IP Library Granted Patent US 12692557
Granted Patent B2
US 12692557 · App. 19/026,092 · Granted Jul 28, 2026

Kit for detecting

Inventors: Angela S. Hudson (San Diego, CA); Damon K. Getman (Poway, CA); Alice Jiang (San Diego, CA); Barbara Eaton (San Diego, CA)
Assignee: GEN-PROBE INCORPORATED
C12Q1/6895C12Q1/6806C12Q1/686C12Q1/689C12Q2600/112C12Q2600/16C12Q2600/166
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Quick Facts
Patent No.
US 12692557
App. No.
19/026,092
Granted
Jul 28, 2026
Kind
B2
Abstract

Disclosed are methods utilizing specific amplification of Candida sp. target nucleic acid for detecting the presence or absence of Candida sp. in a sample. Also disclosed are corresponding oligomers, including amplification oligomers, capture probes and detection probes, and combinations thereof, as well as corresponding reaction mixtures and kits.

Claims (35)

1 . A kit for determining the presence or absence of one or more of Candida ( C .) albicans, C. parapsilosis, C. dubliniensis , and C. tropicalis in a sample, the kit comprising:

(a1) a target capture reagent comprising first and second Candida -specific target capture oligomers (TCOs) and a Candida -specific T7 primer, wherein

(i) the first Candida -specific TCO comprises a first Candida -specific TCO target-hybridizing sequence consisting of the nucleotide sequence of residues 1-20 of SEQ ID NO:24,

(ii) the second Candida -specific TCO comprises a second Candida -specific TCO target-hybridizing sequence consisting of the nucleotide sequence of residues 1-17 of SEQ ID NO:66, and

(iii) the Candida -specific T7 primer comprises (A) a Candida -specific T7 primer target-hybridizing sequence consisting of the nucleotide sequence of residues 28-46 of SEQ ID NO:9 and (B) a T7 promoter sequence located 5′ to the Candida -specific T7 primer target-hybridizing sequence;

(b1) an amplification reagent comprising first and second Candida -specific non-T7 primers, wherein

(i) the first Candida -specific non-T7 primer comprises a first Candida -specific non-T7 primer target-hybridizing sequence consisting of the nucleotide sequence of SEQ ID NO:26, and

(ii) the second Candida -specific non-T7 primer comprises a second Candida -specific non-T7 primer target-hybridizing sequence consisting of the nucleotide sequence of SEQ ID NO:34; and

(c1) a promoter reagent comprising the Candida -specific T7 primer defined in (a1) (iii) and a Candida -specific detection probe, wherein the Candida -specific detection probe comprises a Candida -specific detection probe target-hybridizing sequence consisting of the nucleotide sequence of residues 1-22 of SEQ ID NO:27.

2 . The kit of claim 1 , wherein the kit is for further determining the presence or absence of C. glabrata in the sample, wherein

(a2) the target capture reagent further comprises a C. glabrata -specific target capture oligomer (TCO) and a C. glabrata -specific T7 primer, wherein

(i) the C. glabrata -specific TCO comprises a C. glabrata -specific TCO target-hybridizing sequence consisting of the nucleotide sequence of residues 1-26 of SEQ ID NO:48, and

(ii) the C. glabrata -specific T7 primer comprises (A) a C. glabrata -specific T7 primer target-hybridizing sequence consisting of the nucleotide sequence of residues 28-49 of SEQ ID NO:14 and (B) a T7 promoter sequence located 5′ to the C. glabrata -specific T7 primer target-hybridizing sequence;

(b2) the amplification reagent further comprises a C. glabrata -specific non-T7 primer comprising a C. glabrata -specific non-T7 primer target-hybridizing sequence consisting of the nucleotide sequence of SEQ ID NO:12; and

(c2) the promoter reagent further comprises the C. glabrata -specific T7 primer defined in (a2)(ii) and a C. glabrata -specific detection probe, wherein the C. glabrata -specific detection probe comprises a C. glabrata -specific detection probe target-hybridizing sequence consisting of the nucleotide sequence of residues 1-17 of SEQ ID NO:60.

3 . The kit of claim 1 , wherein

the first Candida -specific TCO has the nucleotide sequence of SEQ ID NO:24, and/or

the second Candida -specific TCO has the nucleotide sequence of SEQ ID NO:66.

4 . The kit of claim 1 , wherein the Candida -specific T7 primer has the nucleotide sequence of SEQ ID NO:9.

5 . The kit of claim 1 , wherein the Candida -specific detection probe further comprises a label, a substitution at the 2′ position of at least one ribose moiety, and/or a blocking group at or near the 3′ end of the detection probe.

6 . The kit of claim 5 , wherein the Candida -specific detection probe comprises the label.

7 . The kit of claim 6 , wherein the label is a fluorescent label and the Candida -specific detection probe further comprises a quencher.

8 . The kit of claim 7 , wherein the Candida -specific detection probe further comprises a non-target-hybridizing sequence.

9 . The kit of claim 8 , wherein the Candida -specific detection probe is a molecular torch or a molecular beacon.

10 . The kit of claim 8 , wherein the Candida -specific detection probe is a molecular torch and has the nucleotide sequence of SEQ ID NO:27 or SEQ ID NO:155.

11 . The kit of claim 2 , wherein the C. glabrata -specific TCO has the nucleotide sequence of SEQ ID NO:48.

12 . The kit of claim 2 , wherein the C. glabrata -specific T7 primer has the nucleotide sequence of SEQ ID NO:14.

13 . The kit of claim 2 , wherein the C. glabrata -specific detection probe further comprises a label, a substitution at the 2′ position of at least one ribose moiety, and/or a blocking group at or near the 3′ end of the detection probe.

14 . The kit of claim 13 , wherein the C. glabrata -specific detection probe comprises the label.

15 . The kit of claim 14 , wherein the label is a fluorescent label and the C. glabrata -specific detection probe further comprises a quencher.

16 . The kit of claim 15 , wherein the C. glabrata -specific detection probe further comprises a non-target-hybridizing sequence.

17 . The kit of claim 16 , wherein the C. glabrata -specific detection probe is a molecular torch or a molecular beacon.

18 . The kit of claim 16 , wherein the C. glabrata -specific detection probe is a molecular torch and has the nucleotide sequence of residues 1-17 of SEQ ID NO:60.

19 . The kit of claim 1 , wherein the kit further comprises an enzyme solution comprising a mixture of an MMLV reverse transcriptase and a T7 RNA polymerase.

20 . The kit of claim 2 , wherein the kit further comprises an enzyme solution comprising a mixture of an MMLV reverse transcriptase and a T7 RNA polymerase.