Description:FIELD OF INVENTION
[0001] Embodiments of the present disclosure relate to the field of biological treatment and more particularly to a device for testing a fluid sample and a method thereof.
BACKGROUND
[0002] Lateral flow immunoassay (LFA) membranes are paper-based chromatographic tools used for measuring analytes from a variety of samples such as blood, water, saliva, urine, and the like. Devices incorporating the LFA membranes are capable of being used as point-of-care devices without requiring assistance from trained personnel. The process of measuring the analytes using the LFA membranes includes a sample collection step in which the samples are collected and transferred onto the LFA membranes manually. Blood is considered a benchmark for analyzing biomolecules in the human body, but the collection of blood requires a phlebotomist. The phlebotomist may need to separate serum or plasma from the blood before applying the separated fluid to the LFA membrane.
[0003] The process of collecting blood is invasive, uncomfortable, and may lead to secondary infections. Also, blood samples collected may provide erroneous results during analysis due to inefficient processing, handling, or storing of the blood samples. On the contrary, the collection of urine samples is non-invasive and voluminous. But the urine samples collected may also provide inaccurate results due to one or more reasons. The one or more reasons may include the presence of the analytes in their metabolized form in the urine samples, or the dependence of the analyte concentration on the hydration levels of an individual.
[0004] While attempts are being made to use the saliva as a sample, current methods for collecting saliva generally include spitting and drooling. The saliva samples collected by spitting may include contaminants such as mucus or food particles. The contaminants may interfere with the movement of the saliva samples onto the LFA membrane resulting in a technical failure or a flawed value by altering the composition of the saliva samples thereby resulting in a misdiagnosis. For collecting the saliva samples by drooling, drool tubes are employed to channel the saliva samples from the mouth into collection tubes. Collection of the saliva samples using the drool tubes requires adherence to a protocol which is difficult. Also, the collection of the saliva sample using the drool tubes is a time-consuming process and may be an unpleasant process for some. Further, the drool tubes require another manual step to transfer the saliva sample onto the LFA membrane which may consequently increase the chances of contamination of the saliva samples.
[0005] Another active method of collecting the saliva samples is by employing sterile swabs which may be kept in the mouth to soak the saliva. The use of sterile swabs is quicker and easier than spitting or drooling and may be used across all age groups. However, the sterile swabs need to be expressed into buffers for extracting the analytes for quantification. Expressing the analytes into buffers may take considerable time, dilutes the analytes, and may require manual intervention. Also, expressing the sterile swabs into buffers limits the applicability of the device for low analyte concentrations.
[0006] Hence, there is a need for an improved device for testing a fluid sample and a method thereof to address the aforementioned issue(s).
BRIEF DESCRIPTION
[0007] In accordance with an embodiment of the present disclosure, a device for testing a fluid sample is provided. The device includes a sample collection unit including a wick partially inserted into a holder. The wick is adapted to absorb a sample of the fluid collected. The holder includes one or more indentations. The device also includes a sample analysis unit operatively coupled to the sample collection unit. The sample analysis unit includes a sample receiving chamber adapted to receive the fluid absorbed by the wick upon squeezing the wick against the inner periphery of the sample-receiving chamber by the holder. The sample receiving chamber comprises one or more wedges adapted to mate with the one or more corresponding indentations to provide unidirectional movement to the holder inside the sample receiving chamber thereby interlocking the holder and the associated wick inside the sample-receiving chamber for tamper-proofing. The sample analysis unit also includes one or more lateral flow assays operatively coupled to the sample-receiving chamber. The one or more lateral flow assays are adapted to test the fluid received from the sample-receiving chamber.
[0008] In accordance with another embodiment of the present disclosure, a method for testing a fluid sample is provided. The method includes placing a wick in a fluid to enable the wick to absorb a sample of the fluid collected, wherein the wick is placed in a holder. The method also includes pushing the holder and the wick into a sample receiving chamber to disburse the fluid absorbed by the wick to be analyzed for a single or multiple analytes.
[0009] To further clarify the advantages and features of the present disclosure, a more explicit description of the disclosure will follow by reference to specific embodiments thereof, which are illustrated in the appended figures. It is to be appreciated that these figures depict typical embodiments of the disclosure and are therefore not to be considered limiting in scope. The disclosure will be described and explained with additional details with the appended figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The disclosure will be described and explained with additional specificity and detail with the accompanying figures in which:
[0011] FIG. 1 is a schematic representation of a device for testing a fluid sample in accordance with an embodiment of the present disclosure;
[0012] FIG. 2 is a schematic representation of one embodiment of the device of FIG. 1, depicting an outlet of a sample receiving chamber in accordance with an embodiment of the present disclosure;
[0013] FIG. 3 is a schematic representation of another embodiment of the device of FIG. 1, depicting an operational arrangement of a sample collection unit and a sample analysis unit in accordance with an embodiment of the present disclosure; and
[0014] FIG. 4 is a flow chart representing the steps involved in a method for testing a fluid sample in accordance with an embodiment of the present disclosure.
[0015] Further, those skilled in the art will appreciate that elements in the figures are illustrated for simplicity and may not have necessarily been drawn to scale. Furthermore, in terms of the construction of the device, one or more components of the device may have been represented in the figures by conventional symbols, and the figures may show only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the figures with details that will be readily apparent to those skilled in the art having the benefit of the description herein.
DETAILED DESCRIPTION
[0016] To promote an understanding of the principles of the disclosure, reference will now be made to the embodiment illustrated in the figures and specific language will be used to describe them. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended. Such alterations and further modifications in the illustrated system, and such further applications of the principles of the disclosure as would normally occur to those skilled in the art are to be construed as being within the scope of the present disclosure.
[0017] The terms ``comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such a process or method. Similarly, one or more devices or sub-systems or elements or structures or components preceded by "comprises... a'' does not, without more constraints, preclude the existence of other devices, sub-systems, elements, structures, components, additional devices, additional sub-systems, additional elements, additional structures, or additional components. Appearances of the phrase "in an embodiment", "in another embodiment" and similar language throughout this specification may, but not necessarily do, all refer to the same embodiment.
[0018] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this disclosure belongs. The system, methods, and examples provided herein are only illustrative and not intended to be limiting.
[0019] In the following specification and the claims, reference will be made to a number of terms, which shall be defined to have the following meanings. The singular forms “a”, “an”, and “the” include plural references unless the context clearly dictates otherwise.
[0020] Embodiments of the present disclosure relate to a device for testing a fluid sample and a method thereof. The device includes a sample collection unit including a wick partially inserted into a holder. The wick is adapted to absorb a fluid sample. The holder includes one or more indentations. The device also includes a sample analysis unit operatively coupled to the sample collection unit. The sample analysis unit includes a sample receiving chamber adapted to receive the fluid absorbed by the wick upon squeezing the wick against the inner periphery of the sample-receiving chamber by the holder. The sample receiving chamber comprises one or more wedges adapted to mate with the one or more corresponding indentations to provide unidirectional movement of the holder inside the sample receiving chamber thereby interlocking the holder and the attached wick inside the sample receiving chamber making the device tamper-proof. The sample analysis unit includes a single or multiple analyte testing strip(s) operatively coupled to the sample-receiving chamber. The single or multiple analyte testing strip(s) is adapted to test the fluid received from the sample-receiving chamber.
[0021] FIG. 1 is a schematic representation of a device (10) for testing a fluid sample in accordance with an embodiment of the present disclosure. The device (10) includes a sample collection unit (20) including a wick (30) partially inserted into a holder (40). The wick (30) is adapted to absorb a sample of the fluid collected. In some embodiments, the fluid may include, but not be limited to, urine, sweat, blood, water, buffers, fruit juices, brews, and the like. In one embodiment, the wick (30) may be composed of but not limited to materials comprising cotton, cellulose, polyester, polypropylene, polyvinyl alcohol, polystyrene, or their combinations in any ratio. In such an embodiment, the material may be porous.
[0022] Further, in a specific embodiment, the wick (30) may be secured to the holder (40) via a slot by the means of a food-grade or medical-grade adhesive. The holder (40) includes one or more indentations (50). The device (10) also includes a sample analysis unit (60) operatively coupled to the sample collection unit (20). The sample analysis unit (60) includes a sample receiving chamber (70) adapted to receive the fluid absorbed by the wick (30) upon squeezing the wick (30) against the inner periphery of the sample receiving chamber (70) by the holder (40).
[0023] The sample receiving chamber (70) includes one or more wedges (110) adapted to mate with one or more corresponding indentations (50) to provide unidirectional movement to the holder (40) inside the sample receiving chamber (70), thereby interlocking the holder (40) and the associated wick (30) inside the sample receiving chamber (70) making the device tamper-proof. In some embodiments, the one or more indentations (50) may be associated with a plurality of grooves (140) provided on the holder (40). In one embodiment, one or more wedges (110) may be associated with a plurality of threads (150) provided in an inside periphery of the sample receiving chamber. In such an embodiment, the plurality of threads (150) may be structurally complementary to the plurality of grooves (140) on the holder (40) to allow insertion of the holder (40) inside the sample receiving chamber (70) by twisting.
[0024] In one embodiment, the holder (40) may be adapted to squeeze the wick (30) against the inner periphery of the sample-receiving chamber (70) by at least one action including pushing or twisting. In some embodiments, the holder (40) may include one or more wings (100) adapted to prevent swallowing of the holder (40) when the fluid is being collected from the mouth of a person.
[0025] Also, the sample analysis unit (60) also includes one or more lateral flow assays (80) operatively coupled to the sample-receiving chamber (70). The one or more lateral flow assays (80) are adapted to test the fluid received from the sample receiving chamber (70). In one embodiment, one or more lateral flow assays (80) are enclosed by a membrane guard (120) comprising a window to provide an unobstructed view of test results. In some embodiments, the device (10) may include a unique identifier (130) for providing device information including the manufacturing date of the device (10), batch number of the device (10), and type of one or more lateral flow assays (80) used in the device (10).
[0026] Additionally, in one embodiment, the sample-receiving chamber (70) may include an outlet (90) comprising one or more tapered edges to guide the fluid to the one or more lateral flow assays (80) as shown in FIG. 2. Operational arrangement of the sample collection unit (20) and the sample analysis unit (60) is shown in FIG. 3.
[0027] FIG. 4 is a flow chart representing the steps involved in a method (160) for testing a fluid sample, in accordance with an embodiment of the present disclosure. The method (160) includes placing a wick in a fluid to enable the wick to absorb a sample of the fluid collected (170). The wick is placed in a holder in step 180. In some embodiments, the fluid may include but not be limited to, urine, sweat, blood, water, buffers, fruit juices, brews, and the like. In one embodiment, the wick (30) may be composed of but not limited to materials comprising cotton, cellulose, polyester, polypropylene, polyvinyl alcohol, polystyrene, or their combinations in any ratio. In such an embodiment, the material may be porous.
[0028] The method (160) also includes pushing the holder and the wick into a sample receiving chamber to disburse the fluid absorbed by the wick to be analyzed by the one or more lateral flow assays in step 160. In some embodiments, the one or more grooves may be adapted to mate with one or more corresponding threads to enable the insertion of the holder inside the sample receiving chamber by twisting.
[0029] In one embodiment, the holder may be adapted to squeeze the wick against the inner periphery of the sample-receiving chamber by at least one of the actions comprising pushing, and twisting. In some embodiments, the holder may include one or more wings adapted to prevent swallowing of the holder when the fluid is being collected from the mouth of a person. In one embodiment, one or more lateral flow assays are enclosed by a membrane guard comprising a window to provide an unobstructed view of test results. In some embodiments, the device may include a unique identifier for providing device information including the manufacturing date of the device, batch number of the device, and type of the one or more lateral flow assays used in the device. In one embodiment, the sample-receiving chamber may include an outlet comprising one or more tapered edges to guide the fluid to the one or more lateral flow assays
[0030] Various embodiments of the device for testing a fluid sample and a method thereof described above enable various advantages. The provision of the wick provides a way for collecting the saliva sample without being contaminated by mucus or food particles. The device provides a way for testing fluids in a noninvasive way thereby avoiding chances of discomfort during sample collection. The quantity of the saliva sample collected may be varied by varying dimensions of the wick or the extent of the pressing or twisting mechanism. Disbursal of the fluid collected by the wick to the sample-receiving chamber is carried out only when the holder is pushed against the inner periphery of the sample receiving chamber, thereby eliminating the chances of leaking the fluid to an outside environment. The provision of one or more wedges on the threads provides unidirectional movement to the holder inside the sample receiving chamber to interlock the holder and the associated wick inside the sample-receiving chamber for tamper-proofing. The provision of the window on the membrane guard enables an unobstructed view of the test results. The device is very simple, cost-effective, and easy to use. The device may be fabricated using inexpensive components, thereby making the device affordable. The device is capable of providing test results without causing time delay. The provision of one or more lateral flow assays provides a way for carrying out multiple tests of the fluid simultaneously.
[0031] It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the disclosure and are not intended to be restrictive thereof. While specific language has been used to describe the disclosure, any limitations arising on account of the same are not intended.
[0032] The figures 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. For example, the order of processes described herein may be changed and is not limited to the manner described herein. Moreover, the actions of any flow diagram need not be implemented in the order shown; nor do all the acts need to be necessarily performed. Also, those acts that are not dependent on other acts may be performed in parallel with the other acts. The scope of embodiments is by no means limited by these specific examples.
, Claims:1. A device (10) for testing a fluid sample comprising:
a sample collection unit (20) comprising a wick (30) partially inserted into a holder (40), wherein the wick (30) is adapted to absorb a sample of the fluid collected, wherein the holder (40) comprises one or more indentations (50);
a sample analysis unit (60) operatively coupled to the sample collection unit (20), wherein the sample analysis unit (60) comprises:
a sample receiving chamber (70) adapted to receive the fluid absorbed by the wick (30) upon squeezing the wick (30) against the inner periphery of the sample-receiving chamber (70) by the holder (40),
wherein the sample receiving chamber (70) comprises one or more wedges (110) adapted to mate with the one or more corresponding indentations (50) to provide unidirectional movement to the holder (40) inside the sample receiving chamber (70), thereby interlocking the holder (40) and the associated wick (30) inside the sample receiving chamber (70) making the device tamper-proof; and
one or more lateral flow assays (80) are operatively coupled to the sample-receiving chamber (70), wherein the one or more lateral flow assays (80) are adapted to test the fluid received from the sample receiving chamber (70).
2. The device (10) as claimed in claim 1, wherein the sample receiving chamber (70) comprises an outlet (90) comprising one or more tapered edges to guide the fluid to the one or more lateral flow assays (80).
3. The device (10) as claimed in claim 1, wherein the holder (40) is adapted to squeeze the wick (30) against the inner periphery of the sample-receiving chamber (70) by at least one of an action comprising pushing, and twisting.
4. The device (10) as claimed in claim 1, wherein the holder (40) comprises one or more wings (100) adapted to prevent swallowing of the holder (40) when the fluid is being collected from the mouth of a person.
5. The device (10) as claimed in claim 1, wherein the one or more indentations (50) are adapted to mate with one or more corresponding wedges (110) located inside the sample receiving chamber (70) to make the device tamper-proof.
6. The device (10) as claimed in claim 1, wherein the wick (30) is composed of but not limited to materials comprising cotton, cellulose, polyester, polypropylene, polyvinyl alcohol, polystyrene, or their combinations in any ratio.
7. The device (10) as claimed in claim 1, wherein the one or more lateral flow assays (80) are enclosed by a membrane guard (120) comprising a window to provide an unobstructed view of test results.
8. The device (10) as claimed in claim 1, comprising of a unique identifier (130) for providing device information including the manufacturing date of the device (10), batch number of the device (10), and type of the one or more lateral flow assays (80) used in the device (10).
9. A method (160) comprising:
placing a wick in a fluid to enable the wick to absorb a sample of the fluid collected, wherein the wick is placed in a holder; (170) and
pushing the holder and the wick into a sample receiving chamber to disburse the fluid absorbed by the wick to be analyzed by the one or more lateral flow assays. (180)
Dated this 22nd day of July 2022 Signature

Jinsu Abraham
Patent Agent (IN/PA-3267)
Agent for the Applicant