Development and validation of a semiquantitative, multitarget PCR assay for diagnosis of bacterial vaginosis

Journal of Clinical Microbiology

Volumn 50, Issue 7, 2012, Pages 2321-2329

  Cartwright, Charles P ^a   Lembke, Bryndon D ^a   Ramachandran, Kalpana ^a   Body, Barbara A ^b   Nye, Melinda B ^b   Rivers, Charles A ^c   Schwebke, Jane R ^c  

^a ViroMed Laboratories Inc Minnesota   (United States)

^b LABORATORY CORPORATION OF AMERICA   (United States)

^c UNIVERSITY OF ALABAMA SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; ARTICLE; ATOPOBIUM VAGINAE; BACTERIAL VAGINOSIS ASSOCIATED BACTERIUM; BACTERIUM DETECTION; BACTERIUM EXAMINATION; CLINICAL EVALUATION; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; FEMALE; GARDNERELLA VAGINALIS; GOLD STANDARD; GRAM STAINING; HUMAN; HUMAN TISSUE; INDICATOR ORGANISM; INTERMETHOD COMPARISON; LACTOBACILLUS CRISPATUS; MAJOR CLINICAL STUDY; MEGASPHAERA; MOLECULAR DIAGNOSIS; NUCLEOTIDE SEQUENCE; POLYMERASE CHAIN REACTION; PREDICTIVE VALUE; PRIORITY JOURNAL; PROCESS DEVELOPMENT; PROSPECTIVE STUDY; QUANTITATIVE ANALYSIS; SCORING SYSTEM; SENSITIVITY AND SPECIFICITY; SYMPTOMATOLOGY; VAGINA FLORA; VAGINA SMEAR; VAGINITIS; VALIDATION PROCESS;

ADULT; AGED; BACTERIA; BACTERIOLOGICAL TECHNIQUES; FEMALE; HUMANS; MIDDLE AGED; MOLECULAR DIAGNOSTIC TECHNIQUES; MULTIPLEX POLYMERASE CHAIN REACTION; PREDICTIVE VALUE OF TESTS; SENSITIVITY AND SPECIFICITY; VAGINA; VAGINOSIS, BACTERIAL;

EID: 84862737191     PISSN: 00951137     EISSN: 1098660X     Source Type: Journal    
DOI: 10.1128/JCM.00506-12     Document Type: Article

References (25)

1. Amsel R, et al. 1983. Nonspecific vaginitis. Am. J. Med. 74:14-22.
2. Biagi E, et al. 2009. Quantitative variations in the vaginal bacterial population associated wih asymptomatic infections: a real-time polymerase chain reaction study. Eur. J. Clin. Microbiol. Infect. Dis. 28:281-285.
3. Brotman RM, Ravel J. 2008. Ready or not: the molecular diagnosis of bacterial vaginosis. Clin. Infect. Dis. 47:44-46.
4. Cauci S, et al. 2002. Prevalence of bacterial vaginosis and vaginal flora changes in peri- and post-menopausal women. J. Clin. Microbiol. 40: 2147-2152.
5. Dumonceaux TJ, et al. 2009. Multiplex detection of bacteria associated with normal microbiota and with bacterial vaginosis in vaginal swabs by use of oligonucleotide-coupled fluorescent microspheres. J. Clin. Microbiol. 47:4967-4977.
6. Eckert LO. 2006. Acute vulvovaginitis. N. Engl. J. Med. 355:1244-1252.
7. Ferris MJ, et al. 2004. Association of Atopobium vaginae, a recently described metronidazole resistant anaerobe, with bacterial vaginosis. BMC Infect. Dis. 4:5.
8. Ferris MJ, Norori J, Zozaya-Hinchliffe M, Martin DH. 2007. Cultivation- independent analysis of changes in bacterial vaginosis flora following metronidazole treatment. J. Clin. Microbiol. 45:1016-1018.
9. Fredricks DN, Fiedler TL, Marrazzo JM. 2005. Molecular identification of bacteria associated with bacterial vaginosis. N. Engl. J. Med. 353:1899-1911.
10. Fredricks DN, Fiedler TL, Thomas KK, Oakley BB, Marrazzo JM. 2007. Targeted PCR for detection of bacteria associated with bacterial vaginosis. J. Clin. Microbiol. 45:3270-3276.
11. Fredricks DN, Fiedler TL, Thomas KK, Mitchell CM, Marrazzo JM. 2009. Changes in bacterial vaginal concentrations with intravaginal metronidazole therapy for bacterial vaginosis as assessed by quantitative PCR. J. Clin. Microbiol. 47:721-726.
12. Hay PE. 2006. National guideline for the management of bacterial vaginosis. Royal Society of Medicine, London, United Kingdom. http://www.bashh.org/documents/62/62.pdf.
13. Hillier SL. 2005. The complexity of microbial diversity in bacterial vaginosis. N. Engl. J. Med. 353:1886-1887.
14. Ison CA, Hay PE. 2002. Validation of a simplified grading of Gram stained vaginal smears for use in genitourinary medicine clinics. Sex Transm. Infect. 78:413-415.
15. Leitich H, et al. 2003. Bacterial vaginosis as a risk factor for preterm delivery: a meta-analysis. Am. J. Obstet. Gynecol. 189:139-147.
16. Menard J-P, Fenollar F, Henry M, Bretelle F, Raoult D. 2008. Molecular quantification of Gardnerella vaginalis and Atopobium vaginae loads to predict bacterial vaginosis. Clin. Infect. Dis. 47:33-43.
17. Nugent RP, Krohn MA, Hillier SL. 1991. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of Gram stain interpretation. J. Clin. Microbiol. 29:297-301.
18. Ravel J, et al. 2011. Vaginal microbiome of reproductive-age women. Proc. Natl. Acad. Sci. U. S. A. 108:4680-4687.
19. Sha BE, et al. 2005. Utility of Amsel criteria, Nugent score, and quantitative PCR for Gardnerella vaginalis, Mycoplasma hominis, and Lactobacillus spp. for diagnosis of bacterial vaginosis in human immunodeficiency virus-infected women. J. Clin. Microbiol. 43:4607-4612.
20. Sherrill CB, et al. 2004. Nucleic-acid analysis using an expanded genetic alphabet to quench fluorescence. J. Am. Chem. Soc. 126:4550-4556.
21. Spiegel CA. 1991. Bacterial vaginosis. Clin. Microbiol. Rev. 4:485-502.
22. Tamrakar R et al. 2007. Association between Lactobacillus species and bacterial-vaginosis associated bacteria, and bacterial vaginosis scores in pregnant Japanese women. BMC Infect. Dis. 7:128.
23. U.S. Preventative Services Task Force. 2008. Screening for bacterial vaginosis in pregnancy to prevent preterm delivery: US Preventative Services Task Force recommendation. Ann. Intern. Med. 148:214-219.
24. Wiesenfeld HC, Hillier SL, Krohn MA, Landers DV, Sweet RL. 2003. Bacterial vaginosis is a strong predictor of Neisseria gonorhoeae and Chlamydia trachomatis infection. Clin. Infect. Dis. 36:663-668.
25. Zozaya-Hinchliffe M, Lillis R, Martin DH, Ferris MJ. 2010. Quantitative PCR assessments of bacterial species in women with and without bacterial vaginosis. J. Clin. Microbiol. 48:1812-1819.