduced into the test apparatus to absorb the treated test fluid. The test fluid, now modified in viscosity, flows through the immunochromatography assay strip via capillary action. The immunochromatography assay strip comprises immobilized antibodies, antigens, or other biochemical reactants that selectively interact with target analytes in the test fluid. As the test fluid migrates, analyte-binding reactions occur, producing detectable results (for example, such as color changes in lateral flow assays).
[0058] Optionally, the method further comprises: wherein further the inner surface of the test apparatus comprises a pH-adjusting reagent in a pre-dried format.
[0059] EXPERIMENTAL PART
[0060] An experiment was conducted to compare time taken by untreated saliva and time taken by pre-treated saliva to travel through the immunochromatographic test strip membranes. The test fluid (i.e., raw saliva) was collected from one individual. This comparison revealed insights into effects of viscosity modifying reagent on viscosity of the test fluid. The experiment was conducted when the test apparatus was a cassette-type test device. In one implementation, the cassette-type test device comprised a fully-assembled immunochromatographic assay strip, wherein assay strips were cut from cards. In another implementation, the cassette-type test device comprised a sample pad that comprised a glass fiber composite membrane. Herein, the glass fiber composite membrane was cut into strips of dimension 5 x 40 millimetres (mm).
[0061] Prior to conducting the experiment, the pre-treated saliva was prepared. The viscosity modifying reagent used in this experiment was aluminum chloride (AlCh). Herein, a volume of 500 microlitres (pL) of 200 millimole per liter (mM) of AlCh was added to 10000 pL of saliva to produce an amount of 100 micromoles (pmol) of the viscosity modifying reagent. Moreover, a volume of 750 pL of 1 mole per liter (M) of Tris(hydroxymethyl)aminomethane (Tris) was added to produce an amount of 750 micromoles of Tris. The mixture was then centrifuged for 2 minutes at 10,000 times the force of gravity (10,000 times g). Finally, a detergent solution was added, wherein the detergent solution comprised 10% of a detergent reagent (i.e., Tween20) dissolved in water. Adding 200 pL of 10 % Tween to a larger volume (10000 pL) of the test fluid dilutes the detergent reagent to end concentration of 0.2 %.
[0062] In one implementation, a volume of 100 pL of the untreated saliva was added to the test apparatus at one time and the time taken for the untreated saliva to travel through the test apparatus, when the fully- assembled immunochromatographic assay strip was used, was determined. A volume of 100 pL of the pre-treated saliva was added to the test apparatus at another time and the time taken for the untreated saliva (with 0.2 % detergent reagent) to travel through the test apparatus, when the fully-assembled immunochromatographic assay strip was used, was also determined. The experiment was replicated for two more samples of untreated saliva and two more samples of pretreated saliva, and following results were obtained, as shown in Table 1,
[0063] TABLE 1
[0064] An average of the time taken for the untreated saliva and the pre-treated saliva to travel through the test apparatus was then calculated, as shown in Table 2 TABLE 2
[0065] A standard deviation of the time taken for the untreated saliva and the pre-treated saliva to travel through the test apparatus was then calculated, as shown in Table 3,
[0066] TABLE 3
[0067] In another implementation, a volume of 100 pL of the untreated saliva (with added 0.2 % detergent reagent) was added to the test apparatus at one time and the time taken for the untreated saliva to travel through the test apparatus, when the sample pad comprising the glass fiber composite membrane was used, was determined. A volume of 100 pL of the pre-treated saliva was added to the test apparatus at another time and the time taken for the untreated saliva to travel through the test apparatus, when the sample pad comprising the glass fiber composite membrane was used, was also determined. The experiment was replicated for two more samples of untreated saliva and two more samples of pre-treated saliva, and following results were obtained, as shown in Table 4,
[0068] TABLE 4
[0069] An average of the time taken for the untreated saliva and the pre-treated saliva to travel through the test apparatus was then calculated, as shown in Table 5,
[0070] TABLE 5
[0071] A standard deviation of the time taken for the untreated saliva and the pre-treated saliva to travel through the test apparatus was then calculated, as shown in Table 6,
[0072] TABLE 6
[0073] This comparative analysis seeks to understand an impact of aluminum treatment on slow properties of the test fluid. In conclusion, it was observed that the pre-treated saliva moved faster than the untreated saliva and variation among the replicated results was very little. In other words, the pre-treated saliva exhibits significant reduced travel times through the test apparatus. This outcome suggests the potential utility of the viscosity modifying reagent for enhancing efficiency and consistency of the viscosity of the test fluid when using the testing apparatus. Such enhanced efficiency and consistency enables reliable and accurate rapid testing. Hence, the viscosity modifying reagent plays a crucial role in reducing the viscosity of test fluids, as shown in the result after conducting the aforementioned experiment.
[0074] The experimental part can be studied in conjunction with FIGs. 6A, 6B, 6C, and 6D.
[0075] DETAILED DESCRIPTION OF THE DRAWINGS
[0076] Referring to FIG. 1, there is shown a schematic illustration of a system 100, in accordance with an embodiment of the present disclosure. The system comprises a test apparatus 102, and an immunochromatographic assay strip 104. The test apparatus 102 has a base portion 106, a wall portion 108 extending upwardly from a periphery of the base portion 106, and an inlet 110 to receive a test fluid 112. The wall portion 108 and the base portion 106 comprise an inner surface 114, wherein the inner surface 114 defines a test-fluid 112 receiving volume 116. Moreover, the inlet 110 is located at an upper end 118 of the wall portion 108, the upper end 118 being opposite to the base portion 106.
[0077] The inner surface 114 is formed to receive an amount of a viscosity modifying reagent 120 that is applied in a dried format to said inner surface 114, wherein the viscosity modifying reagent 120 comprises a viscosity-removing salt that is used to precipitate a viscosity-causing substance present in a test fluid 112. The immunochromatography assay strip 104 is configured to be disposed in contact with the test fluid 112 for absorption, wherein the test fluid 112 is mixed with the viscosity modifying reagent 120, when in use. Optionally, the viscosity modifying reagent 120 is at a first distance DI from the inlet 110.
[0078] Optionally, an amount of pH-adjusting reagent 122, in a pre-dried format, is applied on the inner surface 114. Optionally, the pH-adjusting reagent 122 is at a second distance D2 from the viscosity modifying reagent 120.
[0079] FIG. 1 is merely an example, which should not unduly limit the scope of the claims herein. A person skilled in the art will recognize many variations, alternatives, and modifications of embodiments of the present disclosure.
[0080] Referring to FIGs. 2A, 2B, 2C, 2D, 2E, and 2F collectively, there are illustrated an exemplary implementation of processing a test fluid 112 using the system 100 of claim 1, in accordance with an embodiment of the present disclosure. In FIGs. 2A-B, the inner surface of the test apparatus 102 is provided with a viscosity modifying reagent 120 and the pH-adjusting reagent 122, both in a pre-dried format. The viscosity modifying reagent 120 is at a distance DI from the inlet 110 of the test apparatus 102. The viscosity modifying reagent 120 is at a distance of D2 from the pH-adjusting reagent 122. In FIG. 2B, a test fluid 112 is dispensed into the test-fluid 112 receiving volume 116, via the inlet 110. In FIG. 2C, the test fluid 112 mixes and reacts with the viscosity modifying reagent 120 and optionally with the pH-adjusting reagent 122. A precipitating effect is generated which is utilised for removing viscosity from the test fluid 112. Such viscosity is removed in a form of a viscous substance 202. In FIG 2D, the immunochromatography assay strip 104 is brought close to the inlet 110 of the test apparatus 102. In FIG. 2E, the immunochromatography assay strip 104 is inserted into the test apparatus 102. In this regard, the immunochromatography assay strip 104 is to be disposed in contact with the test fluid 112 that has been mixed and reacted with the viscosity modifying reagent 120 and optionally with the pH-adjusting reagent 122. In FIG. 2F, at least one test marker (depicted as two test markers 204A and 204B) appears on the immunochromatography assay strip 104. FIGs. 2A-F are merely examples, which should not unduly limit the scope of the claims herein. A person skilled in the art will recognize many variations, alternatives, and modifications of embodiments of the present disclosure.
[0081] Referring to FIG. 3, there is illustrated a protrusion 302 in a test apparatus 102 of FIG. 1, in accordance with an embodiment of the present disclosure. Herein, the inner surface 114 also has the protrusion 302, wherein the protrusion 302 provides a fluidic separation between the viscosity modifying reagent 120 and the pH-adjusting reagent 122. It will be appreciated that a direction of flow of the test fluid 112 through the inlet 110 is from right to left direction (as shown by an arrow 304).
[0082] FIG. 3 is merely an example, which should not unduly limit the scope of the claims herein. A person skilled in the art will recognize many variations, alternatives, and modifications of embodiments of the present disclosure.
[0083] Referring to FIG. 4, there is illustrated steps of a method for using a system (100) according to claim 1, in accordance with an embodiment of the present disclosure. At step 402, a test fluid is dispensed into the test-fluid receiving volume. At step 404, the test fluid is exposed to be in contact with the viscosity modifying reagent for a predefined period of time. At step 406, an immunochromatography assay strip is disposed with the test fluid to allow absorption. At step 408, a test result is detected from the immunochromatography assay strip.
[0084] The aforementioned steps are only illustrative and other alternatives can also be provided where one or more steps are added, one or more steps are removed, or one or more steps are provided in a different sequence without departing from the scope of the claims herein.
[0085] Referring to FIGs. 5A, and 5B, there are illustrated perspective views of a test apparatus 500 implemented as a cassette-type test device, in accordance with an embodiment of the present disclosure. In FIG. 4A, there is shown an overall structure of the cassette-type test device that is designed for processing a test fluid. The cassette-type test device comprises a first strip 501 to collect a test fluid. An immunochromatographic assay strip 502 is inside the cassette-type test device and used to bend to be disposed in contact with the test fluid that has been mixed and reacted with the viscosity modifying reagent, and optionally the pH-adjusting reagent. In FIG. 5B represents a top-planar sectional view of the cassette-type test device with a top section removed therefrom. The cassette-type test device comprises an immunochromatographic assay strip 502, a test fluid-receiving volume 504 in a wall portion 506, a squeezing mechanism 507, and an inlet 508 that is on the same level as the wall 506. An amount of a viscosity modifying reagent 510 and an amount pH-adjusting reagent 512 in a dried format is applied on the test fluid-receiving volume 504. The viscosity modifying reagent 510 and the pH-adjusting reagent 512 lie at a second distance (D2) from each other. The cassette-type test device dispenses a test fluid 514 into the test fluid-receiving volume 504 via the squeezing mechanism 507. When upon said dispensing, the test fluid 514 mixes and reacts with the viscosity modifying reagent 510 such that one or viscosity-causing substances present in the test fluid 514 are selectively precipitated out. An immunochromatographic assay strip 502 is used to bend to be disposed in contact with the test fluid 514, thus absorbing the test fluid 514 that has been mixed and reacted with the viscosity modifying reagent 510, and optionally the pH-adjusting reagent 512.
[0086] FIGs. 4A and 4B, are merely examples, which should not unduly limit the scope of the claims herein. A person skilled in the art will recognize many variations, alternatives, and modifications of embodiments of the present disclosure.
[0087] Referring to FIGs. 6A, 6B, 6C, and 6D, there are illustrated graphical illustrations for analysis of viscosity of a test fluid, when a test apparatus is in use, in accordance with an embodiment of the present disclosure. In FIGs. 6A-D, the vertical axis represents time (in minutes and / or seconds) taken by the test fluid to travel through the test apparatus, and the horizontal axis represents the test fluid. The test fluid (i.e., the raw saliva) was collected from one individual. This comparison revealed insights into effects of viscosity modifying reagent on viscosity of the test fluid. The experiment was conducted when the test apparatus was a cassette-type test device. In one implementation, the cassette-type test device comprised a fully-assembled immunochromatographic assay strip, wherein assay strips were cut from cards. In another implementation, the cassette-type test device comprised a sample pad that comprised a glass fiber composite membrane. Herein, the nitrocellulose membrane was cut into strips of dimension 5 x 40 millimetres (mm).
[0088] In one implementation, a volume of 100 pL of the untreated saliva was added to the test apparatus at one time and the time taken for the untreated saliva to travel through the test apparatus, when the fully- assembled immunochromatographic assay strip was used, was determined. A volume of 100 pL of the pre-treated saliva was added to the test apparatus at another time and the time taken for the untreated saliva to travel through the test apparatus, when the fully-assembled immunochromatographic assay strip was used, was also determined. The experiment was replicated for two more samples of untreated saliva and two more samples of pre-treated saliva, and an average of the time taken for the untreated saliva and the pre-treated saliva to travel through the test apparatus was determined. FIG. 6A shows the graphical representation of the average of the time taken for the untreated saliva and the pre-treated saliva to travel through the test apparatus, when time is in minutes. FIG. 6B shows the graphical representation of the average of the time taken for the untreated saliva and the pre-treated saliva to travel through the test apparatus, when time is in seconds.
[0089] In another implementation, a volume of 100 pL of the untreated saliva was added to the test apparatus at one time and the time taken for the untreated saliva to travel through the test apparatus, when the sample pad comprising the glass fiber composite membrane was used, was determined. A volume of 100 pL of the pre-treated saliva was added to the test apparatus at another time and the time taken for the untreated saliva to travel through the test apparatus, when the sample pad comprising the glass fiber composite membrane was used, was also determined. The experiment was replicated for two more samples of untreated saliva and two more samples of pre-treated saliva, and an average of the time taken for the untreated saliva and the pre-treated saliva to travel through the test apparatus was determined. FIG. 6C shows the graphical representation of the average of the time taken for the untreated saliva and the pre-treated saliva to travel through the test apparatus, when time is in minutes. FIG. 6D shows the graphical representation of the average of the time taken for the untreated saliva and the pre-treated saliva to travel through the test apparatus, when time is in seconds.
[0090] FIGs. 6A-6D, are merely an example, which should not unduly limit the scope of the claims herein. A person skilled in the art will recognize many variations, alternatives, and modifications of embodiments of the present disclosure.
Claims
CLAIMS1. A test system (100) comprising:A test apparatus (100, 400) having: a pool (102) having a volume (116), and an inlet (106, 408) for filling the volume of the pool through the inlet with a test fluid (108, 112, 414), wherein an inner surface of the pool (114) comprises an amount of a viscosity modifying reagent (110, 410) in a dried format, an immunochromatography assay strip (104,502), wherein the viscosity modifying reagent comprises a viscosity-removing salt that is used to precipitate a viscosity-causing substance present in the test fluid, and wherein the immunochromatography assay strip is to be entered through the inlet to be in contact with the test fluid, when in use.
2. A system (100) of claim 1, wherein an amount of a pH-adjusting reagent (122, 512) in a pre-dried format is applied on the inner surface (114).
3. A system (100) of claim 1, wherein the amount of the viscosity modifying reagent (120, 510) is in range of 0.001 millimol (mmol) per square meter to 1.00 mmol per square meter.
4. A system (100) of any of the preceding claims, wherein a first distance (DI) of the viscosity modifying reagent (120, 510) from the inlet (110, 508) lies in a range of 0.05 millimetres (mm) - 10 mm.
5. A system (100) of claim 2, wherein a second distance (D2) between the viscosity modifying reagent (120, 510) and the pH-adjusting reagent (122, 512) is at least 0.1 millimeters.
6. A system (100) of claim 2, wherein the inner surface (114)comprises a protrusion (302), that provides a fluidic separation between the viscosity modifying reagent (120, 510) and the pH-adjusting reagent (122, 512).
7. A system (100) of any of the preceding claims, wherein a volume of the viscosity modifying reagent (120, 510) lies in a range of 1 microlitres (pL) to 2000 pL.
8. A system (100) of any of the preceding claims, wherein the viscosity modifying reagent (120, 510) is an aluminum-derived reagent.
9. A system (100) of any of the preceding claims, wherein the viscosity-removing salt is dissolved in water or in an organic solvent, and wherein a concentration of the viscosity modifying reagent (120, 510), prior to drying, is at least 10 millimoles (mmol) per liter.
10. A system (100) of claim 9, wherein the viscosity modifying reagent (120, 510), prior to drying, further comprises a sucrose solution, the sucrose solution comprising sucrose dissolved in water, wherein a concentration of sucrose that lies in a range of 0.1 percent to 30 percent of a total volume of water.
11. A system (100) of any of the preceding claims, wherein the test apparatus (102, 500) is one of: a test tube, a petri dish, a microtiter plate, a cassette-type test device, an automatic test device.
12. A system (100) of any of the preceding claims, wherein the test apparatus (102, 500) further comprises a detergent-dispensing element that is configured to dispense a detergent solution into the test-fluid receiving volume (116, 504), wherein the detergent solution comprises a detergent reagent lying in a range of 0.01 percent to 50 percent of a total volume of water, and wherein a volume of the detergent reagent lies in a range of 1 microlitres (pL) - 50 pL.
13. A method for using a system (100) according to claim 1, the method comprising: dispensing a test fluid (108, 414) into the test-fluid receiving volume (116, 504), exposing the test fluid to be in contact with the viscosity modifying reagent (120, 510) for a predefined period of time; disposing an immunochromatography assay strip (104, 502) with the test fluid to allow absorption; and detecting a test result (204A, 204B) from the immunochromatography assay strip.
14. A method of claim 13, further comprising: wherein further the inner surface (114) of the test apparatus (102, 500) comprises a pH-adjusting reagent (122, 512) in a pre-dried format.