Compositions and Methods for Detecting or Quantifying Hepatitis B Virus
AssigneeGen-Probe Incorporated
InventorsKui Gao, Jeffrey M. Linnen
Life of this patent
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Abstract
This disclosure provides oligomers, compositions, and kits for detecting and quantifying Hepatitis B virus (HBV), including different genotypes and variants thereof, and related methods and uses. In some embodiments, oligomers target the P and/or S open reading frames of HBV and are configured to provide substantially equivalent quantification of different genotypes and variants of HBV.
Claims44
A composition or kit comprising at least first, second,
- third, and fourth amplification oligomers, wherein:
- the first amplification oligomer comprises a target-hybridizing sequence comprising at least 10 contiguous nucleotides of one of SEQ ID NOs:
- 2 or 3;
- the second amplification oligomer comprises a target-hybridizing sequence comprising at least 10 contiguous nucleotides of one of SEQ ID NOs:
- 20, 21, or 22;
- the third amplification oligomer comprises a target-hybridizing sequence comprising at least 10 contiguous nucleotides of SEQ ID NO:
- 41;
- and
- the fourth amplification oligomer comprises a target-hybridizing sequence comprising at least 10 contiguous nucleotides of one of SEQ ID NOs:
- 34 or 35;
- wherein the target-hybridizing sequences of the first, second, third, and fourth amplification oligomers each comprise at least about 14 contiguous nucleotides of Hepatitis B virus sequence or a complement thereof, and
- one or more of the first, second, third, and fourth amplification oligomers is a promoter-primer and/or comprises a non-nucleotide detectable label, and/or the composition or kit further comprises at least one probe oligomer comprising a non-nucleotide detectable label.
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A composition or kit comprising:
- (A) two or more different capture oligomers selected from the following capture oligomers (i)-(iv):
- (i) a first capture oligomer comprising a target-hybridizing sequence comprising at least 10 contiguous nucleotides of SEQ ID NO:
- 49 or 99;
- (ii) a second capture oligomer comprising a target-hybridizing sequence comprising at least 10 contiguous nucleotides of SEQ ID NO:
- 53, 100, 101, or 104;
- (iii) a third capture oligomer comprising a target-hybridizing sequence comprising at least 10 contiguous nucleotides of SEQ ID NO:
- 57, 96, or 102;
- (iv) a fourth capture oligomer comprising a target-hybridizing sequence comprising at least 10 contiguous nucleotides of SEQ ID NO:
- 61, 97, 98, or 103;
- wherein the target-hybridizing sequences of the two or more different capture oligomers each comprise at least about 14 contiguous nucleotides of Hepatitis B virus sequence or a complement thereof;
- or
- (B) a probe oligomer comprising a target-hybridizing region comprising the sequence of SEQ ID NO:
- 83:
- or
- (C) an amplification oligomer comprising a target-hybridizing region comprising at least 10 contiguous nucleotides of SEQ ID NO:
- 35 including the inosine at position 30 of SEQ ID NO:
- 35 and at least 14 contiguous nucleotides of HBV sequence;
- or
- (D) a combination thereof.
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A method of determining a level of Hepatitis B virus in a sample comprising first and second Hepatitis B amplicons associated with first and second labels, respectively, the method comprising:
- detecting a first signal emitted from the first label;
- detecting a second signal emitted from the second label;
- determining whether the first signal or the second signal is above a predetermined threshold;
- and calculating a level of Hepatitis B virus in the sample,
- wherein if the first signal or the second signal is above a predetermined threshold, the level is calculated from the greater of the first and second signals;
- and wherein if the first signal and the second signal are below a predetermined threshold, the level is calculated from an average of the first and second signals.
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Dependencies are inferred from the claim text.