Bacterial vaginosis (BV) is the most common cause of abnormal vaginal discharge in reproductive age women. It is associated with increased susceptibility to HIV/STI and adverse birth outcomes. Diagnosis of BV in resource-poor settings like India is challenging. With little laboratory infrastructure there is a need for objective point-of-care diagnostic tests. Vaginal swabs were collected from women 18 years and older, with a vaginal pH？>？4.5 attending a reproductive health clinic. BV was diagnosed with Amsel’s criteria, Nugent scores, and the OSOM BVBlue test. Study personnel were blinded to test results. There were 347 participants enrolled between August 2009 and January 2010. BV prevalence was 45.1% (95% confidence interval (CI): 41.5%–52.8%) according to Nugent score. When compared with Nugent score, the sensitivity, specificity, positive predictive value, negative predictive value for Amsel’s criteria and BVBlue were 61.9%, 88.3%, 81.5%, 73.7% and 38.1%, 92.7%, 82.1%, 63.9%, respectively. Combined with a “whiff” test, the performance of BVBlue increased sensitivity to 64.4% and negative predictive value to 73.8%. Despite the good specificity, poor sensitivity limits the usefulness of the BVBlue as a screening test in this population. There is a need to examine the usefulness of this test in other Indian populations. 1. Introduction Finding effective methods to diagnose bacterial vaginosis (BV) has taken on increased urgency since BV was associated with a greater than 3-fold increased risk of female-to-male HIV-1 transmission and a doubling of risk for acquiring sexually transmitted infections [1–4]. BV has also been implicated in neonatal morbidity [5], preterm delivery [6–8], and low birth weight infants [9]. BV is usually diagnosed using Amsel’s criteria [10] or Nugent scoring of Gram-stained vaginal smears [11] both of which require microscopy. In countries like India where access to laboratory services is often limited, BV is typically managed using a syndromic approach for vaginal discharge, a method with low sensitivity and specificity [12]. Point-of-care (POC) testing may improve diagnosis of BV by providing accurate results without laboratory or on-site microscopy [13]. Several different approaches have been used in POC testing for BV. Rapid assays detecting the presence of proline amino peptidase [14, 15] have been found to have high sensitivity and specificity. Others which rely on detection of trimethylamine and high vaginal pH have not been compared favorably with Amsel’s criteria or Nugent scoring [16–18]. BVBlue, a chromogenic POC,
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