WO2021217173A1 - Écouvillons de prélèvement d'échantillons cliniques pour des applications de diagnostic moléculaire et leurs procédés de production et d'utilisation - Google Patents

Écouvillons de prélèvement d'échantillons cliniques pour des applications de diagnostic moléculaire et leurs procédés de production et d'utilisation Download PDF

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Publication number
WO2021217173A1
WO2021217173A1 PCT/US2021/070427 US2021070427W WO2021217173A1 WO 2021217173 A1 WO2021217173 A1 WO 2021217173A1 US 2021070427 W US2021070427 W US 2021070427W WO 2021217173 A1 WO2021217173 A1 WO 2021217173A1
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WIPO (PCT)
Prior art keywords
biological sample
sample collection
collection swab
silica
nucleic acid
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PCT/US2021/070427
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English (en)
Inventor
Alex Hofai LEE
Original Assignee
Siemens Healthcare Diagnostics 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.)
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Application filed by Siemens Healthcare Diagnostics Inc. filed Critical Siemens Healthcare Diagnostics Inc.
Publication of WO2021217173A1 publication Critical patent/WO2021217173A1/fr

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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/10—Processes for the isolation, preparation or purification of DNA or RNA
    • C12N15/1003—Extracting or separating nucleic acids from biological samples, e.g. pure separation or isolation methods; Conditions, buffers or apparatuses therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/38—Swabs having a stick-type handle, e.g. cotton tips

Definitions

  • Biological samples that are collected in patients' homes, physicians' offices, clinics, hospitals, and/or even in a remote area may need to be preserved in a controlled environment, such as refrigeration, freezing, or chemical methods for one or more days or even one or more weeks before arrival at a central facility for high throughput analysis and/or screening.
  • Molecular diagnostic assay methods (such as, but not limited to, PCR analysis) require high quality DNA/RNA, and minor degradation or loss of nucleic acids in collected samples leads to inaccurate diagnostic results.
  • Silica-based technologies are widely employed in current kits for processing separated/lysed biological samples.
  • DNA/RNA adsorbs specifically to silica membranes/beads/particles in the presence of certain salts and at a defined pH.
  • the cellular contaminants are removed by wash steps, and DNA/RNA is eluted in a low salt buffer or elution buffer.
  • Chaotropic salts are included in the binding/lysis buffers to aid in protein denaturation and extraction of DNA. This method can be incorporated in spin columns and microchips, and is reasonably cost-effective. See, for example, Tan et al. (J Biomed Biotechnol. (2009) 2009:574398. doi: 10.1155/2009/574398. Erratum in: J Biomed Biotechnol. (2013) 2013:628968).
  • Magnetic separation is another technique utilized for processing separated/lysed biological samples. Magnetic separation is based on DNA/RNA reversibly binding to a magnetic solid surface/bead/particle that has been coated with silica. After DNA/RNA binding, beads are separated from other contaminating cellular components and washed, and then the purified DNA/RNA is eluted with low salt buffer. This method is rapid, simple to perform, and can be automated. See, for example, Akbarzadeh et al. (Nanoscale Res Lett (2012) 7:144) and Ma et al. (J Biomed Nanotechnol. (2013) 9:703-9).
  • FIG. 1 is a perspective view of one non-limiting embodiment of a biological sample collection swab constructed in accordance with the present disclosure.
  • FIG. 2 is a schematic illustrating various steps in one non-limiting embodiment of a method of using the biological sample collection swab of FIG. 1.
  • FIG. 3 is a schematic illustrating various steps in another non-limiting embodiment of a method of using the biological sample collection swab of FIG. 1.
  • FIG. 4 illustrates functional groups present on a surface of a collection swab comprising silica blended into at least a portion of a fibrous material on a collection end portion of the swab (left), along with a reaction schematic illustrating the binding of nucleic acid present in the collected sample to the silica upon the addition of chaotropic salt (right).
  • FIG. 5 illustrates a microscopic image of a glass membrane filter.
  • FIG. 6 graphically indicates an analysis of the collection swabs constructed in accordance with the present disclosure using two HSV viruses, each in a simulated vaginal fluid sample.
  • compositions/devices, kits, and/or methods disclosed herein can be made and executed without undue experimentation in light of the present disclosure. While the compositions/devices, kits, and/or methods have been described in terms of particular embodiments, it will be apparent to those of skill in the art that variations may be applied to the compositions/devices, kits, and/or methods and in the steps or in the sequence of steps of the methods described herein without departing from the concept, spirit, and scope of the present disclosure. All such similar substitutions and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the present disclosure as defined by the appended claims.
  • the use of the term "at least one” will be understood to include one as well as any quantity more than one, including but not limited to, 2, 3, 4, 5, 10, 15, 20, 30, 40, 50, 100, etc.
  • the term “at least one” may extend up to 100 or 1000 or more, depending on the term to which it is attached; in addition, the quantities of 100/1000 are not to be considered limiting, as higher limits may also produce satisfactory results.
  • the use of the term "at least one of X, Y, and Z" will be understood to include X alone, Y alone, and Z alone, as well as any combination of X, Y, and Z.
  • any reference to "one embodiment,” “an embodiment,” “some embodiments,” “one example,” “for example,” or “an example” means that a particular element, feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment.
  • the appearance of the phrase “in some embodiments” or “one example” in various places in the specification is not necessarily all referring to the same embodiment, for example. Further, all references to one or more embodiments or examples are to be construed as non-limiting to the claims.
  • the term "about” is used to indicate that a value includes the inherent variation of error for a composition/apparatus/ device, the method being employed to determine the value, or the variation that exists among the study subjects.
  • the designated value may vary by plus or minus twenty percent, or fifteen percent, or twelve percent, or eleven percent, or ten percent, or nine percent, or eight percent, or seven percent, or six percent, or five percent, or four percent, or three percent, or two percent, or one percent from the specified value, as such variations are appropriate to perform the disclosed methods and as understood by persons having ordinary skill in the art.
  • the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”), or “containing” (and any form of containing, such as “contains” and “contain”) are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.
  • a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherently present therein.
  • the term “substantially” means that the subsequently described event or circumstance completely occurs or that the subsequently described event or circumstance occurs to a great extent or degree.
  • the term “substantially” means that the subsequently described event or circumstance occurs at least 80% of the time, or at least 85% of the time, or at least 90% of the time, or at least 95% of the time.
  • the term “substantially adjacent” may mean that two items are 100% adjacent to one another, or that the two items are within close proximity to one another but not 100% adjacent to one another, or that a portion of one of the two items is not 100% adjacent to the other item but is within close proximity to the other item.
  • sample as used herein will be understood to include any type of biological sample that may be utilized in accordance with the present disclosure.
  • the sample may be any fluidic sample and/or sample capable of being fluidic (e.g., a biological sample mixed with a fluidic substrate).
  • biological samples examples include, but are not limited to, whole blood or any portion thereof (i.e., plasma or serum), saliva, sputum, cerebrospinal fluid (CSF), surgical drain fluid, skin, intestinal fluid, intraperitoneal fluid, cystic fluid, sweat, interstitial fluid, extracellular fluid, tears, mucus, bladder wash, urine, swabs, semen, fecal, pleural fluid, nasopharyngeal fluid, combinations thereof, and the like.
  • the biological sample may be urine, stool, sexually transmitted infection (STI) swabs, respiratory collections, and the like.
  • STI sexually transmitted infection
  • Certain non-limiting embodiments of the present disclosure are directed to a biological sample collection swab configured for collecting a biological sample for nucleic acid analysis.
  • the biological sample collection swab comprises a support body having an elongated conformation with a first end portion for contacting the sample at one end thereof and a gripping portion located at the opposing end for handling of the collection swab.
  • a fibrous material is disposed about and attached to the first end portion of the support body, thus forming a collecting portion configured to absorb a quantity of a biological sample.
  • at least one of silica and glass material is blended into at least a portion of the fibrous material.
  • the support body of the collection swab may be provided with any length as well as any size and shape that allows the collection swab to interact with a biological sample and that allows at least a portion or all of the collecting portion thereof to be disposed within a collection tube or other container during storage and/or transport, as described in detail herein.
  • the support body may be provided with a substantially linear shape, a curved shape, an angled shape, and the like. Selection of particular lengths, sizes, and shapes of support bodies for collection swabs are well within the purview of a person of ordinary skill in the art, depending upon the sample to be collected and the various collection tubes/containers, etc. with which the collection swab will subsequently interact; therefore, no further description thereof is deemed necessary.
  • any fibrous materials known in the art or otherwise contemplated herein for use with sample collection swabs may be utilized in accordance with the present disclosure.
  • Non limiting examples of fibrous materials that may be utilized include polyester, cotton, foam, microfiber, lint-free microfiber, rayon, cellulose, cellulose acetate, silk, and the like, as well as any combinations of two or more of these materials.
  • the fibrous material is soluble in guanidinium salt.
  • the fibrous material is substantially insoluble in guanidinium salt.
  • any silica or glass materials known in the art or otherwise contemplated herein that are capable of being blended with a fibrous material and attached to a sample collection swab may be utilized in accordance with the present disclosure.
  • Non-limiting examples of silica or glass materials that may be utilized include silica/glass wool, fiberglass, non-silane treated silica/glass wool, borosilicate glass wool, silica/glass fiber, borosilicate glass fiber, raw glass fiber, and the like, as well as any combinations of two or more of these materials.
  • the silica/glass material is blended into the fibrous material along only a portion of the collecting portion of the collection swab.
  • the silica/glass material is blended into the fibrous material along substantially all of the collecting portion.
  • the silica/glass material may be present in the collecting portion of the biological sample collection swab at any percentage that allows the biological sample collection swab to function as described herein.
  • the silica/glass material may constitute a percentage of the collecting portion of about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, about 15%, about 16%, about 17%, about 18%, about 19%, about 20%, about 21%, about 22%, about 23%, about 24%, about 25%, about 26%, about 27%, about 28%, about 29%, about 30%, about 31%, about 32%, about 33%, about 34%, about 35%, about 36%, about 37%, about 38%, about 39%, about 40%, about 41%, about 42%, about 43%, about 44%, about 45%, about 46%, about
  • the biological sample collection swabs may be configured for collection of any biological samples for which nucleic acid analysis is desired.
  • biological samples forwhich the collection swabs may be configured foruse therewith include urine, stool, respiratory collections, blood or any portion thereof, saliva, sputum, cerebrospinal fluid (CSF), surgical drain fluid, intestinal fluid, intra peritoneal fluid, cystic fluid, sweat, interstitial fluid, extracellular fluid, tears, mucus, bladder wash, urine, semen, pleural fluid, nasopharyngeal fluid, and the like, as well as any combinations of two or more of the above.
  • CSF cerebrospinal fluid
  • kits containing one or more of any of the biological sample collection swabs disclosed or otherwise contemplated herein.
  • the kit may further contain one or more other component(s) or reagent(s) for performing biological sample collection(s) and/or molecular diagnostic application(s) in accordance with the present disclosure.
  • the kit may further include a collection tube sized and dimensioned for insertion of at least a portion of the biological sample collection swab therein, at least one transport medium (such as, but not limited to, a transport medium comprising a guanidinium salt buffer), at least one nucleic acid elution buffer (such as, but not limited to, a nucleic acid elution buffer comprising at least one chaotropic salt), and the like, as well as any combinations of one or more thereof.
  • a transport medium such as, but not limited to, a transport medium comprising a guanidinium salt buffer
  • nucleic acid elution buffer such as, but not limited to, a nucleic acid elution buffer comprising at least one chaotropic salt
  • kits may each be in separate containers/compartments, or various components/reagents can be combined in one or more containers/compartments, depending on the cross-reactivity and stability of the components/reagents.
  • kit may include a set of written instructions explaining how to use the kit. A kit of this nature can be used in any of the methods described or otherwise contemplated herein.
  • Certain non-limiting embodiments of the present disclosure are directed to a method of using any of the biological sample collection swabs disclosed or otherwise contemplated herein.
  • the method may include the steps of: (1) collecting a biological sample using any of the biological sample collection swabs disclosed or otherwise contemplated herein; (2) disposing the biological sample collection swab having the biological sample thereon in a collection tube containing at least one transport media (such as, but not limited to, a transport media comprising a guanidinium salt buffer), and incubating same under conditions where lysis of cells in the biological sample occurs, wherein nucleic acid released during lysis of the biological sample becomes immobilized on the silica/glass material of the biological sample collection swab; (3) performing at least one wash cycle on the biological sample collection swab; and (4) eluting the nucleic acid from the biological sample collection swab by disposing the biological sample collection swab in an elution buffer.
  • transport media such as, but not limited to
  • the method further comprises the step of shipping the biological sample collection swab to a clinical facility after step (2) and prior to step (4), such that the nucleic acid is eluted at the clinical facility.
  • the method further comprises the step of storing the biological sample disposed upon the biological sample collection swab for at least one week prior to performing step (4).
  • the method further comprises the step of: (5) removing the biological sample collection swab from the elution buffer.
  • the nucleic acid detection technique includes one or more nucleic acid amplification steps.
  • the method may further comprise (in certain non-limiting embodiments), the step of: (6) performing at least one molecular diagnostic assay step on the eluted nucleic acid.
  • Molecular diagnostic assays utilized in accordance with the present disclosure include any nucleic acid detection techniques such as (but not limited to) nucleic acid amplification methods. Any nucleic acid amplification methods known in the art or otherwise contemplated herein may be utilized as part of the nucleic acid detection methods in accordance with the present disclosure. Non-limiting examples of nucleic acid amplification methods that may be utilized include any of the various types of polymerase chain reaction (PCR)(such as, but not limited to, qPCR), loop mediated isothermal amplification (LAMP), nucleic acid sequence based amplification (NASBA), self-sustained sequence replication (3SR), rolling circle amplification (RCA), ligase chain reaction (LCR), and the like.
  • PCR polymerase chain reaction
  • LAMP loop mediated isothermal amplification
  • NASBA nucleic acid sequence based amplification
  • RCA rolling circle amplification
  • LCR ligase chain reaction
  • the present disclosure addresses a need in the art for a collection device that is able to streamline the collection, storage, and sample processing to DNA/RNA extraction workflow of biological samples.
  • the collection device and methods of the present disclosure take into consideration and focus on howto avoid the loss of sample while using less materials and less process steps to accomplish certain tasks.
  • the collection device and methods of the present disclosure result in less waste generation, less time, and less tedious steps with better effectiveness while having the same or better performance in the various analysis applications.
  • the swabs can perform sample processing in conjunction with storage/transport. Lysing, washing, and DNA/RNA steps can all be performed without leaving the collection swab, thereby allowing for preservation and shipping to core lab within the same device used for sample collection.
  • the collection devices and methods of the present disclosure eliminate the complex architecture for magnetic separation and reduce or eliminate extra liquid handling steps (such as, but not limited to media changes, etc.).
  • the collection swabs of the present disclosure were prepared by blending silica and glass material with commercially available fibrous materials used in the production of commonly found swabs.
  • the original commercial materials like cotton, rayon, and microfiber have been fully validated for use in sample collection swabs and in collection performance.
  • the collection swabs of the present disclosure that combine silica or glass material blended with a fibrous material allows the additional features without compromising the original functions of the currently available devices. Indeed, silica is inert and biosafe.
  • the devices and methods of the present disclosure provide cost savings and reduction in infrastructure complexity.
  • the presently disclosed collection swabs containing silica/glass material blended inside fibrous material are capable of performing all method steps from specimen collection to nucleic acid extraction for molecular diagnostic applications like PCR or any other types of nucleic acid detection.
  • the silica/glass containing collection swabs of the present disclosure can collect specimens in the same manner as currently available collection swabs. Samples release and transport by dipping the swabs inside a transport media (such as, but not limited to, Atellica transport media with guanidinium salt, or any buffer recipe come with guanidinium salt), with lysis function.
  • the DNA/RNA bind to the silica/glass material blended inside the collection swabs.
  • One or more washing cycles followed by nucleic acids extraction/elution can then be performed (such as, but not limited to, upon arrival at a laboratory). The whole process is carried out with the same collection swab without a need to change media and with no extra liquid handling or manipulation of magnetic silica particles, thereby reducing the chance of sample loss during sample preparation, handling, and analysis.
  • the glass/silica fiber blended in fibrous material of the presently disclosed collection swabs is insoluble, structurally well-defined, and not lost from any steps of the process during transportation and sample preparation.
  • the blending of silica/glass into the existing types of fibrous materials would not be limited by the dimension, shape, or type of swabs utilized, thereby multiplying the usefulness of the concepts.
  • silica/glass present in the collection swabs of the present disclosure bind nucleic acids in the same manner as magnetic silica beads. As a result, the chance of sample loss from magnetic bead loss during sample preparation is eliminated, as no microparticles are involved in the device. Glass/silica fiber is insoluble and is not lost during any transportation or sample preparation steps of the present disclosure.
  • the presently disclosed collection devices and methods are the first to perform sample collection, DNA/RNA binding, and sample preparation all in one device.
  • Silica/glass fiber can be blended into fibrous materials such as (but not limited to) previously tested swab materials like rayon and cotton, the added feature of DNA/RNA binding can be provided while not compromising collection performance.
  • the devices and methods of the present disclosure allow streamlining of the collection, storage, sample processing to DNA/RNA extraction workflow. It simplifies and combined processes seamlessly to achieve the goals of less waste generation, less time consumption, fewer tedious steps, and less cost in manufacturing and operation. These features make the collection swabs of the present disclosure valuable and extendable to Point-of-Care (POC) applications.
  • POC Point-of-Care
  • materials such as cotton, foam, microfiber, polyester, or rayon are the common choice.
  • special materials like cellulose acetate or biological fibers (i.e., silk) are also commonly used when guanidine salt buffer is present in the storage/transport buffer utilized therewith; these materials are able to dissolve in guanidine buffer to ensure complete extraction of absorbed materials.
  • swab type capable of performing all of the method steps that include: (1) collection of pathogens from patients; (2) storage of the pathogens and allowing lysis to occur on the surface thereof; (3) adsorption/absorption of nucleic acids from collected pathogens/specimens so that the nucleic acids are immobilized on the swab; (4) washing and cleaning of the nucleic acids immobilized on the swab in a very convenient way by spinning or swinging the swaps in the corresponding washing or processing buffers; and (5) extraction/elution of the nucleic acids from the glass material surface from the swabs to allow for molecular diagnostic assays (such as (but not limited to) PCR or any other types of nucleic acid detection techniques) to be performed.
  • molecular diagnostic assays such as (but not limited to) PCR or any other types of nucleic acid detection techniques
  • a swab with silica/glass material can be utilized when performing all the steps from specimen collection to nucleic acid extraction for molecular diagnostic assays (such as, but not limited to, PCR or any other types of nucleic acid detection methods).
  • the silica/glass-containing swabs of the present disclosure eliminate the chance of sample loss from magnetic beads loss during sample preparation, as no microparticles are involved in the device. Glass or silica fiber is insoluble and is not lost from any step of the process during transportation and sample preparation.
  • FIG. 1 shows one non-limiting design of a biological sample collection swab 10 constructed in accordance with the present disclosure.
  • the biological sample collection swab 10 comprises a support body 12 having an elongated conformation with a first end portion 14 for contacting the sample at one end thereof and a gripping portion 16 located at the opposing end for handling of the collection swab.
  • a fibrous material 18 is disposed about and attached to the first end portion 14 of the support body 12, thus forming a collecting portion configured to absorb a quantity of a biological sample.
  • at least one of silica and glass material 20 is blended into at least a portion of the fibrous material 18.
  • silica or glass material 20 is blended into fibrous material 18 such as, but not limited to, regular swab head fiber materials like polyester, cotton, foam, microfiber, lint-free microfiber, rayon, cellulose, and cellulose acetate.
  • the fibrous material 18 can be soluble or substantially insoluble in guanidine salt.
  • Silica or glass material 20 blended to only a tip area of the fibrous material 18 allows for the use of a small volume of reagent for nucleic acid DNA/RNA elution.
  • the whole swab head (brush) area i.e., the entire area of fibrous material 18
  • the silica/glass material can be used to accommodate the silica/glass material.
  • any silica or glass materials known in the art or otherwise disclosed herein can be utilized for blending with the fibrous material, and the blending method is not limited to using non silane treated silica/glass wool, fiber, and borosilicate material or particles those immobilized on the swab heads or stick material. Also, the blending method is not limited by the swab type, head dimension, and/or shape; any swab types, head dimensions, and/or shapes can be utilized to produce the collection swabs of the present disclosure.
  • FIGS. 2-3 illustrate two workflows for the collection swabs containing silica/glass blending material constructed in accordance with the present disclosure from specimen collection to the end of sample preparation and DNA/RNA elution for molecular diagnostic applications (such as, but not limited to, PCR or any other type of nucleic acid analysis applications).
  • specimen is collected with the collection swab 10 and stored in a collection tube/container 30 that contains a buffer 32 containing a chaotropic salt, such as (but not limited to) guanidine salt buffer (i.e., Attelica Transport Media (ATM)).
  • ATM Attelica Transport Media
  • FIG. 3 differs from FIG. 2 in the use of a closure for the collection tube/container after the collected swab is disposed therein (see first two steps depicted in FIG. 3 versus single first step depicted in FIG. 2).
  • the left panel of FIG. 4 illustrates a surface of a collection swab comprising silica blended into at least a portion of a fibrous material on a collection end portion of the swab, with silica S1O2 functional groups present on the surface of the swab.
  • FIG. 5 illustrates a microscopic image of a glass material blended with a fibrous material as described herein.
  • TCID50 Median Tissue Culture Infectious Dose
  • HSV-1 or HSV-2 viruses from ATCC VR260 (HSV-1 HF) or VR540 (HSV-2 MS) were spiked in the amounts shown in Table 1 into a Simulated Vaginal Fluid (SVF); the SVF was produced as shown in Table 2 and as described in Tietz et al. (Dissolution Technologies (2016) 25: 40-51; dx.doi.org/10.14227/DT250318P40).
  • composition in water
  • SVF2 g/L
  • Bovine serum albumin (BSA) 0.018
  • Collection swabs containing lx glass fiber or 5x glass fiber (or magnetic beads as a control) were contacted with the SVF spiked with the viruses, and then the collection swab was placed in a collection tube with a total volume of 200 mI ATM7A with 0.05% AF-A + 10 mI SVF and stored for 2 hours at either 45°C or room temp. Then sample preparation was carried out.
  • FIG. 6 illustrates the results obtained.
  • "C” represents a control of magnetic bead (15 mI control).
  • "1” and “5" represent lx glass fiber and 5x glass fiber, respectively.
  • "1-2” represents a second elution of lx glass fiber, while "5-2” represents a second elution of 5x glass fiber. Each elution was 35 mI.
  • each of the collection swabs containing lx or 5x glass fibers exhibited better efficiency in extraction than the magnetic bead control.
  • the amount of glass fiber present does not appear to be a factor in determining efficiency of extraction; however, the 5x glass fiber did pose some difficulty from a structural standpoint - the particular swab utilized was difficult to completely immerse and thus elute and therefore led to inefficiency of extraction in VR260. Even for lx, the amount of glass is still much higher than the beads and led to 2x fold extraction being possible.
  • the amount of glass fiber to be used for particular applications of the collection swabs can be optimized utilizing these types of experiments.
  • compositions/devices and kits as well as methods of producing and using same, which fully satisfy the objectives and advantages set forth hereinabove.

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Abstract

L'invention concerne un écouvillon de prélèvement d'échantillons biologiques qui peut être utilisé pour le prélèvement, le stockage, le lavage, l'élution d'acide nucléique et des applications de diagnostic moléculaire d'échantillons. L'écouvillon de prélèvement d'échantillons biologiques maintient la stabilité de l'acide nucléique présent dans l'échantillon biologique de telle sorte qu'une ou plusieurs cibles de dosage d'acide nucléique présentes dans l'échantillon biologique ne soient pas sensiblement dégradées pendant le stockage et l'expédition. L'invention concerne également des kits contenant les écouvillons de prélèvement d'échantillons biologiques et des procédés de production et d'utilisation desdits écouvillons.
PCT/US2021/070427 2020-04-21 2021-04-20 Écouvillons de prélèvement d'échantillons cliniques pour des applications de diagnostic moléculaire et leurs procédés de production et d'utilisation WO2021217173A1 (fr)

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