Self-Testing for Bacterial Vaginosis Is Accurate

Lara C. Pullen, PhD

April 20, 2012

April 20, 2012 — Self-tests for bacterial vaginosis (BV) are reasonably accurate (73% sensitive and 67% specific for a pH-based test and 40% sensitive and 90% specific for a self-sialidase test when compared with a clinical diagnosis using modified Amsel criteria). The pH-based test has been available over the counter since 2001 and may be useful when pelvic exams are not feasible. The self-sialidase test received a waiver from the Clinical Laboratory Improvement Amendments and has been marketed by physicians since 2004.

Jill S. Huppert, MD, MPH, from Cincinnati Children's Hospital Medical Center in Ohio, and colleagues published their study results online March 22 in the Journal of Adolescent Health. The goal of the study was to see how the accuracy of self-tests for BV compares with that of diagnostic tests performed by a clinician.

The young women in the study were recruited from an ambulatory clinical setting and had already agreed to participate in a study self-testing for Trichomonas vaginalis. Of the 246 women in that original study, 131 also agreed to perform BV self-testing. Patients who agreed to perform BV self-testing were more likely to have clinical BV (25% vs 14%; P = .03) than those who declined.

The study included 131 sexually active women aged 14 to 22 years who underwent BV testing by a clinician during pelvic exam and then took the self-tests. All the women correctly performed the self-test using self-collected samples. The authors note that they did not confirm diagnosis of BV with Nugent Gram stain.

There was a lower agreement between self-testing for pH and clinician testing for pH in adolescent and young women (κ = 0.53) compared with that reported in another study for older women using the same device (κ = 0.9).

Do Patients Trust the Results of the Self-Test?

On a survey used to measure trust in results, each of 2 items on the survey was rated 1 to 3, with 1 indicating low acceptability and 3 indicating high acceptability.

Patient trust in the self-test was initially lower than trust in the clinician-performed test. Trust in results did not seem to be affected by perceived severity or stigma associated with diagnosis. Trust increased after testing (2.22 to 2.42; P < .01) and discussion of results with the clinician (2.42 to 2.6; P < .01).

BV is an infection caused by overgrowth of the naturally occurring bacteria in the vagina, which produces symptoms of abnormal discharge and itching. BV affects about 21 million (29%) of US women aged 14 to 49 years, according to the Centers for Disease Control and Prevention. "In the future, we should assess how developing better POC [point-of-care] tests and using self-testing strategies may engage young women to become active participants in their own reproductive health," the authors conclude.

MD Visit and Gynecologic Exam Still Needed

Laura Lipold, MD, director of primary care women's health at the Cleveland Clinic in Ohio reviewed the study for Medscape Medical News and provided comments via email. "Unfortunately," she noted, "this study does not represent real world. In this study, the participants were receiving a full pelvic exam and complete testing for sexually transmitted infections. The authors acknowledge that a common barrier for young women to receive appropriate reproductive health care is the gynecological exam, however patients will still need to have a gynecological exam after performing this self testing to assess for trichomonas (which can also have an elevated pH) and other sexually transmitted infections."

David Soper, MD, professor of obstetrics and gynecology at Medical University of South Carolina in Charleston, agrees. He also reviewed the study for Medscape Medical News and wrote by email: "The problem with diagnosing BV at home is that you still need a doctor's prescription for an antibiotic for treatment. In addition, there may be other sexually transmitted infections that she didn't test for that could cause harm if she was not screened. Screening tests for chlamydia and gonorrhea are probably more frequently performed in a doctor's office."

The study was supported by the National Institute of Health, National Institute of Allergy and Infectious Diseases, and National Institute of Biomedical Imaging and Bioengineering. Dr. Huppert reports that she has received kits/reagents from Gen-Probe Inc and kits/reagents and honorarium from Genzyme Diagnostics Inc. Dr. Lipold and Dr. Soper have disclosed no relevant financial relationships.

J Adolesc Health. Published online March 22, 2012. Abstract

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