WO2021245565A1 - Essai rapide de nucléation - Google Patents

Essai rapide de nucléation Download PDF

Info

Publication number
WO2021245565A1
WO2021245565A1 PCT/IB2021/054825 IB2021054825W WO2021245565A1 WO 2021245565 A1 WO2021245565 A1 WO 2021245565A1 IB 2021054825 W IB2021054825 W IB 2021054825W WO 2021245565 A1 WO2021245565 A1 WO 2021245565A1
Authority
WO
WIPO (PCT)
Prior art keywords
sample
reaction tube
biological
diagnostic result
patient
Prior art date
Application number
PCT/IB2021/054825
Other languages
English (en)
Inventor
Daniel DU TOIT
Petrus Jacobus VAN WYK
Leunis Van Rooyen
Zacharias Hendrik SWANEVELDER
Original Assignee
Nucleolife Laboratory (Pty) Ltd
Agricultural Research Council
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 Nucleolife Laboratory (Pty) Ltd, Agricultural Research Council filed Critical Nucleolife Laboratory (Pty) Ltd
Publication of WO2021245565A1 publication Critical patent/WO2021245565A1/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/54—Labware with identification means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L1/00—Enclosures; Chambers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/143—Quality control, feedback systems
    • B01L2200/147—Employing temperature sensors
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/021—Identification, e.g. bar codes
    • B01L2300/022—Transponder chips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/023—Sending and receiving of information, e.g. using bluetooth
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/025—Displaying results or values with integrated means
    • B01L2300/027—Digital display, e.g. LCD, LED
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor

Definitions

  • THIS INVENTION relates to a real-time point-of-care diagnostic device for the identification of one or more biological targets of interest of a biological or synthetic organism which inter alia, allow for diagnosis of a disease, disorder or condition, or the identification of specific attributes in a sample.
  • the specific application of the device to diagnose for COVID-19, caused by the SARS-CoV-2 virus is discussed as an example. It must be noted that the device, however, can be used to diagnose a range of diseases, disorders and conditions by testing for the presence of various biological targets.
  • disease means a condition of the living animal or plant body or of one of its parts that impairs normal functioning and is typically manifested by distinguishing signs and symptoms.
  • disorder means an illness that disrupts normal physical or mental functions.
  • condition means a subject’s state of health which is an abnormal state that feels different from a subject’s normal state of wellbeing.
  • biological targets means living or dead biological material that may have harmful effects for humans or animals, and includes, amongst others, genetic material, microorganisms (such as bacteria, fungi, viruses and parasites), toxins, allergens, hormones, proteins.
  • RT-LAMP diagnostic reverse transcription loop-mediated isothermal amplification
  • targets included the nucleocapsid, spike, RNA-dependent RNA polymerase (RdRP)/helicase, RdRP-P2, ORF1ab, and other genes.
  • RdRP RNA-dependent RNA polymerase
  • the RT-LAMP technology offers a faster and low-resource alternative to RT-PCR based COVID-19 diagnostic tests. It allows for the reaction to be conducted in a single tube without the need for RNA extraction and targets multiple conserved regions in the genome of interest. By targeting two or three regions of the genome, a (positive) test redundancy is provided to accommodate for any mutation in a priming site that might result in a false negative.
  • RT-LAMP diagnostics lacked a reaction control needed to verify a true negative result.
  • Reaction controls enable reaction verification during the test, i.e., a positive reaction control confirms that workflow steps (the RNA extraction and/or RT- PCR reactions) were successful even if the viral pathogen test result was negative. This prevents failed reactions or degraded samples being interpreted incorrectly as a negative result.
  • the COVID-19 diagnostic tests targeting different genomic regions are run concurrently with the reaction control in the same reaction tube for each sample being assessed.
  • RT-LAMP diagnostic applications targeted a single region and provided a positive/negative answer that is endpoint visualised.
  • new sequence specific RT-LAMP target identification approaches now enables multiplexing and includes a reaction control.
  • RT-LAMP reactions are often used in a yes/no testing manner, using easily detectable visualisation dyes (and other methods) linked to nucleic acid accumulation.
  • the use of multiple dyes in RT-LAMP furthermore, allows for the identification of different testing regions. It is therefore possible to use different dyes, each linked to a viral gene target or internal human control gene product, to not only increase the sensitivity and specificity of the test, but also to lower false negatives.
  • RT-LAMP technology is known for its low-cost, low-infrastructure endpoint result detection, with scanners, cell phones or even visual confirmation by eye, often used after an isothermal heating step (Table 1 ). Additionally, there are a number of studies presenting the use of fluorescent dyes in DIY applications on microscopy and other fields.
  • the RT-LAMP assay can be conducted on the invention’s simple point-of-care device which provides the required heat and detection.
  • the invention discloses the development of a portable, point-of-care (POC) device that utilises enzymatic reactions, such as the RT-LAMP assay, strand displacement reactions and digestions and integrates this with radio-frequency identification (RFID) technology, automatic testing and inactivation of samples to conduct and present the results of a detection test, such as a nucleotide (DNA or RNA) specific test.
  • POC point-of-care
  • RFID radio-frequency identification
  • the device is an electronic device that measures a range of biological targets, such as the nucleotides DNA and RNA, using wide band light frequency spectrometric measurement and narrow band light frequency spectrometric measurement.
  • the device can be used to measure, for example, specific viral presence, specific bacterial presence, specific fungi presence, presence of specific chemicals, presence of specific minerals, presence of specific vitamins, specific blood presence, presence of specific fluids, and for various properties and possibilities of each. It can be used to detect at least one biological target or multiple, for example it can detect a single genetic region of interest or can detect multiple genetic regions of interest in a single sample.
  • the device can perform testing for diagnostic purposes, for example nucleotide testing, such as is required in the medical, zoological, forensic, water quality, food safety, and other fields. It is a user-operatable device to be used by adult literate individuals, but can also be used in a formal clinical environment i.e., doctors’ rooms, pharmacies, laboratories, mobile test facilities, or other fields where an onsite diagnostic may be required, e.g., onsite food safety testing, infield water quality testing, etc.
  • diagnostic purposes for example nucleotide testing, such as is required in the medical, zoological, forensic, water quality, food safety, and other fields. It is a user-operatable device to be used by adult literate individuals, but can also be used in a formal clinical environment i.e., doctors’ rooms, pharmacies, laboratories, mobile test facilities, or other fields where an onsite diagnostic may be required, e.g., onsite food safety testing, infield water quality testing, etc.
  • the device provides simplistic, live, aminated demonstrations on a wide screen with audio assistance as well as an operator manual that allows for easy operation and guidance during test procedures. Its robust and inclusive design allows for it to be operated effectively with a minimum of training and does not require a high level of technical expertise. It has testing, diagnostic and research functionality.
  • the device can be used in a number of fields for testing, assays, or diagnostics such as single to multi-virus detection, pathogen screening, disease confirmation and mutation detection where it is used to test for specific genetic fragments or combinations thereof.
  • the patient is rapidly enrolled on the device prior to approval of the test.
  • the patient must accept or reject the terms and conditions using the motion detection function on the screen.
  • the database of the device is linked to a mobile app or a web-based (online) link to allow for the loading of personal data, consent to the diagnostic, agreement to terms, selection of tests, payment, etc.to take place.
  • This link from a phone or smart ID to the device is active at the point of testing and further removes the need for direct interaction with the device.
  • the device provides real time reporting to the required authority or regulatory organization (such as the National Health Laboratory Service, Covid Watch and World Health Organization). Results are released to the relevant body depending on the appropriate authority or offsite server confirmation, thereby allowing for automatic reporting when and/or where mandatory.
  • the information conveyed to the relevant body may include, amongst others, the biochemistry for a specific test, origin and expiry date of the biochemicals in the test tube, location of the test, personal information of the patient being tested, medical symptoms of the patient, a digital picture of the patient, biometrics from the picture, test results and consent of the patient.
  • Patient information is encrypted and/or tracked and/or compiled (e.g., blockchain) to ensure confidentiality and protection of the patient’s rights and legal compliance with prevailing local and international privacy and information disclosure legislation.
  • the device includes a unique and accurate sampling system that ensures consistent sample sizes for testing.
  • This system includes sample tracking.
  • the system can also use current sampling equipment. The risk of contamination is minimized to the user.
  • the screen includes motion detection, thus removing the need to touch the screen. All samples are automatically treated with a built-in ultraviolet-C (UVC) treatment system in the waste bin.
  • UVC ultraviolet-C
  • the device is fast to develop or convert, easy to implement, has a history of previous diagnostic application, but is sensitive enough to be informative in the real-time detection and diagnosis of RNA or DNA in samples.
  • the sample may be in the form of any suitable bodily fluid, such as saliva.
  • the bodily fluid such as saliva is placed in an automatable sample tube and circumvents the swab-to-96-well bottleneck in the RT-PCR workflow.
  • the device runs the test directing on the sample which further expedites the workflow. When a test is run where the reaction is isothermal, the device provides the required heating. The reactions also require low-end processing and thus the POC device is ideal and provides on-site results.
  • the invention is able to run different tests, such as the RT-LAMP assay, to expedite diagnostic tests and utilises resources not used in current standard RT-PCRs, thus lowering the technology needed for implementation, yet retaining a comparable diagnostic sensitivity and specificity.
  • the point-of-care or at-home test allows for rapid detection of genetic material of disease-associated biological material, such as the SARS-CoV-2 virus, in a bodily fluid sample and provides dye-based visualisation of such genetic material.
  • the device can be used by individuals at home for point-of-care testing, enabling said individuals to test themselves using easily obtainable saliva or a similar sample type as the starting point. By allowing fast, accurate and at home or POC site testing, larger numbers of individuals can screen themselves more frequently and most likely cheaper.
  • the test would be faster and easier to implement on sites (i.e., at businesses, homes, schools, etc.). This approach aims to remove the need to travel during testing activities, thereby removing the exposure of health care professionals and the virus spreading.
  • the use of saliva for example, makes the test easier to conduct by the general public and does not require an RNA extraction prior to testing, removing the need for onsite RNA extraction infrastructure and the transport of possible infectious materials to central testing facilities. Additionally, direct testing removes possible biological degradation in samples prior to testing. Since the reaction sample tube is only open to add the bodily fluid sample for testing, possible amplicons and the spread of viruses and bacteria is minimised.
  • the device analyses the sample on the basis of biological, chemical, electrical, thermal, optical, and structural properties, using fluid, acids, light, colour, gas, temperature, energy radiation, microbes, compositions, activators, stimulators, and excitation elements. Secondary input factors that are taken into consideration include body temperature, blood oxygenation, pain, discomfort, colour, infection, symptoms, blood pressure, reaction, and structure.
  • Such assessment utilizes genetic target fragments, biochemicals, spectrometric and/or gas chromatic excretion principles to form an output measurement pattern, and a result that is electronically measured and structured into a simple outcome or as a comprehensive detailed result.
  • One or several sampler sections can be loaded in no particular order for each sample section’s own assessment process.
  • the device can be used to measure or determine the presence of select genetic regions in the genome of an organism of interest. It can also assess tissue, structure, and other properties of the sample, it measures biochemical and electrical properties and behaviour patterns in the sample. Such information gathered can be used for research and development and commercial applications.
  • the device provides the options to measure the presence and properties of particular elements: measure mutations and their properties; stimulate specific activities; measure levels, properties, behaviour, and potential of components of a composition; and observe biochemical factors and properties.
  • the device uses the following principles in assessment or analysis of the sample: measurement of colour and/or frequency spectral properties; measurement of gas presence and/or formation; measurement and/or observation of structural biological, chemical and biochemical formation; measurement of energy activation, behaviour, excretion, radiation and or absorption properties; measurement of chemical reaction properties; measurement of biological behaviour and/or reaction properties; consideration of external influential factors, in this specification, the term “spectrometry” means the measurement of the interactions between light and matter and includes colorimetric and fiuorometric detection.
  • the device utilizes unique spectrometric measurement by using three narrow-band light sources in addition with a Red Green Blue (RGB) light source combined with a white light source to cover the entire spectrum of illumination for a wide spectrum of applications and research options.
  • RGB Red Green Blue
  • White light provides a universal light source and/or for the detection of multiple colours in spectrometry.
  • the specific light sources are selected for detection of specific colours in spectrometry.
  • the device includes the following features:
  • Wireless communication means, such as Wi-Fi USB and/or Bluetooth communication;
  • the device forms part of a system that consists of: a container; a motorized sample door; a sample tube receiving and ejection mechanism; a sample tube guiding structure; a tested sample ejection guide; a tested sample drawer or containment bin; a drawer sensing switch; a UVC sterilizing light source; a UVC sensor; power supply; a LCD touch screen; a camera; an infra-red body temperature sensor; a wireless communication means ⁇ such as a Wi-Fi, RS-485 connection); USB port; on-off switch; micro-controllers; a sample heater; a sample heater temperature sensor; a sample cooling fan or cooling device; a RF tag reader; a gesture processor; an ambient light sensor; an RGB spectrum sensor; a visible light spectrometric sensing device; a narrow band red light source; a narrow band green light source; a narrow band blue light source; a white light source; a visible spectrum RGB light source; a SD card memory holder; internal
  • the device runs from a single 5V power source.
  • the device can be powered from a battery as well as from a power source.
  • the device is therefore portable.
  • USB communication connects the device to a computer.
  • the computer can control the device.
  • the computer can show the device’s functional processes.
  • the computer can receive test results, store, or communicate the results and client data to the internet and to other external systems.
  • a wireless communication means such as Wi-Fi communication, is used to communicate results and client data to another device, such as the internet, to a remote server, such as in an airport, testing facility, hospital etc., or to each of various numbers of test modules that makes up a test system.
  • RS-485 communication is used to communicate to each of various numbers of test modules that make supa test system.
  • the camera provides a photo of the patient being tested.
  • the infrared heat sensor measures the patient’s body temperature or the object’s temperature.
  • UVC is used for killing or deactivating microbes that may be present in the test tubes after testing.
  • a drawer switch indicates to the system when the UVC light may be activated.
  • a UVC sensor indicates to the system that the UVC source is active.
  • a motorized structure opens the sample door for inserting the sample tube.
  • the system will eject the sample tube after completing the test process or when the test tube fails to meet the process requirements.
  • the ejected tube is guided to fall into the tested sample drawer or containment bin.
  • the gesture sensor provides a hands-free operation and instruction feature as a human interface.
  • the RF tag reader reads a RF tag associated with the sample reaction tube or process for a unique serial number in order to track the sample reaction tube with the reagents used, the patient’s data and diagnostic results.
  • the ambient light sensor is used as part of the reference and calibration source.
  • sample excitation / illumination features Five types can be applied, namely, narrow bands Red, Green, Blue; Full White light, and RGB mixed light.
  • Narrowband light sources and wideband light sources are excitation sources for the wide spectrum of biochemical processes, each of which can be individually controlled.
  • the RGB sensor and spectrometric sensors are utilized to measure the biochemical photonic properties of the test sample.
  • the device includes a sample heater and cooler where the temperature controller and measurement system form part of the test process.
  • the LCD display touch screen provides promotional and motivational information, objective information, legal information, process information, user instructions, process details, acts as a user control interface, displays test results, provides user options information, provides relevant feedback data, and provides visual support information and education data.
  • Further applications of the device include, for example, the research of plant extracts, soil minerals and microfiora; the identification of specific biological factors associated with maternal health risk and intervention in livestock; the identification of health- associated factors in livestock; measurement of factors associated with disease treatment in a diseased animal to track progress and recovery; measurement of biological factors to test the sweetness of a fruit.
  • a point-of-care diagnostic device for detection of one or more biological targets of interest in a sample obtained from a patient and diagnosis of the patient based on a diagnostic result of the sample
  • the device comprising the following: a reaction tube receiving chamber for receiving a single reaction tube that is associated with a radiofrequency identification (RFID) tag, wherein the sample is received in the reaction tube and a biological reaction is conducted therein, when the reaction tube is received within the chamber; a sample sterilizer in communication with the reaction tube chamber configured to sterilize the sample by killing or deactivating microbes in the sample; a thermal sensor for measuring and monitoring temperature of the sample during the biological reaction; an RFID reader configured to read the RFID tag associated with the reaction tube for sample tracking; a display screen configured to display the diagnostic result; and a wireless communication device configured to send the diagnostic result and patient data to another device.
  • RFID radiofrequency identification
  • sample tracking includes confirming the type of reaction to be conducted and biochemical logistical history.
  • the one or more biological targets may include genetic mutations in a genome of an organism, or biological structures in an organism.
  • the one or more biological targets may include one or more genetic fragments of a genome of an organism.
  • the device may identify the presence of one or more genetic fragments in the absence of RNA extraction.
  • the one or more biological targets may be detected by DNA or RNA testing using a nucleic-acid based assay, including an RT-LAMP assay.
  • the sample may be bodily fluid, including at least one of saliva, breath, tissue and blood, obtained from the patient.
  • the device may identify the presence of a virus in the sample, including a SARS-CoV- 2 virus for diagnosis of COVID-19.
  • the diagnostic result may be detected using spectrometry, including colorimetric or fluorometric detection.
  • the device may include at least one narrowband excitation source that provides light for the detection using spectrometry.
  • the device may include three narrowband excitation sources, a Red Green Blue (RGB) light source and a white light source that provide light for the detection using spectrometry.
  • the device may include an RGB sensor and a spectrometric sensor to measure biochemical photonic properties of the sample.
  • the device may include an ambient light sensor configured to measure ambient light, such ambient light measurement may be configured to be used for calibration of the RGB sensor and the spectrometric sensor.
  • the sample sterilizer may be an ultraviolet-C sterilizer and may include a sensor configured to detect microbe levels in the sample.
  • the display screen may be a liquid crystal display (LCD) touch screen and may be configured both to display the diagnostic result and to receive a touch-based user input.
  • LCD liquid crystal display
  • the device may include an infrared body temperature sensor to sense a body temperature of the patient and the sensed body temperature may form part of the diagnostic result.
  • the device may include a sample heater and cooler to control the temperature of the sample.
  • the device may include a sample tube guiding structure and a sample tube ejecting mechanism for ejecting tested sample tubes into a containment bin.
  • the device may include a camera for capturing a photograph of the patient.
  • the device may include an RFID writer configured to write the diagnostic result of the sample to the RFID tag that is associated with the sample reaction tube.
  • the RFID tag that is associated with the reaction tube may be a first RFID tag and the RFID reader may be configured to read a second RFID tag associated with a swab used to collect the biological sample, wherein information read from the second RFID tag forms part of the diagnostic result.
  • the device may include a gesture sensor configured to receive a contactless user input from a user to initiate the biological reaction and obtain the diagnostic result of the sample.
  • a method of operating a point-of-care diagnostic device for real-time detection of one or more biological targets of interest in a sample obtained from a patient and diagnosis of the patient based on a diagnostic result of the sample comprising: receiving a single reaction tube in a reaction tube receiving chamber, wherein the single reaction tube is associated with a radiofrequency identification (RFID) tag, the sample being received in the reaction tube and a biological reaction being conducted therein, when the reaction tube is received within the chamber; sterilizing, by a sample sterilizer in communication with the reaction tube chamber, the sample by killing or deactivating microbes in the sample; measuring, by a thermal sensor, temperature of the sample during the biological reaction; reading, by an RFID reader, the RFID tag associated with the reaction tube for sample tracking; displaying, by a display screen, the diagnostic result; and sending, by a wireless communication device, diagnostic result and patient data to another device.
  • RFID radiofrequency identification
  • FIGURE 1 shows different views of the frame of the device; and FIGURE 2 shows the frame of the device indicating where the components are received.
  • the device (10) includes an LCD touch screen (12), a sample loader mechanism (14), a temperature sensor (16), a camera (18) and a samples drawer (20).
  • EXAMPLE Use of the device to test for COVID-19 genetic regions using an RT-
  • Standard colorimetric assays that are easy to interpret by colour, will be the first assay for a fast yes/no assessment (i.e., not taking reagent or sample viability into account).
  • RT-qPCR diagnostic test often utilizes a constitutively expressed human gene as a workflow or reaction validation control.
  • a suitable RT-LAMP assay is developed that targets one of these “in-sample” human gene regions and/or an external RNA standard added to the reaction mix, as an in-reaction viability confirmation.
  • the SARS-CoV-2 gene targets and the in-reaction viability assay are labelled with different labels to facilitate individual reaction confirmation.
  • a positive DNA control LAMP reaction is used as a standard and will convert an RNA template into a more robust DNA template in one of the assays, to conduct the device optimisation. Colorimetric assessment is included for yes/no assays.
  • Samples of bodily fluids are utilised, such as saliva, breath, body odour, tissue, blood, etc.
  • Such sample will be collected by means of paper, stick, spoon, pipette, syringe, disc, needle, flask, bottle, tube, or similar.
  • a saliva sample in-a-tube is easy to obtain, removing the need for swabs and enabling easier self-testing applications and/or liquid handling automation.
  • the RT-LAMP assay includes the use of SARS-CoV-2 RT-LAMP primers and probes. Positive control DNA/RNA fragments will be synthesized for testing the different gene targeting RT-LAMP primers and will include features to allow for in vitro RNA template generation or will include synthesized RNA fragments for workflow testing and quality control purposes. Non-BSL extracted RNA of SARS-CoV-2 would serve as spikes for human samples (e.g., saliva).
  • a standard human housekeeping gene is used as a reaction verification RT-LAMP control. Fluorescent probes and quenchers allow for target specific RT-LAMP product identification. The fluorescent probes are robust enough to distinguish between a COVID-19 test and the internal reaction control. This will initially be validated on a real time PCR system to ensure a working chemistry prior to use in the POC device.
  • the invention is directed at a diagnostic point-of-care device for the identification of biological targets of interest from a biological or synthetic organism of interest for onsite, or at home, diagnosis of diseases, disorders and conditions in real-time.
  • the device reduces assay times and removes the need for central processing.
  • the device may identify, for example, the presence of one or more genetic regions of interest of a genome of a microorganism, such as a virus or bacteria, or the presence of one or more genetic regions of interest or genetic mutations of interest that are associated with a particular disease, disorder or condition.
  • the device alleviates the problems associated with diagnosis by providing a portable device that runs off a simple power source, such as a battery pack; requires a bodily fluid sample that can be easily obtained from a patient; uses a single reaction tube for collecting and running a reaction from a sample; runs the biological reaction entirely within the device and does not require intervention from a user; maintains patient confidentiality; tracks the sample using RFID technology; obtains and presents the diagnostic results in realtime; and conveys such diagnostic results to a user or relevant authority. Bhadra S, Riedel TE, et al. (2020). High-surety isothermal amplification and detection of SARSCoV-2, including with crude enzymes.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Analytical Chemistry (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)

Abstract

L'invention concerne un dispositif de diagnostic de point de soins pour la détection d'une ou de plusieurs cibles biologiques d'intérêt dans un échantillon obtenu à partir d'un patient et le diagnostic du patient, le dispositif comprenant : une chambre de réception de tube de réaction pour recevoir un seul tube de réaction 5 qui est associé à une étiquette d'identification par radiofréquence (RFID), l'échantillon étant reçu dans le tube de réaction et une réaction biologique étant conduite à l'intérieur de celle-ci, lorsque le tube de réaction est reçu à l'intérieur de la chambre ; un stérilisateur d'échantillon en communication avec la chambre de tube de réaction configuré pour stériliser l'échantillon par élimination ou désactivation de microbes dans l'échantillon ; un capteur de geste configuré pour recevoir une entrée d'utilisateur sans contact provenant d'un utilisateur pour initier la réaction biologique et obtenir un résultat de diagnostic de l'échantillon ; un capteur thermique pour mesurer et surveiller la température de l'échantillon pendant la réaction biologique ; un lecteur RFID configuré pour lire l'étiquette RFID associée au tube de réaction ; un écran d'affichage configuré pour afficher le résultat de diagnostic ; et un dispositif de communication sans fil configuré pour envoyer le résultat de diagnostic et les données de patient à un autre dispositif. L'invention concerne également un procédé d'utilisation du dispositif de diagnostic.
PCT/IB2021/054825 2020-06-02 2021-06-02 Essai rapide de nucléation WO2021245565A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ZA2020/03274 2020-06-02
ZA202003274 2020-06-02

Publications (1)

Publication Number Publication Date
WO2021245565A1 true WO2021245565A1 (fr) 2021-12-09

Family

ID=76305953

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2021/054825 WO2021245565A1 (fr) 2020-06-02 2021-06-02 Essai rapide de nucléation

Country Status (1)

Country Link
WO (1) WO2021245565A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030073931A1 (en) * 2001-10-16 2003-04-17 Dirk Boecker Universal diagnostic platform
US20120143018A1 (en) * 2009-01-19 2012-06-07 Skidmore Frank M Portable touchless vital sign acquisition device
US20130027185A1 (en) * 2010-02-27 2013-01-31 Lear Sirous Lavi RFID - Specimen Transport Puck Process Features and Porcess Method to Efficiently Wand, Rack, Transport, Track Specimens in the Laboratory
WO2017106790A1 (fr) * 2015-12-18 2017-06-22 Clear Gene, Inc. Méthodes, compositions, kits et dispositifs pour l'analyse rapide de marqueurs biologiques
US20180100869A1 (en) * 2016-10-07 2018-04-12 Boehringer Ingelheim Vetmedica Gmbh Analysis system for testing a sample

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030073931A1 (en) * 2001-10-16 2003-04-17 Dirk Boecker Universal diagnostic platform
US20120143018A1 (en) * 2009-01-19 2012-06-07 Skidmore Frank M Portable touchless vital sign acquisition device
US20130027185A1 (en) * 2010-02-27 2013-01-31 Lear Sirous Lavi RFID - Specimen Transport Puck Process Features and Porcess Method to Efficiently Wand, Rack, Transport, Track Specimens in the Laboratory
WO2017106790A1 (fr) * 2015-12-18 2017-06-22 Clear Gene, Inc. Méthodes, compositions, kits et dispositifs pour l'analyse rapide de marqueurs biologiques
US20180100869A1 (en) * 2016-10-07 2018-04-12 Boehringer Ingelheim Vetmedica Gmbh Analysis system for testing a sample

Non-Patent Citations (12)

* Cited by examiner, † Cited by third party
Title
BHADRA SRIEDEL TE ET AL.: "High-surety isothermal amplification and detection of SARSCoV-2, including with crude enzymes", BIORXIV2020.04.13.039941, 2020
EL-THOLOTH MBAU HH ET AL.: "A Single and Two-Stage, Closed-Tube, Molecular Test for the 2019 Novel Coronavirus (COVID-19) at Home, Clinic, and Points of Entry", CHEMRXIV. PREPRINT, 2020, Retrieved from the Internet <URL:https://doi.org/10.26434/chemrxiv.11860137.v1>
LAMB LEBARTOLONE SN ET AL., RAPID DETECTION OF NOVEL CORONAVIRUS (COVID19) BY REVERSE TRANSCRIPTION-LOOP-MEDIATED ISOTHERMAL AMPLIFICATION, 2020, Retrieved from the Internet <URL:hitps://ssm.com/abstract=3539654>
LEE JYHBEST N ET AL.: "Validation of a single-step, single-tube reverse transcription-loop mediate isothermal amplification assay for rapid detection of SARS-CoV-2 RNA", BIORXIV2020.04.28.067363, 2020
LU RWU X ET AL.: "A Novel Reverse Transcription Loop-Mediated Isothermal Amplification Method for Rapid Detection of SARS-CoV-2", INT J MOL SCI., vol. 21, no. 8, 18 April 2020 (2020-04-18), pages E2826
LU RWU XWAN Z ET AL.: "Development of a Novel Reverse Transcription Loop-Mediated Isothermal Amplification Method for Rapid Detection of SARS-CoV-2", VIROL SIN., 2020, pages 1 - 4
OSTERDAHL MFLEE KA ET AL.: "Detecting SARS-CoV-2 at point of care: Preliminary datacomparing Loop-mediated isothermal amplification (LAMP) to PCR", MEDRXIV2020.04.01.20047357, 2020
PARK GSKU K ET AL.: "Development of Reverse Transcription Loop-Mediated Isothermal Amplification Assays Targeting Severe Acute Respiratory Syndrome Coronavirus 2", THE JOURNAL OF MOLECULAR DIAGNOSTICS: JMD, 2020, Retrieved from the Internet <URL:https://doi.org/com/10.1016/j.jmoldx.2020.03.006>
YAN C, CUI J ET AL.: "Rapid and visual detection of 2019 novel coronavirus (SARS-CoV-2) by a reverse transcription loop-mediated isothermal amplification assay", CLINICAL MICROBIOLOGY AND INFECTION, vol. 26, no. 6, 2020, pages 773 - 779, XP055760335, DOI: 10.1016/j.cmi.2020.04.001
YANG WDANG W ET AL.: "Rapid Detection of SARS-CoV-2 Using Reverse transcription RT-LAMP method", MEDRXIV2020.03.02.20030130, 2020, Retrieved from the Internet <URL:https://doi.org/10.1101/2020.03.02.20030130>
YU LWU S ET AL.: "Rapid colorimetric detection of COVID-19 coronavirus using a reverse transcriptional loop-mediated isothermal amplification (RT-LAMP) diagnostic platform: iLACO", MEDRXIV2020.02.20.20025874, 2020, Retrieved from the Internet <URL:https://doi.org/10.1101/2020.02.20.20025874>
ZHANG YODIWUOR N ET AL.: "Rapid Molecular Detection of SARS-CoV-2 (COVID-19) Virus RNA Using Colorimetric LAMP", MEDRXIV2020.02.26.20028373, 2020

Similar Documents

Publication Publication Date Title
TW201737135A (zh) 用於疾病監測和評估的方法和系統
CN106520517B (zh) 一种便携式微流控芯片lamp可视化检测仪及其检测方法
EP2407557B1 (fr) Appareil pour une analyse d&#39;acide nucléique en temps réel intégré, et procédé de détection d&#39;un acide nucléique cible à l&#39;aide de celui-ci
JP2020534854A (ja) 診断テストシステムおよび方法
US20090061450A1 (en) System and method for diagnosis of infectious diseases
JP2008518617A5 (fr)
CN106367307A (zh) 一种自动化核酸定量分析装置及分析方法
WO2016004539A1 (fr) Dispositif de réaction en chaîne par polymérase délocalisé pour le dépistage de maladies
US20190168219A1 (en) Systems, apparatus, and methods for inline sample preparation
Ahmed et al. Establishing molecular microbiology facilities in developing countries
US20210291176A1 (en) Rapid diagnostic test with blister pack
Chen et al. Portable magnetofluidic device for point-of-need detection of African swine fever
Mohan et al. Loop-mediated isothermal amplification for the detection of Pasteurella multocida, Mannheimia haemolytica, and Histophilus somni in bovine nasal samples
EP3627513A1 (fr) Procédé d&#39;analyse, appareil de traitement d&#39;informations, système d&#39;analyse de gènes et support d&#39;enregistrement non transitoire
WO2018195951A1 (fr) Systèmes de prélèvement, de traitement et d&#39;analyse d&#39;échantillons intégrés
CN107002066A (zh) 复合式多步核酸扩增
WO2021245565A1 (fr) Essai rapide de nucléation
WO2014058064A1 (fr) Système d&#39;inspection et procédé d&#39;inspection
JP2005512023A (ja) 遠隔遺伝子分析及び診察用のシステム、方法及びキット
US20220033884A1 (en) Methods and systems for identification of spinal muscular atrophy
US20230109581A1 (en) Color reading for diagnostic tests
US20220040699A1 (en) Temperature profile encoding for diagnostic tests
EP2992959A1 (fr) Système portable pour l&#39;analyse génétique in situ
US20230109977A1 (en) Point of need fluid transport device
US20230323482A1 (en) Apparatus, device and method for photodetection of pathogens

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21730666

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 21730666

Country of ref document: EP

Kind code of ref document: A1