To assess the accuracy of clinical diagnosis of bacterial vaginosis (BV) by using Amsel criteria, overall and by human immunodeficiency virus (HIV) infection status.
Women with HIV, or at risk for HIV, participated in the HIV Epidemiology Research Study, a prospective study conducted in 4 US sites. At enrollment and follow-up visits, scheduled at 6-month intervals for ≤5 years, participants received gynecologic examinations, had specimens collected, and underwent standardized interviews. We used McNemar test statistic to evaluate agreement between Amsel criteria and Nugent scoring. Using Nugent scoring as the reference standard, we calculated sensitivity and specificity for Amsel criteria and for 3 other classifications of clinical BV. Our results are based on data collected from 9140 study visits by 862 HIV-infected women and 421 HIV-uninfected women.
Amsel criteria and Nugent scoring did not agree in the classification of BV cases (P < 0.01). Amsel criteria had poor sensitivity (60%; 95% confidence interval, 58%–61%) and specificity (90%; 95% confidence interval, 89%–91%) with wide differences in test properties by study site. We found no differences in diagnosing BV by HIV infection status.
The under- and overdiagnosing of BV clinically suggests that the accuracy of Amsel criteria for routine screening of asymptomatic women might be lower than previous estimates; that clinicians need more rigorous training to apply subjective Amsel criteria accurately; or that wide heterogeneity in cases might prevent agreement between clinical and laboratory diagnoses, with future research needed to better understand the criteria or morphotypes associated with specific adverse outcomes.
A large, prospective study did not find differences in accuracy of diagnosing bacterial vaginosis by women's HIV infection status, but found poor agreement between Amsel criteria and Nugent scoring.
From the *Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA; †Brown University School of Medicine, Providence, RI; ‡Johns Hopkins University School of Medicine, Baltimore, MD; §Mount Sinai School of Medicine, New York, NY; and ¶Department of Medicine, Wayne State University School of Medicine, Detroit, MI
Supported by cooperative agreement Nos. U64/CCU106795, U64/CCU206798, U64/CCU306802, and U64/CCU506831 with the Centers for Disease Control and Prevention.
The HIV Epidemiology Research Study Group consists of the following: Robert S. Klein, MD, Ellie Schoenbaum, MD, Julia Arnsten, MD, MPH, Robert D. Burk, MD, Chee Jen Chang, PhD, Penelope Demas, PhD, and Andrea Howard, MD, MSc, from Montefiore Medical Center and the Albert Einstein College of Medicine; Paula Schuman, MD, and Jack Sobel, MD, from the Wayne State University School of Medicine; Anne Rompalo, MD, David Vlahov, PhD, and David Celentano, PhD, from the Johns Hopkins University School of Medicine; Charles Carpenter, MD, and Kenneth Mayer, MD, from the Brown University School of Medicine; Ann Duerr, MD, Lytt I. Gardner, PhD, Scott Holmberg, MD, Denise Jamieson, MD, MPH, Jan Moore, PhD, Ruby Phelps, Dawn Smith, MD, and Dora Warren, PhD, from the Centers for Disease Control and Prevention; and Katherine Davenny, PhD, from the National Institute of Drug Abuse.
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
Correspondence: Maria F. Gallo, PhD, Division of Reproductive Health, Centers for Disease Control and Prevention, 4770 Buford Highway, Mail Stop K-34, Atlanta, GA 30341–3724. E-mail: firstname.lastname@example.org.
Received for publication April 15, 2010, and accepted September 6, 2010.