DESC:TECHNICAL FIELD
[0001] The present disclosure relates generally to testing kits. More specifically, it relates to an improved, efficient, cost-effective non-invasive test kit based on near infrared technology for rapid detection and screening of COVID-19 (SARS-COV2) and other Viral and Bacterial infections in humans

BACKGROUND
[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
[0003] In recent times, global healthcare burden of infectious diseases such as COVID-19 has been on the rise. The biggest challenge within this situation is posed by viral diseases which are even sometimes caused by new and unknown viruses. The current diagnostic techniques/methods used for such viral infections are limited by the time consumed and their expensive nature. Globally, less than 1% of population are tested and many of the countries are not able to test either due to lack of sufficient numbers of the test kits or defective test kits. In India, only few lakhs symptomatic and asymptomatic patients are tested and even in a lockdown-like scenario, the risk of around 130 crore population getting infected is very high.
[0004] Existing techniques of viral diagnosis include enzyme-linked immunosorbent assays, polymerase chain reactions, immunofluorescent assays, and western blotting. These techniques are limited by their cost-effectiveness, speed, and accuracy as we are observing in the present pandemic outbreak. These are also not suitable for rapid screening or frequent monitoring as each time the test is carried out it entails a definite cost factor. Currently, the rate of outbreak of emerging viruses is increasing and therefore the development and establishment of analytical methods for such viral infections is important.
[0005] In the current diagnostic scenario for viral diseases the suspected patient has to visit a designated test facility or laboratory to perform viral diagnosis tests that are usually based on viral antigen detection or nucleic acid amplification. These tests take a minimum of 5 hours to as long as two days to provide results. In a large country like India, we are faced with shortage of test kits and are presently dependent on huge imports of such test kits. Often, these test kits have also been identified to be faulty. This increases the burden on the testing infrastructure and limits the number of tests that can be carried out in a day. Additionally, within the constraint of a fixed number of available test kits many times patients are prioritized for testing with many primary and secondary contacts not tested until they present themselves with identifiable symptoms. This poses a grave risk of community spread and an increasing positive pressure on the public health infrastructure. The existing methods, though the gold standard with high accuracy, are not suitable for large scale routine screening that is required for surveillance and public health management.
[0006] Therefore, there is need in the art to provide a simple, efficient and cost-effective solution which can overcome the foregoing limitations in the art.

OBJECTS OF THE PRESENT DISCLOSURE
[0007] An object of the present disclosure relates generally to testing kits. More specifically, it relates to an improved, efficient, cost-effective non-invasive test kit based on near infrared technology for rapid detection and screening of COVID-19 (SARS-COV2) and other viral infections in humans.
[0008] Another object of the present disclosure is to provide a device that combines the primary reverse transcription polymerase chain reaction (RTPCR) test analysis and the rapid antibody tests on a real time basis.
[0009] Another object of the present disclosure provides near infrared and advanced sensor technology in a handheld form factor for rapid screening of viral infection in the community.
[0010] Another object of the present disclosure provides the real time monitoring of the Antibodies of the humans by measuring the Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM), levels.
[0011] Another object of the present disclosure provides the simultaneous monitoring of body temperature on the forehead.
[0012] Another object of the present disclosure provides seamless Bluetooth connectivity with IoT integration to companion smartphones, data logging and storage on on-board storage devices may help in centralized data capture, logging, and monitoring by public health department, especially during conditions of epidemic/pandemic spread.
[0013] Another object of the present disclosure is to provide a device that is cost effective and involves practically zero operational costs.
[0014] Another object of the present disclosure parallelly monitors other body vitals to provide a realistic estimate of the viral infection status in a lesser time.
[0015] Another object of the present disclosure is to provide a device that can be deployed directly by the public health department through partnership to all primary and secondary contacts for contact tracing and monitoring.
[0016] Another object of the present disclosure can be used by hospitals to take care of their healthcare workers and monitor their health conditions especially when they are dealing with patients suffering from Covid-19 (SARS-COV2) or similar viral diseases. This may ensure employee wellbeing as well as keep the hospital running. Similarly corporate offices, airports, hotels, schools, colleges and universities may use these handheld scanners to monitor the wellbeing of their employees/students and alert them at the first instance of a possible infection so as to avoid spread to other people.
[0017] Another object of the present disclosure may identify asymptomatic persons and isolate them from high-risk individuals based on age groups and pre-existing health conditions. The use of NIR technology in a non-invasive and rapid manner may help accelerate screening and testing in India and globally.
[0018] Another object of the present disclosure provides on-board data processing and multi-variate analysis for non-invasively determining the Nucleo protein -N-GENE, and Envelope small membrane protein E-GENE Viral Loads can determine the virus positive or negative status.
[0019] Yet another object of the present disclosure provides algorithm based on Machine Learning (ML), for faster detection of different types of mutations of COVID-19 (SARS-COV2) and other types of virus, or bacteria that causes infectious disease.

SUMMARY
[0020] The present disclosure relates generally to testing kits. More specifically, it relates to an improved, efficient, cost-effective non-invasive test kit based on near infrared technology for rapid detection and screening of COVID-19 (SARS-COV2) and other viral infections in humans.
[0021] In an aspect, the present disclosure provides a device for non-invasively determining infection status of a subject,the device including a scanner portion coupled to a top end of a handle portion of the device, a thermal scanner located at the top of the scanner portion, the thermal scanner detects the temperature parameter of the subject, an array of NIR LED of different wavelengths located at front side of the scanner portion, the array of NIR LED scan for infection in the Frenulum of the tongue, Oropharanx, Naso pharynx, Hypo pharynx of the mouth parts of the subject, a photodiode located close to the array of NIR LED in centre at front side of the scanner portion, the photodiode captures a first set of parameters pertaining to NIR spectrum reflected from body parts of the subject, a pulse oximeter located at rear side of the scanner portion, the pulse oximeter monitors a second set of parameters pertaining to any or a combination of blood oxygen saturation, haemoglobin levels, immunoglobulin G (IgG), immunoglobulin M (IgM), Immunoglobulin A (IGA), heartrate of the subject and hemoglobin (HB) of the subject. A controller coupled to the array of NIR LED , the thermal scanner, the photodiode and the pulse oximeter, the controller coupled to a memory, the memory storing instructions executable by the controller to receive, from the photodiode, the first set of parameters pertaining to NIR spectrum reflected from body parts in the form of analog to digital converter (ADC) values of the subject, receive from the thermal scanner, the temperature parameter of the subject, receive, from the pulse oximeter, the second set of parameters pertaining to any or a combination of blood oxygen saturation, haemoglobin levels, immunoglobulin G (IgG), immunoglobulin M (IgM) and heartrate of the subject; and analyse the received set of parameters of the subject to extract a set of values for the received set of parameters, wherein based on the determination of the analysed set of parameters and a deviation of the extracted set of values for the analysed set of parameters from a reference set of values, the controller configured to estimate the infection status of the subject, the status pertaining to any or a combination of positive or negative state of infection in the subject.
[0022] According to an embodiment, the array of NIR LEDs can include IR LED 15, with wave length of 1500- 1550nm, IR Led 18, with wavelength range of 1800 nm to 1890, IR LED 20with wavelength range of 2000nm-2090nm,IR LED 23 with wavelength range of 2300nm-2390nm and any combination thereof, wherein the IR LEDs and FD10D - InGaAs Photodiode, 25 ns Rise Time, 900-2600 nm, Ø1.0 mm Active Area may capture light from 1550nm, 1800nm, 2050nm and 2400nm, are operated simultaneously or in combination to detect the infection in the nose, throat, mouth, tongue and other regions of the subject.
[0023] According to an embodiment, the controller performs any or a combination of multivariate linear regression analysis, spectroscopic analysis, correlation analysis and other statistical analysis to determine the Viral Load of NG infection status of the subject.
[0024] According to an embodiment, the pulse oximeter can include any or a combination of red LED of wavelength 660 nm, green LED of wavelength 530 nm and IR LED of wavelength 880 nm-930nm. wherein these LEDs capture the second set of parameters to estimate the IgG level, IgM level, IGA, oxygen saturation level(SPo2), haemoglobin(HB) level and heart rate(HR) of the subject.
[0025] According to an embodiment, the device can include a communication unit that establishes communication with computing devices associated with government authority, where the communication unit comprises any one or a combination of a global system for mobile communication (GSM), global positioning system (GPS), Wireless Fidelity (Wifi), and Bluetooth.
[0026] According to an embodiment, the device can include a display unit with touch screen that is located at the rear side of the scanner portion, the display unit displays the test report of the subject.
[0027] According to an embodiment, a memory device operatively coupled with the controller, the memory device configured to store a log of operations of the device, the log of operations comprising any or a combination of the analyzed set of parameters, extracted set of values for the analyzed set of parameters, the reference set of values and the estimated status of the subject, wherein the memory device is a cloud storage.
[0028] According to an embodiment, the device is coupled to an integrated IoT device that traces infected subject and configured to trigger an alarm, upon coming in contact with the infected subject, wherein the alarm is triggered on a mobile computing device associated with users.
[0029] According to an embodiment, the controller is operatively coupled to a learning engine, the learning engine is trained using a historical data of correlation of the set of parameters of one or more health attributes of the subject to detect any or a combination of viral and bacterial infections.
[0030] In an aspect, the present disclosure provides a method for non-invasively determining infection status of a subject, the method includes receiving, at a computing device, from a thermal scanner, temperature parameter of the subject, the thermal scanner located at the top of a scanner portion to detect the temperature parameter of the subject, the scanner portion coupled to a top end of a handle portion of the device, receiving, at the computing device, from a photodiode, a first set of parameters pertaining to NIR spectrum reflected in the form of ADC values from body parts of the subject, the photodiode located in centre at front side of the scanner portion, and configured to capture a first set of parameters pertaining to NIR spectrum reflected from body parts of the subject, wherein array of NIR LED of different wavelengths located at front side of the scanner portion , the array of NIR LED scans for infection in the body parts of the subject, receiving, at the computing device, from a pulse oximeter, the second set of parameters pertaining to any or a combination of blood oxygen saturation, haemoglobin levels, immunoglobulin G (IgG), immunoglobulin M (IgM), immunoglobulin A (IGA) and heartrate of the subject, the pulse oximeter located at rear side of the scanner portion; and analysing, at the computing device, the received set of parameters of the subject to extract a set of values for the received set of parameters, wherein based on the determination of the analysed set of parameters and a deviation of the extracted set of values for the analysed set of parameters from a reference set of values, the computing device configured to estimate the infection status of the subject, the status pertaining to any or a combination of positive or negative state of infection in the subject.
[0031] Various objects, features, aspects, and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.

BRIEF DESCRIPTION OF THE DRAWINGS
[0032] The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure. The diagrams are for illustration only, which thus is not a limitation of the present disclosure.
[0033] FIGs. 1A to 1D illustrate exemplary graphical and pictorial representations of scheme of viral infection detection using NIR spectroscopy and multivariate analysis, in accordance with an embodiment of the present disclosure.
[0034] FIGs. 2A to 2D illustrate exemplary isometric view, front view, side view, and rear view of thedisclosed test kit, in accordance with embodiments of the present disclosure.
[0035] FIG. 3 illustrates an exemplary block diagram of the proposed test kit, in accordance with embodiments of the present disclosure.
[0036] FIG. 4 illustrates an exemplary schematic diagram of a controller of the proposed test kit, in accordance with embodiments of the present disclosure.
[0037] FIG. 5 illustrates exemplary schematic diagrams of sensor boards of the proposed test kit, in accordance with embodiments of the present disclosure.
[0038] FIG. 6 illustrates exemplary schematic diagrams of battery protection circuit and charging circuit of the proposed test kit, in accordance with embodiments of the present disclosure.
[0039] FIG. 7 is an exemplary flow chart illustrating a method for non-invasively determining infection status of a subject, in accordance with embodiments of the present disclosure.
[0040] FIGs. 8A to 8F illustrate exemplary circuit diagrams of functional components of device, in accordance with embodiments of the present disclosure.
[0041] FIGs. 9A to 9B illustrate schematic view of the test kit, in accordance with embodiments of the present disclosure.
[0042] FIGs. 10A to 10B illustrate schematic view of UVC sterilization box, in accordance with embodiments of the present disclosure.
[0043] Persons skilled in the art will appreciate that elements in the figures are illustrated for simplicity and clarity and may have not been drawn to scale. For example, the dimensions of some of the elements in the figure may be exaggerated relative to other elements to help to improve understanding of various exemplary embodiments of the present disclosure. Throughout the drawings, it should be noted that like reference numbers are used to depict the same or similar elements, features, and structures.

DETAILED DESCRIPTION
[0044] In the following description, numerous specific details are set forth in order to provide a thorough understanding of embodiments of the present invention. It will be apparent to one skilled in the art that embodiments of the present invention may be practiced without some of these specific details.
[0045] Embodiments of the present invention may be provided as a computer program product, which may include a machine-readable storage medium tangibly embodying thereon instructions, which may be used to program a computer (or other electronic devices) to perform a process. The machine-readable medium may include, but is not limited to, fixed (hard) drives, magnetic tape, floppy diskettes, optical disks, compact disc read-only memories (CD-ROMs), and magneto-optical disks, semiconductor memories, such as ROMs, PROMs, random access memories (RAMs), programmable read-only memories (PROMs), erasable PROMs (EPROMs), electrically erasable PROMs (EEPROMs), flash memory, magnetic or optical cards, or other type of media/machine-readable medium suitable for storing electronic instructions (e.g., computer programming code, such as software or firmware).
[0046] If the specification states a component or feature “may”, “can”, “could”, or “might” be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.
[0047] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.
[0048] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.
[0049] Embodiments explained herein relate to an improved, efficient and-cost effective non-invasive test kit based on near infrared technology for rapid detection and screening of COVID-19 (SARS-COV2) and other viral infections in patients/individuals, and method thereof.
[0050] Infrared (IR) is a type of electromagnetic radiation, including wavelengths between the 780nm to 1000 µm. IR is divided into different bands: Near-Infrared (NIR, 0.78~3.0 µm), Mid-Infrared (MIR, 3.0~50.0 µm) and Far-Infrared (FIR, 50.0~1000.0 µm) as defined in standard ISO 20473:2007 Optics and photonics -- Spectruml bands. Near-infrared (NIR) spectroscopy is a fast, multicomponent assay that enables non-invasive, non-destructive analysis. It does not require any additional reagents or sample preparation for the analysis. By combining the acquired NIR spectrum with multivariate analysis of data from healthy and infected patients, a fair estimate of a disease prediction model specific to each viral infection is obtained. This schema is shown in FIGs. 1A to 1D.
[0051] The present disclosure relates to a hand-held device integrated with NIR-wavelength LEDs and photodiodes to perform NIR spectroscopy from the throat and tongue of suspected viral infection patients along with their body temperature measurements, perform multivariate analysis on the captured data real-time and thus determine if the person is virus positive or negative. The disclosed test kit(hereinafter, alternatively referred to as device) could serve as an efficient tool for regular viral screening as well as one-time screening at entry points such as transport hubs and airports as current thermal scanning methods have proved to be inadequate.
[0052] Thus, though studied quite extensively theoretically, NIR spectroscopy has been sparsely applied for the detection of viral infections in a practical setting. With the evolving pandemic situation across the globe and the possibility of such occurrences becoming a norm it is imperative to device tools that can non-invasively and rapidly screen for virus positive patients from the crowd for disease control and mitigating community spread. Thermal scanners, which are the first line of defence as screening tools presently have proven to be ineffective especially in catching asymptomatic patients.
[0053] In another embodiment, the disclosed test kit relates to the development and methodology of a handheld tool that integrates in-situ NIR spectroscopy for viral infection detection along with thermal scanning to provide a more definitive estimate of the infection status of the person/individuals.
[0054] FIGs. 2A to 2D illustrate exemplary isometric view, front view, side view, and rear view of thedisclosed test kit,in accordance with embodiments of the present disclosure.
[0055] Referring to FIGs. 2A to 2D, where different views including an isometric view, front view, side view, and a rear view of the disclosed test kit are shown. As shown the disclosed test kit 200 (hereinafter, also referred to as device 200) is a hand-held device including a handle portion 218 and a scanner portion 216 coupled to a top end of the handle portion 218. The test kit 200 is integrated with electronic modules, an array of near-infrared (NIR)based sensor/LEDs 202, of three different wavelengths of range 1550nm, 1800 nm, 2000 nm, and 2300 nm, a photodiode 204, a temperature sensor 206 for sensing temperature of an individual/subject using IR-based temperature sensing algorithms, and an integrated pulse oximetry measurement setup 214 (also referred to as pulse oximeter 214, herein) using red, green and 930 nm IR LEDs. The test kit200 includes provision for on-board spectroscopic analysis, data logging, data visualization, multivariate analysis to detect N-gene & S-gene viral infection or viral loads status (whether positive or negative) in about one minute.
[0056] In an embodiment, the thermal scanner 206 located at top of the scanner portion 216 detects temperature parameter of the subject. The NIR based sensors 202 of different wavelengths located at front side of the scanner portion 216, the NIR based sensors scan for infection in body parts of the subject, where the NIR scans for infection in the Frenulum of the tongue, Oropharanx, Naso pharynx, Hypo pharynx of the mouth. The photodiode 204 located close to the array of NIR led of 1550nm, 1800nm ,2050nm or 2400nmin centre at front side of the scanner portion 216, the photodiode captures a first set of parameters pertaining to NIR spectrum reflected from the body parts of the subject. The pulse oximeter 214 located at rear side of the scanner portion 216. The pulse oximeter can include any or a combination of red LED of wavelength 660 nm, green LED of wavelength 530 nm and IR LED of wavelength 880 nm-930nm, where these LEDs capture the second set of parameters to estimate the IgG level, IgM level, IGA level, oxygen saturation level(SPo2), haemoglobin(HB) level and heart rate(HR) of the subject.
[0057] In an embodiment, the test kit 200 includes a display unit 208 (as illustrated in FIG. 2D) with touch screen to display data associated with testing/scanning of the individuals. In an embodiment, the test kit 200 includes a controller302 (as shown in FIG. 4) for on-board spectroscopic analysis, data logging, data visualization, multivariate analysis to provide viral infection status (whether positive or negative) in about one minute.
[0058] In an embodiment, the test kit 200 includes a power switch 210 to activate to the test kit 200.In an embodiment, in the disclosed test kit 200 (hereinafter, also referred to as device) sensors located in the front, top and rear portion of the device at suitable locations based on ergonomics and accessibility. The NIR-based sensors 202located in the front of the scanner portion 216scan for possible viral infection by looking at the reflected NIR spectrum from the tongue, mouth or the mid-throat area. The photodiodes204 located in centre of the front portion of the scanner portion 216detects the reflected light from the patient body parts. The on-board processing platform such as the controller is used to analyse the NIR spectrum captured by the photodiode 204. Three NIR wavelengths as described earlier can be used. The NIR-based sensors 202 and photodiodes 204 of 1450nm, 1750nm, 1900nm and 2400nm, may be either operated simultaneously, or in combination to detect the virus in the throat or other regions of the mouth. The thermal scanner 206 located at the top of the scanner portion 216performs the routine fever and body temperature check.
[0059] The NIR based sensor can include IR LED 15, with wave length of 1500- 1550nm, IRLED 18, with wavelength range of 1800 nm to 1890, IR LED 20with wavelength range of 2000nm-2090nm,IR LED 23 with wavelength range of 2300nm-2390nm and any combination thereof, wherein the IR LEDs and FD10D - InGaAs Photodiode, 25 ns Rise Time, 900-2600 nm, Ø1.0 mm active area , may capture light from 1550nm, 1800nm, 2050nm and 2400nm, are operated simultaneously or in combination to detect the infection in the nose, throat, mouth, tongue and other regions of the subject.
[0060] In an embodiment, the light from the near-infrared IRLEDs is capable of penetrating the skin in any part of the body and measuring the parameters from that region. The device 200 can be connected to any other parts of the body such as the chest, abdomen, armpits, eyes, forehead, thorax, or the venous regions of the wrist either directly using the handheld tool or using additional sensors and electrodes incorporated with the IRLEDs.
[0061] In another embodiment, a specially designed strip integrated with NIR sensors in the strip format without any additional enzymes can also test for the virus or bacterial strain from the saliva, sweat, blood and other body fluid samples (where the virus/bacteria is known to be present). This strip integrated with the sensors and electronics can be used for remote sample collection followed by laboratory testing at a central facility and shall use the same near-infrared technology and determination algorithm used in the main device after suitable calibration for the new form factor. This can be useful for mass screening.
[0062] In an embodiment, the display unit 208 is located at a rear side of the scanner portion 216also includes the pulse oximeter setup. This pulse oximeter setup 214 can monitor the blood oxygen saturation, haemoglobin levels and heartrate of the person under scan.
[0063] In another embodiment, the controller 302 as illustrated in FIG. 3 operatively coupled to the NIR based sensors 202 (also referred to as array of NIR LED 202, herein), the thermal scanner 206, the photodiode 204 and the pulse oximeter 214. The controller 302 coupled to a memory 310, the memory 310 storing instructions executable by the controller 302 to receive, from the photodiode 204, the first set of parameters pertaining to NIR spectrum reflected in the form of analog to digital converter (ADC) values from the body parts of the subject/user/patient, where the body parts may include tongue, mouth, mid-throat area and any combination thereof. The controller 302 can receive from the thermal scanner 206, the temperature parameter of the subject. The controller 302 can receive from the pulse oximeter 214, the second set of parameters pertaining to any or a combination of blood oxygen saturation, haemoglobin levels, IgG, IgM, IgA and heartrate of the user/subject.
[0064] The integrated pulse oximeter 214 has sensor with green(530nm), red(630nm), IR (880nm), may be capable of detecting the capillary based oxygen saturation (SPO2) to monitor the oxygen saturation level <93% , normally detected in COVID-19 (SARS-COV2) infected patients, as well as heart rate, hemoglobin level to provide a multi-parameter estimate of the viral infection status. The present disclosure is the estimation of the IgG and IgM levels through a combination of ADC readings from red (660 nm), green (530 nm), IR (880 nm) through multiple linear regression algorithms.
[0065] The controller 302 can analyse the received set of parameters of the subject to extract a set of values for the received set of parameters, where based on the determination of the analysed set of parameters and a deviation of the extracted set of values for the analysed set of parameters from a reference set of values, the controller 302 configured to estimate the infection status of the subject, the status pertaining to any or a combination of positive or negative state of infection ofthe subject. The multivariate regression analysis can set the range of values (also referred to as reference set of values) which can determine whether the person under scan is infected – positive patients or non-infected – negative persons. The controller performs any or a combination of multivariate linear regression analysis, spectroscopic analysis, correlation analysis and other statistical analysis to determine the viral load of infection status of the subject.
[0066] In an example implementation, when a person comes for scanning first his/her temperature is checked using the thermal sensor/scanner 206. Next, they are asked to open their mouth and the NIR-based viral test scan is performed using the NIR based sensors 202. Once this is done, they are asked to place their finger in the pulse-oximeter setup integrated with the test kit 200. All these multi-parametric data is collected and then fed to the pre-trained algorithm running on-board the device 200 to arrive at an accurate estimate of the viral infection status of the person. A copy of the patient test result can be sent to a computing device associated with government authority, for example the health department of government, as well as to the person under scan via a communication means such as short message service (SMS), whatsapp, email and the likes. The shared test result can be accessible using a unique test sequence generated for the corresponding test result in a particular application, for example MIISKY app, residing in their computing device. The disclosed device 200 after use can quickly be sterilized using ultra violet – C (UVC) sterilization boxes as illustrated in FIG. 10A and FIG. 10B respectively, fit to test for the next human.
[0067] In an exemplary embodiment, the NIR based sensor/LEDs 202 can include any or combination of IR LED 18(1800 to 1890nm), IR LED 20(2000-2090nm), IR LED 23(2300-2390nm), SMC1550(1550nm, 1450NM(IRLED), and 2450NM(IRLED) that provide accurate test results. The disclosed device 200 helps in 1 min test, with multiple repeatable tests.
[0068] In an embodiment, the pulse oximeter214 can be configured for confirmatory tests for SPO2, haemoglobin, IgG, IgA and IgM measurement.
[0069] In an embodiment, average of multiple tests for determining positive, and negative test result status can be used for reference data. In an embodiment, multivariate regression analysis can be performed to determine sigma results.
[0070] In an embodiment, the device 200 can include a communication unit to allow signal/data communication with other computing devices associated with government authority and subject, where the computing devices includes smart phone, laptop, computer system, smart hand band and the likes. In an embodiment, the communication unit can include any one or a combination of a Global System for Mobile communication (GSM), Global Positioning System (GPS), Wifi module, Bluetooth module and the like. In an exemplary embodiment, the communication unit may assist in transmitting and receiving data over wireless communication channels between the device 200 and other devices such as Internet of Things (IOT) devices.
[0071] In an embodiment, the device 200 can include a battery to supply power to controller 302, sensors, display unit 208 and other electronic/electrical components of the device 200. For example, the battery can be a rechargeable lithium ion battery with 1050 mAh to facilitate upto two days of continuous usage. The device 200 can include a charging socket 212 for charging the battery.
[0072] In an embodiment, the controller 302 of the device 200 can be programmable with real time setting. In an embodiment, the device 200 can be used also as a regular thermal scanner. Design of the device 200 includes hand-held form factor and ergonomic. In an embodiment, the device 200 analyses NIRS data from tongue, mid-throat and entry of esophagus of the patient. The device facilitates 0°C to +50°C operational temperature range, 0.1°C accuracy (37°C to 39°C), and 16-Bit (0.00390625°C) temperature resolution
[0073] In an embodiment, the device 200 is based on one-shot and shutdown modes that help in reducing power usage. In an embodiment, the device 200 can further include database/memory/SD card storage for storing data related to testing, reference data, instructions, algorithms, and other required data.
[0074] In an embodiment, the device 200 can also track data from a health band worn by the patient and the applications associated with the computing devices can monitor, in real-time, health of the infected patients.
[0075] The present disclosure measures the Antibody levels, of IgG, IgA, IgM, which may help health authorities to prioritise vaccination, and booster doses to the human. The present disclosure provides on-board data processing and multi-variate analysis for non-invasively determining the Nucleo protein -N-GENE, and Envelope small membrane protein. E-GENE Viral Loads may determine the virus positive or negative status. The present disclosure provides algorithm based on Machine Learning (ML), for faster detection of different types of mutations of COVID-19 (SARS-COV2) and other types of Virus, or Bacteria that causes infectious disease.
[0076] FIG. 3 illustrates an exemplary block diagram of the proposed test kit, in accordance with embodiments of the present disclosure. In an embodiment, the proposed test kit can include at least four 4 printed circuit boards (PCBs)including a controller/motherboard 302 which communicates to all the other subsystems on-board, a sensor interface board 304, an add-on card/display board 306 which interfaces with the display unit 208, and a battery interface board308 which houses the 1050 mAh battery and its control and feedback circuitry. The sensor interface board/card304 can include the sensors including the IR sensors/LEDs, temperature sensor, and other sensor. A memory 310 and an accelerometer 312 are operatively coupled to the controller 302.
[0077] FIG. 4 illustrates an exemplary schematic diagram of a controller of the proposed test kit, in accordance with embodiments of the present disclosure. In an embodiment, the controller (hereinafter, also referred to as control unit) 302 may include one or more processor(s) that 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. Among other capabilities, the one or more processor(s) are configured to fetch and execute computer-readable instructions stored in a memory 310 of the controller. The memory 310 may store one or more computer-readable instructions or routines, which may be fetched and executed to create or share the data units over a network service. The memory 310may comprise any non-transitory storage device including, for example, volatile memory 310 such as RAM, or non-volatile memory 310 such as EPROM, flash memory 310, and the like. The memory 310 can be used to store data and values being computed during operation. The controller 302may include a real time clock (RTC) that may keep track of the time.
[0078] In an exemplary embodiment, the controller/motherboard/main controller board 302 can include MDBT50Q _NRF52840 based BLE module. The controller 302 can also include a secure digital (SD) card driver, a microSD card holder, mating connector between the microcontroller and the add-on board. The controller 302 can include ARM cortex-M4 32-bit processor.
[0079] FIG. 5 illustrates exemplary schematic diagrams of sensor boards of the proposed test kit, in accordance with embodiments of the present disclosure. In an embodiment, the sensor interface board 304 can house the 4 IR LEDs (1550, 1750nm, 1900nm and 2400nm) along with other sensor modules. Driver circuits for driving these LEDs with specific power are also provided. Analog to digital converter (ADC) data captured from the photodiode 204 from these IR LEDs 202 goes to the controller board 302. They may also contain the MAX30101 sensor containing the LEDs for the Photoplethysmography (PPG) analysis for pulse oximetry part of the sensor board.
[0080] FIG. 6 illustrates exemplary schematic diagrams of a battery protection circuit and charging circuit of the proposed test kit, in accordance with embodiments of the present disclosure. The illustrated circuits include the battery charging circuit and the battery protection circuit. The illustrated circuits also include a voltage booster circuit. MCP73833 which is a standalone Li-ion battery charge controller controls the charging and send interrupt signals when the battery is discharged below minimum charge. It also has reverse discharge protection which protects the entire device. The charging current can be set upto 1A. It also monitors the temperature of the battery.
[0081] In an exemplary embodiment, in a test process/workflow for testing using the disclosed test kit/device 200, a registration ID with QR code is provided to every person to be tested by registering the person on a server/cloud server and/or a web page, for example http://twww.miisky.com. The device 200 generates a test sequence number which will map the readings to the respective person. The test result can be saved in memory/SD card and also sent to the server/cloud server, for example Miisky Cloud Server, using the communication unit including Bluetooth and Wifi, dedicated to the person’s health page.
[0082] A memory device operatively coupled with the controller 302, the memory device configured to store a log of operations of the device 200, the log of operations comprising any or a combination of the analyzed set of parameters, extracted set of values for the analyzed set of parameters, the reference set of values and the estimated status of the subject, where the memory device is the cloud storage/server.
[0083] The device 200 is coupled to an integrated IoT device that traces infected subject and configured to trigger an alarm, upon coming in contact with the infected subject, wherein the alarm is triggered on a mobile computing device associated with users. For example, the device 200 is connected to the integrated IoT hardware setup which helps in contact tracing of the positive patients and may trigger alarm for maintaining social distancing with the asymptomatic or infected patients. Alarm can be triggered on the mobile device associated with the users, on a centrally monitored server of the health department, or could be communicated as vibrations on smart wearables on the user.
[0084] The controller 302 is operatively coupled to a learning engine (not shown, also referred to as machine learning environment), the learning engine is trained using a historical data of correlation of the set of parameters of one or more health attributes of the subject to detect any or a combination of viral and bacterial infections. The datasets from the studies carried out on any past or future viral or bacterial infection can be stored in the machine learning environment, and implemented for the screening and detection of infections with the same set up for future viral or bacterial outbreaks.
[0085] In an embodiment, if the results of few persons are positive, a report can be sent to a health manager, doctor for further confirmatory check-up and medical advice for the respective persons. A separate watch with location tracking, temperature tracking and SPO2 can also be provided to the infected persons.
[0086] In an embodiment, during clinical trials the multivariate regression analysis can set the range of values which can determine whether the person under scan is infected – positive patients or non-infected – negative persons. The IgG, IgM, and haemoglobin range may also be based on the clinical trials with infected patients, and non-infected persons.
[0087] In an embodiment, a positive result status may be based on the virus scan sensors and may be simultaneously confirmed based on the other test parameters including temperature, IgG, IgM, SP02, haemoglobin etc.
[0088] In an exemplary embodiment, a predictive analysis can be integrated using python programs.
[0089] In an embodiment, at every stage of testing, a workflow-based alerts, and message may be initiated to the registered persons and the connected doctors.
[0090] In an embodiment, every test has a time stamp and logs to the person, to monitor continuous health. Test reports related to the patients can be downloaded to the computing devices such as smartphone or mailed on request.
[0091] In an embodiment, the disclosed test kit/device 200 can include software/instructions and hardware workflow to determine whether the saliva and throat of the patient has any viral presence. The device200 may be pre-tested for specific viral detection through multi-regression analysis with healthy subjects and patients suffering from the virus of interest (such as SARS-COV2 that causes COVID-19). In addition to this thermal scanning to detect the inner body temperature may also be carried out. From the information from the three IR sensor/LEDs and the thermal analysis an onboard multi-parameter regression and multivariate analysis may be performed on-board to provide the viral infection status of the patient to the specific virus and displayed on the display unit in the device. The test data can also be shared via Bluetooth to the computing device such as a smartphone or uploaded to the central server.
[0092] In an embodiment, for the IgG, IgA and IgM detection, the different LEDs in the max 30101, Red (630 nm), IR (880 nm), Green (530 nm), with band pass filters may capture 40 ADC values into the device 200. These ADC values may be analysed using multiple linear regression model to estimate the IgG, IgA and IgM levels after sufficient validation against gold standards. Different variants of the device 200 can be deployed in the form of handheld device integrated with pulse-oximeter, self-managed health kiosk, wearable with integration for virus scan sensor.
[0093] The present disclosure can be used for any type of viral infection after sufficient pre-analysis with healthy and infected patients. The embodiments of the present disclosure described above provide several advantages. The one or more of the embodiments combines the primary RTPCR test analysis and the rapid antibody tests on a real time basis. The present disclosure provides near-infrared and advanced sensor technology in a handheld form factor for rapid screening of viral infection in the community. The present disclosure provides seamless Bluetooth connectivity with IoT integration to companion smartphones, data logging and storage on on-board storage devices may help in centralized data capture, logging, and monitoring by the public health department, especially during conditions of epidemic/pandemic spread. The device 200 is cost-effective and involves practically zero operational costs. The device 200 parallelly monitors other body vitals to provide a realistic estimate of the viral infection status in a lesser time. Further, the present disclosure provides on-board data processing and multivariate analysis for non-invasively determining virus positive or negative status.
[0094] The device 200 can be deployed directly by the public health department through partnership to all primary and secondary contacts for contact tracing and monitoring. The present disclosure can be used by hospitals to take care of their healthcare workers and monitor their health conditions especially when they are dealing with patients suffering from Covid-19 (SARS-COV2) or similar viral diseases. This may ensure employee wellbeing as well as keep the hospital running. Similarly corporate offices, airports, hotels, schools, colleges and universities may use these handheld scanners to monitor the wellbeing of their employees/students and alert them at the first instance of a possible infection so as to avoid spread to other people. The present disclosure may identify asymptomatic persons and isolate them from high-risk individuals based on age groups and pre-existing health conditions. The use of NIR technology in a non-invasive and rapid manner may help accelerate screening and testing in India and globally.
[0095] FIG. 7 is an exemplary flow chart illustrating a method for non-invasively determining infection status of a subject, in accordance with embodiments of the present disclosure.
[0096] Referring to FIG. 7, the method 700 can be implemented using a computing device, which can include one or more controllers. At block 702 the computing device can receive, from the thermal scanner, temperature parameter of the subject, the thermal scanner located at the top of a scanner portion 216 to detect the temperature parameter of the subject, the scanner portion 216 coupled to top end of the handle portion 218 of the device 200.
[0097] At block 704, the computing device receive from the photodiode the first set of parameters pertaining to NIR spectrum reflected in the form of ADC values from body parts of the subject, the photodiode 204 located in centre at front side of the scanner portion 216, and configured to capture first set of parameters pertaining to NIR spectrum reflected from the body parts of the subject, where array of NIR LED 202 of different wavelengths located at front side of the scanner portion 216, the array of NIR LED scans for infection in the body parts of the subject.
[0098] At block 706, the computing device receive from the pulse oximeter the second set of parameters pertaining to any or a combination of blood oxygen saturation, haemoglobin levels, immunoglobulin G (IgG), immunoglobulin A (IgA), immunoglobulin M (IgM) and heartrate of the user, the pulse oximeter located at rear side of the scanner portion.
[0099] At block 708, the computing device analyze the received set of parameters of the subject to extract a set of values for the received set of parameters, where based on the determination of the analysed set of parameters and a deviation of the extracted set of values for the analysed set of parameters from a reference set of values, the computing device configured to estimate the infection status of the subject, the status pertaining to any or a combination of positive or negative state of infection in the subject.
[00100] FIGs. 8A to 8F illustrate exemplary circuit diagrams of functional components of device, in accordance with embodiments of the present disclosure. As depicted, FIGs. 8A to 8F shows the add on section for IR led and photodiode, controller section, main board sensor section, main board BLE controller section, batter&power section and temperature sensor section respectively.
[00101] FIGs. 9A to 9B illustrate schematic view of the test kit, in accordance with embodiments of the present disclosure. FIG. 9A, shows test kit for rapid detection and screening infectious disease in humans and FIG. 9B illustrates the testing process using the proposed device 200.
[00102] FIGs. 10A to 10B illustrate schematic view of UVC sterilization box, in accordance with embodiments of the present disclosure. As depicted in FIG. 10A and FIG. 10B, UVC sterilization box 1000 may include 11W UVC lamps, two sterilization layers, mask hangers, foldable tray for 360o sterilization and lid with Velcro that ensures zero leakage. The device 200 can be sterilized after every use for 5 seconds in the UVC sterilization box, thereby the device is protected from any contaminants and can be used to test other persons effectively.
[00103] It will be apparent to those skilled in the art that the device 200 of the disclosure may be provided using some or all of the mentioned features and components without departing from the scope of the present disclosure. While various embodiments of the present disclosure have been illustrated and described herein, it will be clear that the disclosure is not limited to these embodiments only. Numerous modifications, changes, variations, substitutions, and equivalents will be apparent to those skilled in the art, without departing from the scope of the disclosure, as described in the claims.

ADVANTAGES OF THE PRESENT DISCLOSURE
[00104] The present disclosure provides a device that combines the primary RTPCR test analysis and the rapid antibody tests on a real time basis.
[00105] The present disclosure measures the antibody levels of IgG, IgA, IgM, which will help health authorities to prioritise vaccination, and booster doses to the human.
[00106] The present disclosure provides near infrared and advanced sensor technology in a handheld form factor for rapid screening of viral infection in the community.
[00107] The present disclosure provides seamless Bluetooth connectivity with IoT integration to companion smart phones, data logging and storage on on-board storage devices may help in centralized data capture, logging, and monitoring by public health department, especially during conditions of epidemic/pandemic spread.
[00108] The present disclosure provides a device that is cost effective and involves practically zero operational costs.
[00109] The present disclosure parallelly monitors other body vitals to provide a realistic estimate of the viral infection status in a lesser time.
[00110] The present disclosure provides on-board data processing and multi-variate analysis for non-invasively determining virus positive or negative status.
[00111] The present disclosure provides a device that can be deployed directly by the public health department through partnership to all primary and secondary contacts for contact tracing and monitoring.
[00112] The present disclosure can be used by hospitals to take care of their healthcare workers and monitor their health conditions especially when they are dealing with patients suffering from Covid-19 (SARS-COV2) or similar viral diseases. This may ensure employee wellbeing as well as keep the hospital running. Similarly corporate offices, airports, hotels, schools, colleges and universities may use these handheld scanners to monitor the wellbeing of their employees/students and alert them at the first instance of a possible infection so as to avoid spread to other people.
[00113] The present disclosure may identify asymptomatic persons and isolate them from high-risk individuals based on age groups and pre-existing health conditions. The use of NIR technology in a non-invasive and rapid manner may help accelerate screening and testing in India and globally.
[00114] The present disclosure provides on-board data processing and multi-variate analysis for non-invasively determining the Nucleo protein -N-GENE, and Envelope small membrane proteinE-GENE Viral Loads may determine the virus positive or negative status.
[00115] The present disclosure provides algorithm based on Machine Learning (ML), for faster detection of different types of mutations of COVID-19 (SARS-COV2) and other types of Virus , or Bacteria that causes infectious disease.
,CLAIMS:1. A device (200) for non-invasively determining infection status of a subject, said device comprising:
a scanner portion (216) coupled to a top end of a handle portion (218) of the device;
a thermal scanner (206) located at top of the scanner portion (216), the thermal scanner (206) detects temperature parameter of the subject;
an array of near-infrared (NIR)LED (202) of different wavelengths located at frontside of the scanner portion (216), said array of NIR LED scan for infection in body parts of the subject;
a photodiode (204) located close to the array of NIR LED of 1550nm, 1800nm, 2050nm or 2400nmin centre at front side of said scanner portion (216), the photodiode captures a first set of parameters pertaining to NIR spectrum reflected from the body parts of the subject;
a pulse oximeter (214) located at rear side of said scanner portion (216), said pulse oximeter monitors a second set of parameters pertaining to any or a combination of blood oxygen saturation (SPo2), haemoglobin levels, immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobin M (IgM) and heart rate of the subject; and
a controller (302) operatively coupled to the array of NIR LED (202), the thermal scanner (206), the photodiode (204) and the pulse oximeter (214), said controller coupled to a memory (310), the memory storing instructions executable by the controller to:
receive, from the photodiode (204), the first set of parameters pertaining to NIR spectrum reflected in the form of analog to digital converter (ADC) values from body parts of the subject;
receive, from the thermal scanner (206), the temperature parameter of the subject;
receive, from the pulse oximeter (214), the second set of parameters pertaining to any or a combination of blood oxygen saturation, haemoglobin levels, IgG, IgA, IgM and heartrate of the subject; and
analyse the received set of parameters of the subject to extract a set of values for the received set of parameters, wherein based on the determination of the analysed set of parameters and a deviation of the extracted set of values for the analysed set of parameters from a reference set of values, said controller (302) configured to estimate the infection status of the subject, the status pertaining to any or a combination of positive or negative state of infection of the subject.
2. The device as claimed in claim 1, wherein said array of NIR LED (202) comprises IR LED 15, with wave length of 1500- 1550nm, IR LED 18, with wavelength range of 1800 nm to 1890, IR LED 20with wavelength range of 2000nm-2090nm,IR LED 23 with wavelength range of 2300nm-2390nm and any combination thereof, wherein said IR LEDs and the photodiode (204) at wavelength range of 1550nm, 1800nm, 2050 nm and 2400nm are operated simultaneously or in combination to detect the infection in the nose, throat, mouth, tongue and other regions of the subject.
3. The device as claimed in claim 1, wherein said controller (302) performs any or a combination of multivariate linear regression analysis, spectroscopic analysis, correlation analysis and other statistical analysis to determine the viral load infection status of the subject.
4. The device as claimed in claim 1, wherein said pulse oximeter (214) comprises any or a combination of red LED of wavelength 660 nm, green LED of wavelength 530 nm and IR LED of wavelength 880 nm-930nm, wherein said LEDs capture the second set of parameters to estimate the IgG level, IgA level, IgM level, oxygen saturation level, hemoglobin level and heart rate of the subject.
5. The device as claimed in claim 1, wherein the device (200) comprises a communication unit that establishes communication with computing devices associated with government authority to convey test report, wherein said communication unit comprises any one or a combination of a global system for mobile communication (GSM), global positioning system (GPS), Wireless Fidelity (Wifi), and Bluetooth.
6. The device as claimed in claim 1, wherein the device (200) comprises a display unit (208) with touch screen that is located at the rear side of the scanner portion (216), the display unit (208) displays the test report of the subject.
7. The device as claimed in claim 1, wherein a memory device operatively coupled with the controller (302), the memory device configured to store a log of operations of the device, said log of operations comprising any or a combination of the analyzed set of parameters, extracted set of values for the analyzed set of parameters, the reference set of values and the estimated status of the subject, wherein the memory device is a cloud storage.
8. The device as claimed in claim 1, wherein the device (200) is coupled to an integrated IoT device that traces infected subject and configured to trigger an alarm, upon coming in contact with the infected subject, wherein the alarm is triggered on a mobile computing device associated with users.
9. The device as claimed in claim 1, wherein the controller (302) is operatively coupled to a learning engine, the learning engine is trained using a historical data of correlation of the set of parameters of one or more health attributes of the subject to detect any or a combination of viral and bacterial infections.
10. A method(700) for non-invasively determining infection status of a subject, said method comprising:
receiving (702), at a computing device, from a thermal scanner, temperature parameter of the subject, the thermal scanner located at top of a scanner portion (216) to detect the temperature parameter of the subject, the scanner portion (216) coupled to a top end of a handle portion (218) of a device;
receiving (704), at the computing device, from a photodiode, a first set of parameters pertaining to NIR spectrum reflected from body parts of the subject, the photodiode (204) located close to an array of NIR LED in centre at front side of the scanner portion (216), and configured to capture the first set of parameters pertaining to NIR spectrum reflected in the form of ADC values from the body parts of the subject, wherein the array of NIR LED of different wavelengths located at front side of the scanner portion (216)scans for infection in the body parts of the subject;
receiving (706), at the computing device, from a pulse oximeter, a second set of parameters pertaining to any or a combination of blood oxygen saturation, haemoglobin (HB) levels, immunoglobulin G (IgG), immunoglobulin A (IgA), immunoglobulin M (IgM) and heartrate (HR) of the subject, the pulse oximeter located at rear side of the scanner portion; and
analysing (708), at the computing device, the received set of parameters of the subject to extract a set of values for the received set of parameters, wherein based on the determination of the analysed set of parameters and a deviation of the extracted set of values for the analysed set of parameters from a reference set of values, the computing device configured to estimate the infection status of the subject, the status pertaining to any or a combination of positive or negative state of infection of the subject.