Maximizes efficiency with one collection.

Bacterial or Candida-based vaginal infections are among the most common reasons for which women in the United States seek medical care–resulting: a) up to 75% of women face some kind of vaginal infection in their life-time, and b) in approximately 10 million visits to physician offices annually (references 1 to 4). However, 40% of women with vaginitis leave a first medical visit undiagnosed (reference 7). Vaginitis is caused by the imbalance of good Lactobacilli and vaginitis-causing pathogens (aerobic bacteria, bacterial vaginitis and candida-based infections).


Traditional microscopic diagnostic techniques tend to be subjective with variable sensitivity and specificity (references 2, 5 and 6) and lack the precision needed for accurate identification, especially in mixed infection scenarios. This lack of sensitivity potentially leads to continued symptoms, repeat visits, inappropriate treatment, poor antimicrobial stewardship and unnecessary associated healthcare system costs (references 1, 7 and 8). The GenviewDx women’s health panel is a highly sensitive real-time polymerase chain reaction (PCR) assay that identifies the 3 most common infectious causes of vaginitis: Bacterial vaginosis (aerobic vaginitis caused by aerobic and enteric bacteria that show increased pH and redness, and general bacterial vaginitis is caused by the overgrowth of pathogenic bacteria over good bacteria), vulvovaginal candidiasis and trichomoniasis.

GenviewDx PCR test can maximize efficiency with one-collection/one-test for the 3 most common infectious causes of vaginitis (Bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis) and supports antimicrobial resistance initiatives by reporting antibiotic resistance genes. GenviewDx also offers real-time PCR using a variety of specimen types including urine and female endocervical/vaginal swabs.

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Women's Health Panel

References
1. Hainer BL et al. Vaginitis. Am Fam Physician. 2011;83(7):807-815.
2. Kent HL. Epidemiology of vaginitis. Am J Obstet Gynecol. 1991;165(4 Pt 2):1168-1176.
3. Sherrard J et al. European (IUSTI/WHO) guideline on the management of vaginal discharge. Int J STD AIDS. 2011;22(8):421-429.
4. Workowski KA et al; Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015;64(RR-03):1-137.
5. Gutman RE et al. Evaluation of clinical methods for diagnosing bacterial vaginosis. Obstet Gynecol. 2005;105(3):551-556.
6. Menard JP et al. Molecular quantification of Gardnerella vaginalis and Atopobium vaginae loads to predict bacterial vaginosis. Clin Infect Dis. 2008;47(1):33-43.
7. Carr PL et al. “Shotgun” versus sequential testing. Cost-effectiveness of diagnostic strategies for vaginitis. JGIM. 2005;793-799.
8. Powell K. Vaginal thrush: quality of life and treatments. Br J Nurs. 2010;19:1107-1111.