Aptima® Vaginal Health

Aptima Vaginitis Panel

The Aptima® vaginitis panel from Hologic consists of molecular nucleic acid amplification tests (NAAT) to aid in the detection of vaginosis and vaginitis.  Our assays detect the three most common causes of infectious vaginitis: bacterial vaginosis, candida vaginitis and trichomoniasis.

Vaginitis is a common problem that affects millions of women

Ten million women each year visit their healthcare providers seeking a cure for vaginitis and a third of all women will have symptoms of vaginitis at some point during their lives, most commonly during their reproductive years.1,2 Some types of vaginitis are transferred through sexual activity, while others arise because of an imbalance in the bacterial or fungal makeup of the vaginal microbiome.3 Combined, bacterial vaginosis (BV), candida vaginitis (commonly known as a yeast infection, CV), and trichomoniasis (Trichomonas vaginalis, TV) make up 90% of vaginitis cases.3

Hologic is an innovative medical technology company focused on improving women’s health, and features two assays that aid in diagnosing BV, yeast infections, and trichomoniasis. Accurate diagnosis using the Aptima vaginal panel supports better guided drug treatment, fewer recurrent doctor’s office visits, and reduced suffering in affected women. The Aptima® BV and Aptima® CV/TV assays usher in a new era of molecular testing, offering a comprehensive and accurate diagnosis of vaginosis and vaginitis.

Establishing a new standard for diagnosing vaginitis4,5

The Aptima BV and Aptima CV/TV assays are indicated for use in symptomatic women to aid in the detection of BV, Candida species, Candida glabrata, and Trichomonas vaginalis on the Panther® system. Specimens must be collected with the familiar orange Aptima® Multitest Swab Specimen Collection Kit, via either clinician-collected or patient-collected vaginal swabs. As with our other Aptima diagnostic assays, one vaginal swab specimen can yield multiple test results on the automated Panther® system.

Bacterial vaginosis

The prevalence of bacterial vaginosis or “BV” in the United States is estimated at 21 million among women ages 14–49.6 Healthcare practitioners often overlook the association of untreated BV infections with serious consequences, including pelvic inflammatory disease7, cervicitis8, higher risk of acquiring STIs (chlamydia, gonorrhea, HSV, HIV),9,10,11 spontaneous abortion, and preterm birth12,13. The Aptima BV assay demonstrates excellent sensitivity and specificity, due to its proprietary algorithm and assay design, targeting Gardnerella vaginalis, Atopobium vaginae, and Lactobacillus species. A simple qualitative BV positive or negative result is returned.

Candida vaginitis and Trichomonas vaginalis

Commonly known as a yeast infection, vulvovaginal candidiasis (candida vaginitis, "CV") is a result of an overgrowth of fungal organisms, usually Candida albicans. Yeast infections can also be caused by the azole-resistant strain Candida glabrata, which is prevalent 8-16% of the time and requires a different treatment pathway than C. albicans.14,15 The Aptima CV/TV assay differentiates between Candida species and C. glabrata and can help healthcare providers determine the most appropriate antifungal therapy for their patients.

Sometimes referred to as "trich", TV is the most common curable STI in the United States.16 Left untreated, TV infection is associated with an increased risk of HIV acquisition and transmission,17,18 prolonged HPV infection19, higher risk of acquiring STIs such as chlamydia, gonorrhea and HPV20, and can lead to premature labor and low birth weight babies.21 The CDC recommends testing for TV in all women seeking treatment for vaginal discharge.22 The Aptima CV/TV assay meets the recommendations by the CDC for a highly sensitive and specific test for detecting TV.

One orange tube, one solution, maximum efficiency

The Aptima vaginal panel rounds out Hologic’s Aptima assay portfolio for sexual and vaginal health, which now includes vaginitis testing alongside comprehensive STI and viral load testing. Labs and healthcare providers now have the flexibility to detect up to seven infections and disease states with just one vaginal swab, including BV, Candida species, C. glabrata, Trichomonas vaginalis, chlamydia, gonorrhea, and Mycoplasma genitalium.23



References:
1.    Kent HL. Epidemiology of vaginitis. Am J Obstet Gynecol. 1991;165(Part 2): 1168-76. 
2.    American College of Obstetricians and Gynecologists. Vaginitis. https://www.acog.org/Patients/FAQs/Vaginitis. Published August 2011. Accessed May 28, 2019.
3.    Paladine HL. Vaginitis: Diagnosis and Treatment. Am Fam Physician. Am Fam Physician. 2018 Mar 1;97(5):321-329.
4.    Aptima BV Assay [package insert] # AW-18811, San Diego, CA; Hologic, Inc.,2019.
5.    Aptima CV/TV Assay [package insert] # AW-18812, San Diego, CA; Hologic, Inc.,2019.
6.    Koumans EH, Sternberg M, Bruce C, McQuillan G, Kendrick J, Sutton M, Markowitz LE. The prevalence of bacterial vaginosis in the United States, 2001-2004; associations with symptoms, sexual behaviors, and reproductive health. External. Sex Transm Dis. 2007 Nov;34(11):864-9.
7.    Haggerty CL, Hillier SL, Bass DC, Ness RB; PID Evaluation and Clinical Health study investigators. Bacterial vaginosis and anaerobic bacteria are associated with endometritis. Clin Infect Dis. 2004 Oct 1;39(7):990-5. Epub 2004 Sep.
8.    Marrazzo JM, Wiesenfeld HC, Murray PJ, Busse B, Meyn L, Krohn M, Hillier SL. Risk factors for cervicitis among women with bacterial vaginosis. J Infect Dis. 2006 Mar 1;193(5):617-624. Epub 2006 Feb 2.
9.    Bautista CT, Wurapa EK, Sateren WB, Morris SM, Hollingsworth BP, Sanchez JL. Association of Bacterial Vaginosis with Chlamydia and Gonorrhea Among Women in the U.S. Army. Am J Prev Med. 2017;52(5):632-639. doi: 10.1016/j.amepre.2016.09.016. 
10.    Cherpes TL, Meyn LA, Krohn MA, Lurie JG, Hillier SL. Association between acquisition of herpes simplex virus type 2 in women and bacterial vaginosis. Clin Infect Dis. 2003 Aug 1;37(3):319-325. 
11.    Cohen CR, Lingappa JR, Baeten JM, et al. Bacterial vaginosis associated with increased risk of female-to-male HIV-1 transmission: a prospective cohort analysis among African couples. PLoS Med. 2012;9(6):e1001251. doi: 10.1371/journal.pmed.1001251.
12.    Işik G, Demirezen, Dönmez HG, Beksaç MS. Bacterial vaginosis in association with spontaneous abortion and recurrent pregnancy losses. J Cytol. 2016 Jul-Sep;33(3):135-140. 
13.    Donders GG, Van Calsteren K, Bellen G, et al. Predictive value for preterm birth of abnormal vaginal flora, bacterial vaginosis and aerobic vaginitis during the first trimester of pregnancy. BJOG. 2009 Sep;116(10):1315-24.
14.    Granato PA. Vaginitis: Clinical and Laboratory Aspects for Diagnosis. Clinical Microbiology Newsletter. Volume 32, Issue 15, 1 August 2010, Pages 111–116. 
15.    J. Achkar and B. Fries Clinical Microbiology Rev. Candida infections of the genitourinary tract. 23(2):253-273
16.    Centers for Disease Control and Prevention. 2015 Sexually Transmitted Diseases Treatment Guidelines. https://www.cdc.gov/std/trichomonas/std-facttrichomoniasis.htm. Updated January 31, 2017. Accessed May 28, 2019.
17.    Mavedzenge SN, Pol BV, Cheng H, Montgomery ET, Blanchard K, de Bruyn G, Ramjee G, Straten Av. Epidemiological synergy of Trichomonas vaginalis and HIV in Zimbabwean and South African women. Sex Transm Dis. 2010 Jul;37(7):460-6.
18.    Petrin D, Delgaty K, Bhatt R, Garber G. Clinical and Microbiological Aspects of Trichomonas vaginalis. Clin Microbiol Rev. 1998;11(2):300–317.
19.    Shew M, et al. Association of condom use, sexual behaviors and sexually transmitted infections with the duration of genital human papillomavirus infection among adolescent women. Arch Pediatr Adolesc Med.2006;160(2):151-156.
20.    Allsworth J, et al. Trichomoniasis and other sexually transmitted infections: results from the 2001-2004 National Health and Nutrition Examination Surveys. Sex Transm Dis. 009;36(12):738-744.
21.    MMWR, Vol. 64, Nr. 3. Sexually transmitted diseases treatment guidelines, June 5, 2015.
22.    CDC. Sexually Transmitted Diseases Treatment Guidelines, 2015. http://www.cdc.gov/std/tg2015/trichomoniasis. Reviewed June 4, 2015. Accessed May 28, 2019.
23.    TRN-00401-001 Hologic, Inc. Aptima Specimen Matrix. 
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