WO2022150857A1 - Apparatus and a method of reading and interpreting the image of a medical special investigations test - Google Patents

Apparatus and a method of reading and interpreting the image of a medical special investigations test Download PDF

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Publication number
WO2022150857A1
WO2022150857A1 PCT/ZA2021/000001 ZA2021000001W WO2022150857A1 WO 2022150857 A1 WO2022150857 A1 WO 2022150857A1 ZA 2021000001 W ZA2021000001 W ZA 2021000001W WO 2022150857 A1 WO2022150857 A1 WO 2022150857A1
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WO
WIPO (PCT)
Prior art keywords
test
data
limited
medical
sensor
Prior art date
Application number
PCT/ZA2021/000001
Other languages
French (fr)
Inventor
Raluca PAUNA
Eeden Samuel VAN
Eeden Walter VAN
Eeden Werner VAN
Original Assignee
Pauna Raluca
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pauna Raluca filed Critical Pauna Raluca
Publication of WO2022150857A1 publication Critical patent/WO2022150857A1/en

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Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H30/00—ICT specially adapted for the handling or processing of medical images
    • G16H30/20—ICT specially adapted for the handling or processing of medical images for handling medical images, e.g. DICOM, HL7 or PACS
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation

Definitions

  • the field of the innovation generally relates to devices and methods used in connection with rapid diagnostic tests. Furthermore, this innovation is part of the Reid of micro-digital electronics and the subfield of optical sensors applied to medical tests, part of the biomedical field.
  • RDT rapid diagnostic tests
  • the rapid diagnostic tests are designed to be used at the point- of-care because they are low cost, easy to operate, relatively stable at various conditions and produce the result in a short period of time.
  • RDTs are used to screen infection diseases in in remote locations where there are limited resources.
  • the result of a rapid diagnostic test is read and interpreted by the medical practitioners who apply their own impressions and interpretations of the results before recording the data in any health information system database allocated for this purpose.
  • RDTs are of many types like: lateral flow tests, agglutination tests, flow through tests, solid phase tests, etc.
  • the most common tests are lateral flow tests for detecting many infectious diseases, including COVID19, and other biomarkers or physical conditions like pregnancy, blood sugar, cholesterol level and fertility tests.
  • the unprecedented development of wireless technologies facilitates the development of telemedicine and health applications.
  • the mobile platform can be used for screening and transferring medical data representing the result of the test using possible interfaces like blue tooth or UBS, GSM, GPS, etc.
  • Several new digital electronic sensors read colour or image form the test results. They are made of CMOS or CCD, thus facilitate the digital reading.
  • the special design of the embodiment of the device protects against tempering and the remote doud module contains algorithms linked to the control and validation of the tests.
  • the innovation consists of a digital micro-electronic apparatus that includes a necessary number of optical sensors and sources of light Installed in a specific designed circuitry and further enclosed in a special designed secure embodiment.
  • the apparatus has the purpose to clearly read any image resulting from any special medical investigation test, including serological, urine, saliva and any other bodily liquids and mucosa with the full protection of the user’s private medical data.
  • the apparatus is designed with two options: it uses tests from a single user using a single reader device or it is produced for multi-users by integrating similar multireader devices.
  • the design of the enclosure is made to detect physical tempering and to display the result of the test on the cell phone screen using a mobile application designed for this innovation.
  • Fig.1 Apparatus represents the innovation device organogram that contains three main modules made of digital electronic parts: automated test data acquisition, image and colour sensors module and test controller & transfer module to the mobile platform.
  • Fig.2 The apparatus described above is integrated with the RDT kit and interfaced with the cell phone of the patient. It uses USB or blue tooth platform to transfer the digital test result to the health information system sitting in the cloud. The result of the test is shared with the medical practitioner allocated online.
  • FIG. 3.1 shows the screen designed for positive test results
  • Fig. 3.2 shows the screen designed for negative test results
  • Fig. 3.3 shows the screen for pending results
  • Fig. 3.4 shows the screen when errors are displayed.
  • Fig. 3.5 shows the screen when more medical support is requested
  • Fig. 3.6 shows the screen for error caused by little blood sample
  • Fig. 3.7 shows the screen for errors caused by lack of antibodies
  • Fig. 3.8 shows the screen when the time allocated for the test expired
  • Fig. 3.9 shows the screen when tempering is detected
  • Fig. 3.10 shows the screen when the fingerprint identification and login with password is required
  • Fig. 3.11 shows the screen with the filling personal data fields
  • Fig. 3.12 shows the screen with the request for password reset.
  • Fig. 3.13 shows the screen with the reading QR code or alternatively introducing manual the code.
  • Fig. 3.14 shows the screen with instructions after receiving the result of the test.
  • Fig. 3.15 shows the screen for user to insert more information or to ask questions.
  • Fig. 4 shows what the modules of basic electronic display are: BLE - blue tooth technology: the sensor is a colour sensor sensing the colour change; ANT- is the antenna
  • Fig. 5 represents the basic block diagram of the device.
  • Fig. 6 represents the encapsulation of the single user with basic sleeves
  • Fig. 7 represents the single user enclosure.
  • Fig. 8 represents a multiuser enclosure.
  • This innovation device helps to collect Information about people infected with infectious diseases in remote areas and even by DIY RDT done in their homes.
  • Health I BOT used in RDTs is of high importance for immediately storing he test results in the information system database. It can be used with many types of tests and beyond medical field.
  • the innovation gives the user/patient a health diagnostic result in the form of a coded image and/or communication message on their mobile device, web based platform or computer/laptop involving minimal human intervention and reducing human error. Furthermore, it uses medical test result or special investigations, vaiidated by healthcare workers/designated individuals, to make accurate diagnosis, to increase the accuracy of recording medical data and to create accurate statistics that can be used by public, private enterprises, institutions and governments to design more effective healthcare management programs in the fight against various pandemics. Heaith i-Bot V1 saves medical resources and saves lives.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Primary Health Care (AREA)
  • Public Health (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

Health i-Bot Is an innovation in the field of micro- digital electronics and the subfield of optical sensors applied to medical tests, part of the biomedical field. This innovation comprises an apparatus and a method to read any image of any medical lest result and to transfer the digitised image to a module Interfaced with any type of health information system. The apparatus has an optical sensors installed in a specific circuitry with the purpose to dearly read any image resulting from any special investigation test, including serological tests. The apparatus and the method increase the accuracy and validity of the medical diagnosis by reducing human intervention and interpretation errors. The apparatus is designed with two options: single user/single reader and multi-user/multi-reader.

Description

APPARATUS AND A METHOD OR READING AND INTERPRETING THE IMAGE OF A MEDICAL SPECIAL INVESTIGATIONS TEST
Technical Fieid
The field of the innovation generally relates to devices and methods used in connection with rapid diagnostic tests. Furthermore, this innovation is part of the Reid of micro-digital electronics and the subfield of optical sensors applied to medical tests, part of the biomedical field.
Backoround of Innovation
At present, the rapid diagnostic tests (“RDT) are designed to be used at the point- of-care because they are low cost, easy to operate, relatively stable at various conditions and produce the result in a short period of time. RDTs are used to screen infection diseases in in remote locations where there are limited resources. Furthermore, the result of a rapid diagnostic test is read and interpreted by the medical practitioners who apply their own impressions and interpretations of the results before recording the data in any health information system database allocated for this purpose.
RDTs are of many types like: lateral flow tests, agglutination tests, flow through tests, solid phase tests, etc. The most common tests are lateral flow tests for detecting many infectious diseases, including COVID19, and other biomarkers or physical conditions like pregnancy, blood sugar, cholesterol level and fertility tests.
The unprecedented development of wireless technologies facilitates the development of telemedicine and health applications. The mobile platform can be used for screening and transferring medical data representing the result of the test using possible interfaces like blue tooth or UBS, GSM, GPS, etc. Several new digital electronic sensors read colour or image form the test results. They are made of CMOS or CCD, thus facilitate the digital reading. The special design of the embodiment of the device protects against tempering and the remote doud module contains algorithms linked to the control and validation of the tests. There are publications and patents awarded prior of this application and some are listed below:
US8916390B2 - Portable rapid diagnostic test reader US20150056719A1 - Universal Rapid Diagnostic Test Reader...
Diagnostics for HIV diagnosis - Consolidated Guidelines by A Sands Target Product Profile for a mobile app to read rapid ... - PLOS by R Kadam, 2020 Implementing COVID-19 (SARS-CoV-21 Rapid ... - Frontiers www.frontiersin.org > articles > fmed.2020,557797 > full 30 Oct 2020
Summary of Innovation
The innovation consists of a digital micro-electronic apparatus that includes a necessary number of optical sensors and sources of light Installed in a specific designed circuitry and further enclosed in a special designed secure embodiment. The apparatus has the purpose to clearly read any image resulting from any special medical investigation test, including serological, urine, saliva and any other bodily liquids and mucosa with the full protection of the user’s private medical data.
The apparatus is designed with two options: it uses tests from a single user using a single reader device or it is produced for multi-users by integrating similar multireader devices. The design of the enclosure is made to detect physical tempering and to display the result of the test on the cell phone screen using a mobile application designed for this innovation.
Brief Description of Drawings
Fig.1 Apparatus represents the innovation device organogram that contains three main modules made of digital electronic parts: automated test data acquisition, image and colour sensors module and test controller & transfer module to the mobile platform.
Fig.2 The apparatus described above is integrated with the RDT kit and interfaced with the cell phone of the patient. It uses USB or blue tooth platform to transfer the digital test result to the health information system sitting in the cloud. The result of the test is shared with the medical practitioner allocated online.
The drawings between Fig 3.1 and 3.14 are representing mobile application screens that could be designed in any way possible. Fig. 3.1 shows the screen designed for positive test results Fig. 3.2 shows the screen designed for negative test results Fig. 3.3 shows the screen for pending results Fig. 3.4 shows the screen when errors are displayed.
Fig. 3.5 shows the screen when more medical support is requested
Fig. 3.6 shows the screen for error caused by little blood sample
Fig. 3.7 shows the screen for errors caused by lack of antibodies
Fig. 3.8 shows the screen when the time allocated for the test expired
Fig. 3.9 shows the screen when tempering is detected
Fig. 3.10 shows the screen when the fingerprint identification and login with password is required
Fig. 3.11 shows the screen with the filling personal data fields Fig. 3.12 shows the screen with the request for password reset.
Fig. 3.13 shows the screen with the reading QR code or alternatively introducing manual the code.
Fig. 3.14 shows the screen with instructions after receiving the result of the test. Fig. 3.15 shows the screen for user to insert more information or to ask questions.
Fig. 4 shows what the modules of basic electronic display are: BLE - blue tooth technology: the sensor is a colour sensor sensing the colour change; ANT- is the antenna
Fig. 5 represents the basic block diagram of the device.
Fig. 6 represents the encapsulation of the single user with basic sleeves Fig. 7 represents the single user enclosure.
Fig. 8 represents a multiuser enclosure.
Industrial applicability This innovation device helps to collect Information about people infected with infectious diseases in remote areas and even by DIY RDT done in their homes. Health I BOT used in RDTs is of high importance for immediately storing he test results in the information system database. It can be used with many types of tests and beyond medical field.
The innovation gives the user/patient a health diagnostic result in the form of a coded image and/or communication message on their mobile device, web based platform or computer/laptop involving minimal human intervention and reducing human error. Furthermore, it uses medical test result or special investigations, vaiidated by healthcare workers/designated individuals, to make accurate diagnosis, to increase the accuracy of recording medical data and to create accurate statistics that can be used by public, private enterprises, institutions and governments to design more effective healthcare management programs in the fight against various pandemics. Heaith i-Bot V1 saves medical resources and saves lives.

Claims

We claim the following:
Claim 1
An apparatus, comprising:
A micro-digital optical sensor/controller, or multiple sensors, using robotics technologies, of any type, embodied in any form, including, but not limited to, a housing fitted to the purpose, wherein the analogue or digital or other methodology optical sensor/controller are specially programmed and (using Artificial Intelligence technologies) to read, interpret, extract, transform, augment, emulate and or digitize an image, holograph or alternative interpretation representing special investigation tests, including, but not limited to, serological tests or any other test with optical outcome and further transfer the image to a module hosted in the cloud/server (using OT & Block Chain technologies).
Claim 2
The apparatus described at Claim 1 designed for single use or multiple use purpose is composed of:
Any electronic circuit board, including, but not limited to, the current electronic circuit board designed and produced to read and interpret the test kits result via analogue, digital or any other methodology, called Electronic Reading Unit or “ERU"; an electronic or other type circuit board, or other methodology to ‘connect* the ERU with the Mobile device/handheld computer, including, but not limited to, the current smartphone solutions called Electronic Communication Unit or "ECU"; an enclosure/s for the circuit board, electronic, and to mount/house a test or reporting method as a module or completed unit, including, but not limited to, the current Point Of Care (POC) or Multiple Point of Care (xPOC) test kits and the power supply unit that can be, but not limited to, any type like of the following: batteries (solar or other type), a power source of the mobile device/handheld computer or an analogue to digital power source unit to be shared among all readers part of the multi-readers; a software application with the function to connect and communicate between the ERU, ECU and Server/cloud or alternative storage method; storage capacity where the data collected is stored and accessed by computer software/hardware applications/modules, including, but not limited to, current software/hardware architecture designed to access and interpret the data from the server/doud or alternative storage.
Claim 3
A method, described:
Where the method transfers or extrapolates the digital image obtained, as described in Claim 1 to a module hosted in the cloud/server/digital storage device by using any type of communication platform called ECU in claim 2, smart device, mobile device, web based technology, protocol or algorithm via any data capturing devices, any data receiving or transferring devices, including mobiie devices containing a mobile application.
Claim 4
The mobile application mentioned in Claim 2 has code-enabled double way communication with a Health i-Bot device through all existing and future communication platforms and includes multiple algorithms used to identify the type of POC test kit used by reading, interpreting, extracting, extrapolating and analysing any possible current or future code (barcode, QR, optical, audio, radio) attached to the POC kit and to link and or communicate to the test ID the correct duration of the test recommended by the medical practice. The variable stored as the "Test Duration* is read, interpreted, extracted, extrapolated and/or analysed using the data stored in the Cloud / server or any similar digital storage device.
Claim 5
A method as described at Claim 2, further comprising:
A sub-method ensuring full protection of the users/organisations/institutions private and personal data by using, but not limited to, data encryption, blockchain and biometric identification technologies on all accessible platforms and or physica!/cloud servers.
Claim 6 A module as described in Claim 1, comprising:
Functions and algorithms to capture, import and/or store and interpret, read, extract, transform, augment and/or emulate all users* special investigation tests, including, but not limited to, serological tests results and to compare the images and extracted data with existing test data and information templates, examples or projections recorded or stored in a template database designed with this purpose; the healthcare worker uses other medical records and information like, but not limited to, users' medical history and users’ behaviour information concurrently with the test results for a more accurate diagnosis and appraisal.
Claim 7
A module as described in Claim 2, further comprising:
Any type of database, including blockchain, cloud, centralised or decentralised, physical, holographic or any other data repository technology, containing records, data, information and analysis for each individuai/user or a plurality of individuals/users representing test diagnostics or results, validated or invalidated by the healthcare worker, organisation and/or individual and with or without a validating/witnessing individual who has access to this data as per GDPR or other future similar regulation.
Claim 8
An interface or as it is described in Claim 2 an ECU unit, part of the above described apparatus, comprising:
Capable of transferring digital, analogue, holographic or any other medium of data content, including, but not limited to, digital images read, interpreted or extracted by the apparatus, device or module in Claim 1 via any mobile device, smart device, cloud or web platform based, desktop or laptop and any device capable of receiving/transmitting wired and wireless data, including, but not limited to, a specific mobile or web application downloaded or interfaced on that device; this device as described above has the role of a receiver/transmitter that uses any type of communication platforms and/or protocols. Claim 9
A database, as described at Claim 5, with all test results comprising:
A plurality of records containing the test diagnostics, analysis or results of any medical special investigations test; a programmed set of instructions and/or sequence of code/specific procedures enabling the validity of the medical special investigations test results, analysis and or diagnosis and recording or predicting a number of possible outcomes, including positive, negative, test done in error and or redo test
Claim 10
A software application part of mobile application claimed in Claim 4, comprising:
Instructions, algorithms and any other interpretation of procedures written in any advanced, intermediate, pseudo, encryption algorithms, ciphers or high level programming language and part of the module, described in claim 4, that links and connects the module or device to any information system with the purpose to exchange or transform data, as described in Claim 2,
Claim 11
A mobile application described in Claim 4 and Claim 10, comprising:
A user interface known as Ul, with the following users’ options: 1. Input Options:
A. Register, login, introduce data using a web based platform, mobile smart device/computer keyboard, by voice, text or alternative data forms, as private data, medical record data, healthcare workers data, insurance data, comments and updates: all and any data introduced by the user is validated by a designated third party/healthcare worker, until then it is stored in a pending validation database: B. Set up the link between the medical special investigations test kit and the receiver using an automated process enabled by ERU claimed in Claim 2 and/or manual command in specific circumstances.
C. Perform the instructions for the test received via the mobile application, web based platform, mobile device or computer/laptop, using any form of data recording/exchange;
D. Give more information, if requested, by the digital, analogue, holographic or any other communication methodology enabled by ECU, including, but not limited to, a chat-bot and/or pre-empted machine learning Al that are part of the mobile application, web based platform or computer/laptop;
E. Finalise the test session and automatically upload the information, in digital or any other format, to a secure centralised or decentralised database and, but not limited to, the user's mobile device and log out from the mobile application, web based platform or computer/laptop.
2. Output Options:
A visual display, including, but not limited to, a screen displaying any type of outcome of the medical special investigation test, analysis and or diagnosis, including, but not limited to, the following options:
• Positive - Infected - Red
• Negative - Not Infected - Green
• Error - Fault - Purple
• Pending - Awaiting further information - Amber
• Seek additional Medical service/advice
A function that is part of the system that will determine the type of error, convert and identify the error by error codes, or any other Identification or referencing system, and provide an explanation, including, but not limited to:
• Not enough blood for the sample
• Negligible antibodies
• Test time out
• Tampering detected
• Get in touch with chat bot And a function to secure the apparatus/device against any tampering experienced by the test kit.
Claim 12
The electronic circuitry claimed in Claim 2 is made of ERU, ECU and a power supply unit (PSU); the ECU receives data from a special investigations test kit, point of care or a medically approved Covid19 test kit, including, but not limited to, Covid-19 test kits using an image, display, holographic sensor that captures the data, in whichever form present, processing the reading, data, extrapolation or interpretation, and communicates with a mobile device, computer/laptop or ECU capable device; this reading will be done by reading the coloured iine(s) test kit results displayed on the lest kit and cohere to/follow the test specific interpretation of result guidelines
Claim 13
The ERU claimed in Claim 12 works as it is described below:
The image/visual sensor, processed by video-analytics software/hardware, enables anything to be sensed, interpreted, extrapolated and analysed; this type of sensor reads, interprets, receives the coloured iine(s) from the test kit, and sends or communicates this information to the microcontroller and/or central processing unit (CPU), part of the ERU; the microcontroller or CPU analyses and processes the reading, interpretation, extrapolation and then stores the data in the board memory and manages the power usage and human interfacing; it communicates with the ECU component which transmits the data in any form to the mobile device application or web based or computer based application which in turn connects and communicates to the database, cloud-server or block chain network via the GSM or any similar network, and upload/transmit the information.
Claim 14
The device/apparatus claimed in Claim 1 and Claim 2 consists of several blocks or modules such as, but not limited to: power supply unit, microcontroller, test kit line/image detection sensor or ERU, coloured LED emitter, communication/transmitting module or ECU, firmware, software and modules containing encryption technologies.
Claim 15
The apparatus daimed in Claim 1 has an endosure, outer encompassing unit or housing that Is designed to: provide protection for internal electronic parts and sensors; ensure compliance to a specific IP rating to ensure protection against water, dust and ingress; control the amount of light inside, in order for the detection sensor to work effectively; ensure ease-of-use for the medical operator; comply with the correct standards for safe disposal; have an aesthetic appeal and detect/deter possible tampering
Claim 16
The visual/image sensor used and claimed in Claim 1 and Claim 2, and part of the ERU unit, is a device that contains, but not limited to, a 16-bit colour sensor; any other sensor, extrapolator, identifier that has required attributes can be used.
Its main attribute is to detectfreceive/read a specific-coloured line, indicating a specific result or analysis, such as, but not limited to, a test kit status;
The 16 bit Image sensor senses red, green, blue, dear, and infra-red (IR) light by incorporating photodiodes, amplifiers, and anaiogue/digitai circuits into a single CMOS chip; the brightness, saturation, vignette and colour temperature of a display backlight can be adjusted based on the ambient light source; the sensor differentiates Indoor from outdoor lighting environments.
Claim 17
The sensor described In Claim 16 has the following, but not limited to, key features: micro and/or nano dimensions; includes integrated modules or devices for colour sensing and signal conditioning IC; provides 16-bit and higher resolution for each channel (R, G, B, C and IR); has low power and energy consumption I2C compatible.
Claim 18 The ECU module, part of the device described in Claim 1 and Claim 2 is based on the micro communication/tra nsmission modules of the Bluetooth platform, or other available platforms, but is not limited to this; this is an integrated module that offers the lowest power consumption and an external component not limited to the likes of an antenna; the ECU serial port service integrated interface contains the programmed instructions for the interface and has a built in micro/nano sensor to measure temperature, including infra-red, or any other electromagnetic spectrum, capable of reading the body temperature and upload the temperature measurement to the cloud together with the results of the test, under the same user name.
Claim 19
The device/apparatus described In Claim 1 has an enclosure as per drawing 6 with the role to attach to house the serological test kit, and/or any other POC test kit, without the possibility to be removed by the user after the testing process has been initiated; the enclosure which allows access to the test kit where blood must be added or inserted is equipped with a sensor that detects user's attempts to mishandle the test kit and includes 3 LED lights (visible through the enclosure) that are switched off by defaulL Claim 20
The LED lights described in Claim 19 signal the following: yellow when the POC test kit cartridge/cassette Is processing, green when the POC test kit cartridge/cassette is completed and the transfer of the information to the mobile device/smartphone is finalised and red when the POC test kit cartridge/cassette detects an error or needs to be repeated; the enclosure is designed to accommodate the functional and technical specifications of the apparatus/device.
Claim 21
The device/apparatus described in Claim 1, and in all other Claims 2 to Claim 19, is also designed for multi-user use as is shown in drawing 8. The multi-user/multi- reader enclosure is designed to accommodate multiple POC test kits; simultaneously read/interpret the results of any type of test; transfer the results to the cloud using WIFI or similar technology and a user identification function based on bar codes, QR or any other existing identification technologies. The multi-user/multi-reader shares similar functionality with the single user/single reader apparatus/device described in Claim 1 and uses the same shared power supply unit and the shared communication module.
PCT/ZA2021/000001 2021-01-10 2021-02-04 Apparatus and a method of reading and interpreting the image of a medical special investigations test WO2022150857A1 (en)

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