Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION:
REUSABLE RAPID TESTING KIT
2. APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

The following specification particularly describes the invention and the manner in which it is to be performed:

FIELD OF INVENTION
[1] The present disclosure relates to the field of medical testing devices. More particularly, the present disclosure relates to a reusable rapid testing kit.
BACKGROUND OF INVENTION
[2] In various fields such as healthcare and environmental monitoring, rapid diagnostic testing offers swift results and ease of use. However, the widespread reliance on disposable, single-use testing kits poses significant economic and environmental challenges. The constant need to replace these kits drives up costs, particularly in scenarios requiring frequent testing. Furthermore, the accumulation of plastic waste from disposable kits presents a substantial obstacle to sustainable practices.
[3] Attempts to address these issues by reusing single-use kits often lead to compromised test accuracy or raise concerns about contamination. The development of partially reusable kits, where only certain components are replaced, offers some improvement but still entails the disposal of elements after each use. Additionally, such solutions may involve complex cleaning procedures, limiting their practicality. Furthermore, existing technologies pose challenges in reusing the single use testing kits, responsibly disposing them, and maintaining both hygiene and cost-effectiveness throughout their usage.
SUMMARY OF INVENTION
[4] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[5] The present disclosure relates to a reusable rapid testing kit. The reusable rapid testing kit includes a cassette body formed from a polymer material. The cassette body has a single opening and a hollow interior area. The reusable rapid testing kit further includes a removable testing strip configured for insertion into the hollow interior area of the cassette body and a cap for selectively closing the single opening of the cassette body. The cassette body is washable and configured for reuse with multiple removable testing strips.
[6] Advantageously, the reusable rapid testing kit of the present disclosure provides a washable and reusable cassette body, constructed from a durable polymer material. This design allows for multiple testing cycles with the same cassette, significantly reducing waste and minimizing the need for frequent replacements. The kit's user-friendliness is enhanced by clear visual and optional audible signals, providing unambiguous positive test results. The distinctive color-change mechanism ensures that users, regardless of their expertise, can easily and accurately interpret test outcomes. Overall, this reusable rapid testing kit prioritizes cost-effectiveness, environmental sustainability, and reliability, making it a valuable advancement within the field of rapid diagnostics.
[7] To further clarify the advantages and features of the present disclosure, a more particular description of the invention will be rendered by reference to specific embodiments thereof, which is illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail with the accompanying drawings.
BRIEF DESCRIPTION OF DRAWINGS
[8] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[9] FIG. 1 illustrates a schematic top view of a reusable rapid testing kit, according to an embodiment of the present invention;
[10] FIG. 2 illustrates a schematic exploded view of the reusable rapid testing kit, according to an embodiment of the present invention;
[11] FIG. 3A illustrates a schematic top view of the reusable rapid testing kit before testing, according to an embodiment of the present invention;
[12] FIG. 3B illustrates a schematic top view of the reusable rapid testing kit after testing, according to an embodiment of the present invention;
[13] FIG. 4 illustrates a schematic top view of a strip holder of the reusable rapid testing kit, according to an embodiment of the present invention;
[14] FIG. 5 illustrates an enlarged view of a removable testing strip of the reusable rapid testing kit, according to an embodiment of the present invention;
[15] FIG. 6A illustrates a schematic perspective view of another reusable rapid testing kit, according to another embodiment of the present invention;
[16] FIG. 6B illustrates a schematic top view of the reusable rapid testing kit of FIG. 6A, according to another embodiment of the present invention; and
[17] FIG. 7 illustrates a flowchart of a method of using the reusable rapid testing kit, according to an embodiment of the present invention.
[18] Further, skilled artisans will appreciate that elements in the drawings are illustrated for simplicity and may not have necessarily been drawn to scale. Furthermore, in terms of the construction of the device, a plurality of components of the device may have been represented in the drawings by conventional symbols, and the drawings may show only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the drawings with details that will be readily apparent to those of ordinary skill in the art having benefit of the description herein.
DETAILED DESCRIPTION OF THE DRAWINGS
[19] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, coupled to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like. Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[20] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean “one or more but not all embodiments” unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
[21] Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.
[22] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[23] Embodiments of the present disclosure will be described below in detail with reference to the accompanying drawings.
[24] The reusable rapid testing kit 100 (interchangeably referred to as “the kit ”) is a diagnostic tool designed to perform rapid tests for various purposes (medical, environmental, etc.) while the main structural element of the kit can be used for multiple tests. The reusable rapid testing kit offers a cost-effective, environmentally responsible, and user-friendly solution for various in-vitro diagnostic applications. The core of the kit is a durable, washable cassette body constructed from a biocompatible polymer material. The cassette body is designed to accommodate specialized, removable testing strips that interact with biological samples such as blood, urine, or saliva. Further, the removable testing strip is configured for insertion into a hollow interior area of the cassette body.
[25] With reference to FIG. 1, the reusable rapid testing kit 100 includes a cassette body 102, a sample collection zone 104, a result viewing window 106, a visual indication viewing area 108 and a cap 110. The cassette body 102 has a single opening at one end and a hollow interior area. The cassette body 102 is washable and configured for use once a testing strip is inserted in the hollow interior area. The testing strip is a removable testing strip that can be removed and disposed once the test is performed and replaced with a new testing strip for use. Thus, cassette body 102 is configured for reuse with minimal effort and has tremendous environmental impact.
[26] The cassette body 102 is formed from a polymer material. In some implementations, the polymer material includes a biocompatible plastic selected from a group consisting of polypropylene, polyethylene, and polystyrene. In some other implementations, the cassette body 102 may be formed with any polymeric material as per application requirement.
[27] The sample collection zone 104 is located on one side of the kit 100. This designated area on the cassette body 102, is designed for the convenient addition of various bodily fluids, such as urine, by a user or a medical professional. The versatility of the sample collection zone 104 allows for the testing of different bodily fluids depending on the specific diagnostic requirements. This feature ensures adaptability for a range of medical applications.
[28] The kit 100 is adaptable to various bodily fluids, including but not limited to blood, sweat, tears, and saliva. The user can easily introduce the selected bodily fluid into the sample collection zone 104 based on the type of test intended. This flexibility broadens the utility of the testing kit, catering to diverse medical or environmental testing needs.
[29] The result viewing window 106 in the cassette body 102 shows a reaction zone of the removable testing strip. From the result viewing window 106, the user can check the result of a rapid test conducted on the reusable rapid testing kit 100.
[30] Upon completion of the test, the result viewing window 106 becomes the focal point for interpreting the test outcome. For example, in the case of a positive result, the result viewing window 106 displays two double lines. The positive portion of the result viewing window 106 exhibits a distinctive color, which may vary and include shades such as red, pink, orange, etc. This color change mechanism provides a clear and visually discernible confirmation of a positive test result, enhancing the interpretability of the outcome.
[31] Conversely, in the event of a negative result, the positive portion of the result viewing window 106 illustrates a single line indicated against control line “C”. This absence of color in the designated area serves as a visual cue for a negative test result. The straightforward differentiation between positive and negative outcomes contributes to the user-friendly nature of the kit 100, ensuring clarity in result interpretation.
[32] Further, the cassette body 102 includes a visual indication viewing area 108 that is used to see a visual indication for example, a change in color, in response to the result of the rapid test. In an example, the visual indication viewing area 108 is a cut out of a word “Positive” that changes the color on a positive result of the rapid test. In an embodiment, the cut out may be covered with a transparent film to prevent debris/moisture/fluid etc. to contact the testing strip.
[33] The reusable rapid testing kit 100 further includes the cap 110 for selectively closing the single opening of the cassette body 102.
[34] The reusable rapid testing kit 100 offers a cost-effective, environmentally responsible, and user-friendly solution for various in-vitro diagnostic applications. The core of the kit 100 is a durable, washable cassette body 102 constructed from a biocompatible polymer material. The cassette body 102 is designed to accommodate specialized, removable testing strips that interact with biological samples such as blood, urine, or saliva.
[35] The kit 100 provides clear and reliable test results by way of one of more notifications. For example, in the event of a positive result, the detection area of the strip (described in Fig. 5) undergoes a visually unambiguous transformation (e.g., from white to pink).
[36] After each test, the cassette body 102 can be thoroughly sanitized with hot water and appropriate disinfectants, ensuring hygienic reuse. This innovative design significantly reduces waste and minimizes the need for frequent replacements, making it an ideal solution for various healthcare settings, laboratories, and potentially even home use.
[37] FIG. 2 illustrates a schematic exploded view of the reusable rapid testing kit 100, according to an embodiment of the present invention. In the illustrated embodiment, the kit 100 includes the cassette body 102. The cassette body 102 includes an upper casing 202A and a lower casing 202B. The upper casing 202A of the cassette body 102 includes the sample collection zone 104, the result viewing window 106, and the visual indication viewing area 108.
[38] The upper casing 202A and the lower casing 202B may be removable coupled with each other defining a hollow interior area. In some examples, the upper casing 202A and the lower casing 202B may be snap fitted together. For example, as shown in Fig. 2, on the lower casing 202B, female connectors 208 are provided which snap fit with the male connectors provided on the opposite end in the upper casing 202A. Alternately, male and female cylindrical or flat connectors can be used. In the hollow interior area, a removable testing strip (or testing strip) 204 provided on a strip holder 206 may be placed.
[39] The cap 110 may be provided with an extension or strip holder 206 on which the testing strip 204 is placed. The cap 110 and the strip holder 206 may be fixedly coupled or coupled via a removable attachment means like hooks. In an embodiment, the strip holder 206 is a hollow rectangular structure that allows the removable testing strip 204 to rest thereon. Alternate shapes of the strip holder 206 as per the dimensions of the cassette body 102 are within the teachings of the present disclosure. Alternately, the strip holder 206 may be a solid plate on which the removable testing strip 204 rests.
[40] The cap 110 of the kit 100 serves a dual purpose. Primarily, it is employed for closing the hollow interior area securely, preventing any external interference during the testing process. Additionally, the cap 110 is designed to securely hold the testing strip 204 in place within the hollow interior area, ensuring proper alignment of the testing strip 204 with the visual indication viewing area 108 for accurate and consistent display of test results. This design feature adds to the overall efficiency and reliability of the kit 100.
[41] The removable testing strip 204 includes a porous material selected from a group consisting of paper, nitrocellulose, and nylon. Further details of the testing strip 204 are disclosed in Fig. 5.
[42] FIG. 3A illustrates a schematic top view of the reusable rapid testing kit 100 before testing, according to an embodiment of the present invention. With reference to FIG. 3A, there is shown that before testing, the result viewing window 106 and the visual indication viewing area 108 do not show any visual indication. Specifically, the result viewing window 106 is blank and the visual indication viewing area 108 is colorless.
[43] FIG. 3B illustrates a schematic top view of the reusable rapid testing kit 100 after testing, according to an embodiment of the present invention. After testing, the result viewing window 106 in the cassette body 102 shows the detection area (described in Fig. 5) depicting two vertical lines indicative of a positive result. In some embodiments, the first vertical line is a test line 508, and the second vertical line is a control line. The removable testing strip of the reusable rapid testing kit 100 includes the detection area (described in Fig. 5) designed to display the visual indication of a test result. Specifically, in some examples, the removable testing strip 204 includes the detection area that changes from white to pink in the presence of the target analyte.
[44] Further, the color of the visual indication viewing area 108 is changed to indicate that the rapid testing result is positive. In case of a negative result of the rapid testing, the result viewing window 106 and the visual indication viewing area 108 may show one visual indicator indicative of the negative result. The color change of the removable testing strip 204 provides a visually unambiguous indication of a positive test result.
[45] FIG. 4 illustrates a schematic top view of the strip holder 206 with the cap 110 of the reusable rapid testing kit 100, according to an embodiment of the present invention. The central component of the reusable rapid testing kit 100 is the strip holder 206 with the cap 110. The strip holder 206 is meticulously designed to facilitate accurate and hygienic testing. Crafted from a durable polymer material like polypropylene, polyethylene, and polystyrene, etc. the strip holder 206 features a hollow interior area 400 specifically sized to securely hold a single testing strip.
[46] The cap 110 provides a leak-resistant seal between the cassette body 102 and the strip holder 206, protecting the removable testing strip 204 during the rapid testing. The leak-resistant seal is ensured by a locking mechanism 402. In an embodiment, the locking mechanism 402 is a snap fit mechanism that is configured to snap fit into the cassette body 102. The design prioritizes both sanitation and longevity, that is, after a test, the cassette body 102 and the strip holder 206 can be easily washed and disinfected, ensuring its readiness for multiple rounds of reliable testing.
[47] FIG. 5 illustrates an enlarged view of the removable testing strip 204 of the reusable rapid testing kit 100, according to an embodiment of the present invention. The removable testing strip 204 includes a reaction zone configured to interact with a fluid sample inserted into the hollow interior area 400 of the cassette body 102.
[48] The reaction zone includes a sample pad 502. The sample pad 502 is strategically positioned as an initial point for sample application. Functioning as a reservoir, it facilitates controlled flow of the sample along the removable testing strip 204. The sample pad 502 is crucial for managing the sample volume and ensuring uniform distribution of the sample as it progresses through subsequent components of the removable testing strip 204.
[49] The reaction zone further includes a conjugate pad 504. Adjacent to the sample pad 502, the conjugate pad 504 plays a pivotal role in the detection process. It contains labeled molecules 506, such as gold nanoparticles or colored latex beads, conjugated with specific detection reagents, typically antibodies or antigens tailored to recognize the target analyte. The conjugate pad 504 serves as the source of labeled molecules 506 that interact with the sample during the testing process.
[50] The removable testing strip 204 further includes a membrane that is constructed from nitrocellulose and serves as the solid phase where the biochemical reaction occurs. The membrane constitutes different detection zones, each with distinct functions. The different detection zones include a sample application zone that is an initial region where the sample flows from the sample pad 502, initiating the testing process. The different detection zones further include a test line (T-line) 508, a control line (C-line) 510, and a testing pad 512.
[51] Positioned strategically along the membrane, the T-Line 508 contains immobilized capture molecules, such as antibodies or antigens, specific to the target analyte. When the target analyte is present in the sample, it forms a visible line at the T-Line 508 by binding to the labeled molecules 506 from the conjugate pad 504, providing a clear indication of a positive result.
[52] Located on the membrane, the C-Line 510 features immobilized molecules, typically antibodies, designed to capture excess labeled molecules 506 from the conjugate pad 504. The appearance of a line at the C-Line 510 verifies the proper functioning of the test, serving as an internal control.
[53] The testing pad 512, containing specialized molecules like antibodies or antigens, plays a crucial role in the final phase of the testing process. When the sample, enriched with labeled molecules 506 from the conjugate pad 504, interacts with the testing pad 512, it results in a visible color change, providing an additional visual confirmation of the test outcome.
[54] The removable testing strip 204 further includes an absorbent pad 514 that is positioned at the end of the removable testing strip 204, the absorbent pad 514 serves to draw the sample through the membrane via a capillary action. The absorbent pad 514 aids in the efficient progression of the sample along the removable testing strip 204, contributing to the overall effectiveness and reliability of the testing process.
[55] The operation of the testing strip 204 follows a straightforward principle. Initially, the sample is applied to the sample pad 502, initiating the rehydration of labeled molecules 506 within the conjugate pad 504. The sample, now combined with the labeled molecules 506, advances along the removable testing strip 204 through the capillary action. If the target analyte is present in the sample, it binds to the labeled molecules 506 in the conjugate pad 504. The mixture proceeds to flow, reaching the test line 508 and testing pad 512. In the presence of the target analyte, binding occurs with the capture molecules on the test line 508 and the testing pad 512, resulting in a visible color. Excess labeled molecules 506 continue to flow, binding to molecules immobilized on the control line 510, generating another visible line. The interpretation of the test result is based on the presence or absence of lines at the test and control lines 508, 510, providing a clear and visual indication of the outcome.
[56] FIG. 6A illustrates a schematic perspective view of another reusable rapid test kit 600, according to another embodiment of the present invention. FIG. 6B illustrates a schematic top view of the reusable rapid testing kit 600 of FIG. 6A, according to another embodiment of the present invention. Referring to FIGS. 6A and 6B, the reusable rapid testing kit 600 exhibits a substantial similarity with the kit 100 depicted in FIG. 1 with regard to functionality. Consequently, identical numerals have been employed to designate analogous components of the kit 600.
[57] FIG. 7 illustrates a flowchart of a method 700 of using the reusable rapid testing kit 100, according to an embodiment of the present invention. In some embodiments, the method 700 may be implemented on the reusable rapid testing kit 600.
[58] At Step 702, the process commences by adding the sample onto the sample collector, ensuring precise and controlled application. Subsequently, in Step 704, a brief waiting period ensues, allowing the test result to develop on the testing strip.
[59] Following the incubation period, Step 706 prompts the user to read the visual test result from the testing strip 204. This step involves a straightforward visual inspection to determine the presence or absence of specific indicators on the removable testing strip 204.
[60] Upon obtaining the initial test result in Step 708, the process advances to Step 710, where the user is instructed to remove the cap, extract the used strip, and proceed to wash the entire kit 100 with hot water. This post-test sanitation step ensures the removal of any residual contaminants, maintaining the kit's cleanliness for subsequent use.
[61] In the subsequent step, Step 712, the user is directed to insert the next strip into the kit 100, preparing it for subsequent tests. Following the completion of these steps, the user can be instructed to follow the aforementioned steps again for the next test. This iterative process allows for the continuous and repeated use of the reusable rapid test kit 100, providing a user-friendly and adaptable testing solution for various applications.
[62] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one ordinary skilled in the art to which this invention belongs. The system, methods, and examples provided herein are illustrative only and not intended to be limiting.
[63] While specific language has been used to describe the present subject matter, any limitations arising on account thereto, are not intended. As would be apparent to a person in the art, various working modifications may be made to the method to implement the inventive concept as taught herein. The drawings and the forgoing description give examples of embodiments. Those skilled in the art will appreciate that one or more of the described elements may well be combined into a single functional element. Alternatively, certain elements may be split into multiple functional elements. Elements from one embodiment may be added to another embodiment.
[64] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM:
1. A reusable rapid testing kit (100), comprising:
a cassette body (102) having a single opening and a hollow interior area;
a removable testing insertion into the hollow interior area of the cassette body (102); and
a cap (110) for selectively closing the single opening of the cassette body (102) forming a leak-resistant seal;
wherein the cassette body (102) is washable and configured for reuse with multiple removable testing strips.
2. The reusable rapid testing kit (100) as claimed in claim 1, wherein the cassette body (102) is formed from a polymer material including a biocompatible plastic selected from a group consisting of polypropylene, polyethylene, and polystyrene.
3. The reusable rapid testing kit (100) as claimed in claim 1, wherein the removable testing strip (204) includes a porous material selected from a group consisting of paper, nitrocellulose, and nylon.
4. The reusable rapid testing kit (100) as claimed in claim 1, wherein the removable testing strip (204) includes a reaction zone configured to interact with a fluid sample inserted into the hollow interior area of the cassette body (102).
5. The reusable rapid testing kit (100) as claimed in claim 1, wherein the removable testing strip (204) includes a detection zone designed to display a visual indication of a test result.
6. The reusable rapid testing kit (100) as claimed in claim 5, wherein the detection area is configured to change its color in the presence of a target analyte.
7. The reusable rapid testing kit (100) as claimed in claim 6, wherein the removable testing strip (204) provides a visually unambiguous indication of a positive test result due to the color change.
8. A testing strip comprises:
a. a reaction zone configured to interact with a fluid sample inserted into a hollow interior area of a cassette body (102), the reaction zone includes a sample pad (502) that functions as a reservoir and a conjugate pad including (504) one or more labeled molecules (506) to recognize a target analyte; and
b. a membrane to facilitate a biochemical reaction and including a detection zone designed to display a visual indication of a test result;
wherein the detection area is configured to change its color in the presence of a target analyte; and
wherein the testing strip is removable.