Compositions and methods for detecting Group B

1 . A method for determining the presence or absence of a Group B Streptococcus (GBS) in a sample, said method comprising:

(1) contacting a sample containing or suspected of containing GBS with an amplification oligomer combination comprising first CFB-factor (CFB)-specific amplification oligomer having a first hybridization sequence (A), a second CFB-specific amplification oligomer having a second hybridization sequence (B), and a CFB-specific detection probe oligomer having a second hybridization sequence (C), wherein:

(i) (A) comprises SEQ ID NO:16, or an RNA equivalent or DNA/RNA chimeric thereof, (B) comprises SEQ ID NO:17, or an RNA equivalent or DNA/RNA chimeric thereof, and (C) is SEQ ID NO:24, or an RNA equivalent or DNA/RNA chimeric thereof; or

(ii) (A) comprises SEQ ID NO:20, or an RNA equivalent or DNA/RNA chimeric thereof, (B) comprises SEQ ID NO:21, or an RNA equivalent or DNA/RNA chimeric thereof, and (C) is SEQ ID NO:25, or an RNA equivalent or DNA/RNA chimeric thereof;

wherein the CFB-specific detection probe oligomer is about 26 to about 35 nucleotides in length and comprises a detectable label

(2) performing an in vitro nucleic acid amplification reaction, wherein performing the in vitro nucleic acid amplification reaction comprises incubating the sample and the CFB-specific amplification oligomers under conditions suitable for amplification, wherein the target region of the GBS CFB target nucleic, if present in the sample, is amplified to generate an amplicon; and

(3) analyzing the sample to detect the presence or absence of the amplicon, wherein the presence of the amplicon indicates the presence of GBS in the sample and absence of the amplicon indicates the absence of the GBS in the sample.

2 . The method of claim 1 , wherein

(i) the first CFB-specific amplification oligomer comprises a nucleic acid sequence consisting of the nucleic acid sequence of SEQ ID NO: 16 the second CFB-specific amplification oligomer comprises a nucleic acid sequence consisting of the nucleic acid sequence of SEQ ID NO: 17, and the CFB-specific detection probe oligomer comprises a nucleic acid sequence consisting of the nucleic acid sequence of SEQ ID NO:24, or an RNA equivalent or DNA/RNA chimeric thereof; or

(ii) the first CFB-specific amplification oligomer comprises a nucleic acid sequence consisting of the nucleic acid sequence of SEQ ID NO:20 the second CFB-specific amplification oligomer comprises a nucleic acid sequence consisting of the nucleic acid sequence of SEQ ID NO:21, and the CFB-specific detection probe oligomer comprises a nucleic acid sequence consisting of the nucleic acid sequence of SEQ ID NO:25, or an RNA equivalent or DNA/RNA chimeric thereof.

3 . The method of claim 1 , wherein the in vitro nucleic acid amplification reaction comprises a PCR amplification reaction.

4 . The method of claim 1 , wherein the detectable label is a fluorescent or chemiluminescent label.

5 . The method of claim 4 , wherein the detectable label is a fluorescent label and the detection probe oligomer further comprises a non-fluorescent quencher.

6 . The method of claim 3 , wherein the detecting step is performed in real time.

7 . The method of claim 1 , further comprising contacting the sample with a second amplification oligomer combination capable of amplifying a target region of a GBS SIP target nucleic acid.

8 . A composition for determining the presence or absence of Group B Streptococcus (GBS) in a sample, said composition comprising:

a first CAMP-factor (CFB)-specific amplification oligomer having a first hybridization sequence (A), a second CFB-specific amplification oligomer having a second hybridization sequence (B), and a CFB-specific detection probe oligomer having a second hybridization sequence (C) wherein:

(i) (A) comprises SEQ ID NO:16, or an RNA equivalent or DNA/RNA chimeric thereof, (B) comprises SEQ ID NO:17, or an RNA equivalent or DNA/RNA chimeric thereof, and (C) is SEQ ID NO:24, or an RNA equivalent or DNA/RNA chimeric thereof, or

(ii) (A) comprises SEQ ID NO:20, or an RNA equivalent or DNA/RNA chimeric thereof, (B) comprises SEQ ID NO:21, or an RNA equivalent or DNA/RNA chimeric thereof, and (C) is SEQ ID NO:25, or an RNA equivalent or DNA/RNA chimeric thereof;

wherein (A) and (B) of (i) or (ii) are capable of amplifying a target region of a GBS CFB target nucleic acid; and

wherein the CFB-specific detection probe oligomer is about 26 to about 35 nucleotides in length and comprises a detectable label.

9 . The composition of claim 8 , wherein the CFB-specific detection probe oligomer comprises a fluorescent label, a chemiluminescent label, or a fluorescent label and a non-fluorescent quencher.

10 . The composition of claim 9 , wherein;

(i) the first CFB-specific amplification oligomer comprises a nucleic acid sequence consisting of the nucleic acid sequence of SEQ ID NO: 16, the second CFB-specific amplification oligomer comprises a nucleic acid sequence consisting of the nucleic acid sequence of SEQ ID NO: 17, and the CFB-specific detection probe oligomer comprises a nucleic acid sequence consisting of the nucleic acid sequence of SEQ ID NO:24, or an RNA equivalent or DNA/RNA chimeric thereof, or

(ii) the first CFB-specific amplification oligomer comprises a nucleic acid sequence consisting of the nucleic acid sequence of SEQ ID NO:20, the second CFB-specific amplification oligomer comprises a nucleic acid sequence consisting of the nucleic acid sequence of SEQ ID NO:21, and the CFB-specific detection probe oligomer comprises a nucleic acid sequence consisting of the nucleic acid sequence of SEQ ID NO:25.

11 . The composition of claim 8 , further comprising at second amplification oligomer combination capable of amplifying a target region of a GBS SIP target nucleic acid.

12 . A kit comprising the first CFB-specific amplification oligomer, the second CFB-specific amplification oligomer, and the CFB-specific detection probe oligomer of claim 8 .