FDA has cleared the Aptima BV and Aptima CV/TV molecular diagnostics from Hologic, Marlborough, Mass. The assays provide an accurate and objective method for diagnosing vaginitis, a common and complex health issue affecting millions of women each year.
About 90% of vaginitis is caused by bacterial vaginosis (BV), vulvovaginal candidiasis (Candida vaginitis, CV, also commonly known as yeast infections), or Trichomonas vaginalis (TV) infections, either individually or in combination. BV is the most common vaginal infection in the United States, affecting an estimated 21 million women ages 14 to 49 years old.1
Diagnosis can be complicated due to the prevalence of coinfections, since approximately 20% to 30% of women with BV are coinfected with Candida species. Traditional methods for diagnosing vaginitis (including microscopy, pH determination, and Nugent scoring) are highly subjective, leading to misdiagnosis and ineffective treatment. When diagnosed using traditional methods and treated based on those subjective results, more than 50% of women with vaginitis experience recurring symptoms.
“Vaginitis is one of the most common reasons women visit a healthcare provider, and Hologic’s new molecular assays have the potential to transform how these infections are diagnosed in that very first appointment,” says Edward Evantash, MD, an obstetrician and gynecologist who is medical director and vice president of medical affairs at Hologic. “The improved sensitivity and specificity of Hologic’s molecular assays over traditional methods in determining the underlying cause of vaginitis not only means identifying the right infection, but enabling the right treatment and, in turn, reducing the potential for recurrent or persistent infections.”
Many women self-diagnose and self-treat before visiting a healthcare provider, assuming that abnormal vaginal discharge, itching, or irritation are due to a simple yeast infection. When BV or TV are left untreated or not properly treated, however, they can put women at risk for complications, including an increased chance of getting a sexually transmitted infection such as chlamydia or HIV; pelvic inflammatory disease; or pregnancy-related risks, including premature delivery, low birth weight, and infertility.
For more information, visit Hologic.
- Koumans EH, Sternberg M, Bruce C, et al. The prevalence of bacterial vaginosis in the United States, 2001–2004; associations with symptoms, sexual behaviors, and reproductive health. Sex Transm Dis. 2007;34(11):864–869; doi: 10.1097/olq.0b013e318074e565.