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WO2025174814A1 - Procédés et kits de détection d'une infection des voies urinaires - Google Patents

Procédés et kits de détection d'une infection des voies urinaires

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Publication number
WO2025174814A1
WO2025174814A1 PCT/US2025/015498 US2025015498W WO2025174814A1 WO 2025174814 A1 WO2025174814 A1 WO 2025174814A1 US 2025015498 W US2025015498 W US 2025015498W WO 2025174814 A1 WO2025174814 A1 WO 2025174814A1
Authority
WO
WIPO (PCT)
Prior art keywords
translucent
sterile vessel
capped
transparent
capped transparent
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/US2025/015498
Other languages
English (en)
Inventor
Robert Michael Williams
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.)
ImmunogeneticsCom Inc
Original Assignee
ImmunogeneticsCom Inc
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Filing date
Publication date
Application filed by ImmunogeneticsCom Inc filed Critical ImmunogeneticsCom Inc
Publication of WO2025174814A1 publication Critical patent/WO2025174814A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • C12Q1/18—Testing for antimicrobial activity of a material
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/493—Physical analysis of biological material of liquid biological material urine
    • 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
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5091—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing the pathological state of an organism

Definitions

  • the present disclosure relates to kits and methods for detecting a urinary tract infection in a subject and determining susceptibility of bacteria and/or fungus causing the urinary tract infection to an antibiotic and/or antifungal agent.
  • Urinary tract infections are one of the most common types of infections, accounting for more than 8 million visits to healthcare providers in the United States per year. UTIs can affect any part of the urinary system including kidneys, ureters, urethra, and bladder. Complications of UTIs can include severe kidney damage, recurrent UTIs, delivery of premature infants in women, and sepsis. Thus, there is need to develop diagnostic tests for early detection of UTIs.
  • kits including: (a) a first capped transparent or translucent sterile vessel; and (b) a second capped transparent or translucent sterile vessel including at least one antibiotic and/or at least one antifungal agent.
  • the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel are composed of glass. In some embodiments of any of the kits described herein, the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel are composed of plastic. In some embodiments of any of the kits described herein, the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel are flat-bottomed vessels. In some embodiments of any of the kits described herein, the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel are round-bottomed vessels.
  • the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel include a screw cap.
  • the screw cap includes a filter or a membrane having a pore size of about 0.03 micrometer to about 0.22 micrometer that allows air to move in and out of the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel.
  • the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel include a snap cap.
  • the snap cap includes a filter or a membrane having a pore size of about 0.03 micrometer to about 0.22 micrometer that allows air to move in and out of the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel.
  • the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel have an interior volume of about 0.2 mL to about 50 mL. In some embodiments of any of the kits described herein, the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel have an interior volume of about 0.5 mL to about 20 mL. In some embodiments of any of the kits described herein, the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel have an interior volume of about 1 mL to about 5 mL.
  • the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel have a height of about 1.0 cm to about 20 cm. In some embodiments of any of the kits described herein, the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel have a height of about 1.5 cm to about 15 cm. In some embodiments of any of the kits described herein, the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel have a height of about 2 cm to about 10 cm.
  • the second capped transparent or translucent sterile vessel includes at least one antibiotic. In some embodiments of any of the kits described herein, the at least one antibiotic is present in the second capped transparent or translucent sterile vessel as a solid. In some embodiments of any of the kits described herein, the at least one antibiotic is present in the second capped transparent or translucent sterile vessel as a solution.
  • the at least one antibiotic is selected from the group consisting of: amoxicillin/clavulanate, ampicillin, ampicillin/sulbactam, cefazolin, cefepime, ceftriaxone, ciprofloxacin, ertapenem, fosfomycin, gentamicin, imipenem, levofloxacin, nitrofurantoin, PIP/tazobactam, tobramycin, and trimethoprim/ SULF A sulfamethoxazole.
  • the at least one antibiotic is a single antibiotic. In some embodiments of any of the kits described herein, the at least one antibiotic is two or more different antibiotics.
  • the second capped transparent or translucent sterile vessel includes at least one antifungal agent. In some embodiments of any of the kits described herein, the at least one antifungal agent is present in the second capped transparent or translucent sterile vessel as a solid. In some embodiments of any of the kits described herein, the at least one antifungal agent is present in the second capped transparent or translucent sterile vessel as a solution.
  • the at least one antifungal agent is selected from the group consisting of: fluconazole, caspofungin, anidulafungin, voriconazole, amphotericin B, an echinocandin, and an azole.
  • the at least one antifungal agent is a single antifungal agent.
  • the at least one antifungal agent is two or more different antifungal agents.
  • the second capped transparent or translucent sterile vessel includes at least one antibiotic and at least one antifungal agent.
  • the kit includes a rack.
  • the kit includes at least one additional capped transparent or translucent sterile vessel including at least one antibiotic and/or at least one antifungal agent that is different from the at least one antibiotic and/or at least one antifungal agent that is present in the second capped transparent or translucent sterile vessel.
  • Also provided herein are methods of diagnosing a urinary tract infection in a subject and determining susceptibility of bacteria and/or fungus causing the urinary tract infection to an antibiotic and/or antifungal agent where the method includes: (a) disposing a volume of urine from a subject into a first capped transparent or translucent sterile vessel; (b) disposing a volume of urine from the subject into a second capped transparent or translucent sterile vessel including at least one antibiotic and/or at least one antifungal agent; (c) incubating the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel for a period of time; (d) determining turbidity of the urine in the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel after the period of time; where: presence of turbidity in the urine in the first capped transparent or translucent sterile vessel after the period of time identifies that the subject has a urinary tract infection and decreased turbidity in the urine in
  • the method further includes collecting urine from the subject.
  • the disposing in steps (a) and (b) include the use of a pipette.
  • the pipette is a disposable plastic pipette.
  • the method further includes, between steps (c) and (d), agitating the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel.
  • the subject is identified as having a urinary tract infection and the bacteria or the fungus causing the urinary tract infection is identified as being susceptible to treatment with the at least one antibiotic and/or the at least one antifungal agent present in the second capped transparent or translucent sterile vessel. In some embodiments of any of the methods described herein, the subject is identified as having a urinary tract infection and the bacteria or the fungus causing the urinary tract infection is identified as not being susceptible to treatment with the at least one antibiotic and/or the at least one antifungal agent present in the second capped transparent or translucent sterile vessel.
  • the subject is identified as not having a urinary tract infection.
  • the method includes informing a physician that the subject has been identified as having a urinary tract infection.
  • the method includes informing a physician that the subject has been identified as having a urinary tract infection and that the bacteria or the fungus causing the urinary tract infection has been identified as being susceptible to treatment with the at least one antibiotic and/or the at least one antifungal agent present in the second capped transparent or translucent sterile vessel.
  • the method includes informing a physician that the subject has been identified as having a urinary tract infection and that the bacteria or the fungus causing the urinary tract infection has been identified as not being susceptible to treatment with the at least one antibiotic and/or the at least one antifungal agent present in the second capped transparent or translucent sterile vessel.
  • the period of time is about 6 hours to about 48 hours. In some embodiments of any of the methods described herein, the period of time is about 12 hours to about 48 hours. In some embodiments of any of the methods described herein, the period of time is about 12 hours to about 36 hours.
  • the incubating in steps (c) and (d) is performed at a temperature of about 22 °C to about 37 °C. In some embodiments of any of the methods described herein, the incubating in steps (c) and (d) is performed at a temperature of about 22 °C to about 30 °C. In some embodiments of any of the methods described herein, the incubating in steps (c) and (d) is performed at a temperature of about 22 °C to about 26 °C.
  • the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel are composed of glass. In some embodiments of any of the methods described herein, the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel are composed of plastic. In some embodiments of any of the methods described herein, the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel are flat-bottomed vessels. In some embodiments of any of the methods described herein, the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel are round-bottomed vessels.
  • the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel include a screw cap.
  • the screw cap includes a filter or a membrane having a pore size of about 0.03 micrometer to about 0.22 micrometer that allows air to move in and out of the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel.
  • the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel include a snap cap.
  • the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel have a height of about 1.0 cm to about 20 cm. In some embodiments of any of the methods described herein, the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel have a height of about 1.5 cm to about 15 cm. In some embodiments of any of the methods described herein, the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel have a height of about 2 cm to about 10 cm.
  • the second capped transparent or translucent sterile vessel includes at least one antibiotic. In some embodiments of any of the methods described herein, the at least one antibiotic is present in the second capped transparent or translucent sterile vessel as a solid. In some embodiments of any of the methods described herein, the at least one antibiotic is present in the second capped transparent or translucent sterile vessel as a solution.
  • the at least one antibiotic is selected from the group consisting of: amoxicillin/clavulanate, ampicillin, ampicillin/sulbactam, cefazolin, cefepime, ceftriaxone, ciprofloxacin, ertapenem, fosfomycin, gentamicin, imipenem, levofloxacin, nitrofurantoin, PIP/tazobactam, tobramycin, and trimethoprim/ SULF A sulfamethoxazole.
  • the at least one antibiotic is a single antibiotic. In some embodiments of any of the methods described herein, the at least one antibiotic is two or more different antibiotics.
  • the second capped transparent or translucent sterile vessel includes at least one antifungal agent.
  • the at least one antifungal agent is present in the second capped transparent or translucent sterile vessel as a solid.
  • the at least one antifungal agent is present in the second capped transparent or translucent sterile vessel as a solution.
  • the at least one antifungal agent is selected from the group consisting of: fluconazole, caspofungin, anidulafungin, voriconazole, amphotericin B, an echinocandin, and an azole.
  • the at least one antifungal agent is a single antifungal agent. In some embodiments of any of the methods described herein, the at least one antifungal agent is two or more different antifungal agents.
  • the second capped transparent or translucent sterile vessel includes at least one antibiotic and at least one antifungal agent.
  • the term “about” is used herein to mean approximately, in the region of, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 10%.
  • Non-human animals can include vertebrates, e.g., mammals and non-mammals, such as non-human primates, sheep, cats, horses, cows, dog, mouse, rat, goat, rabbit, and pig.
  • the subject can be a human.
  • Urinary tract infections are one of the most common types of infection and pose a major burden on the healthcare system. UTIs can affect any part of the urinary system including kidneys, ureters, urethra, and bladder, and can cause complications such as severe kidney damage, recurrent UTIs, delivering premature infants in women, and sepsis, if left untreated.
  • kits including capped transparent or translucent sterile vessels (e.g., a first capped transparent or translucent sterile vessel and a second capped transparent or translucent sterile vessel). Such kits can further include at least one antibiotic, at least one antifungal agent, at least one pH sensitive dye, or a combination thereof.
  • kits including (a) a first capped transparent or translucent sterile vessel; and (b) a second capped transparent or translucent sterile vessel including at least one antibiotic and/or at least one antifungal agent.
  • the first and/or second capped transparent or translucent sterile vessel further includes at least one pH sensitive dye (e.g., any of the exemplary pH-sensitive dyes described herein or known in the art).
  • a capped transparent or translucent sterile vessel (e.g., a first capped transparent or translucent sterile vessel and/or a second capped transparent or translucent sterile vessel) can be any suitable shape and composed of any suitable material described herein or known in the art.
  • a capped transparent or translucent sterile can be composed of glass (e.g., borosilicate glass or fused quartz) and/or plastic (e.g., polypropylene or polystyrene).
  • a capped transparent or translucent sterile vessel is a flat-bottomed vessel.
  • a capped transparent or translucent sterile vessel is a round-bottomed vessel.
  • the cap of a capped transparent or translucent sterile vessel can be any suitable cap described herein or known in the art.
  • the cap can be a screw cap or a snap cap.
  • a cap described herein can include a filter or a membrane (e.g., polycarbonate membrane or PVDF).
  • the cap includes a filter or a membrane having a pore size of about 0.03 micrometer to about 0.22 micrometer.
  • the filter or membrane can have a pore size of about 0.03 micrometer to about 0.18 micrometer, about 0.03 micrometer to about 0.14 micrometer, about 0.03 micrometer to about 0.10 micrometer, about 0.03 micrometer to about 0.06 micrometer, about 0.06 micrometer to about 0.22 micrometer, about 0.06 micrometer to about 0.18 micrometer, about 0.06 micrometer to about 0.14 micrometer, about 0.06 micrometer to about 0.10 micrometer, about 0.10 micrometer to about 0.22 micrometer, about 0.10 micrometer to about 0.18 micrometer, about 0.10 micrometer to about 0.14 micrometer, about 0.14 micrometer to about 0.22 micrometer, about 0.14 micrometer to about 0.18 micrometer, or about 0.18 micrometer to about 0.22 micrometer.
  • a capped transparent or translucent sterile vessel (e.g., a first capped transparent or translucent sterile vessel and/or a second capped transparent or translucent sterile vessel) has an interior volume of about 0.2 mL to about 50 mL.
  • a capped transparent or translucent sterile vessel can have an interior volume of about 0.2 mL to about 45 mL, about 0.2 mL to about 40 mL, about 0.2 mL to about 35 mL, about 0.2 mL to about 30 mL, about 0.2 mL to about 25 mL, about 0.2 mL to about 20 mL, about 0.2 mL to about 15 mL, about 0.2 mL to about 10 mL, about 0.2 mL to about 5 mL, about 0.2 mL to about 1 mL, about 0.2 mL to about 0.5 mL, about 0.5 mL to about 50 mL, about 0.5 mL to about 45 mL, about 0.5 mL to about 40 mL, about 0.5 mL to about 35 mL, about 0.5 mL to about 30 mL, about 0.5 mL to about 25 mL, about 0.5 mL to about 20 mL,
  • a capped transparent or translucent sterile vessel has an interior volume of about 0.2 mL, about 0.5 mL, about 1 mL, about 5 mL, about lOmL, about 15 mL, or about 20 mL. In some embodiments, a capped transparent or translucent sterile vessel has an interior volume of about 0.5 mL to about 20 mL. In some embodiments, a capped transparent or translucent sterile vessel has an interior volume of about 1 mL to about 5 mL.
  • a capped transparent or translucent sterile vessel (e.g., a first capped transparent or translucent sterile vessel and/or a second capped transparent or translucent sterile vessel) has a height of about 1.0 cm to about 20 cm.
  • a capped transparent or translucent sterile vessel can have a height of about 1 cm to about 20 cm, about 1 cm to about 18 cm, about 1 cm to about 16 cm, about 1 cm to about 14 cm, about 1 cm to about 12 cm, about 1 cm to about 10 cm, about 1 cm to about 8 cm, about 1 cm to about 6 cm, about 1 cm to about 4 cm, about 1 cm to about 2 cm, about 1 cm to about 1.5 cm, about 1.5 cm to about 20 cm, about 1.5 cm to about 18 cm, about 1.5 cm to about 16 cm, about 1.5 cm to about 14 cm, about 1.5 cm to about 15 cm, about 1.5 cm to about 12 cm, about 1.5 cm to about 10 cm, about 1.5 cm to about 8 cm, about 1.5 cm to about 6 cm, about 1.5 cm to about 4 cm, about 1.5 cm to about 2 cm, about 2 cm to about 20 cm, about 2 cm to about 18 cm, about 2 cm to about 16 cm, about 2 cm to about 14 cm, about 2 cm to about 12 cm, about 2 cm to about 10 cm, about 2 cm to about 8 cm, about 1.5 cm to about
  • a capped transparent or translucent sterile vessel has a height of about 1.5 cm to about 15 cm. In some embodiments, a capped transparent or translucent sterile vessel has a height of about 2 cm to about 10 cm. In some embodiments, a capped transparent or translucent sterile vessel has a height of about 1.0 cm, about 1.5 cm, about 2 cm, about 4 cm, about 6 cm, about 8 cm, about 10 cm, about 12 cm, about 14 cm, about 16 cm, about 18 cm, or about 20 cm.
  • a capped transparent or translucent sterile vessel (e.g., a second capped transparent or translucent sterile vessel) includes at least one antibiotic.
  • the at least one antibiotic can be present in the capped transparent or translucent sterile vessel (e.g., the second capped transparent or translucent sterile vessel) as a solid or as a solution.
  • Non-limiting examples of an antibiotic that can be present in a capped transparent or translucent sterile vessel described herein include amoxicillin/clavulanate, ampicillin, ampicillin/sulbactam, cefazolin, cefepime, ceftriaxone, ciprofloxacin, ertapenem, fosfomycin, gentamicin, imipenem, levofloxacin, nitrofurantoin, PIP/tazobactam, tobramycin, and trimethoprim/SULFA sulfamethoxazole.
  • the at least one antibiotic is a single antibiotic.
  • the at least one antibiotic is two or more different antibiotics (e.g., two, three, four, five, six or more different antibiotics).
  • a capped transparent or translucent sterile vessel described herein includes at least one antifungal agent.
  • the at least one antifungal agent can be present in the capped transparent or translucent sterile vessel (e.g., the second capped transparent or translucent sterile vessel) as a solid or as a solution.
  • an antifungal agent that can be present in a capped transparent or translucent sterile vessel described herein include fluconazole, caspofungin, anidulafungin, voriconazole, amphotericin B, an echinocandin, and an azole.
  • the at least one antifungal agent is a single antifungal agent. In some embodiments, the at least one antifungal agent is two or more different antifungal agents (e.g., two, three, four, five, six or more different antifungal agents). In some embodiments, a capped transparent or translucent sterile vessel (e.g., a second capped transparent or translucent sterile vessel) includes at least one antibiotic and at least one antifungal agent.
  • a kit described herein further includes at least one additional capped transparent or translucent sterile vessel containing at least one antibiotic and/or at least one antifungal agent that is different from the at least one antibiotic and/or at least one antifungal agent that is present in the second capped transparent or translucent sterile vessel.
  • a kit described herein further includes a rack. pH Sensitive Dyes
  • a capped transparent or translucent sterile vessel (e.g., a first capped transparent or translucent sterile vessel) includes at least one pH sensitive dye.
  • a pH sensitive dye include litmus, phenolphthalein, and phenol red.
  • the methods provided herein include (a) disposing a volume of urine from a subject into a first capped transparent or translucent sterile vessel (e.g., any of the first capped transparent or translucent sterile vessels described herein); (b) disposing a volume of urine from the subject into a second capped transparent or translucent sterile vessel (e.g., any of the second capped transparent or translucent sterile vessels described herein) containing at least one antibiotic and/or at least one antifungal agent (e.g., any of the antibiotics and/or antifungal agents described herein) (c) incubating the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel for a period of time; and (d) determining turbidity of the urine in the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel after the period of time.
  • a first capped transparent or translucent sterile vessel e.g., any of the first capped transparent or translucent sterile
  • the method further includes disposing a volume of urine from the subject into at least one additional capped transparent or translucent sterile vessel containing at least one antibiotic and/or at least one antifungal agent that is different from the at least one antibiotic and/or at least one antifungal agent that is present in the second capped transparent or translucent sterile vessel.
  • the presence or absence of turbidity in the urine can be used to identify a subject having a urinary tract infection.
  • presence of turbidity in the urine in the first capped transparent or translucent sterile vessel after the period of time can identify that the subject has a urinary tract infection.
  • the lack of detectable turbidity in the urine in the first capped transparent or translucent sterile vessel after the period of time identifies that the subject does not have a urinary tract infection.
  • the methods provided herein include (a) disposing a volume of urine from a subject into a first capped transparent or translucent sterile vessel (e.g., any of the first capped transparent or translucent sterile vessels described herein) containing at least one pH sensitive dye (e.g., any of the pH sensitive dyes described herein) (b) disposing a volume of urine from the subject into a second capped transparent or translucent sterile vessel (e g., any of the second capped transparent or translucent sterile vessels described herein) containing at least one antibiotic and/or at least one antifungal agent (e.g., any of the antibiotics and/or antifungal agents described herein) and the at least one pH sensitive dye; (c) incubating the first and second capped transparent or translucent sterile vessels for a period of time; (d) determining a color change of the urine in the first and second capped transparent or translucent sterile vessel after the period of time as compared to a control capped transparent or translucent vessel comprising
  • a pH sensitive dye is meant a dye that is capable of changing color when shifting from a pH of 6 - 8 to a pH of less than 6 and/or shifting from a pH of 6-8 to a pH of greater than 8.
  • Non-limiting examples of pH sensitive dyes are described herein. Additional examples of pH sensitive dyes are known in the art.
  • the methods described herein further include informing a physician that the subject has been identified as having a urinary tract infection.
  • such methods can include informing a physician that the subject has been identified as having a urinary tract infection and that the bacteria or the fungus causing the urinary tract infection has been identified as being susceptible to treatment with the at least one antibiotic and/or the at least one antifungal agent present in the second capped transparent or translucent sterile vessel.
  • the methods include informing a physician that the subject has been identified as having a urinary tract infection and that the bacteria or the fungus causing the urinary tract infection has been identified as not being susceptible to treatment with the at least one antibiotic and/or the at least one antifungal agent present in the second capped transparent or translucent sterile vessel.
  • a period of time as used herein is about 6 hours to about 48 hours.
  • a period of time as used herein can be about 6 hours to about 42 hours, about 6 hours to about 36 hours, about 6 hours to about 30 hours, about 6 hours to about 24 hours, about 6 hours to about 18 hours, about 6 hours to about 12 hours, about 12 hours to about 48 hours, about 12 hours to about 42 hours, about 12 hours to about 36 hours, about 12 hours to about 30 hours, about 12 hours to about 24 hours, about 12 hours to about 18 hours, about 18 hours to about 48 hours, about 18 hours to about 42 hours, about 18 hours to about 36 hours, about 18 hours to about 30 hours, about 18 hours to about 24 hours, about 24 hours to about 48 hours, about 24 hours to about 42 hours, about 24 hours to about 36 hours, about 24 hours to about 30 hours, about 30 hours to about 48 hours, about 30 hours to about 48 hours, about 30 hours to about 48 hours, about 30 hours to about 42 hours, about 30 hours to about 36 hours, about 36 hours to about 48 hours, about 36 hours to about 42 hours
  • a period of time as used herein is about 12 hours to about 48 hours. In some embodiments a period of time as used herein is about 12 hours to about 36 hours. In some embodiments a period of time as used herein is about 6, about 12, about 18, about 24, about 36, or about 48 hours.
  • incubating a capped transparent or translucent sterile vessel is performed at a temperature of about 22 °C to about 37 °C.
  • incubating a capped transparent or translucent sterile vessel can be performed at a temperature of about 22 °C to about 36 °C, about 22 °C to about 34 °C, about 22 °C to about 32 °C, about 22 °C to about 30 °C, about 22 °C to about 28 °C, about 22 °C to about 26 °C, about 22 °C to about 24 °C, about 24 °C to about 36 °C, about 24 °C to about 34 °C, about 24 °C to about 32 °C, about 24 °C to about 30 °C, about 24 °C to about 28 °C, about 24 °C to about 26 °C, about 26 °C to about 36 °C, about 26 °C to about 34 °C, about 26 °C to about 32 °C, about 26 °C to about 34 °C, about 26 °C to about 32 °C, about 26 °C to about 30 °C, about 26 °

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Abstract

La présente divulgation concerne des kits pour détecter des infections des voies urinaires chez un sujet. L'invention concerne également des procédés pour diagnostique une infection des voies urinaires chez un sujet et déterminer la sensibilité de bactéries et/ou de champignons provoquant l'infection des voies urinaires à un antibiotique et/ou à un agent antifongique.
PCT/US2025/015498 2024-02-13 2025-02-12 Procédés et kits de détection d'une infection des voies urinaires Pending WO2025174814A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996028570A1 (fr) * 1995-03-09 1996-09-19 Xechem, Inc. Methode rapide et trousse de diagnostic pour la detection de microorganismes
WO2008007206A2 (fr) * 2006-07-11 2008-01-17 Universita' Degli Studi Roma Tre Procédé colorimétrique et dispositive associé de detection de charge bactérienne
WO2009026920A1 (fr) * 2007-08-31 2009-03-05 Statens Serum Institut Compositions et moyens permettant de diagnostiquer des infections microbiennes
WO2021163462A1 (fr) * 2020-02-12 2021-08-19 Regents Of The University Of Minnesota Méthodes et compositions pour dépistage communautaire d'infections polymicrobiennes
US20230183774A1 (en) * 2021-12-10 2023-06-15 Georgia Tech Research Corporation Colorimetric assay for high throughput, facile and rapid antimicrobial susceptibilities testing

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996028570A1 (fr) * 1995-03-09 1996-09-19 Xechem, Inc. Methode rapide et trousse de diagnostic pour la detection de microorganismes
WO2008007206A2 (fr) * 2006-07-11 2008-01-17 Universita' Degli Studi Roma Tre Procédé colorimétrique et dispositive associé de detection de charge bactérienne
WO2009026920A1 (fr) * 2007-08-31 2009-03-05 Statens Serum Institut Compositions et moyens permettant de diagnostiquer des infections microbiennes
WO2021163462A1 (fr) * 2020-02-12 2021-08-19 Regents Of The University Of Minnesota Méthodes et compositions pour dépistage communautaire d'infections polymicrobiennes
US20230183774A1 (en) * 2021-12-10 2023-06-15 Georgia Tech Research Corporation Colorimetric assay for high throughput, facile and rapid antimicrobial susceptibilities testing

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BOTTINI GIORGIA ET AL: "A New Method For Microbiological Analysis That Could Be Used For Point-Of-Care Testing (POCT)", THE OPEN EMERGENCY MEDICINE JOURNAL, vol. 5, no. 1, 6 September 2013 (2013-09-06), pages 13 - 15, XP093274191, ISSN: 1876-5424, Retrieved from the Internet <URL:https://benthamopenarchives.com/contents/pdf/TOEMJ/TOEMJ-5-13.pdf> DOI: 10.2174/1876542401305010013 *
CHAKRABORTY DEBJIT ET AL: "Diagnostic validation study of rapid urinary tract infection diagnosis kit at peripheral health facilities of West Bengal, India", SCIENTIFIC REPORTS, vol. 14, no. 1, 2 January 2024 (2024-01-02), US, XP093274181, ISSN: 2045-2322, Retrieved from the Internet <URL:https://www.nature.com/articles/s41598-023-49489-0> DOI: 10.1038/s41598-023-49489-0 *

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