DESC:FIELD OF THE INVENTION
[001] The invention relates to a diagnostic test cassette. More particularly, the invention relates to a biodegradable rapid diagnostic test cassette that is particularly useful for various point-of-care applications, including the detection of infectious diseases, monitoring of chronic conditions, and screening for biomarkers.

BACKGROUND OF THE INVENTION
[002] Rapid diagnostic tests (RDTs) have undoubtedly revolutionized healthcare by providing swift and convenient point-of-care diagnoses for a myriad of diseases and conditions. However, the widespread adoption of these kits has inadvertently led to a hidden environmental cost, primarily driven by the prevalent use of plastic components. Conventional plastics like polystyrene or polypropylene, commonly utilized in RDT construction, pose a significant threat to the environment, manifesting in several detrimental ways.
[003] Firstly, the reliance on traditional plastics exacerbates the issue of plastic pollution. Once discarded, RDT kits composed of these durable materials persist in landfills for centuries, due to their resistance to natural breakdown processes. Consequently, these plastic remnants not only occupy valuable landfill space but also disintegrate into microplastics, infiltrating and contaminating soil and water bodies.
[004] Moreover, the release of microplastics from degrading plastic RDTs instigates ecosystem disruption. As these minuscule particles infiltrate the food chain, they pose a direct threat to wildlife. Marine organisms, for instance, may mistake microplastics for prey, leading to ingestion and potentially fatal consequences. Furthermore, microplastics have the propensity to absorb harmful pollutants, thus amplifying their adverse impact on ecosystems.
[005] Additionally, conventional plastics in RDTs often harbour harmful chemicals such as bisphenol A (BPA) and phthalates, which can leach into samples or the environment during disposal, posing risks to both human health and environmental integrity.
[006] Furthermore, the limited options for recycling increase the environmental burden posed by RDT plastic waste. Due to their small size and potential biohazard risk, conventional recycling methods are often insufficient or impractical for RDTs. Consequently, this limitation impedes progress towards achieving a circular economy and perpetuates the cycle of plastic waste accumulation.
[007] The plastic pollution issue stemming from the widespread use of rapid diagnostic tests (RDTs) is indeed considerable, especially given the escalating reliance on these tests for diagnosing infectious and viral diseases worldwide. With millions of RDT kits utilized annually across the globe, the sheer volume of plastic waste generated is staggering, worsening the options of responsible disposal. This poses a pressing environmental concern, particularly considering the limited options available for managing this escalating waste stream effectively.
[008] Further, the ramifications extend beyond environmental considerations alone. The reliance on non-biodegradable plastics in RDT manufacturing presents significant logistical hurdles, particularly in resource-constrained settings. Accumulating used RDTs without proper disposal infrastructure in place burdens healthcare facilities and communities, potentially impeding the accessibility and efficacy of these critical diagnostic tools, especially in regions where they are most needed.
[009] In light of these challenges, the imperative for biodegradable alternatives to conventional plastic RDTs becomes increasingly apparent. Biodegradable materials offer a promising avenue for mitigating both environmental and logistical burdens associated with RDT plastic waste. These materials have the capacity to naturally decompose under specific environmental conditions, thereby curtailing plastic waste accumulation significantly.
[010] Moreover, the adoption of biodegradable cassettes holds the potential to streamline waste management practices. Such cassettes could be safely composted in controlled facilities, reducing dependence on landfills, and simplifying disposal processes, particularly in resource-limited settings where robust waste management infrastructure may be lacking.
[011] Furthermore, embracing biodegradable materials in RDT manufacturing aligns with the broader ethos of sustainable healthcare practices. It underscores a commitment to environmental stewardship within the healthcare sector, advancing the agenda of sustainability while simultaneously addressing pressing public health needs. By prioritizing biodegradability in RDT design, stakeholders can contribute meaningfully to a more sustainable and resilient healthcare ecosystem.
[012] In essence, while RDTs undeniably offer invaluable benefits to healthcare, their reliance on conventional plastics underscores the urgent need for sustainable alternatives to mitigate the environmental toll associated with their use.
[013] The existing techniques are therefore inadequate in addressing the issue of plastic pollution in the medical diagnostic field.
[014] In view of the above, there is a need for a rapid diagnostic test cassette which addresses at least the aforementioned problems.

SUMMARY OF THE INVENTION
[015] In an aspect, the present invention is directed to a rapid diagnostic test cassette. The cassette is devised to be used for the analysis of a sample. The cassette comprises a first part and a second part, which are coupled together to create a test chamber for housing a diagnostic test strip. The first part has a distal end and a proximal end. Further, the first part comprises: a buffer well disposed adjacent to the distal end, the buffer well holding a buffer solution; a sample well disposed between the buffer well and the proximal end, the sample well holding the sample, and at least one visualization window disposed between the sample well and the proximal end, the at least one visualization window determining an outcome of the analysis. The second part has a distal end and a proximal end. The second part comprises: at least one right chamber and at least one left chamber, the diagnostic test strip disposed in the test chamber formed between the at least one right chamber and the at least one left chamber. The cassette is made from a biodegradable material consisting of agricultural crops, sugarcane bagasse, waste paper pulp, sarkanda pulp, parali pulp, and grains.
[016] In an embodiment, each of the at least one right chamber and the at least one left chamber in the second part is disposed continuously between the distal end and the proximal end.
[017] In another embodiment, each of the at least one right chamber and the at least one left chamber in the second part is disposed in a discrete manner between the distal end and the proximal end.
[018] In still another embodiment, each of the at least one right chamber and the at least one left chamber has a curved surface disposed adjacent to the proximal end of the second part.
[019] In yet another embodiment, the curved surface facing a top surface of the diagnostic test strip to at least partially encapsulate the top surface, thereby preventing an upward movement of the diagnostic test strip.
[020] In a further embodiment, the cassette is a single use cassette.
[021] In a still further embodiment, the cassette is obtained by injection moulding or 3D printing of polylactic acid.
[022] In another embodiment, the cassette is obtained by folding paper.
[023] In yet another embodiment, the diagnostic test strip is pre-loaded with one or more reagents.
[024] In another embodiment, the buffer well comprises one or more pores disposed at a bottom end thereof, the one or more pores allowing flow of the buffer solution onto the diagnostic test strip.
[025] In a further embodiment, the sample well comprises one or more pores disposed at a bottom end thereof, the one or more pores allowing flow of the sample onto the diagnostic test strip.
[026] In a still further embodiment, the cassette further comprises a buffer flow down well for storing excess flow of the buffer solution from the buffer well, the buffer flow down well disposed adjacent to the distal end of the second part.
[027] In another embodiment, the cassette further comprises a sample flow down well for storing excess flow of the sample from the sample well, the sample flow down well disposed adjacent to the distal end of the second part.

BRIEF DESCRIPTION OF THE DRAWINGS
[028] Reference will be made to embodiments of the invention, examples of which may be illustrated in accompanying figures. These figures are intended to be illustrative, not limiting. Although the invention is generally described in the context of these embodiments, it should be understood that it is not intended to limit the scope of the invention to these particular embodiments.
Figure 1 illustrates a front view of a rapid diagnostic test cassette in accordance with an embodiment of the present invention.
Figures 2a and 2b illustrate a top view and a perspective view, respectively, of a first part of the rapid diagnostic test cassette of Figure 1 in accordance with an embodiment of the present invention.
Figure 3 illustrates a perspective view of the rapid diagnostic test cassette of Figure 1 in accordance with an embodiment of the present invention.
Figures 4a and 4b illustrate a perspective view of a second part of the rapid diagnostic test cassette of Figure 1 in accordance with an embodiment of the present invention.
Figures 5a and 5b illustrate a front perspective view and a perspective view of a rapid diagnostic test cassette in accordance with an embodiment of the present invention.
Figure 6 illustrates a front perspective view of a second part of the rapid diagnostic test cassette of Figures 5a in accordance with an embodiment of the present invention.
Figure 7 illustrates a top view of the rapid diagnostic test cassette of Figure 5a in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION
[029] The terms “comprising”, “comprises” and “comprised of” as used herein are synonymous with “including”, “includes” or “containing”, “contains”, and are inclusive or open-ended and do not exclude additional, non-recited members, elements, or method steps. It will be appreciated that the terms “comprising”, “comprises” and “comprised of” as used herein comprise the terms “consisting of”, “consists” and “consists of”.
[030] Furthermore, the terms “first”, “second”, “third” or “(a)”, “(b)”, “(c)”, “(d)” etc. and the like in the description and in the claims, are used for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein. In case the terms “first”, “second”, “third” or “(A)”, “(B)” and “(C)” or “(a)”, “(b)”, “(c)”, “(d)”, “i”, “ii” etc. relate to steps of a method or use or assay there is no time or time interval coherence between the steps, that is, the steps may be carried out simultaneously or there may be time intervals of seconds, minutes, hours, days, weeks, months or even years between such steps unless otherwise indicated in the application as set forth herein above or below.
[031] In the following passages, different aspects of the present invention are defined in more detail. Each aspect so defined may be combined with any other aspect or aspects unless clearly indicated to the contrary. In particular, any feature indicated as being preferred or advantageous may be combined with any other feature or features indicated as being preferred or advantageous.
[032] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to a person skilled in the art from this disclosure, in one or more embodiments. Furthermore, while some embodiments described herein include some, but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention and form different embodiments, as would be understood by those in the art. For example, in the appended claims, any of the claimed embodiments can be used in any combination.
[033] Furthermore, the ranges defined throughout the specification include the end values as well, i.e., a range of 1 to 10 implies that both 1 and 10 are included in the range. For the avoidance of doubt, the applicant shall be entitled to any equivalents according to applicable law.
[034] The present disclosure relates to a rapid diagnostic test cassette, a method of preparing the same, and towards the device for testing and diagnosis of diseases. The rapid diagnostic test cassette is designed to provide a quick and accurate method for diagnosing diseases and health conditions.
[035] In an aspect, the rapid diagnostic test cassette (500, 1000). This is shown in Figures 1, 3 and 5a.
[036] In an embodiment, the rapid diagnostic test cassette (500, 1000) comprises of a first part (100, 600) and a second part (300, 800). The first part (100, 600) and the second part (300, 800) are coupled with each other. The coupling creates a test chamber that houses a diagnostic test strip (200, 700). The coupling of the first part (100, 600) and the second part (300, 800) of the rapid diagnostic test cassette (500, 1000) achieves multiple benefits. First, it creates a secure test chamber that protects the diagnostic test strip (200, 700) from external contaminants, ensuring the integrity of the testing environment. This secure design minimizes the risk of movement or exposure, leading to more accurate and reliable results. Additionally, the integrated structure simplifies assembly and operation, making the cassette user-friendly. Improved handling and transportability further reduce the likelihood of damage.
[037] The first part (100, 600) features a distal end (170, 670) and a proximal end (160, 660), with each component strategically disposed to optimize functionality.
[038] Referring to Figures 2a and 7, the first part (100, 600) includes a buffer well (110, 610) for holding a buffer solution, a sample well (120, 620) for containing a sample, and a visualization window (130, 630) for determining the test outcome.
[039] Referring to Figures 2a and 5b, the buffer well (110, 610) is disposed adjacent to the the distal end (170, 670) of the first part (100, 600). The buffer well (110, 610) is responsible for holding a buffer solution essential for the diagnostic process. The buffer well (110, 610) comprises one or more pores disposed at a bottom end (180, 680) to allow the controlled flow of the buffer solution onto the diagnostic test strip (200, 700). The buffer solution utilized may be aqueous in nature, containing constituents such as Tris-HCl, Triton X-100, and SDS, which facilitate immediate lysis of the sample.
[040] The sample well (120, 620) is disposed between the buffer well (110, 610) and the proximal end (160, 660). The sample well (120, 620) is designed for holding the sample to be tested. The sample well (120, 620) comprises one or more pores disposed at a bottom end (190, 690) to facilitate the flow of the sample onto the diagnostic test strip (200, 700).
[041] As shown in the inset view of Figure 6, when the diagnostic test strip (700) is housed within the cassette, the buffer well (610) directs any excess buffer solution into a buffer flow down well (850), capturing it to prevent overflow and safeguarding the integrity of the test. Similarly, any excess sample solution from the sample well (610) is directed to a sample flow down well (840), thereby capturing the excess sample solution to prevent overflow and ensure the integrity of the test. Samples compatible with the test cassette may include those of human, plant, and animal origin, encompassing a range of biological materials such as serum, blood, urine, semen, saliva, tissue lysates, and extracts. Furthermore, samples may consist of bacterial, viral, or cellular lysates containing specific antigens and antibodies relevant for targeted diagnostic tests.
[042] Referring again to Figures 2a and 7 the visualization window (130, 630) is disposed between the sample well (120, 620) and the proximal end (160, 660). The visualization window (130, 630) is useful in determining an outcome of the analysis. The visualization window (130, 630) allows for easy observation of the test results, ensuring that the user can interpret the findings promptly. By providing a clear and unobstructed view of the test area, the visualization window (130, 630) enables users to easily observe the appearance of test lines or indicators, which are essential for determining the outcome of the analysis.
[043] Furthermore, the user-friendly nature of the visualization window enhances the overall efficiency of the testing process, making it suitable for both professional settings and home use.
[044] Referring to Figures 4a, 4b and 6, the second part (300, 800) of the rapid diagnostic test cassette (500, 1000) is designed to house the diagnostic test strip (200, 700). The diagnostic test strip (200, 700) is pre-loaded with one or more reagents. Suitable reagents commonly used in the rapid diagnostic test cassettes are well known to the person skilled in the art.
[045] The second part (300, 800) features a distal end (370, 870) and a proximal end (360, 860), with each component strategically disposed to optimize functionality.
[046] The second part (300, 800) incorporates at least one right chamber (320, 820) and at least one left chamber (310, 810). The diagnostic test strip (200, 700) is disposed in the test chamber formed between the at least one right chamber (320, 820) and the at least one left chamber (310, 810). The chambers ensure the diagnostic test strip (200, 700) remains securely disposed during the diagnostic process. The chambers also ensure structural integrity of the rapid diagnostic test cassette (500, 1000).
[047] In an embodiment, the rapid diagnostic test cassette (500) has each of the at least one right chamber (320) and the at least one left chamber (310). Referring to figure 4b, the right chamber (320) and the left chamber (310) are disposed in a discrete manner between the distal end (370) and the proximal end (360). The discrete arrangement means that the chambers are disposed separately rather than as a continuous structure. Said design offers flexibility in the placement of the diagnostic test strip (200).
[048] In an embodiment, specifically, the rapid diagnostic test cassette (1000) has each of the at least one right chamber (820) and the at least one left chamber (810). Referring to figure 6, the right chamber (820) and the left chamber (810) are disposed continuously between the distal end (870) and the proximal end (860) of the second part (800). This continuous arrangement provides a unified and uninterrupted support structure for the diagnostic test strip (700).
[049] The right chamber (820) and the left chamber (810) includes a curved surface (830a, 830b) that is disposed adjacent to the proximal end (360). These curved surfaces (830a, 830b) are designed to contour around the top surface of the diagnostic test strip (700). The curved surface (830a, 830b) faces a top surface of the diagnostic test strip (700) and is meant to at least partially encapsulate the top surface, thus preventing an upward movement of the diagnostic test strip (700). The support blocks, represented by the right chamber (320, 820) and left chamber (310, 810), play a critical role in the functionality and reliability of the rapid diagnostic test cassette. By securely positioning the diagnostic test strip (200, 700) between these chambers, the support blocks ensure that the test strip remains stable during the diagnostic process. This stability is essential for accurate results, as any movement or misalignment of the strip could lead to erroneous readings.In an embodiment, the rapid diagnostic test cassette (500,1000) is made from biodegradable material, plant-based substrates, biodegradable substrates, organic materials, or other compounds that are environmentally friendly. The materials may be agricultural by-products or agricultural waste.
[050] Plant-based materials offer environmental friendliness both during use, with excellent biodegradability, and in production. Additionally, grain-based materials are abundant and cost-effective, facilitating the manufacture of affordable cassette components.
[051] Conventional materials such as gelatin used in prior art devices/cassettes is derived from animal sources, posing challenges for mass production due to high costs and ethical concerns. This limitation restricts the availability of gelatin-based products in the market. Therefore, in the present invention, gelatin and environmentally harmful substances are not used.
[052] Accordingly, in an embodiment, the cassette (500, 1000) is made from a biodegradable material consisting of agricultural crops, sugarcane bagasse, waste paper pulp, sarkanda pulp, parali pulp, and grain husk.
[053] Suitable additives and/or auxiliaries can also be included in the biodegradable material for imparting functional characteristics. For instance, plasticizers such as any one or more of glycerol, sorbitol and propylene glycol, may be added.
[054] In an embodiment, the rapid diagnostic test cassette (500) is made of sugarcane bagasse or pulp. Bagasse is a waste material procured from agriculture, farm, or factory refuse. The rapid diagnostic test cassette (500) made from sugarcane pulp is treated with silicon grease to achieve hydrophobic surfaces for application of buffer and sample solutions. Optionally one or more additives and/or auxiliaries may also be added along with the sugarcane bagasse. To enhance moldability, the preparation of the pulp can be modified by incorporating suitable resins and adhesives, allowing for the attainment of the required slurry consistency.
[055] The pulp preparation process may also involve extended periods of incubation, enabling the achievement of optimal consistency prior to the molding phase. Various molding techniques can be employed, including metal, plastic, alloy, and injectable molds, which allow for versatile design options in the production of the test cassettes. Additionally, molding equipment compatible with hydraulic presses and heat treatment processes can be utilized to ensure effective molding and preparation of the biodegradable cassette.
[056] Once molded, the cassette can be trimmed to specific shapes and sizes as required, facilitating the accommodation of test strips and precise positioning of sample and buffer application wells. The molded biodegradable test cassettes can then be assembled in various configurations, either by joining upper and lower components or by integrating test strips at the same facility or a different one, depending on production requirements.
[057] Assembly may occur either after the molding process or concurrently during the molding process, allowing flexibility in design and production.
[058] In an embodiment, the rapid diagnostic test cassette (500) is made by injection moulding or 3D printing of polylactic acid (PLA) filament. PLA filament, a recyclable thermoplastic polyester derived from renewable sources like corn starch or sugar cane, possesses biodegradable properties under specific conditions alongside notable heat capacity and mechanical strength attributes.
[059] In an exemplary embodiment, the rapid diagnostic test cassette (500) is made using Tripidium bengalense (sarkanda) pulp. Sarkanda can be obtained from the grass growing near the canals and in roadside plantations from arid areas.
[060] In another exemplary embodiment, the rapid diagnostic test cassette (500) is made using cellulosic substrates, more specifically paper pulp. The rapid diagnostic test cassette (500) made from paper pulp are treated with silicon grease to achieve hydrophobic surfaces for application of buffer and sample solutions. Optionally one or more additives and/or auxiliaries may also be added along with cellulosic substrates to impart functional characteristics. Suitable additives and/or auxiliaries are known to the person skilled in the art. For example, glue, sterilizing agent, and hydrophobic agent may be added to the cellulosic substrates.
[061] In an embodiment, the rapid diagnostic test cassette (1000) is made by folding paper in a specific shape and pattern. The rapid diagnostic test cassette (1000) made from foldable paper is treated with silicon grease to achieve hydrophobic surfaces for application of buffer and sample solutions. Optionally one or more additives and/or auxiliaries may also be added along with the paper.
[062] In an embodiment, the rapid diagnostic test cassette (500, 100) is designed for single-use only. Said design ensures that the rapid diagnostic test cassette (500, 100) is used only once, which minimizes the risk of cross-contamination and guarantees accurate results for each test. After use, the rapid diagnostic test cassette (500, 100) is disposed off, contributing to hygiene and maintaining the integrity of the testing process. The single-use design also simplifies handling and reduces the need for complex cleaning or sterilization procedures.
[063] In another aspect, the present invention is directed to a method for preparing the rapid diagnostic test cassette (500), as described hereinabove. Accordingly, the embodiments pertaining to the rapid diagnostic test cassette (500) shall be applicable here as well.
[064] In an embodiment, the method comprises the following steps:
a) designing the rapid diagnostic test cassette base structure using Blender software to accommodate essential components and converting the design into a digital .stl file for 3D printing,
b) fabricating the rapid diagnostic test cassette base structure with an Ender 3V2 3D printer using a polylactic acid (PLA) filament, following the .stl file for accurate layer-by-layer deposition,
c) designing the rapid diagnostic test cassette upper structure using Blender software, focusing on sample well and buffer well, and converting the design into a digital .stl file, and
d) fabricating the rapid diagnostic test cassette upper structure with the Ender 3V2 3D printer using polylactic acid (PLA) filament and integrating it with the previously printed the rapid diagnostic test cassette base structure to complete the rapid diagnostic test cassette.
[065] Further, the rapid diagnostic test cassette (500) undergoes compatibility tests to verify that the design integrates seamlessly with standard nitrocellulose strips, which are equipped with specific antibodies and gold nanoparticles typically used in rapid diagnostic test cassettes.
[066] In another aspect, the present invention is directed to a method for preparing the rapid diagnostic test cassette (1000), as described hereinabove. Accordingly, the embodiments pertaining to the rapid diagnostic test cassette (1000) shall be applicable here as well.
[067] In an embodiment, the method comprises the following steps:
a) designing the paper layout by developing a detailed design for the rapid diagnostic test cassette (1000) using computer-aided design (CAD) software, which includes precise dimensions and configurations for all necessary components.
b) preparing the paper material by selecting a suitable type of paper that is durable and capable of being folded into the desired shapes and treating or coating the paper as necessary to meet the test’s requirements.
c) printing the design onto the selected paper material, transferring all markings, labels, and component areas to ensure they are clearly defined and accurately disposed.
d) cutting the printed paper according to the design specifications, including sections for wells, windows, and any other components that need to be folded or assembled.
e) folding the paper into the desired cassette shape based on the design, creating compartments for the sample well, buffer well, and test strip, and ensuring all folds are accurately aligned.
f) assembling the components by inserting the diagnostic test strip into the designated compartment of the folded paper cassette, aligning and securing the strip within the cassette, and adding any additional components such as absorbent pads or barriers.
g) sealing the cassette to prevent leakage or misalignment by applying adhesive or using a sealing method appropriate for the paper material to ensure the cassette remains intact and functional.
[068] In another embodiment, the rapid diagnostic test cassette (1000) is made by using Blender and Adobe illustrator softwares. Further, a laser dye containing a layout of the cassette is made and subjected to a hydraulic press to obtain creases which can be assembled or folded to obtain the rapid diagnostic test cassette (1000).
[069] Further, the rapid diagnostic test cassette (1000) undergoes quality control checks to ensure the rapid diagnostic test cassette (1000) meets all design specifications, verifying the integrity of the folds, alignment of components, and overall usability. The rapid diagnostic test cassette (1000) is tested with standard reagents and samples to confirm compatibility and proper performance, ensuring that the rapid diagnostic test cassette (1000) effectively conducts and displays diagnostic results.
[070] In a further aspect, the present invention is directed towards a rapid diagnostic test cassette (500, 1000) for testing and diagnosis of diseases. The rapid diagnostic test cassette (500, 1000) is designed to provide a quick and accurate method for diagnosing diseases. The rapid diagnostic test cassette (500, 1000) has the diagnostic test strip (200, 700). The diagnostic test strip (200,700) is housed within a test chamber. The diagnostic test strip (200, 700) is any conventionally available test strip. The standard nitrocellulose strips containing specific antibodies and gold nanoparticles may be used.
[071] The cassette features distinct wells: namely buffer well (110, 610) for holding a buffer solution and sample well (120, 620) for introducing the sample to be tested. The test strips utilized within the cassette may be made of materials such as nitrocellulose, PVDF, or other biodegradable cellulosic substances, coated with various antigens or antibodies tailored for specific tests.
[072] When the sample interacts with the diagnostic test strip (200, 700), it undergoes a series of chemical or immunological reactions that are indicative of the presence or absence of specific biomarkers related to the disease. The test strip's results are then displayed through a visualization window (130, 630), allowing for straightforward interpretation of the diagnostic outcome. This streamlined process enables timely and efficient disease diagnosis, which is crucial for prompt medical intervention and treatment.
[073] The diagnostic test strip (200, 700) utilized in the cassettes are intended for the detection of various parasitic, bacterial, and viral diseases affecting humans, animals, and plants. The potential human diseases that can be diagnosed using these test cassettes include but are not limited to malaria, dengue, Japanese encephalitis, Zika, chikungunya, filariasis, amoebiasis, rotavirus, COVID-19, cardiovascular diseases, lifestyle-related conditions, and pregnancy-related tests.
[074] Advantageously, the transition to the rapid diagnostic test cassettes addresses the environmental impact associated with traditional plastic-based alternatives. By utilizing biodegradable materials such as PLA filament, paper pulp, and sugarcane bagasse pulp, sarkanda pulp, the present invention promotes a more sustainable healthcare system.
[075] The biodegradable test cassettes are versatile and may be utilized for not only clinical diagnostics but also for food testing, soil analysis, and detection of contaminants such as insecticides and pesticides in various samples. They can effectively house diagnostic test strips that contain antigens, antibodies, aptamers, and nucleic acid probes, facilitating a wide range of diagnostic applications. The design of the cassettes also allows compatibility with LAMP (Loop-mediated Isothermal Amplification) applications, enabling the detection of specific nucleic acid regions of interest.
[076] Further, by incorporating a range of biodegradable materials in the rapid diagnostic test cassettes, the invention demonstrates innovation and responsible material selection. This approach ensures accurate and accessible diagnostics while minimizing the environmental footprint associated with traditional plastic cassettes.
[077] Additionally, the present invention is a step towards achieving the shift towards biodegradable rapid diagnostic test cassettes that in turn facilitates the development and implementation of new solutions that prioritize both patient health and environmental well-being.
[078] The present invention is cost effective and economically viable on an industrial scale. Also, the invention is also compatible with the existing ecosystem of the rapid diagnostic test kits, such that it uses the already established test strips, which does not need any new approvals from regulatory authorities.
[079] Lastly, the present invention aligns seamlessly with government initiatives aimed at environmental protection, offering several unique benefits that enhance its value. Key features include a significant reduction in plastic usage through the adoption of biodegradable materials, promoting sustainability by utilizing home-grown or waste resources, and presenting a lightweight alternative to current diagnostic test cassettes, which minimizes material consumption. The present invention not only supports eco-friendly practices but also contributes to a more sustainable future.
[080] The foregoing description of the invention has been set merely to illustrate the invention and is not intended to be limiting. Since the modifications of the disclosed embodiments incorporating the spirit and substance of the invention may occur to the person skilled in the art, the invention should be construed to include everything within the scope of the disclosure.
,CLAIMS:We Claim:
1. A rapid diagnostic test cassette (500, 1000) for analysis of a sample, the cassette (500, 1000) comprising:
a first part (100, 600) and a second part (300, 800), the first part (100, 600) coupled with the second part (300, 800), thereby creating a test chamber for housing a diagnostic test strip (200, 700),
the first part (100, 600) having a distal end (170, 670) and a proximal end (160, 660), the first part (100, 600) comprising:
a buffer well (110, 610) disposed adjacent to the distal end (170, 670), the buffer well (110, 610) holding a buffer solution,
a sample well (120, 620) disposed between the buffer well (110, 610) and the proximal end (160,660), the sample well (120, 620) holding the sample, and
at least one visualization window (130, 630) disposed between the sample well (120, 620) and the proximal end (160, 660), the at least one visualization window (130, 630) determining an outcome of the analysis,
the second part (300, 800) having a distal end (370, 870) and a proximal end (360, 860), the second part (300, 800) comprising:
at least one right chamber (320, 820) and at least one left chamber (310, 810), the diagnostic test strip (200, 700) disposed in the test chamber formed between the at least one right chamber (320, 820) and the at least one left chamber (310, 810),
wherein the cassette (500, 1000) is made from a biodegradable material consisting of agricultural crops, sugarcane bagasse, waste paper pulp, sarkanda pulp, parali pulp, and grain husk.

2. The rapid diagnostic test cassette (1000) as claimed in claim 1, wherein each of the at least one right chamber (820) and the at least one left chamber (810) in the second part (800) is disposed continuously between the distal end (870) and the proximal end (860).

3. The rapid diagnostic test cassette (500) as claimed in claim 1, wherein each of the at least one right chamber (320) and the at least one left chamber (310) in the second part (300) is disposed in a discrete manner between the distal end (370) and the proximal end (360).

4. The rapid diagnostic test cassette (1000) as claimed in claim 1, wherein each of the at least one right chamber (820) and the at least one left chamber (810) has a curved surface (830a, 830b) disposed adjacent to the proximal end (860) of the second part (800).

5. The rapid diagnostic test cassette (1000) as claimed in claim 4, wherein the curved surface (830a, 830b) facing a top surface of the diagnostic test strip (700) to at least partially encapsulate the top surface, thereby preventing an upward movement of the diagnostic test strip (700).

6. The rapid diagnostic test cassette (500, 1000) as claimed in claim 1, wherein the cassette (500, 1000) is a single use cassette.

7. The rapid diagnostic test cassette (500) as claimed in claim 1, wherein the cassette (500) is obtained by injection moulding or 3D printing of polylactic acid.

8. The rapid diagnostic test cassette (1000) as claimed in claim 1, wherein the cassette (1000) is obtained by folding paper.

9. The rapid diagnostic test cassette (500, 1000) as claimed in claim 1, wherein the diagnostic test strip (200, 700) is pre-loaded with one or more reagents.

10. The rapid diagnostic test cassette (500, 1000) as claimed in claim 1, wherein the buffer well (110, 610) comprises one or more pores disposed at a bottom end (180, 680) thereof, the one or more pores allowing flow of the buffer solution onto the diagnostic test strip (200, 700).

11. The rapid diagnostic test cassette (500, 1000) as claimed in claim 1, wherein the sample well (120, 620) comprises one or more pores disposed at a bottom end (190,690) thereof, the one or more pores allowing flow of the sample onto the diagnostic test strip (200, 700).
12. The rapid diagnostic test cassette (1000) as claimed in claim 1, further comprising a buffer flow down well (850) for storing excess flow of the buffer solution from the buffer well (610), the buffer flow down well (850) disposed adjacent to the distal end (870) of the second part (800).

13. The rapid diagnostic test cassette (1000) as claimed in claim 1, further comprising a sample flow down well (840) for storing excess flow of the sample from the sample well (620), the sample flow down well (840) disposed adjacent to the distal end (870) of the second part (800).

Dated this 24th day of May 2024.

HeteroChem InnoTech Private Limited
By their Agent & Attorney

(Adheesh Nargolkar)
of Khaitan & Co
Reg. No. IN/PA-1086