FDA has granted premarket notification (510(k)) clearance for the Aptima BV and Aptima CV/TV assays from Hologic, Marlborough, Mass, which provide an accurate and objective method for diagnosing vaginitis.

About 90% of vaginitis cases are caused individually or in combination by bacterial vaginosis (BV), Candida vaginitis (CV, commonly known as yeast infections), or Trichomonas vaginalis (TV) infections.1,2  BV is the most common vaginal infection in the United States, affecting an estimated 21 million women aged 14 to 49 years.3 Diagnosis can be especially complicated due to the prevalence of coinfections, as approximately 20% to 30% of women with BV are coinfected with Candida species.1

Traditional methods for diagnosing vaginitis—including microscopy, pH determination, and Nugent scoring—are highly subjective, leading to misdiagnosis and ineffective treatment.1,2 When diagnosed using traditional methods and treated based on those subjective results, more than 50 % of women with vaginitis experience recurring symptoms.1

“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, 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.”

Evantash

Edward Evantash, MD, Hologic.

Unfortunately, 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. But when BV or TV infections are left untreated or not properly treated, they can put women at risk for a wide variety of complications, including an increased chance of getting a sexually transmitted infection such as chlamydia or HIV, pelvic inflammatory disease, and pregnancy-related risks including premature delivery, low birth weight, and infertility.1,2

The Aptima multitest swab specimen collection kit enables healthcare providers to test for up to seven disease states and infections, including BV, Candida species, Candida glabrata, chlamydia, gonorrhea, Mycoplasma genitalium, and trichomoniasis.

Aptima assays, including those using specimens collected in the orange vial Aptima multitest swab collection kit, are performed on Hologic’s Panther system. Hologic’s Panther and Panther Fusion systems now offer 16 FDA-cleared assays that detect more than 20 pathogens, making them the only high-throughput molecular diagnostic platforms on the US market to combine comprehensive cervical health, respiratory testing, sexual health, viral load, and open-channel functionality on a fully automated system.

For further information, visit Hologic.

References

  1. Aptima BV assay [package insert, online]. Marlborough, Mass: Hologic, 2019. Available at: www.hologic.com/package-inserts/diagnostic-products/aptima-bv-assay. Accessed July 22, 2019.
  1. Aptima CV/TV assay [package insert, online]. Marlborough, Mass: Hologic, 2019. Available at: www.hologic.com/package-inserts/diagnostic-products/aptima-cvtv-assay. Accessed July 22, 2019.
  1. 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.
  1. 2015 sexually transmitted diseases treatment guidelines: trichomoniasis [online]. Atlanta: Centers for Disease Control and Prevention, 2015. Available at: www.cdc.gov/std/tg2015/trichomoniasis.htm. Accessed July 22, 2019.