IP Library › Patent Application 17905443

Patent Application

App. No. 17/905,443

COMPOSITIONS AND METHODS FOR DETECTING SARS-COV-2 NUCLEAIC ACID

Loading inventors, assignments & file history…

Monitor This Case

Get email alerts when status or documents change.

Order Certified Copies

Most orders are placed with the USPTO same day — all within 24 business hours.

Order via The Patent Place →

Pre-filled with this patent's details

Quick Facts

Patent No.: US None
App. No.: 17/905,443

External Links

USPTO Patent Center↗ Full Patent PDF↗

Abstract

Disclosed are nucleic acid oligomers, including amplification oligomers, detection probes, and capture probes, for detection of SARS-CoV-2 nucleic acid. Also disclosed are methods of specific nucleic acid amplification and detection using the disclosed oligomers, as well as corresponding formulations, reaction mixtures, and kits and related methods for preparing aqueous reaction mixtures from dried formulations.

Claims (88)

1 . A composition or kit for determining the presence or absence of SARS-CoV-2 in a sample, said composition or kit comprising:

(a) a first amplification oligomer combination comprising first and second SARS-CoV-2-specific amplification oligomers capable of amplifying a target region of a SARS-CoV-2 target nucleic acid,

(i) wherein the first SARS-CoV-2-specific amplification oligomer comprises a first SARS-CoV-2-specific target-hybridizing sequence 18 to 27 contiguous nucleotides in length, wherein the target-hybridizing sequence is contained within SEQ ID NO:26, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:27 or SEQ ID NO:28, and

(ii) wherein the second SARS-CoV-2-specific amplification oligomer comprises a second SARS-CoV-2-specific target-hybridizing sequence 18 to 23 contiguous nucleotides in length, wherein the target-hybridizing sequence is contained within SEQ ID NO:85, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:86, SEQ ID NO:87 or SEQ ID NO:88; and

(b) a second amplification oligomer combination comprising first and second SARS-CoV-2-specific amplification oligomers capable of amplifying a target region of a SARS-CoV-2 target nucleic acid,

(i) wherein the first SARS-CoV-2-specific amplification oligomer comprises a first SARS-CoV-2-specific target-hybridizing sequence 20 to 23 contiguous nucleotides in length, wherein the target-hybridizing sequence is contained within SEQ ID NO:29, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:30, SEQ ID NO:31, or SEQ ID NO:111, and

(ii) wherein the second SARS-CoV-2-specific amplification oligomer comprises a second SARS-CoV-2-specific target-hybridizing sequence 16 to 27 contiguous nucleotides in length, wherein the target-hybridizing sequence is contained within SEQ ID NO:89, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:90, SEQ ID NO:112, or SEQ ID NO:113.

2 . The composition or kit of claim 1 , wherein the first SARS-CoV-2-specific target-hybridizing sequence of (a)(i) contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:12, SEQ ID NO:18, SEQ ID NO:19, SEQ ID NO:20, or SEQ ID NO:21, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific amplification oligomer of (a)(ii) contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:13, SEQ ID NO:71, SEQ ID NO:72, SEQ ID NO:73, SEQ ID NO:74, or SEQ ID NO:75, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

3 . The composition or kit of claim 2 , wherein the first SARS-CoV-2-specific target-hybridizing sequence of (a)(i) contains the nucleotide sequence of SEQ ID NO: 12, SEQ ID NO: 18, SEQ ID NO:19, SEQ ID NO:20, or SEQ ID NO:21, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence of (a)(ii) the nucleotide sequence of SEQ ID NO:13, SEQ ID NO:71, SEQ ID NO:72, SEQ ID NO:73, SEQ ID NO:74, or SEQ ID NO:75, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

4 . The composition or kit of any one of claims 1 - 3 , wherein the first SARS-CoV-2-specific target-hybridizing sequence of (b)(i) contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:15, SEQ ID NO:22, SEQ ID NO:23, SEQ ID NO:24 or SEQ ID NO:25, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence of (b)(ii) contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:16, SEQ ID NO:76, SEQ ID NO:77, SEQ ID NO:79, SEQ ID NO:80, SEQ ID NO:81, SEQ ID NO:82, SEQ ID NO:83 or SEQ ID NO:84, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

5 . The composition or kit of claim 4 , wherein the first SARS-CoV-2-specific target-hybridizing sequence of (b)(i) contains the nucleotide sequence of SEQ ID NO:15, SEQ ID NO:22, SEQ ID NO:23, SEQ ID NO:24 or SEQ ID NO:25, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence of (b)(ii) contains the nucleotide sequence of SEQ ID NO:16, SEQ ID NO:76, SEQ ID NO:77, SEQ ID NO:79, SEQ ID NO:80, SEQ ID NO:81, SEQ ID NO:82, SEQ ID NO:83 or SEQ ID NO:84, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

6 . A composition or kit for determining the presence or absence of SARS-CoV-2 in a sample, said composition or kit comprising an amplification oligomer combination comprising first and second SARS-CoV-2-specific amplification oligomers capable of amplifying a target region of a SARS-CoV-2 target nucleic acid,

(a) wherein the first SARS-CoV-2-specific amplification oligomer comprises a target-hybridizing sequence 18 to 27 contiguous nucleotides in length, wherein the target-hybridizing sequence is contained within SEQ ID NO:26, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:27 or SEQ ID NO:28, and

(b) wherein the second SARS-CoV-2-specific amplification oligomer comprises a second SARS-CoV-2-specific target-hybridizing sequence 18 to 23 contiguous nucleotides in length, wherein the target-hybridizing sequence is contained within SEQ ID NO:85, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:86, SEQ ID NO:87 or SEQ ID NO:88.

7 . The composition or kit of claim 6 , wherein the first SARS-CoV-2-specific target-hybridizing sequence contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:12, SEQ ID NO:18, SEQ ID NO:19, SEQ ID NO:20, or SEQ ID NO:21, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:13, SEQ ID NO:71, SEQ ID NO:72, SEQ ID NO:73, SEQ ID NO:74, or SEQ ID NO:75, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

8 . The composition or kit of claim 7 , wherein the first SARS-CoV-2-specific target-hybridizing sequence contains the nucleotide sequence of SEQ ID NO:12, SEQ ID NO:18, SEQ ID NO:19, SEQ ID NO:20, or SEQ ID NO:21, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence contains the nucleotide sequence of SEQ ID NO:13, SEQ ID NO:71, SEQ ID NO:72, SEQ ID NO:73, SEQ ID NO:74, or SEQ ID NO:75, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

9 . A composition or kit for determining the presence or absence of SARS-CoV-2 in a sample, said composition or kit comprising an amplification oligomer combination comprising first and second SARS-CoV-2-specific amplification oligomers capable of amplifying a target region of a SARS-CoV-2 target nucleic acid,

(a) wherein the first SARS-CoV-2-specific amplification oligomer comprises a first SARS-CoV-2-specific target-hybridizing sequence that is from 20 to 23 contiguous nucleotides in length, wherein the target-hybridizing sequence is contained within SEQ ID NO:29, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:30, SEQ ID NO:31, or SEQ ID NO:111, and

(b) wherein the second SARS-CoV-2-specific amplification oligomer comprises a second SARS-CoV-2-specific target-hybridizing sequence 16 to 27 contiguous nucleotides in length, wherein the target-hybridizing sequence is contained within SEQ ID NO:89, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:90, SEQ ID NO:112, or SEQ ID NO:113.

10 . The composition or kit of claim 9 , wherein the first SARS-CoV-2-specific target-hybridizing sequence contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:15, SEQ ID NO:22, SEQ ID NO:23, SEQ ID NO:24 or SEQ ID NO:25, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:16, SEQ ID NO:76, SEQ ID NO:77, SEQ ID NO:79, SEQ ID NO:80, SEQ ID NO:81, SEQ ID NO:82, SEQ ID NO:83 or SEQ ID NO:84, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

11 . The composition or kit of claim 10 , wherein the first SARS-CoV-2-specific target-hybridizing sequence contains the nucleotide sequence of SEQ ID NO:15, SEQ ID NO:22, SEQ ID NO:23, SEQ ID NO:24 or SEQ ID NO:25, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence contains the nucleotide sequence of SEQ ID NO:16, SEQ ID NO:76, SEQ ID NO:77, SEQ ID NO:79, SEQ ID NO:80, SEQ ID NO:81, SEQ ID NO:82, SEQ ID NO:83 or SEQ ID NO:84, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

12 . A composition or kit comprising a SARS-CoV-2-specific-detection probe oligomer comprising a SARS-CoV-2-specific detection probe target-hybridizing sequence that (i) is from 19 to 27 contiguous nucleotides in length, is contained within SEQ ID NO:50, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:51, SEQ ID NO:52, SEQ ID NO:53, or SEQ ID NO:114; or (ii) is from 25 to 29 contiguous nucleotides in length, is contained within SEQ ID NO:54, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:55, SEQ ID NO:56, or SEQ ID NO:115.

13 . The composition or kit of claim 12 , wherein the SARS-CoV-2-specific detection probe target hybridizing sequence contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:14, SEQ ID NO:17, SEQ ID NO:32, SEQ ID NO:33, SEQ ID NO:34, SEQ ID NO:35, SEQ ID NO:36, SEQ ID NO:37, SEQ ID NO:38, SEQ ID NO:39, SEQ ID NO:40, SEQ ID NO:41, SEQ ID NO:43, SEQ ID NO:44, SEQ ID NO:45, SEQ ID NO:46, SEQ ID NO:47, SEQ ID NO:48, SEQ ID NO: 107, SEQ ID NO:108, SEQ ID NO:109 or SEQ ID NO:110, including a DNA equivalent, an RNA equivalent, or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

14 . The composition or kit of claim 13 , wherein the SARS-CoV-2-specific detection probe target hybridizing sequence contains the nucleotide sequence of SEQ ID NO:14, SEQ ID NO:17, SEQ ID NO:32, SEQ ID NO:33, SEQ ID NO:34, SEQ ID NO:35, SEQ ID NO:36, SEQ ID NO:37, SEQ ID NO:38, SEQ ID NO:39, SEQ ID NO:40, SEQ ID NO:41, SEQ ID NO:43, SEQ ID NO:44, SEQ ID NO:45, SEQ ID NO:46, SEQ ID NO:47, SEQ ID NO:48, SEQ ID NO:107, SEQ ID NO:108, SEQ ID NO:109 or SEQ ID NO:110, including a DNA equivalent, an RNA equivalent, or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs

15 . A formulation for amplifying a SARS-CoV-2 nucleic acid in a sample, the formulation comprising:

(a) a first amplification oligomer combination comprising first and second SARS-CoV-2-specific amplification oligomers capable of amplifying a target region of a SARS-CoV-2 target nucleic acid,

(b) a second amplification oligomer combination comprising first and second SARS-CoV-2-specific amplification oligomers capable of amplifying a target region of a SARS-CoV-2 target nucleic acid,

16 . The formulation of claim 15 , wherein the first SARS-CoV-2-specific target-hybridizing sequence of (a)(i) is SEQ ID NO:12, SEQ ID NO:18, SEQ ID NO:19, SEQ ID NO:20, or SEQ ID NO:21, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence of (a)(ii) is SEQ ID NO:13, SEQ ID NO:71, SEQ ID NO:72, SEQ ID NO:73, SEQ ID NO:74, or SEQ ID NO:75, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

17 . The formulation of claim 15 or 16 , wherein the first SARS-CoV-2-specific target-hybridizing sequence of (b)(i) is SEQ ID NO: 15, SEQ ID NO:22, SEQ ID NO:23, SEQ ID NO:24 or SEQ ID NO:25, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence of (b)(ii) is SEQ ID NO:16, SEQ ID NO:76, SEQ ID NO:77, SEQ ID NO:79, SEQ ID NO:80, SEQ ID NO:81, SEQ ID NO:82, SEQ ID NO:83 or SEQ ID NO:84, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

18 . The formulation of any one of claims 15 to 17 , wherein the formulation is a dried composition.

19 . A formulation for amplifying a SARS-CoV-2 nucleic acid in a sample, the formulation comprising:

(a) an amplification oligomer combination comprising first and second SARS-CoV-2-specific amplification oligomers capable of amplifying a target region of a SARS-CoV-2 target nucleic acid, wherein the first SARS-CoV-2-specific amplification oligomer comprises a first SARS-CoV-2-specific target-hybridizing sequence 18 to 27 contiguous nucleotides in length, wherein the target-hybridizing sequence is contained within SEQ ID NO:26, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:27 or SEQ ID NO:28, and wherein the second SARS-CoV-2-specific amplification oligomer comprises a second SARS-CoV-2-specific target-hybridizing sequence 18 to 23 contiguous nucleotides in length, wherein the target-hybridizing sequence is contained within SEQ ID NO:85, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:86, SEQ ID NO:87 or SEQ ID NO:88; and

(b) a buffer.

20 . The formulation of claim 19 , wherein the first SARS-CoV-2-specific target-hybridizing sequence is SEQ ID NO:12, SEQ ID NO:18, SEQ ID NO:19, SEQ ID NO:20, or SEQ ID NO:21, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence is SEQ ID NO: 13, SEQ ID NO:71, SEQ ID NO:72, SEQ ID NO:73, SEQ ID NO:74, or SEQ ID NO:75, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

21 . The formulation of claim 19 or 20 , wherein the formulation is a dried composition.

22 . A formulation for amplifying a SARS-CoV-2 nucleic acid in a sample, the formulation comprising:

(a) an amplification oligomer combination comprising first and second SARS-CoV-2-specific amplification oligomers capable of amplifying a target region of a SARS-CoV-2 target nucleic acid, wherein the first SARS-CoV-2-specific amplification oligomer comprises a first SARS-CoV-2-specific target-hybridizing sequence 20 to 23 contiguous nucleotides in length, wherein the target-hybridizing sequence is contained within SEQ ID NO:29, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:30, SEQ ID NO:31, or SEQ ID NO:111, and wherein the second SARS-CoV-2-specific amplification oligomer comprises a second SARS-CoV-2-specific target-hybridizing sequence 16 to 27 contiguous nucleotides in length, wherein the target-hybridizing sequence is contained within SEQ ID NO:89, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:90, SEQ ID NO:112, or SEQ ID NO:113; and

(b) a buffer.

23 . The formulation of claim 22 , wherein the first SARS-CoV-2-specific target-hybridizing sequence is SEQ ID NO:15, SEQ ID NO:22, SEQ ID NO:23, SEQ ID NO:24 or SEQ ID NO:25, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence is SEQ ID NO: 16, SEQ ID NO:76, SEQ ID NO:77, SEQ ID NO:79, SEQ ID NO:80, SEQ ID NO:81, SEQ ID NO:82, SEQ ID NO:83 or SEQ ID NO:84, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

24 . The formulation of claim 22 or 23 , wherein the formulation is a dried composition.

25 . A formulation for detecting SARS-CoV-2 in a sample, the formulation comprising:

(a) a buffer; and

(b) a SARS-CoV-2-specific-detection probe oligomer comprising a SARS-CoV-2-specific detection probe target-hybridizing sequence that

(i) is from 19 to 27 contiguous nucleotides in length, is contained within SEQ ID NO:50, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:51, SEQ ID NO:52, SEQ ID NO:53, or SEQ ID NO: 114; or

(ii) is from 25 to 29 contiguous nucleotides in length, is contained within SEQ ID NO:54, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:55, SEQ ID NO:56, or SEQ ID NO:115.

26 . The formulation of claim 25 , wherein the SARS-CoV-2-specific detection probe target hybridizing sequence is selected from the group consisting of: SEQ ID NO:14, SEQ ID NO: 17, SEQ ID NO:32, SEQ ID NO:33, SEQ ID NO:34, SEQ ID NO:35, SEQ ID NO:36, SEQ ID NO:37, SEQ ID NO:38, SEQ ID NO:39, SEQ ID NO:40, SEQ ID NO:41, SEQ ID NO:43, SEQ ID NO:44, SEQ ID NO:45, SEQ ID NO:46, SEQ ID NO:47, SEQ ID NO:48, SEQ ID NO:107, SEQ ID NO: 108, SEQ ID NO: 109 and SEQ ID NO:110, including a DNA equivalent, an RNA equivalent, or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

27 . The formulation of claim 25 or 26 , wherein the formulation is a dried composition.

28 . A kit comprising a dried composition as in any one of claims 18 , 21 , 24 , and 27 .

29 . The kit of claim 28 , further comprising a reconstitution reagent, wherein the dried composition is in a first vial within the kit and the reconstitution reagent is in a second vial within the kit.

30 . A method for preparing an aqueous reaction mixture for determining the presence or absence of a SARS-CoV-2 in a sample, the method comprising the step of combining a dried composition as described in any one of embodiments 18, 21, 24, and 27 with a reconstitution reagent to make an aqueous reaction mixture.

31 . A method for determining the presence or absence of SARS-CoV-2 in a sample, the method comprising:

(a) contacting a sample with at least a first amplification oligomer combination and a second amplification oligomer combination, wherein;

(i) the first amplification oligomer combination comprises first and second SARS-CoV-2-specific amplification oligomers capable of amplifying a first target region of a SARS-CoV-2 target nucleic acid,

(1) wherein the first SARS-CoV-2-specific amplification oligomer comprises a first SARS-CoV-2-specific target-hybridizing sequence 18 to 27 contiguous nucleotides in length, wherein the target-hybridizing sequence is contained within SEQ ID NO:26, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:27 or SEQ ID NO:28, and

(2) wherein the second SARS-CoV-2-specific amplification oligomer comprises a second SARS-CoV-2-specific target-hybridizing sequence 18 to 23 contiguous nucleotides in length, wherein the target-hybridizing sequence is contained within SEQ ID NO:85, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:86, SEQ ID NO:87 or SEQ ID NO:88; and

(ii) a second amplification oligomer combination comprising first and second SARS-CoV-2-specific amplification oligomers capable of amplifying a second target region of a SARS-CoV-2 target nucleic acid,

(1) wherein the first SARS-CoV-2-specific amplification oligomer comprises a first SARS-CoV-2-specific target-hybridizing sequence 20 to 23 contiguous nucleotides in length, wherein the target-hybridizing sequence is contained within SEQ ID NO:29, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:30, SEQ ID NO:31, or SEQ ID NO:111, and

(2) wherein the second SARS-CoV-2-specific amplification oligomer comprises a second SARS-CoV-2-specific target-hybridizing sequence 16 to 27 contiguous nucleotides in length, wherein the target-hybridizing sequence is contained within SEQ ID NO:89, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:90, SEQ ID NO:112, or SEQ ID NO:113;

(b) incubating the sample in conditions suitable for in vitro nucleic acid amplification, wherein any SARS-CoV-2 target nucleic acid, if present in the sample, is used as a template for generating one or more amplicons corresponding to at least one of the first or second SARS-CoV-2 target regions; and

(c) detecting the presence or absence of the one or more amplicons, thereby determining the presence or absence of SARS-CoV-2 in the sample.

32 . The method of claim 31 , wherein the first SARS-CoV-2-specific target-hybridizing sequence of (a)(i) contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO: 12, SEQ ID NO: 18, SEQ ID NO: 19, SEQ ID NO:20, or SEQ ID NO:21, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence of (a)(ii) contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:13, SEQ ID NO:71, SEQ ID NO:72, SEQ ID NO:73, SEQ ID NO:74, or SEQ ID NO:75, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

33 . The method of claim 32 , wherein the first SARS-CoV-2-specific target-hybridizing sequence of (a)(i) contains the nucleotide sequence of SEQ ID NO:12, SEQ ID NO:18, SEQ ID NO:19, SEQ ID NO:20, or SEQ ID NO:21, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence of (a)(ii) contains the nucleotide sequence of SEQ ID NO:13, SEQ ID NO:71, SEQ ID NO:72, SEQ ID NO:73, SEQ ID NO:74, or SEQ ID NO:75, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

34 . The method of any one of claims 31 to 33 , wherein the first SARS-CoV-2-specific target-hybridizing sequence of (b)(i) contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:15, SEQ ID NO:22, SEQ ID NO:23, SEQ ID NO:24 or SEQ ID NO:25, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence of (b)(ii) contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:16, SEQ ID NO:76, SEQ ID NO:77, SEQ ID NO:79, SEQ ID NO:80, SEQ ID NO:81, SEQ ID NO:82, SEQ ID NO:83 or SEQ ID NO:84, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

35 . The method of claim 34 , wherein the first SARS-CoV-2-specific target-hybridizing sequence of (b)(i) contains the nucleotide sequence of SEQ ID NO:15, SEQ ID NO:22, SEQ ID NO:23, SEQ ID NO:24 or SEQ ID NO:25, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence of (b)(ii) contains the nucleotide sequence of SEQ ID NO:16, SEQ ID NO:76, SEQ ID NO:77, SEQ ID NO:79, SEQ ID NO:80, SEQ ID NO:81, SEQ ID NO:82, SEQ ID NO:83 or SEQ ID NO:84, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

36 . A method for determining the presence or absence of SARS-CoV-2 in a sample, the method comprising:

(a) contacting a sample with an amplification oligomer combination comprising first and second SARS-CoV-2-specific amplification oligomers capable of amplifying a target region of a SARS-CoV-2 target nucleic acid,

(b) incubating the sample in conditions suitable for in vitro nucleic acid amplification, wherein any SARS-CoV-2 target nucleic acid, if present in the sample, is used as a template for generating an amplicon corresponding to the SARS-CoV-2 target region; and

(c) detecting the presence or absence of the amplicon, thereby determining the presence or absence of SARS-CoV-2 in the sample.

37 . The method of claim 36 , wherein the first SARS-CoV-2-specific target-hybridizing sequence contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO: 12, SEQ ID NO:18, SEQ ID NO:19, SEQ ID NO:20, or SEQ ID NO:21, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:13, SEQ ID NO:71, SEQ ID NO:72, SEQ ID NO:73, SEQ ID NO:74, or SEQ ID NO:75, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

38 . The method of claim 37 , wherein the first SARS-CoV-2-specific target-hybridizing sequence contains the nucleotide sequence of SEQ ID NO:12, SEQ ID NO: 18, SEQ ID NO: 19, SEQ ID NO:20, or SEQ ID NO:21, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence contains the nucleotide sequence of SEQ ID NO:13, SEQ ID NO:71, SEQ ID NO:72, SEQ ID NO:73, SEQ ID NO:74, or SEQ ID NO:75, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs

39 . A method for determining the presence or absence of SARS-CoV-2 in a sample, the method comprising:

(b) incubating the sample in conditions suitable for in vitro nucleic acid amplification, wherein any SARS-CoV-2 target nucleic acid, if present in the sample, is used as a template for generating an amplicon corresponding to the SARS-CoV-2 target region; and

(c) detecting the presence or absence of the amplicon, thereby determining the presence or absence of SARS-CoV-2 in the sample.

40 . The method of claim 39 , wherein the first SARS-CoV-2-specific target-hybridizing sequence contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO: 15, SEQ ID NO:22, SEQ ID NO:23, SEQ ID NO:24 or SEQ ID NO:25, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:16, SEQ ID NO:76, SEQ ID NO:77, SEQ ID NO:79, SEQ ID NO:80, SEQ ID NO:81, SEQ ID NO:82, SEQ ID NO:83 or SEQ ID NO:84, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

41 . The method of claim 40 , wherein the first SARS-CoV-2-specific target-hybridizing sequence contains the nucleotide sequence of SEQ ID NO:15, SEQ ID NO:22, SEQ ID NO:23, SEQ ID NO:24 or SEQ ID NO:25, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs, and/or wherein the second SARS-CoV-2-specific target-hybridizing sequence contains the nucleotide sequence of SEQ ID NO:16, SEQ ID NO:76, SEQ ID NO:77, SEQ ID NO:79, SEQ ID NO:80, SEQ ID NO:81, SEQ ID NO:82, SEQ ID NO:83 or SEQ ID NO:84, or an RNA equivalent or a DNA/RNA chimeric thereof and including from 0-7 nucleotide analogs.

42 . A multiplex method for determining the presence or absence of SARS-CoV-2 and at least one other pathogen in a sample, wherein the presence or absence of SARS-CoV-2 is determined using the method of any one of claims 31 to 38 .

43 . The multiplex method of claim 42 , wherein the method determines the presence or absence of SARS-CoV-2 and one or more pathogens selected from the group consisting of influenza A, influenza B, respiratory syncytial virus A, respiratory syncytial virus B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, adenovirus, metapneumovirus, rhino virus, coronavirus 229E, coronavirus NL63, coronavirus HKU1, coronavirus OC43, SARS-CoV (SARS), and MERS-CoV.

44 . The method of any one of claims 31 - 41 , wherein detecting the presence or absence of the amplicon comprises contacting the sample with a SARS-CoV-2-specific-detection probe oligomer comprising a SARS-CoV-2-specific detection probe target-hybridizing sequence that (i) is from 19 to 27 contiguous nucleotides in length, is contained within SEQ ID NO:50, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:51, SEQ ID NO:52, SEQ ID NO:53, or SEQ ID NO: 114; or (ii) is from 25 to 29 contiguous nucleotides in length, is contained within SEQ ID NO:54, and contains a nucleotide sequence differing by no more than 0, 1, 2, 3, 4, or 5 nucleotides from the nucleotide sequence of SEQ ID NO:55, SEQ ID NO:56, or SEQ ID NO:115.

Assignments (4)

RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 061639/0513 Recorded Apr 24, 2026

From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT

To: HOLOGIC, INC.; GEN-PROBE INCORPORATED; FAXITRON BIOPTICS, LLC; BIOTHERANOSTICS, INC.

Reel/Frame 075457/0268 →

SECURITY INTEREST Recorded Apr 8, 2026

From: BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; CYTYC CORPORATION; SUROS SURGICAL SYSTEMS, INC.; GYNESONICS, INC.; BOLDER SURGICAL, LLC; FAXITRON BIOPTICS, LLC; HEALTH BEACONS, INC.; HOLOGIC, INC.

To: ROYAL BANK OF CANADA, AS COLLATERAL AGENT

Reel/Frame 075462/0440 →

SECURITY INTEREST Recorded Oct 11, 2022

From: HOLOGIC, INC.; FAXITRON BIOPTICS, LLC; BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED

To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT

Reel/Frame 061639/0513 →

ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 1, 2022

From: SHAH, ANKUR H.; EATON, BARBARA LYNN; GETMAN, DAMON KITTREDGE; MOBERLY, JOSHUA KALANI; DARBY, PAUL M.; PHAM, JIMMYKIM

To: GEN-PROBE INCORPORATED

Reel/Frame 060970/0952 →