# US 2021/0172001 A1 · Bacteria identification and antimicrobial susceptibility test

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- Number: US 2021/0172001 A1
- Document ID: US20210172001A1
- Status: Published application
- Kind: A1
- Application number: 17/036,736
- Filed: 2020-09-29
- Published: 2021-06-10
- Earliest claimed: 2015-02-27
- Assignees: Mastaplex Ltd.
- Applicants: Mastaplex Limited
- Inventors: Olaf Bork
- Web page: https://patentgrep.com/patent/US20210172001A1

## CPC

- C12Q 1/14: Streptococcus; Staphylococcus
- 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)}
- C12Q 1/18: Testing for antimicrobial activity of a material
- G01N 33/04: Dairy products
- G01N 2800/365: Breast disorders, e.g. mastalgia, mastitits, Paget's disease
- 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

The present invention provides compositions, methods and kits for bacteria identification and anti-microbial susceptibility testing for the treatment of, for example, acute and chronic infections including infectious disease. The present invention is particularly useful in the identification of bacteria causing mastitis, and to antibiotic susceptibility testing to facilitate in the identification of an appropriate treatment for mastitis.

## Claims

### Claim at position 1

-14. (canceled)

### Claim 15

A method for identifying the presence of a Group D Streptococci in a human or non-human animal sample, wherein the human or non-human animal may be infected by, or at risk to infection by, Group D Streptococci, the method comprising:
(i) providing a reaction mix comprising biological sample obtained from a human or non-human animal and identification media comprising esculin, ferric citrate and a stabilizing agent; and
(ii) identifying if Group D Streptococci are present in the sample,
wherein, the esculin and ferric citrate is present in the reaction mix in an amount sufficient to inhibit growth of the Group D Streptococci if not for the presence of a stabilizing agent
and wherein, identification of Group D Streptococci in the sample is confirmed by blackening of the reaction mix,
where identification of Group D Streptococci in the sample indicates that the human or non-human animal is infected by, or at risk to infection by, the Group D Streptococci.

### Claim 16

A method for identifying coagulase positive Staphylococci in a human or non-human animal, wherein the human or non-human animal may be infected by, or at risk to infection by, coagulase positive Staphylococci, the method comprising:
(i) providing a reaction mix comprising a biological sample obtained from a human or non-human animal and identification media comprising tellurite and a stabilizing agent; and
(ii) identifying if coagulase positive Staphylococci is present in the sample,
wherein, the tellurite is present in the reaction mix in an amount sufficient to inhibit growth of the coagulase positive Staphylococci if not for the presence of the stabilizing agent
and wherein, identification of coagulase positive Staphylococci in the sample is confirmed by the appearance of a black sediment in the reaction mix,
where identification of coagulase positive Staphylococci in the sample indicates that the human or non-human animal is infected by, or at risk to infection by, coagulase positive Staphylococci.

### Claim 17 (depends on 16)

A method for identifying coagulase negative Staphylococci in a human or a non-human animal, wherein the human or non-human animal is infected by, or is at risk of infection by, coagulase negative Staphylococci, the method comprising;
(i) establishing that coagulase positive Staphylococci are not present in the sample according to the method of claim 16;
(ii) providing a reaction mix comprising a biological sample obtained from the same human or non-human animal with an identification media comprising high salt concentration, a carbohydrate source and a colour based pH indicator; and
(iii) identifying if coagulase negative Staphylococci are present in the sample,
and wherein, the pH indicator in the reaction mix is present in an amount sufficient to inhibit growth of the coagulase negative Staphylococci if not for the presence of the stabilizing agent,
and wherein, the carbohydrate source in the reaction mix is selected from one or more of the group consisting of glucose fructose, maltose, sucrose, glycerol, galactose, mannose and lactose,
and wherein, identification of coagulase negative Staphylococci is confirmed by a colour change in the second reaction mix caused by a change in pH,
where identification of coagulase negative Staphylococci in the sample indicates that the human or non-human animal is infected by, or at risk to infection by, coagulase negative Staphylococci.

### Claim at position 5

-20. (canceled)

### Claim 21

A test kit for performing an antimicrobial susceptibility test on a biological sample obtained from a human or a non-human animal, wherein the human or non-human animal may be infected by, or at risk of infection by, one or more infection causing bacteria, the test kit comprising:
(i) a bacteria growth media;
(ii) a colour based pH indicator;
(iii) a stabilizing agent comprising a milk derived protein or milk-derived protein extract;
(iv) an antimicrobial agent; and
(v) optionally instructions for performing the antimicrobial susceptibility test on the biological sample,
wherein the colour based pH indicator is present at greater than or equal to 0.0035% when the components of the test kit are combined with the biological sample.