WO2025174814A1 - Methods and kits for detection of a urinary tract infection - Google Patents

Abstract

The present disclosure provides kits for detecting urinary tract infections in a subject. Also provided 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.

Description

METHODS AND KITS FOR DETECTION OF A URINARY TRACT INFECTION

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Patent Application No. 63/552,917, filed February 13, 2024; the entire contents of which are herein incorporated by reference.

TECHNICAL FIELD

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.

BACKGROUND

Urinary tract infections (UTIs) 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.

SUMMARY

Provided herein are 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.

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 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.

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 include a screw cap. In some embodiments of any of the kits described herein, 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. 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 include a snap cap. In some embodiments of any of the kits described herein, 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.

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 0.2 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.

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 1.0 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.

In some embodiments of any of the kits described herein, 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.

In some embodiments of any of the kits described herein, 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.

In some embodiments of any of the kits described herein, 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.

In some embodiments of any of the kits described herein, 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.

In some embodiments of any of the kits described herein, the at least one antifungal agent is selected from the group consisting of: fluconazole, caspofungin, anidulafungin, voriconazole, amphotericin B, an echinocandin, and an azole. In some embodiments of any of the kits described herein, the at least one antifungal agent is a single antifungal agent. In some embodiments of any of the kits described herein, the at least one antifungal agent is two or more different antifungal agents. In some embodiments of any of the kits described herein, the second capped transparent or translucent sterile vessel includes at least one antibiotic and at least one antifungal agent.

In some embodiments of any of the kits described herein, the kit includes a rack.

In some embodiments of any of the kits described herein, 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 second capped transparent or translucent vessel after the period of time compared to the turbidity of the urine in the first capped transparent or translucent sterile vessel after the period of time identifies that the bacteria or the fungus causing the urinary tract infection is 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; presence of turbidity in the urine in the first capped transparent or translucent sterile vessel identifies that the subject has a urinary tract infection and similar turbidity in the urine in the second capped transparent or translucent vessel after the period of time compared to the turbidity in the urine in the first capped transparent or translucent sterile vessel after the period of time, identifies the bacteria or the fungus causing the infection is not susceptible to the 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; or the lack of detectable turbidity in the urine in the first capped transparent or translucent sterile vessel after the period of time identifies the subject does not have a urinary tract infection.

In some embodiments of any of the methods described herein, the method further includes collecting urine from the subject. In some embodiments of any of the methods described herein, the disposing in steps (a) and (b) include the use of a pipette. In some embodiments of any of the methods described herein, the pipette is a disposable plastic pipette. In some embodiments of any of the methods described herein, 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.

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 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.

In some embodiments of any of the methods described herein, the subject is identified as not having a urinary tract infection. In some embodiments of any of the methods described herein, the method includes informing a physician that the subject has been identified as having a urinary tract infection. In some embodiments of any of the methods described herein, 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. In some embodiments of any of the methods described herein, 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.

In some embodiments of any of the methods described herein, 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.

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 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.

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 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.

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 include a screw cap. In some embodiments of any of the methods described herein, 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. 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 include a snap cap. In some embodiments of any of the methods described herein, 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.

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 an interior volume of about 0.2 mL to about 50 mL. 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 an interior volume of about 0.5 mL to about 20 mL. 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 an interior volume of about 1 mL to about 5 mL.

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 1.0 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.

In some embodiments of any of the methods described herein, 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.

In some embodiments of any of the methods described herein, 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.

In some embodiments of any of the methods described herein, 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.

In some embodiments of any of the methods described herein, where the second capped transparent or translucent sterile vessel includes at least one antifungal agent. In some embodiments of any of the methods 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 methods described herein, the at least one antifungal agent is present in the second capped transparent or translucent sterile vessel as a solution. In some embodiments of any of the methods described herein, the at least one antifungal agent is selected from the group consisting of: fluconazole, caspofungin, anidulafungin, voriconazole, amphotericin B, an echinocandin, and an azole.

In some embodiments of any of the methods described herein, 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.

In some embodiments of any of the methods described herein, the second capped transparent or translucent sterile vessel includes at least one antibiotic and at least one antifungal agent.

Definitions

As used herein, 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%.

As used herein, the term “subject” can refer to human and non-human animals. 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. For example, the subject can be a human.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Methods and materials are described herein for use in the present invention; other, suitable methods and materials known in the art can also be used. The materials, methods, and examples are illustrative only and not intended to be limiting. All publications, patent applications, patents, sequences, database entries, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. Other features and advantages of the invention will be apparent from the following detailed description and figures, and from the claims.

DETAILED DESCRIPTION

Urinary tract infections (UTIs) 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

The present disclosure provides 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. In some embodiments, provided herein are 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. In some embodiments, 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).

Sterile Vessels

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. For example, 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). In some embodiments, a capped transparent or translucent sterile vessel is a flat-bottomed vessel. In some embodiments, a capped transparent or translucent sterile vessel is a round-bottomed vessel.

The cap of 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 cap described herein or known in the art. For example, the cap can be a screw cap or a snap cap.

In some embodiments, a cap described herein can include a filter or a membrane (e.g., polycarbonate membrane or PVDF). In some embodiments, the cap includes a filter or a membrane having a pore size of about 0.03 micrometer to about 0.22 micrometer. For example, 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. In some embodiments, the filter or membrane has a pore size of about 0.03 micrometer, about 0.06 micrometer, about 0.10 micrometer, about 0.18 micrometer, or about 0.22 micrometer. In some embodiments, the filter or membrane allows air to move in and out of the capped transparent or translucent sterile vessel (e.g., the first capped transparent or translucent sterile vessel and/or the second capped transparent or translucent sterile vessel).

In some embodiments, 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. For example, 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, about 0.5 mL to about 15 mL, about 0.5 mL to about 10 mL, about 0.5 mL to about 5 mL, about 0.5 mL to about 1 mL, about 1 mL to about 50 mL, about 1 mL to about 45 mL, about 1 mL to about 40 mL, about 1 mL to about 35 mL, about 1 mL to about 30 mL, about 1 mL to about 25 mL, about 1 mL to about 20 mL, about 1 mL to about 15 mL, about 1 mL to about 10 mL, about 1 mL to about 5 mL, about 5 mL to about 50 mL5 mL to about 45 mL, about 5 mL to about 40 mL, about 5 mL to about 35 mL, about 5 mL to about 30 mL, about 5 mL to about 25 mL, about 5 mL to about 20 mL, about 5 mL to about 15 mL, about 5 mL to about 10 mL, about 10 mL to about 50 mL, about 10 mL to about 45 mL, about 10 mL to about 40 mL, about 10 mL to about 35 mL, about 10 mL to about 30 mL, about 10 mL to about 25 mL, about 10 mL to about 20 mL, about 10 mL to about 15 mL, about 15 mL to about 50 mL, about 15 mL to about 45 mL, about 15 mL to about 40 mL, about 15 mL to about 35 mL, about 15 mL to about 30 mL, about 15 mL to about 25 mL, about 15 mL to about 20 mL, about 20 mL to about 50 mL, about 20 mL to about 45 mL, about 20 mL to about 40 mL, about 20 mL to about 35 mL, about 20 mL to about 30 mL, about 20 mL to about 25 mL, about 25 mL to about 50 mL, about 25 mL to about 45 mL, about 25 mL to about 40 mL, about 25 mL to about 35 mL, about 25 mL to about 30 mL, about 30 mL to about 50 mL, about 30 mL to about 45 mL, about 30 mL to about 40 mL, about 30 mL to about 35 mL, about 35 mL to about 50 mL, about 35 mL to about 45 mL, about 35 mL to about 40 mL, about 40 mL to about 50 mL, about 40 mL to about 45 mL, or about 45 mL to about 50 mL. In some embodiments, 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.

In some embodiments, 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. For example, 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 2 cm to about 6 cm, about 2 cm to about 4 cm, about 4 cm to about 20 cm, about 4 cm to about 18 cm, about 4 cm to about 16 cm, about 4 cm to about 14 cm, about 4 cm to about 12 cm, about 4 cm to about 10 cm, about 4 cm to about 8 cm, about 4 cm to about 6 cm, about 6 cm to about 20 cm, about 6 cm to about 18 cm, about 6 cm to about 16 cm, about 6 cm to about 14 cm, about 6 cm to about 12 cm, about 6 cm to about 10 cm, about 6 cm to about 8 cm, about 8 cm to about 20 cm, about 8 cm to about 18 cm, about 8 cm to about 16 cm, about 8 cm to about 14 cm, about 8 cm to about 12 cm, about 8 cm to about 10 cm, about 10 cm to about 20 cm, about 10 cm to about 18 cm, about 10 cm to about 16 cm, about 10 cm to about 14 cm, about 10 cm to about 12 cm, about 12 cm to about 20 cm, about 12 cm to about 18 cm, about 12 cm to about 16 cm, about 12 cm to about 14 cm, about 14 cm to about 20 cm, about 14 cm to about 18 cm, about 14 cm to about 16 cm, about 16 cm to about 20 cm, about 16 cm to about 18 cm, or about 18 cm to about 20 cm. In some embodiments, 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.

Antibiotic and 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. 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. In some embodiments, the at least one antibiotic is a single antibiotic. In some embodiments, the at least one antibiotic is two or more different antibiotics (e.g., two, three, four, five, six or more different antibiotics).

In some embodiments, a capped transparent or translucent sterile vessel described herein (e.g., a second capped transparent or translucent sterile vessel) 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. Non-limiting examples of 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. In some embodiments, 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.

In some embodiments, 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. In some embodiments, a kit described herein further includes a rack. pH Sensitive Dyes

In some embodiments, a capped transparent or translucent sterile vessel (e.g., a first capped transparent or translucent sterile vessel) includes at least one pH sensitive dye. Non-limiting examples of a pH sensitive dye include litmus, phenolphthalein, and phenol red.

Methods

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.

In some embodiments, 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. In some embodiments, 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. For example, 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. In some embodiments, 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.

In some embodiments, decreased turbidity in the urine in the second capped transparent or translucent vessel after the period of time compared to the turbidity of the urine in the first capped transparent or translucent sterile vessel after the period of time identifies that the bacteria or the fungus causing the urinary tract infection is 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, similar turbidity in the urine in the second capped transparent or translucent vessel after the period of time compared to the turbidity in the urine in the first capped transparent or translucent sterile vessel after the period of time, identifies that the bacteria or the fungus causing the infection is not susceptible to the 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, 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, 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 at least one additional capped transparent or translucent sterile vessel.

In some embodiments, 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. In some embodiments, 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 at least one additional capped transparent or translucent sterile vessel.

In some embodiments, the subject is identified as not having a urinary tract infection.

In some embodiments, 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 sterile water or a pH neutral buffered solution (pH of 6 to 8) and the at least one pH sensitive dye, wherein detection of a significant color change 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 detection of no significant color change in the urine in the second capped transparent or translucent vessel after the period of time compared to the control capped transparent or translucent vessel after the period of time identifies that the bacteria or the fungus causing the urinary tract infection is 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; detection of a significant color change in the urine in the first capped transparent or translucent sterile vessel identifies that the subject has a urinary tract infection and detection of a significant color change in the urine in the second capped transparent or translucent vessel after the period of time as compared to the control capped transparent or translucent vessel after the period of time, identifies the bacteria or the fungus causing the infection is not susceptible to the 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; or detection of no significant color change in the urine in the first capped transparent or translucent sterile vessel after the period of time as compared to the capped transparent or translucent vessel identifies the subject does not have a urinary tract infection. As used herein, 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.

Urine can be disposed into 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) using a pipette. For example, urine can be disposed into a capped transparent or translucent sterile vessel using a disposable plastic pipette or a plastic transfer pipette. In some embodiments, the methods described herein further include collecting urine from a subject.

In some embodiments, the methods described herein further include agitating any of the capped transparent or translucent sterile vessels described herein (e.g., a first capped transparent or translucent sterile vessel and/or a second capped transparent or translucent sterile vessel). For example, the first capped transparent or translucent sterile vessel and/or the second capped transparent or translucent sterile vessel can be agitated before the turbidity, acidity, or alkalinity of the urine in the first capped transparent or translucent sterile vessel and/or the second capped transparent or translucent sterile vessel is determined. In some embodiments, the first capped transparent or translucent sterile vessel and/or the second capped transparent or translucent sterile vessel are agitated between steps (c) and (d).

In some embodiments, the methods described herein further include informing a physician that the subject has been identified as having a urinary tract infection. For example, 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.

In some embodiments, 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.

In some embodiments, a period of time as used herein is about 6 hours to about 48 hours. For example, 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 42 hours, about 30 hours to about 36 hours, about 36 hours to about 48 hours, about 36 hours to about 42 hours, or about 42 hours to about 48 hours. In some embodiments, 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.

In some embodiments, incubating 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) is performed at a temperature of about 22 °C to about 37 °C. For example, 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 30 °C, about 26 °C to about 28 °C, about 28 °C to about 36 °C, about 28 °C to about 34 °C, about 28 °C to about 32 °C, about 28 °C to about 30 °C, about 30 °C to about 36 °C, about 30 °C to about 34 °C, about 30 °C to about 32 °C, about 32 °C to about 36 °C, about 32 °C to about 34 °C, or about 34 °C to about 36 °C. In some embodiments, incubating a capped transparent or translucent sterile vessel is performed at a temperature of about 22 °C to about 30 °C. In some embodiments, incubating a capped transparent or translucent sterile vessel is performed at a temperature of about 22 °C to about 26 °C. In some embodiments, incubating a capped transparent or translucent sterile vessel is performed at a temperature of about 22 °C, about 24 °C, about 26 °C, about 28 °C, about 30 °C, about 32 °C, about 34 °C, or about 37 °C. OTHER EMBODIMENTS

It is to be understood that while the invention has been described in conjunction with the detailed description thereof, the foregoing description is intended to illustrate and not limit the scope of the invention which is defined by the scope of the appended claims. Other aspects, advantages, and modification are within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:

1. A kit comprising:

(a) a first capped transparent or translucent sterile vessel; and

(b) a second capped transparent or translucent sterile vessel comprising at least one antibiotic and/or at least one antifungal agent.

2. The kit of claim 1, wherein the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel are composed of glass.

3. The kit of claim 1, wherein the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel are composed of plastic.

4. The kit of any one of claims 1-3, wherein the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel are flat-bottomed vessels.

5. The kit of any one of claims 1 -3, wherein the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel are round-bottomed vessels.

6. The kit of any one of claims 1-5, wherein the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel comprise a screw cap.

7. The kit of claim 6, wherein the screw cap comprises 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.

8. The kit of any one of claims 1- 5, wherein the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel comprise a snap cap.

9. The kit of claim 8, wherein the snap cap comprises 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.

10. The kit of any one of claims 1-9, wherein 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 mb.

11. The kit of claim 10, wherein 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.

12. The kit of claim 11, wherein 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.

13. The kit of any one of claims 1-12, wherein 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.

14. The kit of claim 13, wherein 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.

15. The kit of claim 14, wherein 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.

16. The kit of any one of claims 1-15, wherein the second capped transparent or translucent sterile vessel comprises at least one antibiotic.

17. The kit of claim 16, wherein the at least one antibiotic is present in the second capped transparent or translucent sterile vessel as a solid.

18. The kit of claim 16, wherein the at least one antibiotic is present in the second capped transparent or translucent sterile vessel as a solution.

19. The kit of any one of claims 16-18, wherein 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/ SULFA sulfamethoxazole.

20. The kit of any one of claims 16-19, wherein the at least one antibiotic is a single antibiotic.

21. The kit of any one of claims 16-19, wherein the at least one antibiotic is two or more different antibiotics.

22. The kit of any one of claims 1-15, wherein the second capped transparent or translucent sterile vessel comprises at least one antifungal agent.

23. The kit of claim 22, wherein the at least one antifungal agent is present in the second capped transparent or translucent sterile vessel as a solid.

24. The kit of claim 22, wherein the at least one antifungal agent is present in the second capped transparent or translucent sterile vessel as a solution.

25. The kit of any one of claims 22-24, wherein the at least one antifungal agent is selected from the group consisting of: fluconazole, caspofungin, anidulafungin, voriconazole, amphotericin B, an echinocandin, and an azole.

26. The kit of any one of claims 22-25, wherein the at least one antifungal agent is a single antifungal agent.

27. The kit of any one of claims 22-26, wherein the at least one antifungal agent is two or more different antifungal agents.

28. The kit of any one of claims 1-15, wherein the second capped transparent or translucent sterile vessel comprises at least one antibiotic and at least one antifungal agent.

29. The kit of any one of claims 1- 28, wherein the kit further comprises a rack.

30. The kit of any one of claims 1-28, wherein the kit further comprises at least one additional capped transparent or translucent sterile vessel comprising 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.

31. A method 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, wherein the method comprises:

(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 comprising 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; wherein: 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 second capped transparent or translucent vessel after the period of time compared to the turbidity of the urine in the first capped transparent or translucent sterile vessel after the period of time identifies that the bacteria or the fungus causing the urinary tract infection is 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; presence of turbidity in the urine in the first capped transparent or translucent sterile vessel identifies that the subject has a urinary tract infection and similar turbidity in the urine in the second capped transparent or translucent vessel after the period of time compared to the turbidity in the urine in the first capped transparent or translucent sterile vessel after the period of time, identifies the bacteria or the fungus causing the infection is not susceptible to the 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; or the lack of detectable turbidity in the urine in the first capped transparent or translucent sterile vessel after the period of time identifies the subject does not have a urinary tract infection.

32. The method of claim 31, wherein the method further comprises collecting urine from the subject.

33. The method of claim 31 or 32, wherein the disposing in steps (a) and (b) comprise the use of a pipette.

34. The method of claim 33, wherein the pipette is a disposable plastic pipette.

35. The method of any one of claims 31-34, wherein the method further comprises, between steps (c) and (d), agitating the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel.

36. The method of any one of claims 31-35, wherein 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.

37. The method of any one of claims 31-35, wherein 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.

38. The method of any one of claims 31-35, wherein the subject is identified as not having a urinary tract infection.

39. The method of claim 36 or 37, wherein the method further comprises informing a physician that the subject has been identified as having a urinary tract infection.

40. The method of claim 36, wherein the method further comprises 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.

41. The method of claim 37, wherein the method further comprises 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.

42. The method of any one of claims 31-41, wherein the period of time is about 6 hours to about 48 hours.

43. The method of claim 42, wherein the period of time is about 12 hours to about 48 hours.

44. The method of claim 43, wherein the period of time is about 12 hours to about 36 hours.

45. The method of any one of claims 31 - 44, wherein the incubating in step (c) is performed at a temperature of about 22 °C to about 37 °C.

46. The method of claim 45, wherein the incubating in step (c) is performed at a temperature of about 22 °C to about 30 °C.

47. The method of claim 46, wherein the incubating in step (c) is performed at a temperature of about 22 °C to about 26 °C.

48. The method of any one of claims 31-47, wherein the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel are composed of glass.

49. The method of any one of claims 31-47, wherein the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel are composed of plastic.

50. The method of any one of claims 31-49, wherein the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel are flat-bottomed vessels.

51. The method of any one of claims 31-49, wherein the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel are round-bottomed vessels.

52. The method of any one of claims 31 -51, wherein the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel comprise a screw cap.

53. The method of claim 52, wherein the screw cap comprises 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.

54. The method of any one of claims 31 -51, wherein the first capped transparent or translucent sterile vessel and the second capped transparent or translucent sterile vessel comprise a snap cap.

55. The method of claim 54, wherein the snap cap comprises 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.

56. The method of any one of claims 31-55, wherein 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.

57. The method of claim 56, wherein 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.

58. The method of claim 57, wherein 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.

59. The method of any one of claims 31-58, wherein 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.

60. The method of claim 59, wherein 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.

61 . The method of claim 60, wherein 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.

62. The method of any one of claims 31-61, wherein the second capped transparent or translucent sterile vessel comprises at least one antibiotic.

63. The method of claim 62, wherein the at least one antibiotic is present in the second capped transparent or translucent sterile vessel as a solid.

64. The method of claim 62, wherein the at least one antibiotic is present in the second capped transparent or translucent sterile vessel as a solution.

65. The method of any one of claims 62-64, wherein 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/ SULFA sulfamethoxazole.

66. The method of any one of claims 62-65, wherein the at least one antibiotic is a single antibiotic.

67. The method of any one of claims 62-65, wherein the at least one antibiotic is two or more different antibiotics.

68. The method of any one of claims 31-61, wherein the second capped transparent or translucent sterile vessel comprises at least one antifungal agent.

69. The method of claim 68, wherein the at least one antifungal agent is present in the second capped transparent or translucent sterile vessel as a solid.

70. The method of claim 68, wherein the at least one antifungal agent is present in the second capped transparent or translucent sterile vessel as a solution.

71. The method of any one of claims 68-70, wherein the at least one antifungal agent is selected from the group consisting of: fluconazole, caspofungin, anidulafungin, voriconazole, amphotericin B, an echinocandin, and an azole.

72. The method of any one of claims 68-71, wherein the at least one antifungal agent is a single antifungal agent.

73. The method of any one of claims 68-71, wherein the at least one antifungal agent is two or more different antifungal agents.

74. The method of any one of claims 31-61, wherein the second capped transparent or translucent sterile vessel comprises at least one antibiotic and at least one antifungal agent.