System and apparatus to determine body parameter and microbial load and method thereof
Patent Information
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2024-05-16
- Publication Date
- 2026-03-25
AI Technical Summary
Current methods for detecting microbes in body fluids, such as urine and blood, are laborious, time-consuming, and require laboratory visits, making early detection of infections like urinary tract infections and blood poisoning inefficient.
A system and apparatus that utilize a two-dimensional surface with delivery media and microbial growth substrates, including antibiotic media, to culture microorganisms, combined with colorimetric agents and imaging sensors to determine microbial load and body parameters, allowing for on-site infection status assessment and antibiotic recommendations.
Enables rapid, cost-effective detection of microbial loads and infection severity, facilitating timely antibiotic intervention without the need for laboratory testing, thereby improving patient outcomes.
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Figure IN2024050570_21112024_PF_FP_ABST
Abstract
Description
[0001] SYSTEM AND APPARATUS TO DETERMINE BODY PARAMETER AND MICROBIAL LOAD AND METHOD THEREOF
[0002] TECHNICAL FIELD
[0003] The present disclosure relates generally to a medical device and more particularly to a system and an apparatus to determine body parameter and microbial load and method thereof.
[0004] BACKGROUND
[0005] Infections in body fluids due to microbes are dangerous. Urinary tract infection and blood poisoning are the two major infection and take millions of lives each year.
[0006] Urinary tract infection is an infection in any part of the urinary system that includes kidney, ureters, bladder and urethra. Urinary tract infection (UTI) are the most common outpatient infections with a lifetime incident of 50-60% in adult women. The prevalence of UTI increases with age, and women aged over 65 is approximately double the rate seen in the female population overall.
[0007] Blood poisoning is a serious infection that occurs due to the growth of microbes such as bacteria in the blood stream. According to the World Health Organization, microbial infection in blood stream kills 11 million people each year, many of the affected individuals are children. If the infection is not diagnosed at the early stage, this causes multiple organ failure and death. The infected individuals are not out of danger, only the early stage detected individuals are completely recovering, rest will either die within 1 year or be burdened by long-term disabilities.
[0008] Detecting microbes in urine, blood and other body fluids is tedious, costly and laborious. Usually, the infected individuals need to consult a physician for the counseling, once the physician recommends the infected individual for testing the body sample, the infected individuals may need to visit a laboratory to provide the samples. Once the samples get collected by the laboratory analyst, the analyst performs pour plating or spread plating followed by incubation for 24 hours in order to get microbial colonies. The microbial colonies are further captured by Colony Counting Technique (CCT) and further results have been generated. Then the results need to be validated by the physician to diagnose the presence of infectious disease in the body fluid. The available conventional procedures are tedious and involve much labor and time.
[0009] Thus, there is a need for a technical solution that overcomes the aforementioned problems related to laborious microbial growth determination method and system.
[0010] SUMMARY
[0011] In an aspect, a two-dimensional surface is provided. The two-dimensional surface includes one or more delivery media adapted to transfer a sample within the two- dimensional surface and one or more strips adapted to hold one or more delivery media. In some aspects, the two-dimensional surface is for culturing microorganisms and further includes a carrier substrate adapted to receive a sample at a first end and transfer the sample towards a second end, the first end being opposite to the second end and a microbial growth substrate comprising a microbial culture medium in fluid communication with the carrier substrate to receive the sample.
[0012] In some aspects, the microbial growth substrate further includes an antibiotic media to inhibit the growth of a microbial load present in the sample.
[0013] In some aspects, the antibiotic media is disposed on the microbial growth substrate in an exponential gradient.
[0014] In some aspects, the sample is a sample fluid selected from a group comprising blood, serum, plasma, urine, saliva or sweat.
[0015] In some aspects, the two- dimensional surface further includes a body adapted to mount one or more strips.
[0016] In some aspects, the two-dimensional surface further includes a microbial growth medium positioned axially relative to the one or more delivery media.
[0017] In some aspects, the microbial growth medium further comprises a microbial culture medium such that the culture medium may be adapted to promote microbial growth. In another aspects, apparatus for determining one or more body parameters and microbial load value of a sample is provided. The apparatus includes a body adapted to transfer a received sample from a proximal end to a distal end of the body, one or more delivery media adapted to deliver the sample to a growth medium having a culture medium and one or more colorimetric agents, and one or more strips adapted to grasp the one or more delivery media.
[0018] In some aspects, the one or more colorimetric agents are placed on each media of the one or more delivery media.
[0019] In another aspect, a system for determining a status of an infection is provided. The system includes one or more delivery media adapted to receive a sample such that the one or more delivery media having a microbial culture medium and one or more colorimetric agents to determine one or more body parameter and microbial load value of the sample, an imaging sensor configured to capture one or more images of the culture medium and one or more colorimetric reagents. The system further includes a processing circuitry that is coupled to the imaging sensor, configured to determine one or more body parameter and a microbial load value of the sample based on one or more images received from the imaging sensor, determining severity of an infection by comparing determined one or more body parameter and microbial load value with a threshold value and recommending an antibiotic to a user based on the determined severity of infection.
[0020] In some aspects, the system further includes a triggering engine, such that the triggering engine is coupled to the processing circuitry such that the processing circuitry provides control to the triggering engine such that the triggering engine generates alerts. The triggering engine generates a first alert when the determined data is equal / greater than a pre-determined body condition data stored in the storage unit. The triggering engine generates a second alert when the determined data is less than the predetermined body condition data and generates a third alert when the quantity of sample in the one or more delivery media is low or not detectable. In some aspects, the microbial load value represents the microbial load selecting from a group comprising a bacterial load, a viral load, a fungal load, algal load, yeast load, and other pathogen load.
[0021] In an aspect of the present disclosure, a method for determining microbial load value in a sample is disclosed. The method includes receiving a sample by dipping a distal end of an apparatus in a sample followed by delivering the sample to a growth medium containing culture medium and one or more colorimetric agents. Further, the method includes incubating the culture medium and capturing one or more images of the culture medium and one or more colorimetric agents using an imaging sensor. Furthermore, the method includes identifying body parameters in the sample by processing one or more captured images of one or more colorimetric agents, determining microbial load in the sample by processing one or more images of the culture medium post-incubation, followed by determining the severity of the infection and suggesting intake / stopping of antibiotics based on the determined severity.
[0022] In some aspects of the present disclosure, the sample is a sample fluid selected from a group comprising blood, serum, plasma, urine, saliva, or sweat.
[0023] In some aspects of the present disclosure, the sample is transferred from the distal end to a proximal end of the apparatus and delivered to the microbial growth medium by way of at least one capillary and one or more delivery media.
[0024] In some aspects of the present disclosure, the method further includes identifying the body parameters and determining microbial load from the processed one or more images of the colorimetric agents and one or more images of the culture medium captured post-incubation. In some aspects of the present disclosure, the method further includes comparing the identified body parameters and determined microbial load with a pre-determined threshold value stored in a storage unit.
[0025] In another aspect, a two-dimensional lateral flow assay for determining one or more body parameters and microbial load value of a sample is provided. The two- dimensional lateral flow assay includes a body adapted to transfer a received sample from a proximal end to a distal end of the body, one or more delivery media adapted to deliver the sample to a growth medium having a culture medium and one or more colorimetric agents and one or more strips adapted to grasp the one or more delivery media.
[0026] In another aspect, a two-dimensional lateral flow assay for determining one or more body parameters and microbial load value of a sample is provided. The two- dimensional lateral flow assay includes a body having a proximal end and a distal end and adapted to receive a sample, one or more capillary adapted to transfer the sample from the distal end to the proximal end, one or more delivery media adapted to deliver the sample to a microbial growth medium having a microbial culture medium and one or more colorimetric agents and one or more strips adapted to hold the one or more delivery media.
[0027] In another aspect, an apparatus for determining one or more body parameters and microbial load value of a sample is provided. The apparatus includes a body having a proximal end and a distal end and adapted to receive a sample, one or more capillary adapted to transfer the sample from the distal end to the proximal end, one or more delivery media adapted to deliver the sample to a microbial growth medium having a microbial culture medium and one or more colorimetric agents, and one or more strips adapted to hold the one or more delivery media.
[0028] In another aspect, a system for determining an infection is provided. The system includes one or more delivery media adapted to receive a sample, wherein the one or more delivery media having a microbial culture medium and one or more colorimetric agents to determine one or more body parameter and microbial load value of the sample, wherein the sample is transferred by way of one or more capillary, an imaging sensor configured to capture one or more images of the culture medium and one or more colorimetric reagents. He system further includes aa processing circuitry that is coupled to the imaging sensor, and further configured to determine one or more body parameter and a microbial load value of the sample based on one or more images received from the imaging sensor, determining severity of an infection by comparing determined one or more body parameter and microbial load value with a threshold value and recommending an antibiotic to a user based on the determined severity of infection.
[0029] In another aspect, a method for predicting urinary tract infection is disclosed. The method includes receiving a sample by dipping a distal end of an apparatus in a sample followed by delivering the sample to a growth medium containing culture medium and one or more colorimetric agents. Further, the method includes incubating the culture medium followed by capturing one or more images of the culture medium and one or more colorimetric agents using an imaging sensor. Furthermore, the method includes identifying body parameters in the sample by processing one or more captured images of one or more colorimetric agents, determining microbial load in the sample by processing one or more images of the culture medium post-incubation, determining the severity of an infection and thus suggesting intake / stopping of antibiotics based on the determined severity.
[0030] In an aspect of the present disclosure, a method for predicting urinary tract infection is disclosed. The method includes receiving a sample by dipping a distal end of an apparatus in a sample followed by delivering the sample to a growth medium containing culture medium and one or more colorimetric agents. Further, the method includes incubating the culture medium followed by capturing one or more images of the culture medium and one or more colorimetric agents using an imaging sensor. Furthermore, the method includes identifying body parameters in the sample by processing one or more captured images of one or more colorimetric agents, determining microbial load in the sample by processing one or more images of the culture medium post-incubation, determining the severity of an infection and thus suggesting intake / stopping of antibiotics based on the determined severity.
[0031] BRIEF DESCRIPTION OF DRAWINGS
[0032] The above and still further features and advantages of aspects of the present disclosure becomes apparent upon consideration of the following detailed description of aspects thereof, especially when taken in conjunction with the accompanying drawings, and wherein:
[0033] FIG. 1 illustrates a block diagram of a system, according to an aspect herein;
[0034] FIG. 2 illustrates a schematic view of a two-dimensional surface, in accordance with an aspect of the present disclosure;
[0035] FIG. 3 illustrates a schematic view of an apparatus, according to an aspect herein;
[0036] FIG. 4 illustrates a schematic view of an exemplary apparatus, according to an aspect herein;
[0037] FIG. 5 illustrates another schematic view of the exemplary apparatus, according to an aspect herein;
[0038] FIG. 6 illustrates another schematic view of the exemplary apparatus, according to an aspect herein; and
[0039] FIG. 7 illustrates a flowchart depicting method of determining the microbial load in the sample fluid, according to an aspect herein.
[0040] To facilitate understanding, like reference numerals have been used, where possible, to designate like elements common to the figures.
[0041] DETAILED DESCRIPTION
[0042] Various aspects of the present disclosure provide a system and an apparatus to determine microbial load. The following description provides specific details of certain aspects of the disclosure illustrated in the drawings to provide a thorough understanding of those aspects. It should be recognized, however, that the present disclosure can be reflected in additional aspects and the disclosure may be practiced without some of the details in the following description.
[0043] The various aspects including the example aspects are now described more fully with reference to the accompanying drawings, in which the various aspects of the disclosure are shown. The disclosure may, however, be embodied in different forms and should not be construed as limited to the aspects set forth herein. Rather, these aspects are provided so that this disclosure is thorough and complete, and fully conveys the scope of the disclosure to those skilled in the art. In the drawings, the sizes of components may be exaggerated for clarity.
[0044] It is understood that when an element or layer is referred to as being “on,” “connected to,” or “coupled to” another element or layer, it can be directly on, connected to, or coupled to the other element or layer or intervening elements or layers that may be present. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items.
[0045] The subject matter of example aspects, as disclosed herein, is described with specificity to meet statutory requirements. However, the description itself is not intended to limit the scope of this patent. Rather, the inventor / inventors have contemplated that the claimed subject matter might also be embodied in other ways, to include different features or combinations of features similar to the ones described in this document, in conjunction with other technologies. Generally, the various aspects including the example aspects relate to an apparatus to determine body condition and microbial load. As mentioned, there remains a need for an apparatus, a method and a system that overcomes the limitations such as laborious microbial determination method. The present disclosure, therefore, provides an apparatus, a system and a method for a status of microbial infection in sample fluid of a user by analysing one or more body parameters and a microbial load in the sample fluid of the user. FIG. 1 illustrates a block diagram of a system 100, according to an aspect herein. The system 100 may be configured to determine a status of an infectious disease by comparing one or more body parameters and a microbial load value in a sample fluid of a user. The system 100 may be further configured to facilitate the user to monitor antibiotic schedule without having to visit a laboratory and / or a physician. The system 100 may be further configured to recommend suitable antibiotics and track antibiotic requirements based on the determined microbial load. The system 100 may include an apparatus 102, one or more imaging sensors 104 (hereinafter collectively referred to and designated as “the imaging sensors 104”), a server 106, and one or more user devices of which a user device 108 is shown. The apparatus 102, the imaging sensors 104, the server 106, and the user device 108 may be communicatively coupled by way of a communication network 110.
[0046] The communication network 110 may include suitable circuitry to perform one or more operations. For example, the communication network 110 may be configured to provide one or more network ports and one or more communication channels for transmission and reception of data related to operations of various entities (such as the apparatus 102, the imaging sensors 104, the server 106, and the user device 108) of the system 100. Each network port of the one or more network ports may correspond to a virtual address (or a physical machine address) for transmission and reception of the communication data. For example, the virtual address may be an Internet Protocol Version 4 (IPV4) (or an IPV6 address) and the physical machine address may be a Media Access Control (MAC) address. The communication network 106 may be associated with an application layer for implementation of communication protocols based on one or more communication requests from the imaging sensors 104, the server 106, and the user devices 108). The communication data may be transmitted or received, via communication protocols. Examples of the communication protocols may include, but are not limited to, Hypertext Transfer Protocol (HTTP), File Transfer Protocol (FTP), Simple Mail Transfer Protocol (SMTP), Domain Network System (DNS) protocol, Common Management Interface Protocol (CMIP), Transmission Control Protocol and Internet Protocol (TCP / IP), User Datagram Protocol (UDP), Long Term Evolution (LTE) communication protocols, or any combination thereof.
[0047] In one aspect, the communication data may be transmitted or received via at least one communication channel of the one or more of communication channels in the communication network 110. Each communication channel of the one or more communication channels may include, but are not limited to, a wireless channel, a wired channel, a combination of wireless and wired channel thereof. The wireless or wired channel may be associated with a data standard which may be defined by one of a Local Area Network (LAN), a Personal Area Network (PAN), a Wireless Local Area Network (WLAN), a Wireless Sensor Network (WSN), Wireless Area Network (WAN), Wireless Wide Area Network (WWAN), a metropolitan area network (MAN), a satellite network, the Internet, a fiber optic network, a coaxial cable network, an infrared (IR) network, a radio frequency (RE) network, and a combination thereof. Aspects of the present disclosure are intended to include or otherwise cover any type of communication channel, including known, related art, and / or later developed technologies.
[0048] The apparatus 102 may be configured to determine the one or more body parameters and the microbial load in the sample fluid of the user. In an exemplary scenario, a sample collection portion of the apparatus 102 may be dipped in the sample fluid containing one or more analyte and microbes. The sample fluid may flow across a sample collection portion of the apparatus 102 to reach a reaction zone. The reaction zone may include one or more reaction pads and a microbial development area. The one or more analytes in the sample fluid may be adapted to react with one or more reaction pads and may change colour of the one or more reaction pads. The microbial development area in the reaction zone may facilitate a growth of microorganisms and may allow the microorganisms to form microbial colonies. Such colour change in the one or more reactions pads and the microbial colonies formed by the microorganisms in the microbial development area may be imaged by way of the imaging sensors 104. The imaging sensors 104 may be further configured to transmit one or more images of the one or more reaction pads and the colonies with the server 106. The imaging sensors 104 may be configured to communicate the signals with the server 106 by way of the communication network 110.
[0049] In some aspects of the present disclosure, the imaging sensors 104 may include, but is not limited to, a camera, a spectrophotometer, a colorimeter, an optical sensor, and the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the imaging sensors 104, including known, related and later developed imaging sensors. In an exemplary scenario, when the imaging sensors 104 is the spectrophotometer or the colorimeter, the imaging sensors 104 may be configured to detect light intensity from the reaction zone of the apparatus 102. In some aspects of the present disclosure, the imaging sensor 104 may be disposed in the user device 108. The server 106 may include an operating system that provides executable instructions for a basic management and operation of the server 106. The server 106 may typically include a computer-readable storage unit 114 (e.g., hard disk, random access memory, read only memory, etc.) that may store instructions that, when executed by the processing circuitry 112 of the server 106. The processing circuitry 112 may allow the server 106 to perform intended functions.
[0050] In some aspects of the present disclosure, the server 106 may include processing circuitry 112 and a storage unit 114. The processing circuitry 112 may be any or a combination of microprocessor, microcontroller, development board, or other similar processing units, and the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the processing circuitry 112, including known, related and later developed processing circuitry 112.
[0051] In some aspects of the present disclosure, the processing circuitry 112 may be implemented as one or more microprocessors, microcomputers, microcontrollers, digital signal processors, central processing units, logic circuitries, and / or any devices that manipulate data based on operational instructions stored in the storage unit 114. Computer-readable instructions or routines stored in the storage unit 114 may be fetched and executed to create or share data units over a network service. The storage unit 114 may include any non-transitory storage device including, for example, volatile memory such as RAM, or non-volatile memory such as EPROM, flash memory, and the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the storage unit, including known, related and later developed technology.
[0052] In some aspects of the present disclosure, the processing circuitry 112 may be implemented as a combination of hardware and instructions (for example, machine executable instructions) to implement one or more functionalities of the processing circuitry 112. In examples described herein, such combinations of hardware and instructions may be implemented in several different ways. In an exemplary scenario, the instructions for the processing circuitry 112 may be processor executable instructions stored on a non-transitory machine-readable storage medium and the hardware for the processing circuitry 112 may include a processing resource (for example, one or more processors), to execute such instructions. In such examples, the processing circuitry 112 may include the machine -readable storage medium to store the instructions and the processing resource to execute the instructions, or the machine- readable storage medium may be separate but accessible to the processing circuitry 112 and the processing resource. In other examples, the processing circuitry 112 may be implemented by an electronic circuitry.
[0053] The processing circuitry 112 may include a data processing engine 116 and a triggering engine 118. The data processing engine 116 in the processing circuitry 112 may be configured to receive the one or more images of the one or more reaction pads and the microbial colonies. The data processing engine 116 may be configured to segment the one or more captured images and may compare the one or more captured image with one or more images pre-stored in the storage unit 114. In an exemplary scenario, the data processing engine 116 may be configured to segment the one or more image of the microbial colonies into ten equal parts. The data processing engine 116 may further be configured to count a number of microbial colonies in a first part of the ten equal parts. Furthermore, the data processing engine 116 may be configured to multiply the number of microbial colonies in the first part with a total number of equal halves to obtain total number of microbial colonies formed in the microbial development area.
[0054] In some aspects, the data processing engine 116 may compare the total number of microbial colonies formed in the microbial development area with a predetermined threshold values of the number of microbial colonies, stored in the storage unit 114. In another exemplary scenario, the data processing engine 116 may be configured to detect the color changes in each image of the one or more images corresponding to the one or more reaction pads. The data processing engine 116 may further be configured to compare the one or more images of the one or more reaction pads with the one or more images pre-stored in the storage unit 114. In some aspects of the present disclosure, the data processing engine 116 may further be configured to determine one or more of, the one or more body parameters, a microbial load value, a number of microbial colonies, a turbidity value, and the like. The data processing engine 116 may further be configured to transmit the determined one or more body parameters and the microbial load value the triggering engine 118.
[0055] In some aspects of the present disclosure, the triggering engine 118 may be configured to compare the determined one or more body parameters and determined microbial load value received from the data processing engine 116 with a predetermined one or more body parameters and a predetermined microbial load value, that is stored as a predetermined body condition data in the storage unit 114. The triggering engine 118 may further be configured to generate first alerts when the determined data may be greater than the predetermined body condition data. Furthermore, the triggering engine 118 may be configured to generate second alerts when the determined data is less than the predetermined body condition data. In some aspects of the present disclosure, the triggering engine 118 may be configured to generate a third alert when the quantity of sample fluid in the apparatus 102 is low or not-detectable.
[0056] The triggering engine 118 may further be configured to communicate the generated alerts (the first alert, the second alert and the third alert) implication of each signal individually or in combination with the user by way of the user device 108. In some aspects of the present disclosure, the triggering engine 118 may be configured to suggest the user to intake antibiotics and may recommend antibiotics based on the determined microbial load.
[0057] The storage unit 114 may be configured to store data including predetermined threshold values of the number of microbial colonies, the predetermined values of one or more body parameters, the predetermined microbial load value, predetermined optical density values, predetermined images of the microbial colonies, database of antibiotics, database representing antibiotics with respect to the body parameters, and the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of data, including known, related and later developed data.
[0058] The user device 108 may facilitate the user to input data, share one or more results, and / or transmit data within the system 100. It will be apparent to a person of ordinary skill in the art that the user may be any personnel using the system 100 for connecting with other users having similar likes, without deviating from scope of the disclosure. Examples of the user device 108 may include, but are not limited to, a desktop, a notebook, a laptop, a handheld computer, a touch sensitive device, a computing device, a smart-phone, and / or a smart watch. It may be apparent to a person of ordinary skill in the art that the user device 108 may include any device / apparatus that is capable of manipulation by the user. In the illustrated aspect of FIG. 1, the user devices 108 may include an interface 120 and a processing unit 122.
[0059] The interface 120 may include an input interface for receiving inputs from the user. In some aspects of the present disclosure, the input interface may include, but are not limited to, a touch interface, a mouse, a keyboard, a motion recognition unit, a gesture recognition unit, a voice recognition unit, or the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the interface, including known, related and later developed interfaces.
[0060] The interface 120 may further include an output interface for displaying (or presenting) an output to the user. In some aspects of the present disclosure, the output interface may include, but are not limited to, a display device, a printer, a projection device, and / or a speaker. In some other aspects of the present disclosure, the output interface may include, but are not limited to, a digital display, an analog display, a touch screen display, a graphical user interface, a website, a webpage, a keyboard, a mouse, a light pen, an appearance of a desktop, and / or illuminated characters.
[0061] The processing unit 122 may include suitable circuitry for executing various operations, to control one or more operations executed by the user device 108 in response to the input received at the user device 108 from the user. In some aspects of the present disclosure, of the processing unit 122 may be one of, but are not limited to, an application-specific integrated circuit (ASIC) processor, a reduced instruction set computing (RISC) processor, a complex instruction set computing (CISC) processor, a field-programmable gate array (FPGA), a Programmable Logic Control unit (PLC), and the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the processing units 122, including known, related and later developed processing units 122.
[0062] The user device 108 may further include a first memory 124 configured to store logic, instructions, circuitry, interfaces, and / or codes of the processing unit 122, data associated with the user device 108, and data associated with the system 100. In some aspects of the present disclosure, the first memory 124 may be one of, but are not limited to, a Read-Only Memory (ROM), a Random Access Memory (RAM), a flash memory, a removable storage drive, a hard disk drive (HDD), a solid-state memory, a magnetic storage drive, a Programmable Read Only Memory (PROM), an Erasable PROM (EPROM), and / or an Electrically EPROM (EEPROM). Aspects of the present disclosure may be intended to include or otherwise cover any type of the memory including known, related art, and / or later developed technologies.
[0063] In some aspects of the present disclosure, the user device 108 may further include one or more computer executable applications configured to be executed by the processing unit 122. The one or more computer executable applications may include suitable logic, instructions, and / or codes for executing various operations. The one or more computer executable applications may be stored in the first memory 124. In some aspects of the present disclosure, the one or more computer executable applications may include, but are not limited to, an audio application, a video application, a social media application, a navigation application, The one or more computer executable applications, as shown in FIG. 1 may include an application 126. One or more operations associated with the application 126 may be controlled by the server 106.
[0064] The user device 108 may further include a communication interface 128. The communication interface 128 may be configured to enable the user device 108 to communicate with the server 106 and other components of the system 100 by way of the communication network 110, according to an aspect of the present disclosure.
[0065] In some aspects of the present disclosure, the communication interface 128 may be one of, but are not limited to, a modem, a network interface such as an Ethernet card, a communication port, and / or a Personal Computer Memory Card International Association (PCMCIA) slot and card, an antenna, a radio frequency (RF) transceiver, one or more amplifiers, a tuner, one or more oscillators, a digital signal processor, a coder-decoder (CODEC) chipset, a subscriber identity module (SIM) card, and a local buffer circuit. It will be apparent to a person of ordinary skill in the art that the communication interface 128 may include any device and / or apparatus capable of providing wireless or wired communications between the user device 108 and the server 106. In some aspects, the user device 108 may further include a receiver antenna (not shown), such that the receiver antenna (not shown) may be configured to receive radio waves containing modulated signal information transmitted from the data processing engine 116 and the triggering engine 118, transmitted by way of a transceiver over a wireless network. The user device 108 may further be configured to demodulate the modulated signal to generate an output data.
[0066] In some aspects of the present disclosure, the wireless network may include, an access point (e.g., a Wi-Fi access point), a femtocell, a cellular phone or personal communication or data device, a desktop computer, an RFID device, a portable computing device such as a laptop, a tablet, etc., and may allow wireless communication devices to connect to a wireless network using Wi-Fi, Bluetooth, an element such as a base station using a cellular communication technology such as Code Division Multiple Access (CDMA), Time Division Multiple Access (TDMA), Frequency Division Multiple Access (FDMA), Orthogonal Frequency Division Multiple Access (OFDMA), Single-Carrier Frequency Division Multiple Access (SC- FDMA), or another wireless technology and / or standard. The wireless network can utilize one or more technologies such as Universal Mobile Telecommunications System (UTMS), Long Term Evolution (LTE), Evolution-Data Optimized or Evolution-Data only (EV-DO), Global System for Mobile communications (GSM), Worldwide Interoperability for Microwave Access (WiMAX), Code division multiple access (CDMA)-2000, or Time Division Synchronous Code Division Multiple Access (TD-SCDMA).
[0067] FIG. 2 illustrates a schematic view of a two-dimensional surface 1 , in accordance with an aspect of the present disclosure. The two -dimensional surface 1 may be adapted to analyze the sample. In some aspects, the two-dimensional surface 1 may be adapted to analyze one or more analytes present in the sample. In some aspects, the sample may be a biological sample or any sample fluid. In some aspects of the present disclosure, the biological sample (herein after referred as ‘sample’) may be a sample fluid selected from a group comprising, but not limited to, blood, serum, plasma, urine, saliva or sweat. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the biological sample, including known, related, and later developed biological samples. In some aspects, the sample may be a fluid that may include, but not limited to, water, milk and the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the fluid, including known, related, and later developed fluids. Examples of one or more analytes include, but not limited to, Estradiol glucuronide (E3G), Luteinizing Hormone (LH), Pregnanediol Glucuronide (PdG) and Follicle-stimulating hormone (FSH), antibody, metabolite, virus, bacteria, protein, and the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the analytes, including known, related, and later developed analytes.
[0068] In some aspects, the two-dimensional surface 1 may be provided for a lateral flow assay. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the lateral flow assay, including known, related, and later developed lateral flow assays.
[0069] The two-dimensional surface 1 may include a body 2, one or more strips 3a-3n, one or more delivery media 4a-4n of which first through third delivery media 4A-C are explicitly shown, a microbial growth substrate 5, and one or more colorimetric reagents 6a-6n.
[0070] The body 2 may include a first end 7 and a second end 8 (for purposes of this disclosure, “first end 7” refers to the portion of the two-dimensional surface 1 that is far from the user during normal use and “second end 8” refers to the portion of the two-dimensional surface 1 that is closer to the user during normal use). The first end 7 may be adapted to be dipped into the sample fluid and the second end 8 may be adapted to flow excess sample fluid.
[0071] The body 2 may be adapted to hold one or more delivery media 4a-4n. Specifically, the body 2 may be adapted to hold the one or more delivery media 4a-4n by way of the one or more strips 3a-3n. In some aspects of the present disclosure, the one or more strips 3a-3n may be mounted on the body 2 and may be adapted to grasp each media of the one or more delivery media 4a-4n to prevent displacement of each medium of the one or more delivery media 4a-4n. In some aspects of the present disclosure, the one or more delivery media 4a-4n may be one of membrane, gel composition, or the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the delivery media 4a-4n, including known, related and later developed delivery medium. In some aspects of the present disclosure, the gel composition may be silica gel. In some aspects, the body 2 may include a carrier substrate (not shown) adapted to receive a sample at the first end 7 and transfer the sample towards the second end 8 of the body such that the first end 7 being opposite to the second end 8 of the body.
[0072] Each medium of the one or more delivery media 4a-4n may include a first end of each medium 9a-9n and a second end of each medium 1 la-1 In. The first end of each medium 9a-9n of the one or more delivery media 4a-4n may be disposed adjacent to the first end 7 of the body 2. The second end of each medium 1 la- 1 In may be disposed adjacent to the second end 8 of the body 2.
[0073] The microbial growth substrate 5 may be positioned axially relative to the one or more delivery media 4a-4n. In some aspects of the present disclosure, the microbial growth substrate 5 may be positioned on any one medium of the one or more delivery media 4a-4n. In other aspects of the present disclosure, the microbial growth substrate 5 may be positioned on each medium of the one or more delivery media 4a-4n.
[0074] The microbial growth substrate 5 may contain a microbial culture medium 12. In some aspects of the present disclosure, the microbial culture medium 12 may be casted on the microbial growth substrate 5. The microbial culture medium 12 may be adapted receive the sample fluid by way of the one or more delivery media 4a-4n. In some aspects of the present disclosure, the one or more delivery media 4a-4n may be adapted to deliver the sample fluid to the bottom of the microbial growth substrate 5 containing the microbial culture medium 12. In some aspects of the present disclosure, the microbial growth substrate 5 may include a temperature controller, that may regulate temperature of the microbial culture medium 12. In some aspects, the microbial culture medium 12 may be disposed on the microbial growth substrate 5 in an exponential gradient.
[0075] In some aspects, the microbial growth substrate 5 may further include an antibiotic media to inhibit the growth of a microbial load present in the sample. In some aspects, the antibiotic media is disposed on the microbial growth substrate 5 in an exponential gradient.
[0076] The second end of each medium 1 la- 1 In of the one or more delivery media 4a-4n may be attached to one or more colorimetric reagents 6a-6n placed on the one or more delivery media 4a-4n. In some aspects of the present disclosure, the one or more delivery media 4a-4n may be axially spaced apart from the one or more colorimetric reagents 6a-6n. In other aspects of the present disclosure, the one or more colorimetric reagents 6a-6n may be placed on each delivery medium of the one or more delivery media 4a-4n. In some aspects of the present disclosure, the one or more colorimetric reagents 6a-6n may be one of, but not limited to, a pH (Power of Hydrogen) detecting reagent, a leukocyte esterase detecting reagent, a nitrite detecting reagent, a urobilinogen detecting reagent, a proteins detecting reagent, a specific gravity detecting reagent, an albumin detecting reagent, a bilirubin detecting reagent, a blood detecting reagent, a creatinine detecting reagent, an albumin-creatinine ratio detecting reagent and the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the colorimetric reagents 6a-6n, including known, related and later developed colorimetric reagents.
[0077] In some aspects, the two-dimensional surface 1 may be dipped in a container containing the sample fluid. The first end 7 of the two-dimensional surface 1 may be dipped in the sample fluid. The sample fluid may be adapted to flow in a direction from the first end 7 to the second end 8 of the two-dimensional surface 1. The one or more deliver media 4a-4n may be facilitated to deliver sample fluid to the microbial culture medium 12 and the one or more colorimetric reagents 6a-6n.
[0078] The one or more analytes in the delivered sample fluid may be adapted to react with the one or more colorimetric reagents 6a-6n and may be adapted to change colour of the one or more colorimetric reagents 6a-6n.
[0079] The one or more microbes in the delivered sample fluid may be adapted to be inoculated on the microbial culture medium 12 in the microbial growth substrate 5. The microbial culture medium 12 may facilitate a growth of microbes and may allow the microbes to form one or more microbial colonies.
[0080] In some aspects, the one or more colorimetric reagents 6a-6n and the microbial culture medium 12 may be imaged by way of the imaging sensors 104. In some aspects of the present disclosure, the imaging sensors 104 may be configured to capture one or more images of the colorimetric reagents 6a- 6n and one or more images of the microbial culture medium 220 containing one or more microbial colonies formed by the microbes in the delivered sample fluid.
[0081] In an exemplary aspect, a two-dimensional lateral flow assay for determining one or more body parameters and microbial load value of a sample, the two-dimensional lateral flow assay includes a body 2 adapted to transfer a received sample from a first end 7 to the second end 8 of the body, one or more delivery media 4a-4n adapted to deliver the sample to a microbial growth substrate 5 having a microbial culture medium 12 and one or more colorimetric agents 6a-6n and one or more strips 3a-3n adapted to grasp the one or more delivery media.
[0082] In another exemplary aspect, a two-dimensional lateral flow assay for determining one or more body parameters and microbial load value of a sample is provided. The two- dimensional surface lateral flow assay includes a body 2 having a first end 7 and a second end 8 and adapted to receive a sample, one or more capillary adapted to transfer the sample from the first end 7 to the second end 8 of the body 2, one or more delivery media 4a-4n adapted to deliver the sample to a microbial growth substrate 5 having a microbial culture medium 12 and one or more colorimetric agents 6a- 6n and one or more strips 3a- 3n adapted to hold the one or more delivery media 4a-4n.
[0083] FIG. 3 illustrates a schematic view of the apparatus 102, according to an aspect herein. The apparatus 102 may include a body 202, one or more strips 204a-204n, one or more delivery media 206a-206n of which first through third delivery media 206A-206C are explicitly shown, a microbial growth medium 208, and one or more colorimetric reagents 210a-210n.
[0084] The body 202 may include a distal end 212 and a proximal end 214 (for purposes of this disclosure, “distal end 212” refers to the portion of the apparatus 102 that is far from the user during normal use and “proximal end 214” refers to the portion of the apparatus 102 that is closer to the user during normal use). The distal end 212 may be adapted to dip into the sample fluid and the proximal end 214 may be adapted to flow excess sample fluid.
[0085] The body 202 may be adapted to hold one or more delivery media 206a-206n. Specifically, the body may be adapted to hold the one or more delivery media 206a- 206n by way of the one or more strips 204a-204n. In some aspects of the present disclosure, the one or more strips 204a-204n may be mounted on the body 202 and may be adapted to grasp each media of the one or more delivery media 206a-206n to prevent displacement of each medium of the one or more delivery media 206a-206n. In some aspects of the present disclosure, the one or more delivery media 206a-206n may be one of membrane, gel composition, or the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the delivery media 206a-206n, including known, related and later developed delivery medium. In some aspects of the present disclosure, the gel composition may be silica gel.
[0086] Each medium of the one or more delivery media 206a-206n may include a first end 216a-216n and a second end 218a-218n. The first end 216a-216n of the one or more delivery media 206a-206n may be disposed adjacent to the distal end 212 of the body 202. The second end 218a-218n may be disposed adjacent to the proximal end 214 of the body 214.
[0087] The microbial growth medium 208 may be positioned axially relative to the one or more delivery media 206a-206n. In some aspects of the present disclosure, the microbial growth medium 208 may be positioned on any one medium of the one or more delivery media 206a-206n. In other aspects of the present disclosure, the microbial growth medium 208 may be positioned on each medium of the one or more delivery media 206a-206n.
[0088] The microbial growth medium 208 may contain a microbial culture medium 220. In some aspects of the present disclosure, the microbial culture medium 220 may be casted on the microbial growth medium 208. The microbial culture medium 220 may be adapted receive the sample fluid by way of the one or more delivery media 206a- 206n. In some aspects of the present disclosure, the one or more delivery media 206a- 206n may be adapted to deliver the sample fluid to the bottom of the microbial growth medium 208 containing the microbial culture medium 220. In some aspects of the present disclosure, the microbial growth medium 208 may include a temperature controller, that may maintain temperature of the microbial culture medium 220.
[0089] The proximal end 214 of the one or more delivery media 206a-206n may be attached to one or more colorimetric reagents 210a-210n placed on the one or more delivery media 206a-206n. In some aspects of the present disclosure, the one or more delivery media 206a-206n may be axially spaced apart from the one or more colorimetric reagents 210a-210n. In other aspects of the present disclosure, the one or more colorimetric reagents 210a-210n may be placed on each delivery medium of the one or more delivery media 206a-206n. In some aspects of the present disclosure, the one or more colorimetric reagents 210a-210n may be one of, but not limited to, a pH (Power of Hydrogen) detecting reagent, a leukocyte esterase detecting reagent, a nitrite detecting reagent, a urobilinogen detecting reagent, a proteins detecting reagent, a specific gravity detecting reagent, an albumin detecting reagent, a bilirubin detecting reagent, a blood detecting reagent, a creatinine detecting reagent, an albumin-creatinine ratio detecting reagent and the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the colorimetric reagents 210a-210n, including known, related and later developed colorimetric reagents.
[0090] The apparatus 102 may be dipped in a container containing the sample fluid. The distal end 212 of the apparatus 102 may be dipped in the sample fluid. The sample fluid may be adapted to flow in a direction from the distal end 212 to the proximal end 214 of the apparatus 102 (represented as arrows in the FIG.3). Each medium of the one or more delivery media 206a-206n may facilitate to transfer of the sample fluid from the first end 216a-216n to the second end 218a-218n.
[0091] The one or more deliver media 206a-206n may be facilitated to deliver sample fluid to the microbial culture medium 220 and the one or more colorimetric reagents 210a- 21 On.
[0092] The one or more analytes in the delivered sample fluid may be adapted to react with the one or more colorimetric reagents 210a-210n and may be adapted to change colour of the one or more colorimetric reagents 210a-210n.
[0093] The one or more microbes in the delivered sample fluid may be adapted to inoculate on the microbial culture medium 220 in the microbial growth medium 208. The microbial culture medium 220 may facilitate a growth of microbes and may allow the microbes to form one or more microbial colonies.
[0094] The one or more colorimetric reagents 210a-210n and the microbial culture medium 220 may be imaged by way of the imaging sensors 104. In some aspects of the present disclosure, the imaging sensors 104 may be configured to capture one or more images of the colorimetric reagents 210a- 21 On and one or more images of the microbial culture medium 220 containing one or more microbial colonies formed by the microbes in the delivered sample fluid.
[0095] The image sensors 104 may further be configured to transmit the one or more captured image of the one or more colorimetric reagents 21 Oa-21 On and the one or more captured image of the microbial culture medium 220 to the processing circuitry 112. The image sensors 102 may be configured to transmit the one or more captured image of the one or more colorimetric reagents 210a-210n and the one or more captured image of the microbial culture medium 220 to the data processing engine 116.
[0096] The data processing engine 116 in the processing circuitry 112 may be configured to determine the one or more body parameters of the user based on detecting a reaction in of the one or more captured images of each colorimetric reagent of the one or more colorimetric reagents 210a-210n. In some aspects of the present disclosure, the reactions may be one of, but not limited to, colour change, precipitate formation, degradation, or effervescence. In an exemplary scenario, the data processing engine 116 may identify the reactions in the protein detecting reagent, the albumin detecting reagent, the creatinine detecting reagent of the one or more colorimetric reagents 210a- 21 On. The data processing engine 116 may further be configured to determine the presence of chronic kidney disease in the sample fluid.
[0097] In another exemplary scenario, the data processing engine 116 may be configured to identify the reactions in the leukocyte esterase detecting reagent, the nitrite detecting reagent, the pH detecting reagent, and the blood detecting reagent in the one or more captured image of the one or more colorimetric reagents 210a-210n, then the data processing engine 116 may be configured to determine the presence of urinary tract infection in the sample fluid associated the user.
[0098] In another exemplary scenario, the data processing engine 116 may be configured to identify reactions in the pH (Power of Hydrogen) detecting reagent, the leukocyte esterase detecting reagent, the nitrite detecting reagent, the urobilinogen detecting reagent, the proteins detecting reagent, the specific gravity detecting reagent, the albumin detecting reagent, the bilirubin detecting reagent, the creatinine detecting reagent, and the blood detecting reagent of the one or more colorimetric reagents 210a- 21 On, to determine the presence of urinary tract infection and preeclampsia in the sample fluid. In another exemplary scenario, the data processing engine 116 may be configured to determine urine albumin to creatinine ratio based on the reactions in albumin detecting reagent and the creatine detecting reagent and may further generate an output as normal or abnormal A2 or abnormal A3. Specifically, the data processing engine 116 may be configured to generate output as normal, when the urine albumin to creatinine ratio may be less than 30mg / g (milligram / gram). The data processing engine 116 may generate output as abnormal A2, when the urine albumin to creatinine ratio may be between 30mg / g to 299mg / g. The data processing engine 116 may generate output as abnormal A3, when the urine albumin to creatinine ratio may be more than 300mg / g (milligram / gram).
[0099] In another exemplary scenario, the data processing engine 116 may be configured to determine the pH of the sample fluid based on the reactions in the pH (Power of Hydrogen) detecting reagent and may generate output as normal pH and abnormal pH. Specifically, the data processing engine 116 may be configured to generate result as normal, when the pH of the sample fluid may be between 4.5 to 8. The data processing engine 116 may be configured to generate result as abnormal, when the pH of the sample fluid may be less than 4.5 or more than 8.5.
[0100] In another exemplary scenario, the data processing engine 116 may be configured to determine nitrile concentration in the sample fluid and may further generate the result as specific when the values are more than 90%, and sensitive when the values are between 39% to 81%.
[0101] In another exemplary scenario, the data processing engine 116 may be configured to determine LE concentration and may further generate the result as specific when the values are equal or approximate to 55%, and sensitive when the values are between 61.7% to 77%.
[0102] In another exemplary scenario, the data processing engine 116 may be configured to determine albumin concentration and may further generate the result as specific when the values are between 45%-83%, and sensitive when the values are between 91% to 99%.
[0103] In another exemplary scenario, the data processing engine 116 may be configured to identify the reactions in the creatinine detecting reagent and the proteins detecting reagent and generate a result as preeclampsia when the protein to creatinine ratio is more than 0.6 or absolute urinary protein levels of 30mg / dL or more.
[0104] The data processing engine 116 in the processing circuitry 112 may be configured to determine the microbial load in the sample fluid by counting one or more microbial colonies formed by the microbe in the microbial culture medium 220. The microbial culture medium 220 may be incubated for at least 24 hours at room temperature for ideal growth of the microbes and to form the one or more microbial colonies. In some aspects of the present disclosure, the microbial culture medium 220 may be incubated at 32°C to 42°C for at least 24 hours for the ideal growth of the microbes and to form the one or more microbial colonies. In some aspects of the present disclosure, the microbial culture medium 220 may be incubated for 24 to 96 hours. In some aspects of the present disclosure, the microbial load be one of, a bacterial load, a viral load, a fungal load, algal load, yeast load, and other pathogen load.
[0105] The data processing engine 116 may further be configured to compare the determined microbial load in the sample fluid with the predetermined threshold values stored in the storage unit 114. In some aspects of the present disclosure, the data processing engine 116 may further be configured to correlate Colony Forming Unit (CFU) / ml with density of the one or more microbial colonies in the microbial culture medium 220 to determine the microbial load.
[0106] In an exemplary scenario, the data processing engine 116 may be configured to determine bacterial load in the sample fluid and may be further configured to generate output as normal and abnormal. Specifically, the data processing engine 116 may be configured to generate results as normal, when the bacterial load in the sample fluid may be 105CFU / ml. The data processing engine 116 may be configured to generate results as abnormal, when the bacterial load in the sample fluid may be more than 105CFU / ml.
[0107] In some aspects of the present disclosure, the data processing engine 116 may include a suggestion engine (not shown). The suggestion engine may be configured to suggest antibiotics to the user based on the microbial load and the one or more body parameters determined by the reactions in one or more colorimetric reagents 210a-210n with the sample fluid. The suggestion engine may further be configured to select a type of antibiotic based on the body parameters and may recommend the user to intake the selected antibiotic when the microbial load is higher than the predetermined microbial load. Furthermore, the suggestion engine may be configured to track the antibiotic intake by the user and recommend the user to stop taking antibiotics when the microbial load is equal or less than the predetermined values.
[0108] In some aspects of the present disclosure, the triggering engine 118 of the processing circuitry 112 may further be configured to generate a first alert, when the determined microbial load may be equal or more than the predefined threshold. The triggering engine 118 in the processing circuitry 112 may be configured to generate a second alert, when the determined microbial load may be less than a predefined threshold.
[0109] In some aspects of the present disclosure, the imaging sensors 104 may be configured to capture one or more images of a pre-incubated microbial culture medium 220 and may scan an identifier printed on the apparatus 102. After incubation, the imaging sensors 104 may be configured to capture one or more images of the post-incubated microbial culture medium 220. The data processing engine 116 may be configured to calculate an incubation period of the microbial load by subtracting a time difference between the one or more captured image of the post-incubated microbial culture medium 220 with the one or more captured images of the pre-incubated microbial culture medium 220. The data processing engine 116 may further determine the microbial load in the sample with respect to the incubation period. Specifically, the imaging sensors 104 may be configured to scan the identifier printed on the apparatus 102 to record time of the one or more captured image of pre-incubated microbial culture medium 220 and time of the one or more captured image of post-incubated microbial culture medium 220. In some other aspects of the present disclosure, the colonies may be counted by way of a colony counting technique.
[0110] FIG. 4 illustrates a schematic view of an exemplary apparatus 300, according to an aspect herein. The apparatus 300 is substantially similar to that of the apparatus 108 of FIG. 3 with like elements referred by way of like reference numerals. However, added one or more culture medium 302A-302N of the apparatus 400 has a different element with same functionality when compared to microbial culture medium 220 of the apparatus 108.
[0111] The one or more microbial culture media 302a-302n may be adapted to grow one or more microbes present in the sample fluid. In an exemplary scenario, the first microbial culture medium 302a may be suitable for bacterial strains. The second microbial culture medium 302b may be suitable for fungal strains. The third microbial culture medium 302c may be suitable for growing yeast. The fourth microbial culture medium 302d may be suitable for growing viral strains. The fifth microbial culture medium 302e may be suitable for algal strains.
[0112] In some aspects of the present disclosure, the one or more microbial culture media 302a-302n may be one of, but not limited to, MacConkey Agar, Chromogenic Agar, YPD Yeast agar, Luria Bertani agar, chocolate agar, blood agar, nutrient agar, neomycin agar, Tryptic soy agar, Thayer Martin agar, Eosin methylene blue agar, Hektoen agar, mannitol salt agar, triple sugar iron agar, sheep blood agar, and the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of culture media, including known, related and later developed culture media.
[0113] In some aspects of the present disclosure, the microbial growth medium 208 may be configured to adopt a tank containing broth for culturing the microbes in the sample fluid. In some other aspects of the present disclosure, the tank may be imaged by way of the imaging sensors 104. In some other aspects of the present disclosure, the broth may be one of, but not limited to, nutrient broth, glucose broth, infusion broth, alkaline peptone water, selenite F broth, Luria Bertani broth or the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of broth media, including known, related and later developed broth media. In an exemplary scenario, the imaging sensors 104 may detect a turbidity value of the broth and may determine the microbial load based on the turbidity value.
[0114] In some aspects of the present disclosure, the apparatus 102 may include a light source that emits light behind the tank or refract over the one or more colorimetric reagents. In some aspects of the present disclosure, the light emitted by the light source may be configured to pass through the tank or the one or more colorimetric reagents and reaches the imaging sensors 104.
[0115] In an exemplary scenario, the imaging sensors 104 may be configured to detect a preincubation turbidity of the broth media in the tank prior to incubation and may be configured to scan the identifier printed on the apparatus 102. After incubation, the imaging sensors 104 may be configured to detect post-incubation turbidity of the broth media in the tank. The data processing engine 116 may be configured compare the time difference between the pre-incubation turbidity and post-incubation turbidity to obtain the incubation period. The data processing engine 116 may be further configured to compare the post-incubation turbidity values with a predetermined threshold values stored in the storage unit 114 with respect to the incubation period.
[0116] FIG. 5 illustrates a schematic view of the exemplary apparatus 400, according to an aspect herein. The apparatus 400 is substantially similar to that of the apparatus 108 of FIG. 3 with like elements referred by way of like reference numerals. However, added at least one capillary 402 of the apparatus 400 has a different element with same functionality when compared to one or more delivery media 206A-206N of the apparatus 108.
[0117] The apparatus 102 may include at least one capillary 402 that may be adapted to transfer the sample fluid from the distal end 212 of the apparatus to the proximal end 214 of the apparatus 102. The capillary 402 has an inlet 404 that may be adapted to collect the sample fluid when the apparatus 102 may be dipped in the sample fluid.
[0118] In some aspects of the present disclosure, the inlet 404 of the capillary 402 may be disposed adjacent to the distal end 212 of the body 202. In some other aspects of the present disclosure, the capillary 402 may be configured to deliver the sample fluid to bottom of the microbial culture medium 220.
[0119] In some aspects of the present disclosure, the inlet 404 of the capillary 402 may be disposed along with a longitudinal axis of the one or more delivery media 206a-206n. In some aspects of the present disclosure, the capillary 402 may be configured to deliver the sample fluid to the microbial culture medium 220 and eliminates a need for streaking, pour plate, spread plate or the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of inoculation method, including known, related and later developed inoculation method.
[0120] FIG. 6 illustrates a schematic view of the exemplary apparatus 500, according to an aspect herein. The apparatus 500 is substantially similar to that of the apparatus 108 of FIG. 3 with like elements referred by way of like reference numerals. However, added at atomizer 502 of the apparatus 500 has a different element with same functionality when compared to one or more delivery media 206A-206N of the apparatus 108.
[0121] The apparatus 500 may include an atomizer 502. The atomizer 502 may be disposed substantially parallel and relative to one or more delivery media. The atomizer may be adapted to provide the sample fluid to the microbial culture medium 220. The atomizer 502 may include a tube 504 and a button 506. The tube 504 may include an inlet that may be disposed adjacent to the distal end 212 of the body 202. The tube 502 may be adapted to accept and transfer the amount of the sample fluid to the microbial culture medium 220. The button 506 may be disposed on the tube 504 and may be adapted to pump the sample fluid from the inlet of the tube 504 to the microbial culture medium 220. FIG. 7 illustrates a flowchart depicting a method 600 of determining the microbial load in the sample fluid, according to an aspect herein.
[0122] At step 602, the distal end of the apparatus 102 may be dipped in the sample fluid.
[0123] At step 604, the sample fluid may be enabled to flow across the distal end 212 to the proximal end 214 of the apparatus 102 by way of at least one of, one or more delivery media 206a-206n and at least one capillary 402. The one or more delivery media 206a- 206n and at least one capillary 402 may deliver the sample fluid to a microbial growth medium 208 containing microbial culture medium 220 and one or more colorimetric reagents 210a-210n respectively.
[0124] At step 606, the microbial culture medium 220 may be incubated at room temperature for at least 24 hours. In some aspects of the present disclosure, the incubation period may be extended up to 96 hours, such that the data processing engine 116 may determine the microbial load based on the one or more colonies formed on the microbial culture medium 220 with respect to the incubation period.
[0125] At step 608, the system 100 may be configured to capture the one or more images of the microbial culture medium 220 and the one or more images of the one or more colorimetric reagents 210a-210n by way of the imaging sensors 104.
[0126] At step 610, the system 100 may be configured to determine the one or more body parameter in the sample fluid by processing the one or more captured images of the one or more colorimetric reagents 210a-210n by way of the processing circuitry 112.
[0127] At step 612, the system 100 may be configured to determine the microbial load in the sample fluid by processing the one or more captured images of the microbial culture medium 220 after incubation.
[0128] At step 614, the system 100 may be configured to determine the severity of in the infection by comparing the identified body parameter and the determined microbial load with the predetermined threshold value stored in the storage unit 114. At step 616, the system 100 may be configured to suggest the user to take antibiotics and to stop the antibiotics based on the determined severity.
[0129] In some aspects, the method 600 may predict an infection based on the predicted microbial load value. In some aspects, the method 600 may predict a urinary tract infection.
[0130] The foregoing discussion of the present disclosure has been presented for purposes of illustration and description. It is not intended to limit the present disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the present disclosure are grouped together in one or more aspects of the present disclosure, configurations, or aspects for the purpose of streamlining the disclosure. The features of the aspects, configurations, or aspects may be combined in alternate aspects, configurations, or aspects other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention the present disclosure requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, configuration, or aspect. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate aspect of the present disclosure.
[0131] Moreover, though the description of the present disclosure has included description of one or more aspects, configurations, or aspects and certain variations and modifications, other variations, combinations, and modifications are within the scope of the present disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, configurations, or aspects to the extent permitted, including alternate, interchangeable and / or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and / or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.
Claims
We Claim1. A two-dimensional surface 1, comprising: a) one or more delivery media 4a- 4n adapted to transfer a sample within the two-dimensional surface 1 ; and b) one or more strips 3a-3n adapted to hold one or more delivery media 4a-4n.
2. The two dimensional surface 1 as claimed in claim 1, wherein the two- dimensional surface 1 is for culturing microorganisms comprising: a) a carrier substrate adapted to receive a sample at a first end 7 and transfer the sample towards a second end 8, the first end 7 being opposite to the second end 8; and b) a microbial growth substrate 5 comprising a microbial culture medium 12 in fluid communication with the carrier substrate to receive the sample fluid.
3. The two-dimensional surface 1 as claimed in claim 1, wherein the microbial growth substrate 5 further comprises an antibiotic media to inhibit the growth of a microbial load present in the sample.
4. The two-dimensional surface 1 as claimed in claim 1, wherein the antibiotic media is disposed on the microbial growth substrate 5 in an exponential gradient.
5. The two-dimensional surface 1 as claimed in claim 1, wherein the sample is a sample fluid selected from a group comprising blood, serum, plasma, urine, saliva or sweat.
6. The two-dimensional surface 1 as claimed in claim 1, wherein the surface further comprises a body 2 adapted to mount one or more strips 3a-3n.
7. The two-dimensional surface 1 as claimed in claim 1, further comprises a microbial growth substrate 5 positioned axially relative to the one or more delivery media 4a-4n.
8. The two-dimensional surface as claimed in claim 1, wherein the microbial growth substrate 5 further comprises a microbial culture medium such that the culture medium may be adapted to promote microbial growth.
9. An apparatus 102 for determining one or more body parameters and microbial load value of a sample, the apparatus 102 comprising: i. a body 202 adapted to transfer a sample received from a distal end 212 to a proximal end 214 of the body 202; ii. one or more delivery media 206a- 206n adapted to deliver the sample to a microbial growth medium 208 having a microbial culture medium 220 and one or more colorimetric agents 210a-210n; and iii. one or more strips 204a-204n adapted to grasp the one or more delivery media 206a- 206n.
10. The apparatus 102 as claimed in claim 9, wherein the sample is sample fluid selected from a group comprising blood, serum, plasma, urine, saliva or sweat.
11. The apparatus 102 as claimed in claim 9, wherein the one or more colorimetric agents 210a-210n are placed on each media of the one or more delivery media 206a-206n.
12. A system 100 comprising: i. one or more delivery media 206a-206n adapted to receive a sample, wherein the one or more delivery media 206a-206n having a microbial culture medium 220 and one or more colorimetric agents 210a-210n to determine one or more body parameter and microbial load value of the sample; ii. an imaging sensor 104 configured to capture one or more images of the microbial culture medium 220 and one or more colorimetric reagents 210a-210n; iii. a processing circuitry 112 that is coupled to the imaging sensor 104, configured toi. determine one or more body parameters and a microbial load value of the sample based on one or more images received from the imaging sensor 104; ii. comparing determined one or more body parameter and microbial load value with a threshold value; and iii. recommending an antibiotic to a user based on the determined status of infection.
13. The system 100 as claimed in claim 12, wherein the system 100 further comprises a data processing engine 116 and storage unit 114, such that the data processing engine 116 and storage unit 114 are coupled to the processing circuitry 112, wherein the processing circuitry 112 provides control to the data processing engine 116 to i. compare total number of microbial colonies formed on the microbial growth medium 208 with a pre-determined threshold values representing number of microbial colonies stored in the storage unit 114; ii. determine the colour changes in each image of the captured one or more images corresponding to the one or more colorimetric reagents 210a- 210n; and iii. compare the one or more images received from the imaging sensor 104 with one or more images stored in the storage unit 114 and further determine a set of parameters comprising one or more body parameter, microbial load value, number of microbial colonies and / or turbidity value.
14. The system 100 as claimed in claim 12, further comprises a triggering engine 118, such that the triggering engine 118 is coupled to the processing circuitry 112, wherein the processing circuitry 112 provides control to the triggering engine 118 such that the triggering engine 118 generates alerts:i. generates a first alert when the determined data is equal / greater than a pre-determined body condition data stored in the storage unit; ii. generates a second alert when the determined data is less than the predetermined body condition data; and iii. generates a third alert when the quantity of sample in the one or more delivery media is low or not detectable.
15. The system 100 as claimed in claim 12, wherein the microbial load value represents the microbial load selecting from a group comprising a bacterial load, a viral load, a fungal load, algal load, yeast load, and other pathogen load.
16. The system 100 as claimed in claim 12, wherein the sample is a sample fluid selected from a group comprising blood, serum, plasma, urine, saliva or sweat.
17. A method 600 for determining microbial load value in a sample, the method comprising: i. receiving 602 a sample by dipping a distal end of an apparatus 102 in a sample; ii. delivering 604 the sample to a microbial growth medium containing microbial culture medium and one or more colorimetric agents; iii. incubating 606 the culture medium; iv. capturing 608 one or more images of the culture medium and one or more colorimetric agents by way of an imaging sensor 104; v. identifying 610 body parameter in the sample by processing the one or more captured images of the one or more colorimetric agents; vi. determining 612 microbial load in the sample by processing one or more images of the culture medium post incubation; vii. determining 614 severity of an infection; and viii. suggesting 616 intake / stopping of antibiotics based on the determined severity.
18. The method 600 as claimed in claim 17, the sample is a sample fluid selected from a group comprising blood, serum, plasma, urine, saliva or sweat.
19. The method 600 as claimed in claim 17, wherein the sample is transferred from the distal end 212 to a proximal end 214of the apparatus 102 and delivered to the microbial growth medium 208 by way of atleast one capillary and one or more delivery media 206a-206n.
20. The method 600 as claimed in claim 17, further comprises identifying the body parameters and determining microbial load from the processed one or more images of the colorimetric agents and one or more images of the culture medium captured post incubation.
21. The method 600 as claimed in claim 17, wherein the method further comprises comparing the identified body parameters and determined microbial load with a pre-determined threshold value stored in a storage unit 114.
22. A two-dimensional lateral flow assay for determining one or more body parameters and microbial load value of a sample, the two-dimensional lateral flow assay comprising: i. a body 2 adapted to transfer a received sample from a first end 7 to the second end 8 of the body 2; ii. one or more delivery media 4a-4n adapted to deliver the sample to a microbial growth substrate 5 having a microbial culture medium 12 and one or more colorimetric agents 6a-6n; and iii. one or more strips 3a- 3n adapted to grasp the one or more delivery media 4a-4n.
23. A two-dimensional lateral flow assay for determining one or more body parameters and microbial load value of a sample, the two-dimensional lateral flow assay comprising: i. a body 2 having a first end 7 and a second end 8 and adapted to receive a sample fluid;ii. one or more capillary adapted to transfer the sample from the first end to the second end of the body; iii. one or more delivery media 4a-4n adapted to deliver the sample to a microbial growth substrate 5 having a microbial culture medium 12 and one or more colorimetric agents 6a-6n; and iv. one or more strips adapted to hold the one or more delivery media.
24. An apparatus 400 for determining one or more body parameters and microbial load value of a sample, the apparatus 400 comprising: i. a body 202 having a proximal end 214 and a distal end 212 and adapted to receive a sample fluid; ii. one or more capillary 402 adapted to transfer the sample from the distal end 212 to the proximal end 214; iii. one or more delivery media 206a- 206n adapted to deliver the sample to a microbial growth medium 208 having a microbial culture medium 220 and one or more colorimetric agents 210a-210n; and iv. one or more strips 204a- 204n adapted to hold the one or more delivery media 206a-206n.
25. A system 100 comprising: i. one or more delivery media 206a-206n adapted to receive a sample, wherein the one or more delivery media 206a-206n having a microbial culture medium 220 and one or more colorimetric agents 210a-210n to determine one or more body parameter and microbial load value of the sample, wherein the sample is transferred by way of one or more capillary 402; ii. an imaging sensor 104 configured to capture one or more images of the microbial culture medium 220 and one or more colorimetric reagents 210a-210n;iii. a processing circuitry 212 that is coupled to the imaging sensor 104, configured to i. determine one or more body parameter and a microbial load value of the sample based on one or more images received from the imaging sensor 104; ii. comparing determined one or more body parameter and microbial load value with a threshold value; and iii. recommending an antibiotic to a user based on the determined status of the infection.
26. A method 600 for predicting urinary tract infection, the method comprising: i. receiving a sample by dipping a distal end of an apparatus in a sample; ii. delivering the sample to a growth medium containing culture medium and one or more colorimetric agents; iii. incubating the culture medium; iv. capturing one or more images of the culture medium and one or more colorimetric agents by way of an imaging sensor; v. identifying body parameter in the sample by processing the one or more captured images of the one or more colorimetric agents; vi. determining microbial load in the sample by processing one or more images of the culture medium post incubation; vii. determining status of an infection; and viii. suggesting intake / stopping of antibiotics based on the determined severity.