# US 10,480,035 B2 · Multiplex diagnostic assays for Lyme disease and other tick-borne diseases

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- Number: US 10,480,035 B2
- Document ID: US10480035B2
- Status: Granted
- Kind: B2
- Application number: 15/021,317
- Filed: 2014-09-10
- Published: 2016-10-06
- Granted: 2019-11-19
- Earliest claimed: 2013-09-13
- Assignees: Rutgers, The State University of New Jersey
- Applicants: Rutgers, The State University of New Jersey
- Inventors: Nikhat Parveen; Salvatore A. Marras
- Web page: https://patentgrep.com/patent/US10480035B2

## CPC

- C12Q 1/689: for bacteria
- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12Q 2600/158: Expression markers
- C12Q 2600/16: Primer sets for multiplex assays
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention provides novel methods of diagnosing and determining treatment strategies for Lyme disease and other tick-borne illnesses.

## Claims

### Claim 1

A kit for diagnosing a tick-borne disease, the kit comprising at least two of the following:
a. a pair of Borrelia primers for a recA gene sequence of Lyme disease-causing Borrelia, having the respective sequences of SEQ ID Nos: 12 and 13; and a Borrelia-specific molecular beacon probe capable of distinguishing among B. burgdorferi, B. afzelii, and B. garinii having the sequence of SEQ ID No: 5;
b. a pair of Babesia primers for a conserved B. microti thiamine pyrophosphokinase (BmTPK) gene sequence having the respective sequences of SEQ ID Nos: 14 and 15 or of SEQ ID Nos: 24 and 25 and a Babesia-specific molecular beacon probe having the sequence of SEQ ID No: 16; and
c. a pair of Anaplasma primers for a conserved Anaplasma phagocytophilum (APH) 1387 gene sequence of A. phagocytophilum having the respective sequences of SEQ ID Nos: 18 and 19, or of SEQ ID Nos: 26, and 27 and an Anaplasma-specific molecular beacon probe having the sequence of SEQ ID No: 20,
wherein each of said primer pairs amplifies an amplicon that is 70-300 base pairs in length, wherein primer annealing is performed at a temperature below or equal to a primer-extension temperature during an amplification reaction, and wherein each molecular beacon probe is labeled with a spectrally distinguishable fluorescent or luminescent signaling moiety.

### Claim 2 (depends on 1)

The kit of claim 1 further comprising a pair of ACT A1 primers having the sequences of SEQ ID Nos. 21 and 22 for a human DNA ACT A1 gene sequence and an ACT A1 molecular beacon probe having the sequence of SEQ ID No. 23.

### Claim 3 (depends on 1)

The kit of claim 1 further comprising one or more reagents selected from the group consisting of a buffer, a DNA polymerase, and nucleotides.