Methods for the diagnosis of bacterial vaginosis

摘要

The present invention relates to methods for the diagnosis of bacterial vaginosis based on an analysis of a patient sample. For example, patient test samples are analyzed for the presence or absence of one or more lactobacilli and two or more pathogenic organisms. The presence or absence of one or more lactobacilli and two or more pathogenic organisms may be detected using PCR analysis of nucleic acid segments corresponding to each target organism. The quantity of the target organisms can then be used to determine a score which is indicative of a diagnosis of bacterial vaginosis.

主权项

1. A method for identifying bacterial vaginosis in a human female subject, the method comprising:
a. obtaining a vaginal swab sample from the subject; b. measuring levels of at least two of Atopobium vaginae, Megasphaera genus, or Gardnerella vaginalis, and one or more Lactobacilli species selected from the group consisting of Lactobacillus acidophilus, Lactobacillus crispatus, and Lactobacillus jensenii in the sample, wherein the levels of at least two of Atopobium vaginae, Megasphaera genus, and/or Gardneralla vaginalis, and of one or more Lactobacilli species are detected with one or more oligonucleotides capable of specifically hybridizing to a target nucleic acid sequence from Atopobium vaginae, Megasphaera genus, Gardneralla vaginalis, Lactobacillus acidophilus, Lactobacillus crispatus, and/or Lactobacillus jensenii, wherein levels of Mobiluncus sp are not measured; wherein the levels are determined with one or more oligonucleotide primers selected from SEQ ID NOs: 1, 2, 4, 5, 11, 12, 14 15, 17, and 18 and complements thereof; c. calculating a diagnostic score as the ratio of a logarithmic function of the levels of the one or more Lactobacilli species and a logarithmic function of the levels of at least two of Atopobium vaginae, Megasphaera genus, and/or Gardneralla vaginalis; and d. identifying the subject as having bacterial vaginosis with the diagnostic score lower than a reference score.