# US 9,434,977 B2 · Rapid identification of organisms in bodily fluids

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- Number: US 9,434,977 B2
- Document ID: US9434977B2
- Status: Granted
- Kind: B2
- Application number: 13/778,619
- Filed: 2013-02-27
- Published: 2014-08-28
- Granted: 2016-09-06
- Earliest claimed: 2013-02-27
- Assignees: Avent, Inc.
- Applicants: Avent, Inc.
- Inventors: James M. Takeuchi; Adrienne A. Hershey; Scott M. Teixeira; Stephanie M. Martin; Juan Pablo Aragon; Cindy C. Korir-Morrison; Jonathan Hofmekler
- Web page: https://patentgrep.com/patent/US9434977B2

## CPC

- C12Q 1/06: Quantitative determination
- C12Q 1/04: Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor {(C12Q1/6897 takes precedence)}
- G01N 33/54388: {based on lateral flow}
- G01N 33/54393: {Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding}
- G01N 33/56911: {Bacteria}
- 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
- 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

There is provided a lateral flow assay that can provide an indication of Gram negative (GN) or Gram positive (GP) infection (or both) within 30 minutes, and desirably in less than 15 minutes. The immediate result would signal the presence of Gram negative bacteria, Gram positive bacteria, both Gram negative and Gram positive bacteria, or no bacteria detected. The detection level would be above a specific bacterial concentration threshold that is clinically significant infection source (e.g. 10^3 cfu/ml) versus the presence of a colonizing bacteria that is not a part of the active infection.

## Claims

### Claim 1

A lateral flow assay for detecting the presence or quantity of bacteria within a sample, the lateral flow assay comprising:
an assay device; and
a test strip inserted into said assay device, said test strip having capture antibodies and detection antibodies, said detection antibodies immobilized in a specific zone on a proximal end of said test strip, said capture antibodies immobilized in a detection zone separate from and distal to the detection antibodies;
said test strip further comprising a conjugate pad disposed to receive a test sample, said detection antibodies immobilized on said conjugate pad;
said assay device further comprising a well disposed above said conjugate pad so as to prevent a large release of the sample from initially flooding the conjugate pad and a plurality of spaced-apart ribs disposed above and axially along said conjugate pad downstream of the well; said ribs pressed onto an upper surface of said conjugate pad.

### Claim 2 (depends on 1)

The lateral flow assay of claim 1, wherein said detection zone comprises a test line in a distal area thereof.

### Claim 3 (depends on 1)

The lateral flow assay of claim 1, wherein said detection antibodies are conjugated to colloidal gold or latex nanoparticles.

### Claim 4 (depends on 3)

The lateral flow assay of claim 3, wherein said colloidal gold nanoparticles are between 20 and 80 nm in size.

### Claim 5 (depends on 1)

The lateral flow assay of claim 1, wherein said detection antibodies include two monoclonal antibodies targeting lipoteichoic acid (LTA) and peptidoglycan of S. aureus for GP detection.

### Claim 6 (depends on 1)

The lateral flow assay of claim 1, wherein said detection antibodies include one monoclonal antibody targeting lipopolysaccharide (LPS) and one polyclonal antibody targeting multiple Klebsiella antigens for GN detection.

### Claim 7 (depends on 6)

The lateral flow assay of claim 6, further comprising targeting antibodies on said test strip in a zone between said detection antibodies and said capture antibodies adapted to bind Protein A or Protein G or to neutralize the reactivity of whole cell Staphylococcus and whole cell Streptococcus.

### Claim 8 (depends on 1)

The lateral flow assay of claim 1, wherein the test strip detects bacteria within a sample of respiratory fluid.