WO2023212067A1 - Dispositif de collecte et de concentration d'échantillon et ses procédés d'utilisation - Google Patents

Dispositif de collecte et de concentration d'échantillon et ses procédés d'utilisation Download PDF

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Publication number
WO2023212067A1
WO2023212067A1 PCT/US2023/020005 US2023020005W WO2023212067A1 WO 2023212067 A1 WO2023212067 A1 WO 2023212067A1 US 2023020005 W US2023020005 W US 2023020005W WO 2023212067 A1 WO2023212067 A1 WO 2023212067A1
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WO
WIPO (PCT)
Prior art keywords
fluid sample
fluid
sample
infectious agent
absorbing material
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Application number
PCT/US2023/020005
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English (en)
Inventor
Henry Hongjun Ji
Original Assignee
Sorrento Therapeutics, 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 Sorrento Therapeutics, Inc. filed Critical Sorrento Therapeutics, Inc.
Publication of WO2023212067A1 publication Critical patent/WO2023212067A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/40—Concentrating samples
    • G01N1/4077—Concentrating samples by other techniques involving separation of suspended solids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • 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
    • C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/04—Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor
    • 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
    • C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/24—Methods of sampling, or inoculating or spreading a sample; Methods of physically isolating an intact microorganisms
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/40—Concentrating samples
    • G01N1/405—Concentrating samples by adsorption or absorption
    • 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
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • 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
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983—Viruses
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/005—Assays involving biological materials from specific organisms or of a specific nature from viruses
    • G01N2333/08—RNA viruses
    • G01N2333/165—Coronaviridae, e.g. avian infectious bronchitis virus

Definitions

  • the present disclosure relates generally to a sample collection device, and more specifically relates to a sample collection and concentration device and methods of its use.
  • Infectious agents are organisms capable of causing medical condition. Examples of infectious agents include viruses and bacteria. Coronaviruses are infectious agents of particular recent concern. Coronaviruses can cause diseases in certain animals and humans. The diseases include respiratory infections and enteric infections which can be mild or lethal. Coronaviruses are viruses in the subfamily Orthocoronavirinae, in the family Coronaviridae, in the order Nidovirales. The 2019-2020 China pneumonia outbreak in Wuhan was traced to a novel coronavirus, labeled 2019-nCoV by the World Health Organization (WHO) and is also known as SARS-CoV-2.
  • WHO World Health Organization
  • the present disclosure provides a device for concentrating a fluid sample suspected of containing an infectious agent.
  • the device includes a container configured to receive at least a portion of the fluid sample suspected of containing the infectious agent, thereby generating a received fluid sample, and to hold the received fluid sample.
  • the device includes a fluid-absorbing material configured to contact at least a portion of the received fluid sample and absorb at least a portion of the fluid from the received fluid sample, thereby generating a concentrated fluid sample.
  • the device can further include the following details, which can be combined with one another in any combinations unless clearly mutually exclusive:
  • the device may comprise a solution that is added to: (i) the fluid sample; and/or (ii) the received fluid sample; and/or (iii) the fluid-absorbing material; and/or (iv) the concentrated fluid sample.
  • the device may comprise a solution that comprises one or more detergents or surfactants.
  • the solution may be added to: (i) the fluid sample; and/or (ii) the received fluid sample; and/or (iii) the fluid-absorbing material; and/or (iv) the concentrated fluid sample.
  • the device may comprise one or more detergents or surfactants selected from the group consisting of: Tween-20, Tween-40, Tween-60, Tween-80, Brij-35, Brij-58, NP-40, Triton X-100, Triton X-114, octyl glucopyranoside, octyl thioglucoside, 3-[(3- cholamidopropyl)dimethylammonio]-l -propanesulfonate, 3 -[(3- cholamidopropyl)dimethylammonio]-2-hydroxy-l -propanesulfonate, sodium cholate, sodium deoxycholate, hexadecyl trimethyl ammonium bromide, and sodium dodecyl sulfate and/or combinations of one or more thereof.
  • the one or more detergents or surfactants may be added to: (i) the fluid sample; and/or (i)
  • the fluid-absorbing material may comprise material containing one or more of a desiccant, a solid material, a gel-like material, a colloidal material, a superabsorbent polymer (SAP), and combinations thereof.
  • the fluid-absorbing material may comprise one or more of a polyacrylamide, polyacrylic acid, polyacrylate, poly(vinylamine) hydrochloride, poly(L-lysine hydrobromide, a poly(methacrylic acid), polyvinyl pyrrolidone, a dextran, a polydextran, a cellulose, a cellulose hydroxyethyl ether, hydroxypropylmethyl cellulose (HPMC), hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), sodium carboxy methyl cellulose (Na-CMC), a polyvinyl alcohol, a polyhyaluronic acid, guar gum, a carrageenan, an agarose, a chitin, a chitosan derivative, a polychitosan, a polyaliginic acid, polyalginate sodium, a pectin, a xantham gum, a polyphosphazene,
  • the container may further be configured to allow at least a portion of the concentrated fluid sample to be removed from the container for detection of the infectious agent.
  • the concentration of the infectious agent in the concentrated fluid sample is greater than the concentration of the infectious agent in the received fluid sample.
  • the fluid-absorbing material may be selective against the infectious agent.
  • the device may include means for facilitating passage of at least a portion of the at least a portion of the fluid sample held by the container into and/or through the fluid-absorbing material.
  • the device may include means for facilitating absorption of at least a portion of the fluid from the fluid sample by the fluid-absorbing material.
  • the device may include means for applying a positive pressure or force, means for applying a negative pressure or force, means for applying a centrifugal pressure or force, means for allowing or permitting gravity flow, or combinations thereof.
  • the device may include a plunger, a piston, a centrifuge, means for allowing for or facilitating gravity flow, or combinations thereof.
  • the device may include a selective layer configured to minimize or prevent absorption or adsorption of the infectious agent onto or into the fluid-absorbing material.
  • the device may include a selective layer configured to exclude or partition the infectious agent from the fluid-absorbing material and/or to minimize or prevent absorption or adsorption of the infectious agent onto or into the fluid-absorbing material.
  • the device may include a selective layer comprising: a membrane; a semi- permeable membrane; a size-exclusion material; or combinations thereof.
  • the container may include an opening configured to receive the fluid sample suspected of containing the infectious agent and means for applying a positive pressure or force to the received fluid sample.
  • the container may include a first opening configured to receive means for applying a positive pressure or force to the received fluid sample.
  • the means may be inserted subsequent to or during receipt of the fluid sample through the first opening.
  • the container may optionally include a second opening.
  • the container may be configured to allow one or both of removal of the concentrated fluid sample through the first opening subsequent to or during removal of the means for applying a positive pressure from the first opening and ejection of the concentrated fluid sample from the second opening when the means for applying a positive pressure during or subsequent to application of the means for applying a positive pressure or force.
  • the container may include a first opening and a second opening.
  • the first opening may be configured to receive means for applying positive pressure.
  • the container may be configured to allow one or both of removal of the concentrated fluid sample through the top opening when the means for applying a positive pressure is removed from the top opening and ejection of the concentrated fluid sample from the bottom opening when the means for applying a positive pressure is inserted in the top opening.
  • the fluid-absorbing material may be selective against the infectious agent, and the device may be configured to cause at least a portion of the received fluid sample to pass into the fluid-absorbing material.
  • the fluid-absorbing material may be selective against the infectious agent.
  • the device may be configured to cause at least a portion of the received fluid sample to pass into the fluid-absorbing material and cause the concentrated fluid sample to be ejected from a bottom opening of the device.
  • the container may include a plunger or a piston.
  • the container may include a syringe.
  • the container may include a syringe and means for applying a positive pressure or force to the received fluid sample.
  • the container may include a syringe and a plunger or a piston.
  • the fluid-absorbing material may selectively absorb an aqueous portion from the received fluid sample.
  • the fluid-absorbing material may selectively absorb water from the received fluid sample.
  • the infectious agent may be selected from a one or more microbial cells, one or more fungal cells, one or more bacterial cells, one or more virion particle, and identifying components thereof.
  • the infectious agent may include a virus or viral agent.
  • the infectious agent may include a coronavirus.
  • the infectious agent may include SARS, SARS-Cov-2, MERS, or a variant thereof.
  • the infectious agent may include SARS-Cov-2 or a variant thereof.
  • the device may further include a detection system.
  • the fluid sample may include an oral sample, a buccal sample, a gastrointestinal sample, a nasal sample, an ophthalmic sample, a rectal sample, saliva, tears, nasal secretions, sinus secretions, mucous, sputum, digestive contents, blood, a blood component, blood plasma, blood serum, seminal fluid, vaginal fluid, feces, or urine.
  • the device may further include one or more solutions comprising one or more of: (i) an aqueous solution; and/or (ii) water; and/or (iii) a lysis buffer; and/or (iv) a lysis agent; and/or (v) a detergent and/or a surfactant.
  • the one or more solutions may be independently added to: (i) the fluid sample; and/or (ii) the received fluid sample; (iii) the fluid absorbing material; and/or (iv) the concentrated fluid sample.
  • the present disclosure provides a method of detecting a presence of an infectious agent in a fluid sample.
  • the method includes providing the fluid sample to the device of this disclosure; providing the concentrated fluid sample from the device to a detection system; and detecting, using the detection system, the presence of the infectious agent in the concentrated fluid sample.
  • the method can further include the following details, which can be combined with one another in any combinations unless clearly mutually exclusive:
  • the method may further include performing a sample preparation operation.
  • the method may further include performing a sample preparation operation, wherein the performing comprises, prior to or during providing the concentrated fluid sample to the detection system, contacting or mixing the fluid sample with a preparative solution.
  • the method may further include performing a sample preparation operation wherein further comprising, prior to or during providing the concentrated fluid sample to the detection system, contacting or mixing the fluid sample with a preparative solution.
  • the preparative solution may include: a) a buffer; b) a lysis buffer; c) a lysis agent; d) a detergent and/or a surfactant; and/or e) a combination of two or more of a) - d).
  • the method may further include obtaining the fluid sample from a subject.
  • the present disclosure provides a method of treating a disease or condition associated with an infectious agent, or one or more symptoms associated therewith.
  • the method includes detecting the infectious agent according to any method of this disclosure, and after detecting the infectious agent, administering a therapeutic agent to treat the disease or condition.
  • the method can further include the following details, which can be combined with one another in any combinations unless clearly mutually exclusive:
  • the infectious agent may include SARS, SARS-Cov-2, MERS, or a variant thereof.
  • FIG. 1A is a diagram illustrating an example sample collection and concentration device, according to embodiments of this disclosure.
  • FIG. IB is a diagram illustrating another example sample collection and concentration device, according to embodiments of this disclosure.
  • FIG. 2 is a flow diagram illustrating an example method of using a sample collection and concentration device of this disclosure for concentrating a fluid sample, detecting an infectious agent, and administering a therapeutic agent, according to embodiments of this disclosure;
  • FIG. 3 is a diagram illustrating an example syringe-based sample collection and concentration device, according to embodiments of this disclosure.
  • FIGS. 4 A and 4B are diagrams illustrating an example syringe-based sample collection and concentration device and its operation to collect and concentrate a fluid sample, according to embodiments of this disclosure.
  • FIG. 5 is a flow chart of an example method of operating a sample collection and concentration device of this disclosure.
  • the present disclosure relates generally to a fluid sample collection and concentration device, and more specifically relates to a device configured to receive a fluid sample suspected of containing an infectious agent, absorb water from the sample, thereby providing a sample with a higher concentration of any present infectious agent for more effective and reliable detection.
  • the present disclosure also relates to methods detecting an infectious agent by concentrating the infectious agent and detecting a presence of the infectious agent in the concentrated sample.
  • the present disclosure also relates to methods of administering a therapeutic agent based at least in part on the presence of infectious agent detected in a concentrated sample concentrated by the disclosed device.
  • the sample collection and concentration device includes a container that can receive a fluid sample suspected of containing an infectious agent and hold the fluid sample.
  • the container may be any receptacle having a geometry suitable to receive and retain the fluid sample.
  • the container may have a geometry that substantially prevents or minimizes loss of portions of the fluid sample via spillage.
  • Non-limiting examples of containers include cups and cup-like shaped devices, vials, beakers, flasks, pipettes, syringes, cylinders, and the like.
  • a water-absorbing material within or adjacent to the container is adapted to absorb water from the received sample.
  • the water-absorbing material is selective against (e.g., absorption of, adsorption of, or the like) of the infectious agent, such that little or no infectious agent is collected by the water-absorbing material.
  • a material that is “selective against” one or more components is a material that, inter alia, substantially excludes and/or otherwise does not substantially absorb or adsorb appreciable amounts of the one or more components of a received fluid sample.
  • a fluid-absorbing material may be “selective against” appreciable amounts of an infectious agent suspected of being present in a received fluid sample, thereby providing for retention of the infectious agent in a concentrated fluid sample generated or obtained in accordance with the disclosure.
  • a material that is “selective for” one or more components is a material that, inter alia, absorbs and/or adsorbs the one or more components of a received fluid sample at the substantial exclusion of other components in a received fluid sample.
  • a selective layer such as a membrane or other appropriate material, may be included to reduce or prevent the collection of infectious agent by the waterabsorbing material.
  • the selective layer may be configured to minimize or prevent absorption or adsorption of the infectious agent onto or into the fluid-absorbing material.
  • the selective layer may exclude or partition the infectious agent from the fluid-absorbing material.
  • the selective layer may minimize or prevent absorption or adsorption of the infectious agent onto or into the fluid-absorbing material.
  • selective layers include membranes, semi-permeable membranes; size-exclusion materials, and combinations of these.
  • the sample collection and concentration device includes a means for facilitating passage of at least a portion of the fluid sample held by the container into and/or through the fluid-absorbing material.
  • the device may include a means for facilitating absorption of at least a portion of the fluid from the fluid sample by the fluid-absorbing material.
  • the device may include a means for applying a positive pressure or force, means for applying a negative pressure or force, means for applying a centrifugal pressure or force, means for allowing or permitting gravity flow, or combinations thereof.
  • the device may include a plunger, a piston, a centrifuge, means for allowing for or facilitating gravity flow, or combinations thereof.
  • the container of the sample collection and concentration device comprises a syringe, which can be operated to collect a sample and provide (e.g., by ejection from a syringe outlet) the concentrated sample.
  • the concentrated sample can be provided to a sample analysis system such as a lateral flow test.
  • the sample collection and concentration device provides a concentrated sample with an increased concentration of infectious agent compared to that of the original sample provided to the device.
  • a container may have on opening to receive a fluid sample and walls to hold the received sample.
  • the fluid sample is generally an aqueous sample, such as saliva, urine, tears, or the like, suspected of containing an infectious agent.
  • the fluid sample may be an aqueous rinse solution that was used to obtain a sample from a patient’s mouth. The patient may move the rinse solution about their mouth.
  • the rinse solution is transferred to the sample collection and concentration device (e.g., by allowing the patient to spit the rinse solution into the device or any other appropriate sample-transfer method) where the water-absorbing material removes water from the sample and concentrates any infectious agent that was collected from the mouth by the aqueous rinse solution.
  • the fluid sample may be obtained from an oral or nasal swab, a tear sample, a urine sample, or the like. This disclosure contemplates the concentration of infectious agents in any fluid sample suspected of containing an infectious agent.
  • the sample collection and concentration device increases the concentration of the infectious agent in the fluid sample through the removal of water for subsequent analysis.
  • sample concentration and collection device described herein advantageously provides a cost-effective solution for concentrating samples for analysis.
  • sample concentration and collection device described herein facilitates the use of lower cost and more widely available infectious agent detection strategies. For example, after a sample is concentrated by the sample collection and concentration device described herein, lower cost and more widely available tests can be used to detect the infectious agent without requiring very high sensitivity tests, which can be complex, slow, and high cost.
  • sample concentration and collection device described herein facilitates more rapid and reliable detection of an infectious agent. Because of this, the sample concentration and collection device described herein facilitates the administration of an appropriate therapeutic agent to address a medical condition associated with a detected infectious agent. Additionally, the sample concentration and collection device described herein is simple to use, providing hand-held, manual operability for effective sample concentration.
  • FIG. 1A illustrates an example sample collection and concentration device 100.
  • the example device 100 includes a container 102 and a fluid-absorbing material 104.
  • the fluidabsorbing material may (e.g., selectively) absorb, for example, an aqueous phase or a component or solute of such an aqueous phase.
  • the aqueous phase may include water.
  • the aqueous phase may include water and one or more solute.
  • the aqueous phase may consist essentially of water.
  • the aqueous phase may consist of water.
  • the fluid-absorbing material 104 may selectively absorb an aqueous portion from a received fluid sample.
  • the fluidabsorbing material 104 may selectively absorb water from a received fluid sample.
  • the container 102 is generally configured to receive a fluid sample (e.g., fluid sample 208 of FIG. 2, described below) suspected of containing an infectious agent and hold the received fluid sample.
  • the container 102 may be any receptacle having a geometry suitable to receive and retain the fluid sample.
  • the container 102 may have a geometry that substantially prevents or minimizes loss of portions of the fluid sample via spillage.
  • a non-limiting set of examples of containers 102 includes cups and cup-like shaped devices, vials, beakers, flasks, pipettes, syringes, cylinders, and the like.
  • the container 102 may include a bottom surface 106 and one or more walls 108 to hold the fluid sample and an opening 110 to receive the fluid sample suspected of containing the infectious agent.
  • the container 102 also allows at least a portion of a concentrated fluid sample generated by the device 100 to be removed from the container 102. In the example of FIG. 1A, the concentrated fluid sample may be removed via opening 110.
  • Other device configurations such as those illustrated in FIGS. 3 and 4A-B and described below, may allow concentrated fluid sample to be released through another opening (e.g., an opening as exemplified in 302 of FIGS. 3, 4A, and 4B)
  • the fluid-absorbing material 104 may be located within or adjacent to the container 102 (e.g., at or near the bottom surface 106 or at some height relative to the bottom surface 106 of the container 102). When the device 100 is in use, the fluid-absorbing material 104 contacts at least a portion of the fluid sample held by the container 102 and absorbs water from the fluid sample, thereby generating a concentrated fluid sample.
  • the fluid-absorbing material 104 may include one or more of a desiccant, a solid material, a gel-like material, a colloidal material, a superabsorbent polymer (SAP), a hydrogel, and combinations thereof.
  • the fluid-absorbing material 104 may be any hygroscopic substance that can absorb water from its surroundings.
  • the fluid-absorbing material 104 may be a desiccant such as a silica gel.
  • the fluid-absorbing material 104 may be a fluid-absorbing polymer that forms a hydrogel when in contact with a water-containing fluid.
  • the fluid-absorbing material 104 may have a solid or porous structure.
  • the fluid-absorbing material 104 may be a suspension of one or more fluid-absorbing substances (e.g., one or more of the example materials described above).
  • the fluid-absorbing material 104 may initially be a solid or crystalline material that forms a gel or colloidal suspension when water is absorbed from a fluid sample received by the container 102. If the infectious agent is present in the fluid sample received by the device 100, a concentration of the infectious agent in the concentrated fluid sample is greater than a concentration of the infectious agent in the received fluid sample.
  • the fluid-absorbing polymer may be obtained from Zhengzhou Fortune Bioscience Co., Ltd., also known as Fortune Bio or Fortune Bioscience.
  • the fluid-absorbing polymer may comprise one or more of a polyacrylamide, polyacrylic acid, polyacrylate, poly(vinylamine) hydrochloride, poly(L-lysine hydrobromide, a poly(methacrylic acid), polyvinyl pyrrolidone, a dextran, a polydextran, a cellulose, a cellulose hydroxyethyl ether, hydroxypropylmethyl cellulose (HPMC), hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), sodium carboxy methyl cellulose (Na-CMC), a polyvinyl alcohol, a polyhyaluronic acid, guar gum, a carrageenan, an agarose, a chitin, a chitosan derivative, a polychito
  • the fluid-absorbing material 104 comprises, inter alia, one or more detergents.
  • such one or more detergents may comprise Tween- 20, Tween-40, Tween-60, Tween-80, Brij-35, Brij-58, NP-40, Triton X-100, Triton X-114, octyl glucopyranoside, octyl thioglucoside, 3-[(3-cholamidopropyl)dimethylammonio]-l- propanesulfonate, 3-[(3-cholamidopropyl)dimethylammonio]-2-hydroxy-l-propanesulfonate, sodium cholate, sodium deoxycholate, hexadecyl trimethyl ammonium bromide, and sodium dodecyl sulfate and/or combinations of one or more of the same, as well as other molecules, as disclosed, for example, in European patent application publication number EP 388
  • the fluid-absorbing material 104 is selective against collection of the infectious agent.
  • the fluid-absorbing material 104 may be adapted or configured to absorb water from the fluid sample held in the container 102 without collecting a substantial amount of infectious agent present in the sample.
  • a substantial amount may refer to an amount that is greater than a threshold value.
  • a substantial amount of the infectious agent may refer to 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, or more (e.g., up to 20%) of the infectious agent originally present in a fluid sample collected for analysis.
  • a layer of selective material may be employed to reduce or prevent the collection of infectious agent by the fluid-absorbing material 104.
  • FIG. IB another example sample collection and concentration device 120 is illustrated.
  • the example device 120 of FIG. IB differs from device 100 of FIG. 1 A in that, inter alia, device 120 includes a selective layer 122 and a fluid-passage means 124 for providing passage of sample fluid into the fluid-absorbing material 104, for example, by applying a force or pressure 126 to facilitate the collection of sample fluid by the fluidabsorbing material 104.
  • the fluid-passage means 124 may be a piston or plunger of a syringe.
  • the fluid-passage means 124 may employ another mechanism, such as centrifugation, gravity flow, or the like, for providing passage of sample fluid into the fluid-absorbing material 106.
  • the fluid-passage means 124 may be a means of applying a positive pressure or force, means for applying a negative pressure or force, means for applying a centrifugal pressure or force, means for allowing or permitting gravity flow, or combinations thereof, as illustrated by force or pressure 126 of FIG. IB.
  • the fluid-passage means 124 may include a plunger, a piston, a centrifuge, means for allowing for or facilitating gravity flow, or combinations thereof.
  • the selective layer 122 excludes, or reduces/prevents the passage of, infectious agent from the fluid sample held in the container 102 into the fluid-absorbing material 104.
  • the selective layer 122 may be a size-selective membrane or filter, a chemically selective membrane or filter, a biologically selective, or the like, and may comprise one or more materials possessing combinations of one or more of size-selective, chemically selective, and biologically selective attributes or properties.
  • a selective layer 122 may prevent the passage of larger virion/bacterial particles to the fluid-absorbing material 104, while smaller solutes and other solution components can be collected by the fluid-absorbing material 104.
  • the piston or plunger can be depressed to apply a pressure 126 that drives water from the fluid sample held by the container into the fluid- absorbing material 104. This may increase the rate of water absorption by the fluid-absorbing material 104 and/or the amount of water absorbed by the fluid-absorbing material 104, thereby further concentrating any infectious agent in the fluid sample.
  • FIG. IB shows a fluid-passage means 124 for applying pressure 126, it should be understood that any other mechanism may be used to facilitate passage of fluid sample into the fluid-absorbing material 104.
  • a deformable membrane may be used to apply pressure 126.
  • a negative pressure may be applied at or near the bottom surface 106 of the container 102 to drive water into the fluid-absorbing material 104.
  • centrifugation may be used to facilitate passage of fluid sample into the fluid-absorbing material 104.
  • gravity flow is used to facilitate passage of fluid sample into the fluid-absorbing material 104.
  • FIG. 2 illustrates an example process 200 of using a sample collection and concentration device of this disclosure. While the process 200 is illustrated with respect to the example device 100 of FIG. 1 A, the process 200 can be performed using any sample collection and concentration device or configuration contemplated by this disclosure (e.g., device 120 of FIG. IB, device 300 of FIG. 3, and device 400 of FIGS. 4A and B).
  • the process 200 may begin at operation 202 where a fluid sample 208 is collected from a patient 204 and provided to the container 102 of the device.
  • the fluid sample 208 may include one or more of an oral sample, a buccal sample, a gastrointestinal sample, a nasal sample, an ophthalmic sample, a rectal sample, saliva, tears, nasal secretions, sinus secretions, mucous, sputum, digestive contents, blood, a blood component, blood plasma, blood serum, seminal fluid, vaginal fluid, feces, or urine.
  • the fluid sample 208 may be include or be mixed with another solution, such as an aqueous solution, water, a lysis buffer, a detergent, a surfactant, or a detergent.
  • the solution(s) may be independently added to the collected fluid sample; and/or the fluid sample received by the device; and/or the fluid-absorbing material; and/or the concentrated fluid sample 216.
  • the fluid sample includes an infectious agent 210 (illustrated by circles in FIG. 2).
  • the infectious agent 210 may be a virus, bacteria, fungus, protozoa, or some other microscopic entity associated with a medical condition.
  • the infectious agent 210 may be a coronavirus, such as the alpha-, beta-, gamma-, and delta- coronaviruses.
  • the infectious agent 210 is associated with a medical condition such as Middle East Respiratory syndrome (MERS) or COVID-19.
  • the infectious agent 210 may include one or more of microbial cells, one or more fungal cells, one or more bacterial cells, one or more virion particle, and identifying components thereof.
  • the infectious agent 210 may include a virus or viral agent.
  • the infectious agent 210 may include a coronavirus.
  • the infectious agent 210 may include a SARS virus or viral particle, a SARS-Cov-2 virus or viral particle, a MERS virus or viral particle, or a variant thereof.
  • the infectious agent 210 may include a SARS-Cov-2 virus or viral particle or a variant thereof.
  • the SARS-Cov-2 virus or viral particle is selected from the group consisting of a) a SARS-CoV-2 Wuhan/Washington variant; b) a SARS-CoV-2 Alpha variant; c) a SARS-CoV-2 Beta variant; d) a SARS-CoV-2 Gamma variant; e) a SARS-CoV-2 Delta variant; f) a SARS-CoV-2 Delta Plus variant; g) a SARS-CoV-2 Kappa variant; h) a SARS- CoV-2 Lambda variant; i) a SARS-CoV-2 Omicron variant; j) a SARS-CoV-2 Zeta variant; k) a SARS-CoV-2 Epsilon variant; 1) a SARS-CoV-2 Omicron variant; m) a SARS-CoV-2 Omicron Plus variant; n) an Omicron BA.1 variant; o) an Omicron B A.2 variant;
  • the SARS-Cov-2 virus or viral particle comprises a spike protein comprising one or more or the following mutations: D614G; A69/70-A 144-N501 Y-A570D-D614G-P681H-T716I-S982 A-D 1118H; D80A- D215G-A242/244-K417N-E484K-N501 Y-D614G-A701V; D614G, S13I, W152C, L452R; G142D, E154K, L452R, E484Q, D614G, P681R, Q1071H, H1101D; T19R, (G142D), A156- 157, R158G, L452R, T478K, D614G, P681R, D950N; T19R, (G142D), A156-157, R158G, K417N, L452R, T478K, D614G; D950
  • the fluid sample 208 may be provided to the container 102 using a sample manipulation tool 206, such as a dropper, pipette, swab, or the like. Alternatively, the fluid sample 208 may be provided directly from the patient 204 without preprocessing or dilution. In some cases, the fluid sample 208 may be diluted, for example, by an oral rinse used to collect the fluid sample 208 and/or any preprocessing agents, such as lysis agents (also known as lysis buffers, used interchangeably throughout), detergents or surfactants, and the like, to prepare the fluid sample 208 for detection of any infectious agent 210.
  • lysis agents also known as lysis buffers, used interchangeably throughout
  • detergents or surfactants and the like
  • water from the fluid sample 208 is contacted to allowed to be absorbed by the fluid-absorbing material 104.
  • the fluidabsorbing material 104 may expand due the absorption of water to form the expanded fluidabsorbing material 214.
  • a concentrated fluid sample 216 is generated that includes all or most of the infectious agent 210 from the original fluid sample 208 in a smaller overall volume.
  • a pressure 126 may be applied as illustrated in FIG. IB to increase that rate of water absorption and/or the amount of water absorbed by the fluid-absorbing material 104.
  • the amount of fluid sample 208 provided to the device is generally selected to exceed the water absorbing capacity of the fluid-absorbing material 104, such that a sufficient volume of the concentrated fluid sample 216 is retained for subsequent detection of the infectious agent 210.
  • the concentrated fluid sample 216 is provided to a detection system 222, such as a lateral flow assay (as illustrated in FIG. 2).
  • the concentrated fluid sample 216 may collected from the container 102 using any appropriate sample manipulation tool 206, such as a dropper, pipette, swab, or the like.
  • the concentrated fluid sample 216 may be received through the opening 110 (see FIG. 1A).
  • the sample collection and concentration device is a syringe-based device (see examples of FIGS. 3, 4A, and 4B, described below)
  • the concentrated sample 216 may be ejected from an opening of the device.
  • the concentrated fluid sample 216 is provided directly to an inlet port 224 or other appropriate location of the detection system 222.
  • the concentrated fluid sample 216 may be deposited into a buffer with reagents associated with the detection system 222.
  • the concentrated fluid sample 216 may be deposited into solution comprising: an aqueous solution; a lysis buffer; and/or a lysis agent; and/or a detergent or surfactant; and/or other solution that is used to prepare/lyse the concentrated fluid sample 216 for analysis.
  • results determined using the detection system 222 are used to identify a therapeutic agent 232 and/or a dosage of a therapeutic agent 232 to administer to the patient 204. In the example, of FIG.
  • the detection system 222 is a lateral flow test device with a control line 226 that, if visible following application of the concentrated fluid sample 216, indicates that the sample 216 was properly applied to the detection system 222 and a test line 228 that, if visible following application of the concentrated fluid sample 216, indicates that the infectious agent 210 is present in the concentrated fluid sample 216.
  • a control line 226 that, if visible following application of the concentrated fluid sample 216, indicates that the sample 216 was properly applied to the detection system 222
  • a test line 228 that, if visible following application of the concentrated fluid sample 216, indicates that the infectious agent 210 is present in the concentrated fluid sample 216.
  • the therapeutic agent 232 is administered to the patient 204.
  • An effective amount of therapeutic agent 232 may be administered.
  • the therapeutic agent 232 may be administered to the patient at an effective amount determined based at least in part on results provided by the detection system 222.
  • An “effective amount” or a “therapeutically effective dose” in reference to a therapeutic agent 232 is an amount sufficient to treat, ameliorate, or reduce the intensity of at least one symptom associated with a medical condition associated with the infectious agent 210.
  • an effective amount of a therapeutic agent 232 is an amount sufficient to impart a beneficial or desired clinical result including alleviation or reduction in one or more symptoms of a medical condition.
  • an effective amount of the medicament is an amount sufficient to alleviate all symptoms of a medical condition.
  • a dose of the therapeutic agent 232 will be administered that is not therapeutically effective by itself.
  • multiple doses may be administered to the patient either sequentially or simultaneously such that the combination of the individual doses is therapeutically effective.
  • a sample collection and concentration device may have a syringe-like structure, such that fluid samples may be collected and/or provided for analysis in a convenient and user-friendly manner.
  • Such syringe-based sample collection and concentration devices generally include at least one additional opening (e.g., in addition to the opening 110 of devices 100 and 120 described above). Fluid samples suspected of containing an infectious agent may be collected using the opening (e.g., by pulling back a plunger to collect the fluid sample) and/or received through the top opening (e.g., by receiving the fluid sample through the opening through which the plunger of the syringe passes). Concentrated fluid samples may be removed through the top opening (e.g., following removal of the plunger, similar to as described above with respect to the device 120 of FIG. IB) and/or ejected from the opening.
  • FIG. 3 illustrates an example of a first syringe-based sample collection and concentration device 300 with a container 102 that is a syringe (or is syringe-like).
  • the container 102 is a cylindrical tube within which the plunger 124 fits tightly.
  • a fluid sample 304 received by the example device 300 passes through the water absorbing material 104 (thereby facilitating absorption of water from the fluid sample 304 by the fluidabsorbing material 104) and a concentrated fluid sample 306 is ejected from an opening 302 of the device 300.
  • the fluid-absorbing material 104 is selective against the collection of infectious agent, such that little or no infectious agent is collected by the fluidabsorbing material 104.
  • the container 102 of device 300 includes a top opening 110 through which the plunger 124 is inserted and an opening 302 through which the concentrated fluid sample 306 may be ejected.
  • a fluid sample 304 suspected of containing an infectious agent may be introduced through the top opening 110 with the plunger 124 removed.
  • the plunger 124 may be replaced in the opening 110 and depressed to apply a pressure 126 to drive the fluid sample 304 through the fluid-absorbing material 104.
  • Water from the fluid sample 304 is absorbed by the fluid-absorbing material 104, and the resulting concentrated fluid sample 306 is ejected out of the opening 302.
  • the concentrated fluid sample 306 may be provided to a collection port of a detection or test device (e.g., detection system 222 of FIG. 2).
  • FIGS. 4A and 4B illustrate another example syringe-based sample collection and concentration device 400.
  • the example device 400 is similar to the device 300 of FIG. 3. However, in the example device 400, the fluid-absorbing material 104 is separated by the bottom surface 106 of the container 102.
  • the device 400 may also include a selective layer 122 that is the same or similar to the selective layer 122 described above with respect to the example device 120 of FIG. IB.
  • FIG. 4A illustrates the device 400 when a fluid sample 304 is collected by the device 400.
  • the plunger 124 may be pulled up to provide a negative pressure 402 to draw a fluid sample 304 suspected of containing an infectious agent into the container 102 through the opening 302.
  • the fluid sample 304 contacts the water absorbing material 104 (or the selective layer 122), and water is absorbed by the fluid-absorbing layer 104.
  • a volume of the collected fluid sample 304 is greater than a capacity of the fluid-absorbing material 104.
  • FIG. 4B shows the device 400 after a concentrated fluid sample 306 is generated.
  • the volume of the concentrated fluid sample 306 is smaller than that of the received fluid sample 304.
  • the volume of the fluid-absorbing material 104 may be increased following absorption of water from the fluid sample 304.
  • the fluid-absorbing material 104 itself may be selective against the collection of infectious agent from the fluid sample 304 and/or the selective layer 122 may reduce or prevent the passage of infectious agent into the water absorbing material 104.
  • the plunger 124 may be depressed to provide a pressure 126 to eject the concentrated fluid sample 306 out of the opening 302.
  • the concentrated fluid sample 306 may be provided to a collection port of a detection or test device (e.g., detection system 222 of FIG. 2).
  • FIG. 5 is a flowchart of an example method 500 of operating a sample collection and concentration device of this disclosure (e.g., any of devices 100, 120, 300, or 400 described above).
  • Method 500 may begin at operation 502 where a fluid sample is obtained that is suspected of containing an infectious agent.
  • the fluid sample may be obtained directly from a patient (e.g., patient 204 of FIG. 2).
  • the fluid sample may be any fluid that may contain an infectious agent associated with a medical condition.
  • the fluid sample may an oral sample, a buccal sample, a gastrointestinal sample, a nasal sample, an ophthalmic sample, a rectal sample, saliva, tears, nasal secretions, sinus secretions, mucous, sputum, digestive contents, blood, a blood component, blood plasma, blood serum, seminal fluid, vaginal fluid, feces, urine, or the like.
  • the fluid sample may include one or more other fluids or reagents used to aid in collection or processing of the fluid sample, or in the concentration of the infectious agent to facilitate subsequent analysis, detection, identification, and/or quantification thereof.
  • the fluid sample may include a mouth rinse used to aid in collecting a sample from the mouth of a patient and/or a reagent solution used to prepare a sample for eventual analysis, detection, identification, and/or quantification (e.g., a lysis buffer).
  • a mouth rinse used to aid in collecting a sample from the mouth of a patient
  • a reagent solution used to prepare a sample for eventual analysis, detection, identification, and/or quantification
  • At operation 504 at least a portion of the collected fluid sample (e.g., fluid sample 208, 304 described above) is placed in the container 102 of the sample collection and concentration device (e.g., any of the devices 100, 120, 300, 400 described above).
  • the fluid sample may be provided directly to the sample concentration and collection device (e.g., a patient may transfer a mouth rinse into the device).
  • a sample manipulation tool e.g., tool 206 of FIG. 2, described above, such as a dropper, pipette, swab, or the like, may be used to provide the fluid sample to the sample collection and concentration device.
  • the fluid sample may be collected using the syringe (see FIGS. 3, 4A, and 4B and the corresponding description above).
  • a plunger 124 may be removed from the device, and the sample may be provided through the exposed top opening with the plunger 124 removed.
  • the plunger 124 may be used to draw the fluid sample into the device (see, e.g., FIGS. 4A and 4B).
  • the fluid sample is concentrated to generate a concentrated fluid sample (e.g., concentrated fluid sample 216, 306 described above).
  • a concentration of the infectious agent in the concentrated fluid sample is greater than a concentration of the infectious agent in the fluid sample provide at operation 504.
  • the concentrated fluid sample is generated by contacting the fluid sample from operation 504 to a fluid-absorbing material 104.
  • the fluid sample may be allowed to contact the fluid-absorbing material for a predefined period of time to absorb water from the fluid sample and generate the concentrated fluid sample.
  • a pressure 126 may be applied to increase the rate and/or amount of water absorption.
  • the concentrated fluid sample from operation 506 is provided for testing the presence and/or amount of an infectious agent in the concentrated fluid sample.
  • the concentrated fluid sample may be provided to the inlet port of any appropriate test device that is configured to detect the presence of the infectious agent (see, e.g., the detection system 222 and operation 218 of FIG. 2, described above).
  • a sample manipulation tool e.g., tool 220 of FIG. 2, described above, such as a dropper, pipette, swab, or the like, may be used to transfer the concentrated fluid sample for testing.
  • the concentrated fluid sample may be ejected from the syringe outlet (e.g., by depressing the plunger) or by removing the plunger and collecting the concentrated fluid sample from the syringe.
  • Method 500 may include performing a sample preparation operation prior to or during providing the concentrated fluid sample to the detection system.
  • the fluid sample is contacted to or mixed with a preparative solution.
  • the preparative solution facilitates subsequent detection, analysis, processing, etc. of the components of the concentrated fluid sample, such that one or more components, such as the infectious agent, can be measured, detected, identified, and/or quantified.
  • a preparative solution include solutions comprising one or more of buffers, lysis buffers, lysis agents, surfactants, detergents, solvents, and compositions comprising combinations of two of more of the same.
  • a therapeutic agent is administered based at least in part the test results obtained after operation 508 (see, e g., therapeutic agent 232 and operation 234 of FIG. 2, described above).
  • therapeutic agent “medicament”, “medication”, “medicine”, and “drug” are used interchangeably herein and describe a pharmaceutical composition or product intended for the treatment of a medical condition having at least one symptom.
  • the pharmaceutical composition or product will have a physiological effect on the patient when it is introduced into the body of a patient.
  • the pharmaceutical composition can be in any suitable formulation unless a specific formulation type is required or disclosed.
  • the medicament will be approved by the US FDA while in other instances it may be experimental (e.g., in clinical or pre-clinical trials) or approved for use in a country other than the United States (e.g., approved for use in China or Europe). In instances where these terms are used, it is understood that they refer to both singular and plural instances.
  • two or more medicaments may be used in a form of combination therapy. In all cases, the selection of the proper medicament (singular or plural) will be based on the medical condition of the patient and the assessment of the medical professional administering, supervising and/or directing the treatment of the patient. Combination therapies are sometimes more effective than a single agent and used for many different medical conditions.
  • patient refers to a warm-blooded animal such as a mammal which is the subject of a medical treatment for a medical condition that causes at least one symptom. It is understood that at least humans, dogs, cats, and horses are within the scope of the meaning of the term. In some embodiments, the patient is a human.
  • the term “and/or” used herein is to be taken mean specific disclosure of each of the specified features or components with or without the other.
  • the term “and/or” as used in a phrase such as “A and/or B” herein is intended to include “A and B,” “A or B,” “A” (alone), and “B” (alone).
  • the term “and/or” as used in a phrase such as “A, B, and/or C” is intended to encompass each of the following aspects: A, B, and C; A, B, or C; A or C; A or B; B or C; A and C; A and B; B and C; A (alone); B (alone); and C (alone).
  • the term “about” refers to a value or composition that is within an acceptable error range for the particular value or composition as determined by one of ordinary skill in the art, which will depend in part on how the value or composition is measured or determined, i.e., the limitations of the measurement system.
  • “about” or “approximately” can mean within one or more than one standard deviation per the practice in the art.
  • “about” or “approximately” can mean a range of up to 10% (i.e., ⁇ 10%) or more depending on the limitations of the measurement system.
  • about 5 mg can include any number between 4.5 mg and 5.5 mg.
  • administering refers to the physical introduction of an agent to a subject, using any of the various methods and delivery systems known to those skilled in the art.
  • exemplary routes of administration for the formulations disclosed herein include intravenous, intramuscular, subcutaneous, intraperitoneal, spinal or other parenteral routes of administration, for example, by injection or infusion.
  • parenteral administration means modes of administration other than enteral and topical administration, usually by injection, and includes, without limitation, intravenous, intramuscular, intraarterial, intrathecal, intralymphatic, intralesional, intracapsular, intraorbital, intracardiac, intradermal, intraperitoneal, transtracheal, subcutaneous, subcuticular, intraarticular, subcapsular, subarachnoid, intraspinal, epidural and intrastemal injection and infusion, as well as in vivo electroporation.
  • the formulation is administered via a non-p ar enteral route, e.g., orally.
  • non-parenteral routes include a topical, epidermal or mucosal route of administration, for example, intranasally, vaginally, rectally, sublingually or topically.
  • Administering can also be performed, for example, once, a plurality of times, and/or over one or more extended periods.

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Abstract

L'invention concerne un dispositif de collecte et de concentration d'échantillon conçu pour concentrer un agent infectieux dans un échantillon de fluide. La présente invention concerne également des procédés de détection d'un agent infectieux à l'aide de l'échantillon de fluide concentré obtenu par le dispositif et l'administration d'un agent thérapeutique lorsqu'un agent infectieux est détecté.
PCT/US2023/020005 2022-04-28 2023-04-26 Dispositif de collecte et de concentration d'échantillon et ses procédés d'utilisation WO2023212067A1 (fr)

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WO2022054524A1 (fr) * 2020-09-11 2022-03-17 富士フイルム株式会社 Dispositif de concentration, procédé de concentration d'échantillon liquide, procédé d'inspection d'échantillon liquide, et kit d'inspection
WO2022054516A1 (fr) * 2020-09-11 2022-03-17 富士フイルム株式会社 Dispositif de concentration, procédé de concentration d'une solution d'échantillon, procédé de test d'une solution d'échantillon et trousse de test

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