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WO2025168226A1 - Appareil et procédé de détection - Google Patents

Appareil et procédé de détection

Info

Publication number
WO2025168226A1
WO2025168226A1 PCT/EP2024/065771 EP2024065771W WO2025168226A1 WO 2025168226 A1 WO2025168226 A1 WO 2025168226A1 EP 2024065771 W EP2024065771 W EP 2024065771W WO 2025168226 A1 WO2025168226 A1 WO 2025168226A1
Authority
WO
WIPO (PCT)
Prior art keywords
detection
sample
target
chambers
chamber
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/EP2024/065771
Other languages
English (en)
Inventor
Douglas T. Gjerde
Daniel Bollinger
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.)
Vosbio Inc
Original Assignee
Vosbio 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 Vosbio Inc filed Critical Vosbio Inc
Publication of WO2025168226A1 publication Critical patent/WO2025168226A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Measuring devices for evaluating the respiratory organs
    • A61B5/082—Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Measuring devices for evaluating the respiratory organs
    • A61B5/097—Devices for facilitating collection of breath or for directing breath into or through measuring devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B2010/0083—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements for taking gas samples
    • A61B2010/0087—Breath samples
    • 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
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0694—Creating chemical gradients in a fluid
    • 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
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0672—Integrated piercing tool
    • 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
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0861—Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/0864—Configuration of multiple channels and/or chambers in a single devices comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
    • 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
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0861—Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/0867—Multiple inlets and one sample wells, e.g. mixing, dilution
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0457—Moving fluids with specific forces or mechanical means specific forces passive flow or gravitation
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6844—Nucleic acid amplification reactions
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/22—Devices for withdrawing samples in the gaseous state
    • G01N2001/2244—Exhaled gas, e.g. alcohol detecting

Definitions

  • the apparatus and method of the invention allow detection and semi-quantification of a virus, cell or biological molecule present in a biological sample.
  • DNA is amplified usually by an isothermal amplification. Usually, LAMP amplification is used currently. Detection after amplification may be optical, electrochemical, or chemical. The tests are called molecular tests because they measure directly the presence or absence of the nucleic acids, RNA or DNA in the biological sample.
  • the molecular tests on the market can detect low levels of the target pathogen, usually lower levels than by the antigen test.
  • the most common type of point of care testing technology is the antigen test, sometimes called a lateral flow test.
  • capillary action of a buffer is used to move a biological sample (usually from a nose swab) along the surface of a pad. Sample and buffer contact the end of the pad and capillary action is initiated.
  • the pad contains reactive molecules in a strip perpendicular to flow that are sensitive to protein. Detection is of proteins specific to the pathogen and does not require amplification.
  • the chemistry is based on an enzyme-linked immunosorbent assay. The tests have high specificity and are known to not give false positive results.
  • the apparatus and method of the invention is based on amplifying a target sequence (or sequences) from different mass amounts of nucleic acid from a primary sample.
  • the amplification reactions are carried out with different mass amounts to determine the minimum mass at which the sample will be detected.
  • the apparatus and method of the invention is not a digital signal system for quantification.
  • the goal of the invention is to provide yes/no information at different sensitivities. This is accomplished by adjusting the absolute mass amount of the analyte available in the sample by changing the reaction chamber size or by diluting the primary sample.
  • FIG. 1 is a schematic diagram of a gravity-fed analyte mass dilution apparatus according to an embodiment of the invention
  • FIG. 2 is a schematic diagram of a gravity-fed apparatus to detect sample with varying chamber volumes and analyte mass
  • Reaction chamber or detection chamber Device chamber in which reactions, amplification and/or detection take place.
  • a chamber having a low limit of detection This is a highly sensitive detection chamber or detection reactor. A positive indication signal is given when even a small amount of pathogen is present and detected within a sample. Or, only a small amount of nucleic acid target is needed for detection within a given volume.
  • Medium level detection limit detection capability is chosen to be between a low value detecting low concentrations (or low amounts of targets such as pathogens) and a high value detecting only high concentrations or high amounts of pathogen present.
  • a chamber having a high limit of detection This is an insensitive detection chamber or other reactor. This detection chamber produces a positive signal only when a higher amount of target such as a pathogen is present and detected. A higher amount of field sample target is needed for detection. A molecular test might be detuned (or made less sensitive) to detect high levels of antigen for example.
  • Sample containing target including a virus, cell or biomolecule The sample, e.g. nasal swab, saliva, breath, breath condensate, etc. containing a target, such as a virus, cell or biomolecule.
  • the sample may contain a pathogen or a part or component of a pathogen.
  • Each detection chamber can have a different detection limit for detecting a target or other entities.
  • Each reaction chamber having a specific detection limit may have duplicate reaction chambers for confirmation of a positive or negative signal.
  • Detection is of a target, including a pathogen or pathogens or component of a pathogen. But the invention can detect any molecule, combination of molecules or parts of molecules using any type of detector or sensor.
  • Detection limit, or limit of detection The amount of a target that can be consistently detected. For example, the same amount of sample can be tested/analyzed multiple times under the same conditions. This is related to the original field sample.
  • the amount of target can be defined by a number such as a copy number or by a concentration. This amount may be determined empirically as the amount of the target that is detected when present effectively 100% of the time, 99% of the time after 100 trials, 95% of the time after 19 of 20 trials, 80% of the time after 4 of 5 trials, or 75% of the time after or 3 of 4 trials.
  • Reaction mass amount Amount of the target detection, including pathogen, virus, cell or biomolecule in the detection reaction chamber undergoing detection.
  • the reaction chamber size can be adjusted to change the sample reaction mass amount.
  • the detection reaction chamber analyte produced by dilution of the primary sample with a diluent can be adjusted to change the reaction analyte mass amount.
  • Reaction analyte mass concentration Concentration of the target, including a virus, cell, biomolecule or pathogen in the detector reaction chamber undergoing detection.
  • target, virus, cell, biomolecule or pathogen terms are used interchangeably.
  • Pathogen lysing Process of breaking up a pathogen including a virus, a cell, a cell wall, a bacterial or spore wall, envelope or any type of barrier to release nucleic acid.
  • Primary sample Any sample taken from an individual or taken from biological material. This could be from a biological fluid or tissue, blood, breath, breath condensate, saliva, nose or cheek swab, etc. This is the primary sample that undergoes mass analyte dilution in the method of the invention.
  • Mass analyte reduction factor The mass amount that of the primary sample is reduced in a detection chamber. Reduction of the mass amount can be obtained by dilution to reduce concentration in the chamber or by reducing the volume of the chamber. The sample solution or liquid that undergoes mass analyte dilution in the method of the invention.
  • Reduction step Any process from one chamber to another that reduces the mass of the target within the sample. This may be achieved by adding diluent to the sample in one chamber, or by adding a smaller volume of the primary sample. Reduction steps may be repeated to further compound the total mass reduction.
  • Total reduction factor The total reduction factor is the multiplication of all reduction steps. Each reduction factor is multiplied by the next reduction factor to get total reduction factor.
  • the goal of the apparatus and method of the invention is to provide a series of detection conditions for a molecular test using a gravity-fed liquid flow process of a primary sample.
  • the test has a progression of detection limits within the apparatus and method of the invention.
  • a target including a virus, cell, or biomolecule that is present in a sample taken from the field results in a positive signal in any one detection chamber, then it is above the minimum amount of target needed in any one or more of the detection chamber reactions.
  • Other reaction chambers in the detection device may be present for positive controls for the apparatus and method of the invention.
  • Yes/no diagnostic methods are designed to give a yes answer when any target material is reliably detected. They are designed to work at the highest sensitivity possible. This is the reason that antigen tests for Covid-19 for example are much less sensitive than molecular tests for Covid-19.
  • the apparatus and method of the invention is purposely detuned to give progressively lower sensitivity results.
  • a series of reaction chambers are used with progressive detuning.
  • the primary sample mass is reduced by a gravity-fed process to reduce the analyte mass amount. This process can be called detuning because it makes the test less able to detect a target, including a virus, cell or biomolecule. Detuning may be linear or any form desired. In principle, any type of yes/no diagnostic test will work for this invention as long as the test can be detuned to reduce the sensitivity, thereby increasing the detection limit.
  • different mass amounts are achieved through serial dilution of the target with a diluent to produce a series of sample concentrations in a series of chamber reactors. Each concentration provides a different detection limit in terms of the concentration of the target in the primary sample.
  • sample and detection reagent mixture concentrations are kept constant and are filled into a series of reaction chamber with varying volumes. Larger reaction chambers have lower detection limits because more sample nucleic acid product mass is available for amplification or detection. Smaller reaction chambers necessarily have higher detection limits in terms of concentration because less nucleic acid analyte mass is available to amplify or detect. Reaction chambers of different sizes may or may not have the same detection limit in terms of total number of copies of template.
  • each detection chamber results can be reported as negative or positive.
  • three-level detection limit detection chambers are used.
  • a chamber having a low limit of detection (LLOD) would produce a positive indication even if only a small amount of target, including virus, cell or biomolecule were present and detected.
  • This detection chamber has the highest ability to detect even if only a small amount of target is in the field sample.
  • a chamber having a medium limit of detection (MLOD) would produce a positive indication even if only an intermediate amount of target was present and detected from the field sample.
  • a chamber having a high limit of detection (HLOD) would detect pathogen only if a very high amount of target was present.
  • a detection device may have three detection chambers having LLOD, MLOD and HLOD capability. Depiction of results from a three-detection chamber device would be the following:
  • Negative LLOD, Negative MLOD, Negative HLOD Target, including virus, cell, pathogen or other biomolecule not detected at any level.
  • Positive LLOD, Negative MLOD, Negative HLOD Target, including virus, etc., detected but it is present at low level.
  • Positive LLOD, Positive MLOD, Negative HLOD Target, including virus, etc. detected and is at a higher level.
  • detection limits can have different names such as level 1, 2, 3 etc. sensitivity or molecular level sensitivity, antigen level sensitivity, or high sensitivity, medium sensitivity and low sensitivity, etc.
  • detection chambers may have a 2-fold difference in limits of detection produced by a 2-fold reduction in analyte mass.
  • the pathogen may be detected in some chambers below their limit of detection, while pathogen might not be detected in other chambers with a lower limit of detection.
  • this overlap in the range of limits of detection may be undesirable, posing a practical limitation on how similar the limits of detection can be.
  • limits of detection may require greater than a 1.5-fold difference, greater than a 2- fold difference, greater than a 3-fold difference, greater than a 4-fold difference, greater than a 5-fold difference, or greater than a 10-fold difference in each step of analyte mass reduction by gravity-fed liquid flow.
  • Gravity feed can be used to fill chambers of different volumes or with different concentrations as shown in FIG. 1.
  • a diluent reservoir 2 contains diluent 4 in sufficient quantity to fill all reaction chambers with a series of analyte solution with progressively lower concentrations.
  • the reservoir is disposed at a higher elevation than the subsequent chambers.
  • hydrophobic air vent 6 On the top of the reservoir is hydrophobic air vent 6, which allows air to pass through, while prohibiting liquid from entering or exiting the reservoir.
  • the bottom of the reservoir is attached to fluidic channel 8, which terminates at pierceable seal 10.
  • gravity feed is used to fill in parallel flow a series of detection reaction chambers of different volumes.
  • the reaction chambers will have different analyte mass amounts and different analyte detection limits.
  • a sample is prepared with a buffer and drains into the device through opening 40. The sample travels through fluidic channels 42 to multiple analysis chambers of varying volumes. In one instance, the largest chamber 44 has a volume of 1.6 mL, the next largest chamber 46 has a volume of 40 pL, and the smallest chamber 50 has a volume of 1 pL.
  • a second 40 pL chamber 48 is used to detect the presence of a positive control sample. Air is able to escape from each chamber via a hydrophobic vent 52, which permits air but not liquid to pass through.
  • FIG. 3 is a flow diagram show steps in a method 100 for evaluating a breath condensate sample for the presence of a target that is an embodiment of the invention.
  • the method 100 may use the apparatus shown in FIGs. 1 and 2.
  • the method begins with a step 102 of obtaining a breath condensate sample, e.g. by collecting exhaled breath from a user in a sample collection device.
  • the method continues with a step 104 of delivering the collected sample to a detection device, e.g. by using a plunger to push the collected sample out of the modified syringe discussed above.
  • the method continues with a step 106 of conveying the sample into a plurality of detection chambers, e.g. using any of the gravity feed structures discussed above.
  • the method continues with a step 108 of testing the sample in each of the detection chambers and then a step 110 of determining presence of the target based on the results of the testing, as explained in more detail below.
  • this dynamic range can be expanded by including larger and smaller chambers.
  • Analyte mass amounts can be determined with more precision by increasing the number of chamber volumes between the maximum and minimum volumes.
  • Each reaction sample contained Codex HiRev Isothermal DNA Polymerase, Codex HiRev Reaction Buffer and SYBR Green I dye at a concentration of 1X, per manufacturers guidelines, 1.1 mM dNTP mix, and 1.6 pM of FIP and BIP primers, 0.4 pM of FL and BL primers, and 0.2 pM of F3 and B3 primers.
  • Single stranded DNA template was added to separate aliquots reach concentrations of 2.5, 0.25, 0.025, 0.01 copies/pL. These aliquots were then each subdivided into reaction volumes of 5, 10, 20, 50, 100, and 200 pL. They were incubated for 60 minutes at 65°C, with fluorescent measurements collected every 30 seconds. Following amplification, a melt-curve was performed to verify the specificity of the amplification.
  • the analyte mass concentration is predicted to be between 10 - 50 copies/pL, which agrees with the qPCR quantification of 30 copies/pL.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Physiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

L'invention concerne un procédé et un appareil de test moléculaire destinés à détecter ou mesurer le niveau d'une cible qui peut être une maladie pathogène ou un autre matériau biologique. Dans certains modes de réalisation, le procédé constitue un procédé d'amplification isotherme ou de cyclage thermique. Dans certains modes de réalisation, des techniques de détection autres que l'amplification sont utilisées. Dans certains modes de réalisation de l'appareil et du procédé de l'invention, l'échantillon est introduit par gravité dans l'appareil. Dans certains modes de réalisation, l'appareil et le procédé de l'invention sont basés sur l'amplification dans différentes conditions avec différentes quantités de masse d'acide nucléique provenant de l'échantillon primaire afin de déterminer le point de masse où l'échantillon sera ou ne sera pas détecté. Dans certains modes de réalisation de l'invention, l'agent pathogène cible contient de l'ARN. L'agent pathogène peut être lysé afin de libérer l'ARN, soumis à une transcription inverse en ADN puis amplifié. Dans certains modes de réalisation de l'invention, l'agent pathogène cible contient de l'ADN. L'agent pathogène cible peut être lysé puis l'ADN peut être amplifié et détecté. Dans certains modes de réalisation de l'invention, le test moléculaire isotherme ou de thermocyclage est utilisé pour mesurer la progression d'une maladie pathogène.
PCT/EP2024/065771 2024-02-07 2024-06-07 Appareil et procédé de détection Pending WO2025168226A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202463550651P 2024-02-07 2024-02-07
US63/550,651 2024-02-07
US202463575079P 2024-04-05 2024-04-05
US63/575,079 2024-04-05

Publications (1)

Publication Number Publication Date
WO2025168226A1 true WO2025168226A1 (fr) 2025-08-14

Family

ID=91481769

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2024/065771 Pending WO2025168226A1 (fr) 2024-02-07 2024-06-07 Appareil et procédé de détection

Country Status (1)

Country Link
WO (1) WO2025168226A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130059329A1 (en) * 2010-02-22 2013-03-07 Jose Carlos Barrenechea Oar Apparatus and method for distributing liquid samples in small volumes
AU2015200465A1 (en) * 2009-03-24 2015-02-19 University Of Chicago Slip chip device and methods
US20200400534A1 (en) * 2018-02-27 2020-12-24 CytoChip, Inc. Devices and methods for sample analysis with serial dilution
EP4279920A2 (fr) * 2015-12-03 2023-11-22 C A Casyso GmbH Système et procédé de tests sanguins

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2015200465A1 (en) * 2009-03-24 2015-02-19 University Of Chicago Slip chip device and methods
US20130059329A1 (en) * 2010-02-22 2013-03-07 Jose Carlos Barrenechea Oar Apparatus and method for distributing liquid samples in small volumes
EP4279920A2 (fr) * 2015-12-03 2023-11-22 C A Casyso GmbH Système et procédé de tests sanguins
US20200400534A1 (en) * 2018-02-27 2020-12-24 CytoChip, Inc. Devices and methods for sample analysis with serial dilution

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