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Journal of Clinical Microbiology, March 2005, p. 1304-1308, Vol. 43, No. 3
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.3.1304-1308.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Evaluation of a Point-of-Care Test, BVBlue, and Clinical and Laboratory Criteria for Diagnosis of Bacterial Vaginosis

C. S. Bradshaw,1,2* A. N. Morton,1 S. M. Garland,3,4 L. B. Horvath,1,5 I. Kuzevska,1,5 and C. K. Fairley1,2

Melbourne Sexual Health Centre, The Alfred Hospital,1 School of Population Health,2 Department of Obstetrics and Gynaecology,4 Microbiological Diagnostic Unit, University of Melbourne,5 Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Melbourne, Victoria, Australia3

Received 23 September 2004/ Returned for modification 7 November 2004/ Accepted 20 November 2004

Bacterial vaginosis (BV) remains the most common cause of abnormal vaginal discharge in women of reproductive age and is associated with increased susceptibility to human immunodeficiency virus and sexually transmitted infections and preterm delivery. Present diagnostic methods require access to microscopy and laboratory expertise; however, the majority of women, particularly those in populations with a high prevalence of BV, do not have access to clinical services with on-site microscopy capabilities. We evaluated a point-of-care test for the diagnosis of BV, the BVBlue test, with 288 women attending a sexual health service with symptoms of abnormal vaginal discharge and/or odor. The BVBlue test performed well compared with conventional diagnostic methods for the assessment of women with symptoms suggestive of BV at the bedside and significantly better than other simple tests, such as vaginal pH determination and the amine test, that do not require microscopy. The BVBlue test was sensitive (88%; 95% confidence interval [CI], 81 to 93%) and specific (95%; 95% CI, 91 to 98%) compared to the method of Nugent et al. (R. P. Nugent, M. A. Krohn, and S. L. Hillier, J. Clin. Microbiol. 29:297-301, 1991) and performed well compared with the method of Amsel et al. (R. Amsel, P. A. Totten, C. A. Spiegel, K. C. Chen, D. Eschenbach, and K. K. Holmes, Am. J. Med. 74:14-22, 1983), with a sensitivity of 88% (95% CI, 81 to 93%) and a specificity of 91% (95% CI, 85 to 94%). The BVBlue test is a simple, rapid, and objective test for the diagnosis of BV and has the potential to facilitate prompt diagnosis and appropriate treatment of BV in the absence of microscopy. The majority of women at the greatest risk for the sequelae of BV are not in settings where the conventional diagnostic methods are either practical or possible, and they would greatly benefit from access to rapid and reliable point-of-care tests to improve the diagnosis and management of BV.


* Corresponding author. Mailing address: Melbourne Sexual Health Centre, 580 Swanston St., Carlton, 3053, Victoria, Australia, Phone: 61-3-9341 6253. Fax: 61-3-9347 6757. E-mail: cbradshaw{at}mshc.org.au.


Journal of Clinical Microbiology, March 2005, p. 1304-1308, Vol. 43, No. 3
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.3.1304-1308.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.




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