Diagnostic methods and markers for bacterial vaginosis
Inventors
Cartwright, Charles Paul • Lembke, Bryndon Denae • Ramachandran, Kalpana
Assignees
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Publication Number
US-12139769-B2
Publication Date
2024-11-12
Expiration Date
Abstract
A method of diagnosing bacterial vaginosis in a woman, which involves determining an amount of each of more than one BV-associated bacterium in a vaginal sample obtained from the female and assessing a BV status of the female based on the amount of each of the more than one BV-associated bacterium in the sample.
Core Innovation
The disclosed subject matter provides methods for detecting positive marker bacterial vaginosis (BV)-associated bacteria in a gynecological sample obtained from a female in need of BV detection. The methods detect nucleic acid sequences characteristic of BVAB-2, Megasphaera-1, and Atopobium vaginae using a polymerase chain reaction (PCR) assay.
The description emphasizes objective quantification of multiple BV-associated bacterial markers in vaginal samples, determining amounts of nucleic acid markers and assessing BV status using a scoring and/or composite-score system. Marker combinations are used to improve classification, including optional negative predictors such as Gardnerella vaginalis and Lactobacillus crispatus as described.
PCR can be quantitative or semi-quantitative and can be implemented as real-time PCR and/or a multiplex assay. The disclosure also describes internal controls and/or extraction controls, detection of bacterial DNA sequences, and indeterminate BV category handling based on marker detection and the scoring framework.
Claims Coverage
The independent claims focus on detecting positive marker BV-associated bacteria in gynecological samples by PCR using nucleic acid sequences characteristic of a defined bacterial marker set. Each independent claim has a core set of inventive features centered on the PCR detection of BVAB-2, Megasphaera-1, and Atopobium vaginae, with dependent claims refining assay format and/or sample and target specifics.
PCR detection of BVAB-2, Megasphaera-1, and Atopobium vaginae nucleic acid sequences
Detecting by a polymerase chain reaction (PCR) assay in a gynecological sample obtained from a female in need of BV detection nucleic acid sequences characteristic of the positive marker BV-associated bacteria consisting of BVAB-2, Megasphaera-1, and Atopobium vaginae.
PCR detection of BVAB-2, Megasphaera-1, and Atopobium vaginae for vaginal microflora alterations
Detecting by a polymerase chain reaction (PCR) assay in a gynecological sample obtained from a female in need of detection of vaginal microflora alterations nucleic acid sequences characteristic of the positive marker BV-associated bacteria BVAB-2, Megasphaera-1, and Atopobium vaginae.
Across the independent claims, the inventive core is PCR-based detection of nucleic acid sequences characteristic of the positive marker BV-associated bacteria BVAB-2, Megasphaera-1, and Atopobium vaginae in a gynecological sample from a female in need of BV detection or detection of vaginal microflora alterations.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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