# US 2025/0084451 A1 · Method and Device for Detecting Presence, Concentration, and Antibiotic Resistance of Bacteria in Urine Samples

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- Number: US 2025/0084451 A1
- Document ID: US20250084451A1
- Status: Published application
- Kind: A1
- Application number: 18/765,978
- Filed: 2024-07-08
- Published: 2025-03-13
- Earliest claimed: 2023-07-07
- Applicants: Astek Diagnostics Inc.
- Inventors: Mustafa Al-Adhami; Courtney Cavin
- Web page: https://patentgrep.com/patent/US20250084451A1

## CPC

- C12Q 1/18: Testing for antimicrobial activity of a material
- B01L 3/502753: {characterised by bulk separation arrangements on lab-on-a-chip devices, e.g. for filtration or centrifugation}
- G01N 21/6428: {Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" (in vivo A61B5/00; immunoassay G01N33/53)}
- B01L 2200/028: Modular arrangements
- B01L 2200/0647: Handling flowable solids, e.g. microscopic beads, cells, particles
- B01L 2200/16: Reagents, handling or storing thereof
- B01L 2300/0681: Filter
- G01N 2021/6439: {with indicators, stains, dyes, tags, labels, marks}
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

An automated system that determines the presence of bacteria in a urine sample, concentration of the bacteria, and the bacteria's resistance to a panel of antibiotics, in around one hour instead of days. An automated assay to detect cell viability in mammalian cell cultures using reduction of alamarBlue through oxidation by NADH to NAD+. The assay is conducted within a fluidic chip, wherein a sample is mixed with alamarBlue, a weakly fluorescent indicator dye. Its rate of conversion to a highly fluorescent compound is monitored using a kinetics fluorimeter for 15 minutes, and metabolic activity is shown by an increase in fluorescence. A sample with live bacteria displays a consistent and rapid increase in fluorescence, whereas the negative control exhibits little to no increase over time.

## Claims

### Claim 1

A method for rapid diagnosis and antibiotic susceptibility testing of urinary tract infections, comprising the steps of:
a. collecting a urine sample from a patient,
b. transferring the urine sample into a fluidic cartridge,
c. performing a buffer exchange to isolate and concentrate bacteria present in the urine sample,
d. introducing a panel of antibiotics to the concentrated bacterial suspension,
e. incubating the bacteria-antibiotic mixtures for a predetermined period,
f. introducing a reagent to assess bacterial metabolic activity,
g. determining bacterial concentration in the original urine sample based on fluorescence readings, and
h. determining antibiotic susceptibility by comparing fluorescence intensities with predetermined threshold values.

### Claim 2 (depends on 1)

The method of claim 1, wherein the buffer exchange process involves passing the urine sample through a series of filters and buffer solutions to separate bacteria from other cellular debris and contaminants.

### Claim 3 (depends on 1)

The method of claim 1, wherein the panel of antibiotics includes a range of antibiotics commonly used to treat urinary tract infections.

### Claim 4 (depends on 1)

The method of claim 1, wherein the reagent for assessing bacterial metabolic activity is alamarBlue.

### Claim 5 (depends on 1)

A fluidic cartridge for use in the method of claim 1, comprising:
a. a sample input for receiving the urine sample,
b. a buffer exchange module for isolating and concentrating bacteria present in the urine sample,
c. a plurality of microchambers for accommodating bacteria-antibiotic mixtures, and
d. a reagent introduction module for introducing the reagent to assess bacterial metabolic activity.

### Claim 6 (depends on 1)

An analyzer for use in the method of claim 1, comprising:
a. a solid-state laser for excitation,
b. a photodiode with a bandpass filter for detecting emitted light, and
c. a processor for calculating bacterial concentration in the urine sample and determining antibiotic susceptibility based on fluorescence readings.

### Claim 7 (depends on 1)

The method of claim 1, wherein filtration, incubation and analysis takes place within a total duration of less than 60 minutes.