WO2026022012A1 - Système de détection pour diagnostic in vitro et méthode de détection pour diagnostic in vitro pour détermination de présence d'une substance fluide reposant sur la technologie des radiofréquences - Google Patents

Système de détection pour diagnostic in vitro et méthode de détection pour diagnostic in vitro pour détermination de présence d'une substance fluide reposant sur la technologie des radiofréquences

Info

Publication number
WO2026022012A1
WO2026022012A1 PCT/EP2025/070587 EP2025070587W WO2026022012A1 WO 2026022012 A1 WO2026022012 A1 WO 2026022012A1 EP 2025070587 W EP2025070587 W EP 2025070587W WO 2026022012 A1 WO2026022012 A1 WO 2026022012A1
Authority
WO
WIPO (PCT)
Prior art keywords
antenna
signal
sample
ivd
antennas
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/EP2025/070587
Other languages
English (en)
Inventor
Michael Lambertson
Berkin YANARSOENMEZ
Florian Hoffmann
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Roche Diagnostics GmbH
Roche Diagnostics Operations Inc
Original Assignee
F Hoffmann La Roche AG
Roche Diagnostics GmbH
Roche Diagnostics Operations Inc
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 F Hoffmann La Roche AG, Roche Diagnostics GmbH, Roche Diagnostics Operations Inc filed Critical F Hoffmann La Roche AG
Publication of WO2026022012A1 publication Critical patent/WO2026022012A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N22/00—Investigating or analysing materials by the use of microwaves or radio waves, i.e. electromagnetic waves with a wavelength of one millimetre or more
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N22/00—Investigating or analysing materials by the use of microwaves or radio waves, i.e. electromagnetic waves with a wavelength of one millimetre or more
    • G01N22/04—Investigating moisture content
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G01N33/4915—Blood using flow cells

Definitions

  • the present invention relates to an In-vitro diagnostics sensing system and In-vitro diagnostics sensing method of determining a presence of a fluid substance based on radio-frequency technology.
  • the present invention provides a sensitive, simple and/or cheap concept to detect the presence of fluid substances in the pl-range.
  • diagnostic analyzers it is important to determine whether or not a fluid, such as a liquid and more specifically a sample liquid or another liquid, which is supposed to flow through the diagnostic analyzer, is present in a certain position of the diagnostic analyzer. Further, it may be important to determine and/or classify the type of fluid if present in the certain position.
  • a parameter of a blood sample may be determined by a sensor in a fluid channel. If the sensor shows irregular behavior, it may be determined whether the irregular behavior arises from the absence of the blood sample or from a defect in the sensor if the blood sample is present. Further, it may be required to determine the type of fluid that is present near the sensor for example. If for example, a standby solution and/or a buffer is in the channel, the measurement sensor may not be supposed to determine the parameter that should be determined for the blood sample. Therefore, the sensor measurement may only be initiated in a case when the presence of the blood sample is detected.
  • the measurement cartridges may comprise channels and/or channel systems, specifically microfluidic channels.
  • electrochemical conductivity measurements are performed to determine the presence and/or the type of sample in the channel.
  • specific sensors comprising two or more electrodes are provided to physically contact the liquid inside the channel.
  • the electrodes are often integrated in the cartridges increasing the degree of complexity in the cartridge and the production cost. Further, the electrodes are disposed together with the cartridge even if they are still fully functional. Moreover, if only one of these electrodes has a defect, the entire cartridge may be required to be disposed - in some cases even before its actual use.
  • a potentiometric filling level measurement is described for example in EP 1 992 921 Al.
  • optical systems in the visible and/or near to midinfrared range and being based on extinction and/or vibrational spectroscopy may be provided. Such systems may be provided permanently inside the diagnostic analyzer and/or outside of the cartridge however, the setup of such systems is complex, expensive and requires a lot of maintenance.
  • the IVD sensing system can provide a concept for determining the presence of minor amounts of fluids in the pL range while allowing to reduce the complexity of cartridges in diagnostic analyzers and/or reducing the waste and/or use of material and/or reducing the production costs, as well as keeping the setup of the diagnostic analyzer as simple as possible.
  • the analysis of RF signals is simple and does not require complex electronic and/or mechanical analyzers and/or processors. Antennas are cheap in production and require a low degree in maintenance.
  • the IVD sensing system may provide a stable geometry and/or design such that the circumstances, under which multiple measurements are performed, constantly remain the same, hence being very robust and therefore require a low degree in maintenance while performing measurements at high precision.
  • determining the presence of minor amounts of fluids may be provided without the requirement of a physical contact with the fluid, specifically a fluid sample. Therefore, non- invasive detection of fluids can be provided.
  • the system allows detecting and/or determining whether or not a fluid that has a small volume in the pL range is present in a certain position where the measurement is performed.
  • the system may or may not allow to determine the fluid volume/sub stance volume and/or a range of the fluid volume/sub stance volume.
  • the IVD sensing system for the determination of the presence of the fluid substance which is based on RF technology may comprise: exactly one antenna (no more than one antenna), wherein the one antenna is configured to emit the RF signal and wherein the one antenna is configured to receive the emitted RF signal, i.e.
  • the antenna corresponds to a transceiver that emits and detects a signal; the sample space being positioned with respect to the one antenna such that the RF signal can pass at least a portion of the sample space after being emitted and before being received and the sample space being configured to receive the sample support for receiving the fluid substance; and the transformer being configured to transform the received RF signal into the readable signal that is sensitive to indicate the presence of the fluid substance in the sample support having the substance volume in the range between 500pL and 0,1 pL, specifically in the range between 20pL and 0,5pL.
  • the IVD sensing system for the determination of the presence of the fluid substance which is based on RF technology may comprise: exactly two antennas (no more than two antennas), wherein a first antenna of the two antennas is configured to emit the RF signal and wherein a second antenna of the two antennas is configured to receive the RF signal emitted by the first antenna; the sample space being positioned with respect to the two antennas, i.e.
  • the first and the second antenna such that the RF signal can pass at least a portion of the sample space after being emitted and before being received and the sample space being configured to receive the sample support for receiving the fluid substance; and the transformer being configured to transform the received RF signal into the readable signal that is sensitive to indicate the presence of the fluid substance in the sample support having the substance volume in the range between 5OOpL and 0,1 pL, specifically in the range between 20pL and 0,5pL.
  • the IVD sensing system for the determination of the presence of the fluid substance which is based on RF technology may comprise: more than two antennas, specifically multiple first antennas configured to emit the RF signal and/or multiple second antennas configured to receive the RF signal emitted by the first antenna(s).
  • the RF signal that is transmitted may generally be considered the same RF signal that is received however, the received RF signal may carry information if it has passed a medium such as the fluid substance which is not yet carried by the RF signal that is transmitted before passing the information.
  • the RF signal that may be transmitted by one or more first antenna(s) may change upon passing a medium and contain information about whether or not a certain medium, such as a fluid substance was passed.
  • the one or more second antenna(s) can receive this RF signal that was sent out by the one or more first antenna(s) wherein the RF signal may carry the information about the medium after passing the same.
  • the term “determination of a presence of a fluid substance” may refer in the present case to a determination whether a fluid substance of more than approximately 0, 1 pl, specifically more than approximately 0,5pl is present in the position that is subjected to the detection. It may be determined whether or not, a fluid substance at volumes higher than approximately 0,1 pl, specifically higher than approximately 0,5 pl is passing and/or present in this position. Specifically, it may be detected whether or not a fluid substance having a volume in a range between approximately 500pL and 0,1 pL, specifically in a range between approximately 20pL and 0,5pL is present in the position that is subjected to the detection.
  • a “fluid substance” may refer to a substance that can flow and take the shape of its container. It may adopt one of the three classical states of matter, alongside solid and gas. Fluids include liquids and gases, which share the common characteristic of being able to flow and conform to the shape of their containers. However, also solids, for example having a granular and/or powder-like configuration, may be considered a fluid substance. Liquids have a definite volume but no definite shape. They can flow and take the shape of the container they are placed in. Liquids comprise liquid particles that are close together but are able to move past each other. Gases, such as oxygen, nitrogen, and carbon dioxide, have neither a definite volume nor a definite shape. They can expand to fill the entire space of their container. Gases comprise gas particles that are farther apart than in a liquid and move freely in all directions. Fluids have important properties such as viscosity, density, pressure, and buoyancy, which govern their behavior.
  • the fluid substance may comprise a buffer, a standby solution, a calibrator, a biological and/or biomedical sample, specifically a bodily fluid and more specifically at least one of the following: blood and/or a component of blood, saliva, sweat, a lacrimal fluid and the like.
  • sample may correspond to a fluid sample which may be considered a “fluid substance” and in some cases an “object”.
  • antenna refers to a device which may be used for transmitting and/or receiving electromagnetic waves, for example in the field of communication but also for detection.
  • An antenna may comprise metal and may be designed to efficiently radiate and/or receive radio frequency signals.
  • Antennas may generally be used in various applications, including radio and television broadcasting, wireless communication systems, radar systems, and satellite communication. Antennas may vary in shape and/or size depending on the frequency range and specific requirements of the communication system.
  • Radio frequency (RF) technology refers to the use of electromagnetic waves within the radio frequency spectrum for various applications. In general, it may involve the transmission and/or reception of signals within the range of frequencies from a few kilohertz (kHz) to several gigahertz (GHz).
  • RF technology is generally used in wireless communication systems, such as radio and television broadcasting, cellular networks, Wi-Fi, Bluetooth, RFID (Radio Frequency Identification), and satellite communication.
  • RF technology generally enables the wireless transfer of information, allowing devices to communicate with each other without the need for physical cables and RF signals can typically carry information, such as voice, data, video, and other types of information, making it a versatile technology used in a wide range of industries, including telecommunications, healthcare, transportation, and entertainment.
  • the technology behind RF involves the generation, modulation, amplification, and demodulation of radio waves to transmit and receive information. It relies on antennas to efficiently transmit and receive these signals.
  • the transformer is configured to transform the received RF signal into a readable signal that is sensitive to indicate the presence of the fluid substance in the sample support having a substance volume in a range between 500pL and 0,1 pL, specifically in a range between 20pL and 0,5pL, specifically, the readable signal may be sensitive to a change in properties of the dielectric medium as the detection and/or sensing is based on a capacitive measurement. As the change in the dielectric medium is dependent from the volume of the dielectric medium, a change in the volume may also be detectable.
  • the determination of the presence of a fluid substance may specifically be performed in a contactless manner, in which the antenna(s) is/are not in direct contact with the fluid substance of a sample. In other words, physical contact between an antenna and a sample may be avoided during the measurement. There may however be a physical contact between an antenna and the sample support and/or container.
  • the readable signal may comprise and/or correspond to a DC current.
  • the readable signal may be sensitive to indicate the substance volume and/or a volume range of the fluid substance, specifically in a precision range between +/- 0.5pL and +/-0.1pL, more specifically in a precision range between +/-0.3pL and +/-0.2pL.
  • the readable signal may be analyzed for the substance volume and/or a range of the substance volume at a high precision. Therefore, the readable signal may be sensitive to the slightest differences in substance volume, specifically in a precision range between +/- 0.5pL and +/-0.1pL, more specifically in a precision range between +/-0.3pL and +/- 0.2pL.
  • the readable signal may be sensitive to irregularities such as bubbles and/or clots and/or solid particles and/or impurities inside the fluid substance. Detecting the volume, the volume range and/or other physical properties of the substance may allow further assessing the reliability of other measurements that are performed to determine parameters of the substance.
  • the IVD sensing system may be configured to be operated in a reflection configuration: the one or more antennas may correspond to at least one first antenna configured to emit the RF signal and configured to receive the RF signal after being emitted, after passing the sample space at least partially and after being reflected from a reflection element and/or back scattered from the sample support and/or a sample, or wherein the one or more antennas may correspond to: the at least one first antenna; and the at least one second antenna being configured to receive the RF signal after being emitted by the at least one first antenna, after passing the sample space at least partially and after being reflected from a reflection element and/or back scattered from the sample support and/or a sample.
  • the IVD sensing system may be configured to be operated in a reflection configuration: the one or more antennas may consist of and/or comprise at least one first antenna configured to emit the RF signal and configured to receive the RF signal after being emitted, after passing the sample space at least partially and after being reflected from a reflection element and/or back scattered from the sample support and/or a sample, or the one or more antennas may consist of and/or comprise the at least one first antenna and the at least one second antenna being configured to receive the RF signal after being emitted by the at least one first antenna, after passing the sample space at least partially and after being reflected from a reflection element and/or back scattered from the sample support and/or a sample.
  • the sample is passed multiple times and therefore the signal can be averaged , which may be of interest if the precision should be increased and/or a physical property should be determined at a high degree of precision.
  • only one antenna may be provided to reduce the number of elements, to safe space and/or to reduce the degree of complexity of the system.
  • the IVD sensing system may comprise the reflection element, specifically wherein the reflection element may be positioned adjacent the at least one first antenna such that the sample space is positioned between the at least one first antenna and the reflection element, specifically to allow the emitted RF signal to pass at least a portion of the sample space twice.
  • the reflection configuration may be realized in a simple and/or cheap manner.
  • the IVD sensing system may be configured to be operated in a transmission configuration: the one or more antennas may correspond to: the at least one first antenna; and the at least one second antenna, wherein the at least one second antenna may be positioned adjacent the at least one first antenna such that the sample space is positioned between the at least one first antenna and the at least one second antenna, specifically to allow the emitted RF signal to pass from the at least one first antenna to the at least one second antenna at least a portion of the sample space only once.
  • the IVD sensing system may be configured to be operated in a transmission configuration: the one or more antennas may consist of and/or comprise the at least one first antenna and the at least one second antenna, wherein the at least one second antenna may be positioned adjacent the at least one first antenna such that the sample space is positioned between the at least one first antenna and the at least one second antenna to allow the emitted RF signal to pass from the at least one first antenna to the at least one second antenna at least a portion of the sample space only once.
  • the transmission configuration it may be simple to align at least one first antenna with at least one second antenna in a stable and/or robust manner.
  • the same system may be configured and/or comprise elements such that, in some cases, it may be used in the transmission configuration and in other cases it may be used in the reflection configuration.
  • the RF signal may comprise at least one frequency in the radar frequency range and/or in the microwave frequency range, specifically in the frequency range between 90MHz and 50GHz, more specifically in the frequency range between 10GHz and 20GHz and/or in the K-Band frequency range between 18GHz and 27GHz.
  • Radar stands for "Radio Detection and Ranging.” It is a system that uses radio waves to detect and locate objects such as aircraft, ships, vehicles, weather formations, and even terrain and/or to determine the distance (ranging), angle, or velocity of objects. Radar works by emitting radio waves and then measuring the time it takes for those waves to bounce back after they hit an object. This information allows radar systems to determine the distance, speed, and direction of the objects it detects. Radar technology has a wide range of applications, including air traffic control, weather monitoring, military defense, and navigation systems.
  • a radar system comprises a transmitter producing electromagnetic waves in the radio or microwaves domain, a transmitting antenna, a receiving antenna (often the same antenna is used for transmitting and receiving) and a receiver and processor to determine properties of the object(s).
  • Radio waves (pulsed or continuous) from the transmitter may be reflected off an object and may return to the receiver, giving information about the object's location and speed. In other cases, it may be transmitted through a medium from a transmitter to a receiver.
  • the one or more antennas may comprise a strip antenna array, specifically a microstrip antenna array.
  • Strip antenna arrays specifically microstrip antenna arrays are simple and/or cheap and provide a possibility to realize the invention at a low level of complexity, while maintaining and/or achieving a high level of sensitivity.
  • the IVD sensing system may comprise: the sample support, specifically wherein the sample support may comprise a test strip and/or a sample container and the sample support may be configured to receive the complete substance volume, specifically wherein the sample container may comprise at least one of a capillary, a cuvette, a pipette tip, a tube, a microfluidic channel, a vial.
  • the sample support may confine the substance in at least one dimension.
  • the sample support may comprise a test strip, specifically a substrate with a lateral flow assay and/or a pad positioned thereon and that can hold and/or contain a fluid by capillary forces.
  • the sample support may correspond in some cases to a container that at least partially encloses the substance.
  • the IVD sensing system may be configured to determine whether or not a fluid substance has reached a certain position on the test strip and/or in the sample container.
  • Providing a sample support, specifically a sample container helps providing and/or realizing a contact-free measurement configuration in which the sample and/or fluid substance does not contact the antenna(s).
  • the sample support may be dimensioned to leave a gap between at least one of the one or more antennas and a surface of the sample support that faces the at least one of the one or more antennas when the sample support is received by the sample space.
  • the sample support is not in direct physical contact with the respective antenna.
  • the gap maybe an air-filled gap or a gap for an (optical) element and/or a spacer element. Providing a gap further helps providing and/or realizing a contact-free measurement configuration in which the sample and/or fluid substance does not contact the antenna(s).
  • the IVD sensing system may comprise: at least one waveguide coupler and/or at least one optical lens, each one being dimensioned to be positioned in the gap and configured to at least partially transmit the RF signal via at least a portion of the gap.
  • a waveguide coupler and/or an optical lens allow to efficiently couple and/or focus the electromagnetic wave corresponding to the RF signal into the sample support.
  • the sensitivity may therefore be increased and the position of detection inside the sample area may be well defined.
  • the gap may be defined by an antenna distance between at least one of the one or more antennas and the surface of the sample support that faces the at least one of the one or more antennas when the sample support is received by the sample space and wherein the distance is in a range between 1 cm and 15cm, specifically between 3cm and 10cm, specifically wherein the antenna distance may be configured to be permanently fixed, and/or the antenna distance may be configured to be varied.
  • a permanently fixed antenna distance allows keeping the design stable and robust for a long time and it ensures that the measurements can be performed under constant circumstances for a long time.
  • a variable antenna distance allows for a high degree of versatility.
  • the RF signal may comprise a temporally varying frequency sweeping a frequency range and/or at least one temporally constant frequency. This allows the measurement of a film and/or layer thickness, specifically in a case when the frequency, the intensity and/or the phase can be detected and analyzed.
  • an IVD sensing method of determining a presence of a fluid substance based on RF technology comprises: providing one or more antennas; providing a sample space in which a sample support with the fluid substance is received; emitting an RF signal with at least one first antenna of the one or more antennas; passing the RF signal via at least a portion of a sample space and the sample support after being emitted; receiving, by the at least one first antenna and/or by at least one second antenna of the one or more antennas the emitted RF signal after passing the sample space and the sample support; and transforming the received RF signal into a readable signal that is sensitive to indicate the presence of the fluid substance in the sample support having a substance volume in a range between 500pL and 0.1 pL, specifically in a range between 20pL and 0.5pL.
  • the IVD sensing method may provide a stable concept such that the circumstances, under which multiple measurements are performed, constantly remain the same, hence being very robust and therefore requiring a low degree in maintenance while performing measurements at high precision.
  • determining the presence of minor amounts of fluids may be provided without the requirement of a physical contact with the fluid, specifically a fluid sample. Therefore, non- invasive detection of fluids can be provided and maintenance and/or cleaning and/or disposing activities may be reduced or even avoided.
  • the method allows detecting and/or determining whether or not a fluid that has a small volume in the pL range is present in a certain position where the measurement is performed.
  • the method may or may not allow to determine the fluid volume/sub stance volume and/or a range of the fluid volume/sub stance volume.
  • the RF signal may be passed once via at least a portion of a sample space and the sample support; and/or in a reflection configuration, the RF signal may be passed twice via at least a portion of a sample space and the sample support.
  • the IVD sensing method may comprise transforming the received RF signal into the readable signal comprising a DC current, and/or wherein the readable signal may be sensitive to indicate the substance volume and/or a volume range of the fluid substance, specifically in a precision range between +/- 0.5pL and +/-0.1pL, more specifically in a precision range between +/-0.3pL and +/-0.2pL.
  • the IVD sensing method and all embodiments thereof may have the same technical effects and/or advantages as their corresponding IVD sensing system.
  • all devices, systems, methods and/or processes described herein may be realized or may be performed half-automated, partially automated and/or fully automated.
  • the terminology “half-automated” and/or “partially automated” and “fully automated” systems and/or processes refer to the level of automation in the processes and/or systems described herein.
  • some tasks or steps are performed by humans, specifically manually, while others are automated by machines and/or software.
  • a fully automated system and/or process is one where substantially all tasks or steps are performed by at least one machine and/or software without human intervention.
  • half-automated and/or partially automated systems and/or processes lies in the extent of human involvement and the level of control over the process/system.
  • humans are responsible for certain tasks, such as inputting data, making decisions, or performing physical actions, which may range between approximately 45-99%, specifically between approximately 50-80%.
  • the automation may be used to streamline or assist with certain aspects of the process, but humans may still be required to oversee and manage the overall operation.
  • at least one machine and/or software performs at least approximately 80%, specifically at least approximately 90% of all process steps.
  • a fully automated system and/or process is designed and/or constructed to operate substantially without human intervention.
  • Substantially all tasks, from data input to decision-making and physical actions, may be handled by at least one machine and/or software.
  • a high level of automation may increase efficiency, reduce errors, and allow for continuous operation.
  • Fig- 1 is a scheme demonstrating the general concept of radar technology
  • Fig- 2 is a scheme showing an IVD sensing system in a transmission configuration, according to an embodiment
  • Fig- 3 is a scheme showing an IVD sensing system in a reflection configuration, according to an embodiment
  • Fig. 4 is a scheme showing the electronics of an IVD sensing system in a reflection configuration, according to an embodiment
  • Fig. 5 is a recording of a readable signal recorded with an IVD sensing system, according to an embodiment.
  • Fig. 6 shows a flow chart of the IVD sensing method according to an embodiment.
  • Fig. 1 is a scheme demonstrating the general concept of radar technology.
  • a first antenna 2a emits an RF signal 3a, which is a radar wave in this scheme.
  • the RF signal 3a “hits” an object 1, such as a cuvette with a sample fluid being filled therein, and gets at least partially reflected off the object 1.
  • the reflected RF signal 3b is received by the second antenna 2b and a processor (not shown) may calculate for example the distance between the antennas 2a, 2b and the object 1.
  • the emitted RF signal 3a and the received RF signal 3b may substantially correspond to each other or may differ (at least slightly) in at least one physical property such as the frequency, the divergence, the intensity, the energy density and/or another physical property.
  • Fig. 2 is a scheme showing an IVD sensing system 10 or at least some components thereof in a transmission configuration TC, according to an embodiment.
  • One first antenna 2a also denoted “transmitting antenna”, which transmits an electromagnetic wave 3a
  • one second antenna 2b also denoted “ receiving antenna”, which receives the electromagnetic wave 3b after passage of the sample 1 are positioned adjacent to each other such that the sample space 4 is positioned between the first antenna 2a and the second antenna 2b.
  • the electromagnetic wave is transmitted through the object/sample 1.
  • first antenna 2a and one second antenna 2b are shown in the present embodiment of Fig. 2, only one first antenna 2a and one second antenna 2b is shown.
  • another embodiment of the IVD sensing system 10 in a transmission configuration TC may comprise multiple first antennas 2a (two, three, four, five, six, seven, eight, nine, ten or more, such as up to about 100, 200, 300, or more) and/or the IVD sensing system 10 may comprise multiple second antennas 2b (two, three, four, five, six, seven, eight, nine, ten or more, such as up to about 100, 200, 300, or more).
  • Fig- 3 is a scheme showing an IVD sensing system 10 in a reflection configuration RC, according to an embodiment.
  • One antenna having the function of a first antenna 2a (also denoted “transmitting antenna”) and a second antenna 2b (also denoted “ receiving antenna”) is positioned adjacent the sample space 4.
  • the object 1 which may correspond to a cuvette or another type of container, which is configured to contain a liquid, such as a sample fluid, is positioned in the sample space 4.
  • the electromagnetic wave is partially absorbed by the object/sample 1 and partially reflected and/or scattered off such that the antenna can receive a at least a portion of the transmitted electromagnetic wave.
  • a first antenna 2a also denoted “transmitting antenna”
  • a second antenna 2b also denoted “ receiving antenna”
  • another embodiment of the IVD sensing system 10 in a reflection configuration RC may comprise multiple first antennas 2a (two, three, four, five, six, seven, eight, nine, ten or more, such as up to about 100, 200, 300, or more) and/or the IVD sensing system 10 may comprise multiple second antennas 2b (two, three, four, five, six, seven, eight, nine, ten or more, such as up to about 100, 200, 300, or more), positioned in the sense of the reflection configuration RC.
  • Fig- 4 is a scheme showing the electronics of an IVD sensing system 10 in a reflection configuration RC, according to an embodiment.
  • the radar detection is acquired by the use of an antenna strip array comprising multiple antennas 2. This array of antennas 2 is designed for the desired resonance frequency.
  • the use of K-Band Radar is performed in the present embodiment at approximately 24 GHz, as an example.
  • the substance volume that is detected in the present embodiment ranges around approximately 10 pL and 5 pL.
  • the general setup of the IVD sensing system 10 according to an embodiment may be based on an aluminum chamber, which may comprise a 24 GHz radar module/radar unit 12 and a sample support 5, e.g. a cuvette 5 which may comprise a pipette and the substance 1, as shown in Fig. 4. This pipette may hold up to approx. 10 pL of the fluid substance 1. Minor amounts/volumes of a blood sample may for example be contained by the sample support 5, specifically the pipette.
  • the radar unit 12 comprises and/or is coupled to a mixing stage 13 which mixes the sent and received signal 3a, 3b into a fundamental frequency plus and fundamental minus the received frequency.
  • the fundamental “minus information” is transformed into a readable signal 7 comprising a DC voltage by using a low pass filter value, which reflects the RMS value of the difference between the fundamental and the received frequency.
  • Fig- 5 is a recording of a readable signal 7 recorded with the IVD sensing system 10 according to the embodiment described together with Fig. 4.
  • the cuvette 5 is loaded with approx. lOpL of water, with approx. 5 pL of water or it may be substantially emptied.
  • the empty state of the cuvette is indicated by the value of 160 mV (in the empty state of the cuvette).
  • the reading of approx. 115 mV corresponds to the DC value indicating a substance volume V of approx. 10 pL of water.
  • the reading of approx. 130 mV corresponds to the DC value indicating a substance volume V of approx. 5 pL of water.
  • Fig. 6 shows a flow chart of the IVD sensing method 100 according to an embodiment.
  • the IVD sensing method 100 of or for determining a presence of a fluid substance 1 comprises: providing 101 one or more antennas 2, specifically an antenna array which comprises a high number of antennas 2, wherein the antenna array comprises at least one first type antenna 2a which is configured for emitting the RF signal 3a and may be configured for also receiving the RF signal 3b and the antenna array may comprise at least one second type antenna 2b which is configured for receiving the RF signal 3b.
  • the IVD sensing method 100 comprises providing 102 a sample space 4 in which a sample support 5 with the fluid substance 1 can be received.
  • the IVD sensing method 100 may comprise positioning the sample support 5 in the sample space 4 and potentially introducing the fluid substance 1 into or onto the sample support 5.
  • the IVD sensing method 100 further comprises emitting 103 an RF signal 3a with and/or by at least one first antenna 2a of the one or more antennas 2; passing 104 the RF signal 3 a, after being emitted, via at least a portion of a sample space 4 and the sample support 5 and potentially the fluid substance 1 if present.
  • the IVD sensing method 100 further comprises receiving 105, by the at least one first antenna 2b and/or by at least one second antenna 2a of the one or more antennas 2 the emitted RF signal 3b after passing the sample space 4 and the sample support 5; and transforming 106 the received RF signal 3b into a readable signal 7 that is sensitive to indicate the presence of the fluid substance 1 in the sample support 4 having a substance volume V in a range between approx. 500pL and 0.1 pL, specifically in a range between approx. 20pL and 0.5pL and more specifically between approx. lOpL and 5pL.
  • the RF signal 3a may be passed once via at least a portion of a sample space 4 and the sample support 5.
  • the RF signal 3b may be passed twice via at least a portion of a sample space 4 and the sample support 5.
  • the transforming 106 of the received RF signal 3b into the readable signal 7 may comprise transforming 106 of the received RF signal 3b into a DC current.
  • the readable signal 7 may be sensitive to indicate the substance volume V, as previously shown with the measurement results of Fig. 5, and/or a volume range of the fluid substance 1.
  • the volume V or the volume range may specifically be determined in a precision range between approx. +/- 0.5pL and +/-0.1pL, more specifically in a precision range between approx. +/-0.3pL and +/-0.2pL.

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Abstract

L'invention concerne un système de détection de diagnostic in vitro (DIV) (10) destiné à déterminer la présence d'une substance fluide (1), reposant la technologie des radiofréquences (RF), le système de détection DIV comprenant : une ou plusieurs antennes (2), au moins une première antenne (2a) de la ou des antennes (2) étant configurée pour émettre un signal RF (3a), et ladite au moins une première antenne (2a) et/ou au moins une seconde antenne (2b) de la ou des antennes (2) étant configurées pour recevoir le signal RF (3b) émis par ladite au moins une première antenne (2a) ; un espace d'échantillonnage (4) positionné par rapport à la ou aux antennes (2) de sorte que le signal RF (3a) puisse traverser au moins une partie de l'espace d'échantillonnage (4) après avoir été émis et avant d'être reçu, et l'espace d'échantillonnage étant configuré pour recevoir un support d'échantillon (5) destiné à recevoir la substance fluide (1) ; et un transformateur (6) configuré pour transformer le signal RF reçu (3b) en un signal lisible (7) sensible pour indiquer la présence de la substance fluide (1) dans le support d'échantillon (5) dont le volume de substance (V) est compris entre 500 µL et 0,1 µL, plus particulièrement entre 20 µL et 0,5 µL.
PCT/EP2025/070587 2024-07-23 2025-07-18 Système de détection pour diagnostic in vitro et méthode de détection pour diagnostic in vitro pour détermination de présence d'une substance fluide reposant sur la technologie des radiofréquences Pending WO2026022012A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1992921A1 (fr) 2007-05-16 2008-11-19 FAFNIR GmbH Procédé et dispositif destiné à la détection de l'état de remplissage
WO2013155193A1 (fr) * 2012-04-12 2013-10-17 Elwha Llc Équipements connexes pour rapporter des informations concernant des pansements pour plaies
US20150033823A1 (en) * 2013-07-31 2015-02-05 Deka Products Limited Partnership System, Method, and Apparatus for Bubble Detection in a Fluid Line Using a Split-Ring Resonator
US20170188874A1 (en) * 2015-09-29 2017-07-06 Avraham Suhami Linear Velocity Imaging Tomography

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1992921A1 (fr) 2007-05-16 2008-11-19 FAFNIR GmbH Procédé et dispositif destiné à la détection de l'état de remplissage
WO2013155193A1 (fr) * 2012-04-12 2013-10-17 Elwha Llc Équipements connexes pour rapporter des informations concernant des pansements pour plaies
US20150033823A1 (en) * 2013-07-31 2015-02-05 Deka Products Limited Partnership System, Method, and Apparatus for Bubble Detection in a Fluid Line Using a Split-Ring Resonator
US20170188874A1 (en) * 2015-09-29 2017-07-06 Avraham Suhami Linear Velocity Imaging Tomography

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ELSHEIKH DALIA M ET AL: "Rapid detection of blood entero-viruses using microstrip antenna bio-sensor", 2013 EUROPEAN MICROWAVE CONFERENCE, EUROPEAN MICROWAVE ASSOCIATION, 6 October 2013 (2013-10-06), pages 878 - 880, XP032535795 *

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