IP Library › Granted Patent US 9,057,111
Granted Patent B2
US 9,057,111 · App. 13/771,550 · Granted Jun 16, 2015

Diagnostic methods and markers for bacterial vaginosis

Inventors: Charles Paul Cartwright (Plymouth, MN); Bryndon Denae Lembke (Eden Prairie, MN); Kalpana Ramachandran (Shakopee, MN)
Assignee: Laboratory Corporation of America Holdings
C12Q1/689C12Q2600/16
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Quick Facts
Patent No.
US 9,057,111
App. No.
13/771,550
Granted
Jun 16, 2015
Kind
B2
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.

Claims (11)

1. A kit for assessing bacterial vaginosis (BV) status in a female, comprising primers containing a fluorescent reporter dye coupled to synthetic initial 5′-nucleotide and other reagents for detecting in a sample obtained from the female nucleic acid sequences characteristic of positive marker BV-associated bacteria wherein the bacteria are BVAB-2 , Megasphaera -1 and at least one of Atopobium vaginae or Gardnerella vaginalis and wherein the kit does not contain reagents for detecting a Lactobacillus bacterium.

2. The kit of claim 1 , wherein the fluorescent reporter dye comprises a fluorescein moiety.

3. The kit of claim 1 , wherein the primers contain a 2′-deoxy-5-methyl-isocytidine base coupled to a fluorescein moiety immediately proximal to 5′ terminus.

4. The kit of claim 1 , wherein the positive marker BV-associated bacteria are BVAB-2 , Megasphaera -1 and Atopobium vaginae or Gardncrclla vaginalis.

5. The kit of claim 1 , wherein the kit comprises pairs of primers for conducting a quantitative PCR assay or a semi-quantitative PCR assay for detecting BVAB-2 , Megasphaera -1 and at least one of Atopobium vaginae or Gardnerella vaginalis.

6. The kit of claim 1 , wherein the positive marker BV-associated bacteria are BVAB-2 , Megasphaera -1 and Gardnerella vaginalis.

7. The kit of claim 1 , wherein the kit comprises at least three pairs of primers for conducting a quantitative PCR assay or a semi-quantitative PCR assay for detecting BVAB-2 , Megasphaera -1 and Atopobium vaginae , and does not contain pairs of primers for detecting a Lactobacillus bacterium.

8. A kit for assessing bacterial vaginosis (BV) status in a female, comprising pairs of primers containing a fluorescent reporter dye coupled to synthetic initial 5′-nucleotide for detecting in a sample obtained from the female by a multiplexed quantitative or a semi-quantitative PCR assay nucleic acid sequences characteristic of BVAB-2 , Megasphaera -1 and at least one of Gardnerella vaginalis or Atopobium vaginae , wherein the kit does not contain reagents for detecting a Lactobacillus bacterium.

9. The kit of claim 8 , comprising pairs of primers characteristic of BVAB-2 , Megasphaera -1 and Gardnerella vaginalis.

10. The kit of claim 8 , comprising pairs of primers characteristic of BVAB-2 , Megasphaera -1 and Atopobium vaginae.

11. The kit of claim 8 , wherein the pairs of primers are selected from the group consisting of pairs of primers for detecting BVAB-2 , Megasphaera -1 and Atopobium vaginae.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 17, 2013
From: CARTWRIGHT, CHARLES PAUL; LEMBKE, BRYNDON DENAE; RAMACHANDRAN, KALPANA
To: LABORATORY CORPORATION OF AMERICA HOLDINGS
Reel/Frame 030433/0178 →
Continuity (2)
Provisional Application 61600845 · Feb 20, 2012
Related Publication 20130288988A1 · Oct 31, 2013