Kits for the diagnosis of bacterial vaginosis
AssigneeQuest Diagnostics Investments Incorporated
InventorsErik P. Johnson, Dale A. Schwab
Life of this patent
Estimating the term…
Abstract
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.
Claims28
A quantitative kit for diagnosing vaginitis in a female subject comprising no more than six primer pairs including:
- (i) a primer pair for amplifying a fragment of a nucleic acid from Atopobium vaginae, wherein the fragment of a nucleic acid is a fragment of a 16S ribosomal RNA gene;
- (ii) a primer pair for amplifying a fragment of a nucleic acid from Megasphaera genus, wherein the fragment of a nucleic acid is a fragment of a 16S ribosomal RNA gene;
- (iii) a primer pair for amplifying a fragment of a nucleic acid from Gardnerella vaginalis;
- (iv) a primer pair for amplifying a fragment of a nucleic acid from Lactobacillus jensenii, wherein the fragment of a nucleic acid is a fragment of a 16S ribosomal RNA gene;
- and
- (v) a primer pair for amplifying a fragment of a nucleic acid from Lactobacillus crispatus, wherein the fragment of a nucleic acid is a fragment of a 16S ribosomal RNA gene,
- wherein at least one primer of each primer pair is detectably labeled to allow quantification of amplification products, and wherein all primer pairs in the kit are specific for organisms associated with vaginitis or Lactobacilli species.
A quantitative kit for diagnosing vaginitis in a female subject comprising no more than six primer pairs including:
- (i) a primer pair and a probe for amplifying and detecting a fragment of a nucleic acid from Atopobium vaginae, wherein the fragment of a nucleic acid is a fragment of a 16S ribosomal RNA gene;
- (ii) a primer pair and a probe for amplifying and detecting a fragment of a nucleic acid from Megasphaera genus, wherein the fragment of a nucleic acid is a fragment of a 16S ribosomal RNA gene;
- (iii) a primer pair and a probe for amplifying and detecting a fragment of a nucleic acid from Gardnerella vaginalis;
- (iv) a primer pair and a probe for amplifying and detecting a fragment of a nucleic acid from Lactobacillus jensenii, wherein the fragment of a nucleic acid is a fragment of a 16S ribosomal RNA gene;
- and
- (v) a primer pair and a probe for amplifying and detecting a fragment of a nucleic acid from Lactobacillus crispatus, wherein the fragment of a nucleic acid is a fragment of a 16S ribosomal RNA gene,
- wherein the probe of each set of two primers and probe is detectably labeled to allow quantitation of amplification products, and wherein all primer pairs and probes in the kit are specific for organisms associated with vaginitis or Lactobacilli species.
Dependencies are inferred from the claim text.