IP Library Patent Application 13445780
Patent Application
App. No. 13/445,780

CHEMILUMINESCENT PROBES FOR MULTIPLEX MOLECULAR QUANTIFICATION AND USES THEREOF

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Quick Facts
Patent No.
US None
App. No.
13/445,780
Filed
Apr 12, 2012
Art Unit
1634
USPC
435/6.11
Abstract

A novel method is disclosed for simultaneous detection and quantification of two or more nucleic acid targets, without need for amplification. The method depends on spectral-temporal resolution of chemiluminescence emitted from independent hybridization-induced chemiluminescent signal (HICS) probes. The utility of this method has been demonstrated by use of resolvable N-linked acridinium and 2,7-dimethoxyacridinium ester labeled probes in a homogeneous assay for sensitive and simultaneous independent quantification of several bacterial and fungal target sequences. Compositions and kits for practicing the method of the present invention are also disclosed.

Claims (37)

1 . A homogeneous assay for quantifying at least two target nucleic acid sequences in a sample, said assay comprising the steps of:

(a) sequentially or simultaneously:

(i) contacting the sample with a first hybridization induced chemiluminescent signal (HICS) probe comprising a first chemiluminescent molecule, under conditions allowing hybridization of the first probe to a first target nucleic acid sequence;

(ii) contacting the sample with a second HICS probe comprising a second chemiluminescent molecule, under conditions allowing hybridization of the second probe to a second target nucleic acid sequence that is different from the first target sequence;

(b) chemically triggering the first and second chemiluminescent molecules;

(c) detecting chemiluminescence emissions from the first and second chemiluminescent molecules, wherein the first and second chemiluminescent molecules have sufficiently different emission profiles to allow spectral and/or temporal resolution of the chemiluminescence emissions; and

(d) quantifying the target nucleic acid sequences in the sample based on the chemiluminescence emissions from the first and second chemiluminescent molecules.

2 . The assay of claim 1 , wherein the emission maxima of the first and second chemiluminescent molecules are separated by at least 50 nm.

3 . The assay of claim 1 , wherein the first and second chemiluminescent molecules comprise different acridinium ester (AE) moieties conjugated through an acridinium position other than C9 to a stem-loop oligonucleotide.

4 . The assay of claim 3 , wherein the first chemiluminescent molecule comprises an unsubstituted AE moiety, and the second chemiluminescent molecule comprises a 2,7-substituted AE moiety.

5 . The assay of claim 3 , wherein the AE moieties are conjugated through the N10 acridinium position to a stem-loop oligonucleotide.

6 . The assay of claim 5 , wherein the first chemiluminescent molecule comprises an unsubstituted AE moiety, and the second chemiluminescent molecule comprises a 2,7-substituted AE moiety.

7 . The assay of claim 6 , wherein the unsubstituted AE moiety is a 9-(2,6-dibromophenoxycarbonyl)-10-(3-carbonylpropyl)acridinium salt.

8 . The assay of claim 6 , wherein the substituted AE moiety is a 2,7-dimethoxy-9-(2,6-dibromophenoxycarbonyl)-10-(3-carbonylpropyl)acridinium salt.

9 . The assay of claim 1 , wherein the target nucleic acid sequences are selected from the group consisting of a pan-bacterial target sequence, a pan-fungal target sequence, a Chlamydia trachomatis ( C. trachomatis ) target sequence and a Neisseria gonorrhoeae ( N. gonorrhoeae ) target sequence.

10 . The assay of claim 9 , wherein the pan-bacterial target sequence comprises an Escherichia coli ( E. coli ) 23S rRNA fragment consisting of SEQ ID NO:1, allowing for a DNA equivalent thereof.

11 . The assay of claim 10 , wherein one of the probes comprises a stem-loop oligonucleotide having a target complementary base sequence consisting of SEQ ID NO:5, allowing for a DNA equivalent thereof.

12 . The assay of claim 11 , wherein the stem-loop oligonucleotide comprises a base sequence consisting of SEQ ID NO:9, SEQ ID NO:10 or SEQ ID NO:11, allowing for DNA equivalents thereof.

13 . The assay of claim 9 , wherein the pan-fungal target sequence comprises a Candida albicans ( C. albicans ) 18S rRNA fragment consisting of SEQ ID NO:2, allowing for a DNA equivalent thereof.

14 . The assay of claim 13 , wherein the one of the probes comprises a stem-loop oligonucleotide having a target complementary sequence consisting of SEQ ID NO:6, allowing for an RNA equivalent thereof.

15 . The assay of claim 14 , wherein the stem-loop oligonucleotide comprises a base sequence consisting of SEQ ID NO:12 or SEQ ID NO:13, allowing for RNA equivalents thereof.

16 . The assay of claim 9 , wherein the C. trachomatis target sequence comprises a 23S rRNA fragment consisting of SEQ ID NO:3, allowing for a DNA equivalent thereof.

17 . The assay of claim 16 , wherein one of the probes comprises a stem-loop oligonucleotide having a target complementary sequence consisting of SEQ ID NO:7, allowing for a DNA equivalent thereof.

18 . The assay of claim 17 , wherein the stem-loop oligonucleotide comprises a base sequence consisting of SEQ ID NO:14, allowing for a DNA equivalent thereof.

19 . The assay of claim 9 , wherein the N. gonorrhoeae target sequence comprises a 16S rRNA fragment consisting of SEQ ID NO:4, allowing for a DNA equivalent thereof.

20 . The assay of claim 19 , wherein one of the probes comprises a stem-loop oligonucleotide having a target complementary base sequence consisting of SEQ ID NO:8, allowing for a DNA equivalent thereof.

21 . The assay of claim 20 , wherein the stem-loop oligonucleotide comprises a base sequence consisting of SEQ ID NO:15, allowing for a DNA equivalent thereof.

22 . A composition comprising a 2,7-dimethoxy-9-(2,6-dibromophenoxycarbonyl)-10-(3-carbonylpropyl)acridinium salt.

23 . The composition of claim 22 , wherein the salt is 2,7-dimethoxy-9-(2,6-dibromophenoxycarbonyl)-10-(3-carbonylpropyl)acridinium iodide.

24 . The composition of claim 22 , wherein the 2,7-dimethoxy-9-(2,6-dibromophenoxycarbonyl)-10-(3-carbonylpropyl)acridinium salt is directly or indirectly conjugated to a small organic biomolecule, a macromolecule, a viral particle, a sub-cellular component, or a cell.

25 . The composition of claim 24 , wherein the macromolecule is selected from the group consisting of a protein, a peptide, a nucleic acid, an oligonucleotide, a polysaccharide, an oligosaccharide, a glycoprotein, a glycosaminoglycan, a lectin, a lipoprotein, a lipopolysaccharide, a hormone, a toxin, a cytokine, and a combination thereof.

26 . The composition of claim 25 , wherein the oligonucleotide is a stem-loop oligonucleotide.

27 . A kit comprising the composition of claim 22 and reagent means for triggering a chemiluminescence emission.

28 . The kit for detecting and/or quantifying a target nucleic acid sequence in a sample, the kit comprising the composition of claim 26 and reagent means for triggering a chemiluminescence emission.

29 . A kit for detecting and/or quantifying at least two target nucleic acid sequences in a sample, the kit comprising the probes according to claim 6 and reagent means triggering a chemiluminescence emission.

30 . The kit of claim 29 , wherein the unsubstituted AE moiety is a 9-(2,6-dibromophenoxycarbonyl)-10-(3-carbonylpropyl)acridinium salt.

31 . The kit of claim 29 , wherein the substituted AE moiety is a 2,7-dimethoxy-9-(2,6-dibromophenoxycarbonyl)-10-(3-carbonylpropyl)acridinium salt.

Assignments (5)
CORRECTIVE ASSIGNMENT TO CORRECT THE INCORRECT PATENT NO. 8081301 PREVIOUSLY RECORDED AT REEL: 028810 FRAME: 0745. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY AGREEMENT. Recorded Nov 9, 2017
From: HOLOGIC, INC.; BIOLUCENT, LLC; CYTYC CORPORATION; CYTYC SURGICAL PRODUCTS, LIMITED PARTNERSHIP; SUROS SURGICAL SYSTEMS, INC.; THIRD WAVE TECHNOLOGIES, INC.; GEN-PROBE INCORPORATED
To: GOLDMAN SACHS BANK USA
Reel/Frame 044432/0565 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCORRECT PATENT NO. 8081301 PREVIOUSLY RECORDED AT REEL: 035820 FRAME: 0239. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST RELEASE. Recorded Nov 9, 2017
From: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
To: HOLOGIC, INC.; BIOLUCENT, LLC; CYTYC CORPORATION; CYTYC SURGICAL PRODUCTS, LIMITED PARTNERSHIP; SUROS SURGICAL SYSTEMS, INC.; THIRD WAVE TECHNOLOGIES, INC.; GEN-PROBE INCORPORATED
Reel/Frame 044727/0529 →
SECURITY INTEREST RELEASE REEL/FRAME 028810/0745 Recorded Jun 4, 2015
From: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
To: HOLOGIC, INC.; BIOLUCENT, LLC; CYTYC CORPORATION; CYTYC SURGICAL PRODUCTS, LIMITED PARTNERSHIP; SUROS SURGICAL SYSTEMS, INC.; THIRD WAVE TECHNOLOGIES, INC.; GEN-PROBE INCORPORATED
Reel/Frame 035820/0239 →
SECURITY AGREEMENT Recorded Aug 1, 2012
From: HOLOGIC, INC.; BIOLUCENT, LLC; CYTYC CORPORATION; CYTYC SURGICAL PRODUCTS, LIMITED PARTNERSHIP; SUROS SURGICAL SYSTEMS, INC.; THIRD WAVE TECHNOLOGIES, INC.; GEN-PROBE INCORPORATED
To: GOLDMAN SACHS BANK USA
Reel/Frame 028810/0745 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 18, 2012
From: BROWNE, KENNETH A.; WEEKS, IAN
To: GEN-PROBE INCORPORATED
Reel/Frame 028233/0147 →