Accurate Testing for Vaginitis

Vaginitis is the leading reason for OBGYN visits1-2

Most women will experience an episode of vaginitis at least once in their lifetime.3 90% of vaginitis is caused by bacterial vaginosis (BV), yeast infection (CV) and trichomonas vaginalis (TV) infections, either individually or in combination; resulting in approximately 10 million OB/GYN visits each year.4-5

Complexity and poor accuracy contribute to diagnostic
and treatment errors

Mixed infections and overlapping symptoms make clinical diagnosis a challenge.6 In fact, in one study, 37% of women with BV were also infected with TV and/or Candida species.7 Appropriate diagnosis is essential to prescribe the optimal treatment for vaginitis and—just as crucial—to reduce the likelihood of persistence or recurrence. While current guidelines primarily recommend examination of vaginal discharge, microscopy, and culture methods, they are not sufficient to accurately diagnose vaginitis, especially when multiple pathogens are present.8 Because each etiology requires different treatment, accurate testing is essential for patients to receive the right diagnosis the first time.

5_Women

NAAT results in more accurate diagnosis and better clinical management

The Aptima® BV and Aptima® CV/TV assays are NAAT tests that identify bacterial vaginosis (BV), vulvovaginal candidiasis (Candida vaginitis or CV) and Trichomoniasis (Trichomonas vaginalis or TV) in symptomatic women from one vaginal sample. NAAT detects 3x more mixed infections cases than clinical diagnosis with wet mount and Amsel’s criteria.9

The Aptima® BV and Aptima® CV/TV assays are NAAT tests that identify bacterial vaginosis (BV), vulvovaginal candidiasis (candida vaginitis or CV) and Trichomoniasis (trichomonas vaginalis or TV) in symptomatic women from one vaginal sample. NAAT detects 3x more mixed infections cases than clinical diagnosis with wet mount and
Amsel’s criteria.9

NAAT detects:
  • 3X more Candidiasis + BV mixed infections
  • 3X more Candidiasis + TV mixed infections
  • 4X more BV + TV mixed infections

Association Between Vaginitis and STIs10

~1 in 5 (18.5%) women who presented with symptoms of vaginitis had a least 1 STI.

1 in 5

“…we found high rates for STIs in women seeking care for symptoms of vaginitis and bacterial vaginosis…”

– Schwebke et al, 202410

STI Prevalence10

Vaginitis Info

BV-positive women had a 2x higher STI infection rate compared to BV-negative women.

Vaginitis Info 3

STI Prevalence in Women with NAAT BV Diagnosis10

TV and M. gen are significantly associated with BV.

  • TV affected nearly 11% of women with BV; M. gen was present in over 9% of women with BV.

Chlamydia (CT) and Gonorrhea (NG) are less common than M. gen and TV in women with BV.

  • Women should still be tested for CT and NG as these are serious STIs that can cause significant health problems if left untreated.

Hologic’s offerings

Our suite of testing tools leads the market in accuracy and sensitivity, providing the insights you need for your patient’s best care.11

Aptima® BV Assay

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Aptima® CV/TV Assay

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References

1. CDC. Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention. Bacterial Vaginosis (BV) Statistics. 2. Schwebke JR, Taylor SN, Ackerman R, et al. Clinical validation of the Aptima bacterial vaginosis and Aptima Candida/Trichomonas vaginitis assays: results from a prospective multicenter clinical study. J Clin Microbiol. 2020;58(2):e01643-19. 3. Goje O. Advancing the Diagnosis of Vaginitis. CLPMag. 2020. 4. ACOG Practice Bulletin No. 72. Clinical management guidelines for obstetrician-gynecologists: Vaginitis. Obstet Gynecol reaffirmed 2019; 107(5): 1195-1206. 5. Kent HL. Epidemiology of vaginitis. Am J Obstet Gynecol. 1991;165(Part 2): 1168-76. 6. Anderson MR, Klink K and Cohrssen A. Evaluation of Vaginal Complaints. JAMA. 2004;291(11):1368–1379. doi:10.1001/jama.291.11.1368. 7. Belley-Montfort L, Lebed J, Smith B, Farrell M, Schwebke J, Nyirjesy P, et al. Sensitivity of the Amsel’s Criteria Compared to the Nugent Score in Absence and in Presence of Trichomonas vaginalis (TV) and/or Candida SPP among Women with Symptomatic Vaginitis/Vaginosis. Sex Transm Infect: first published as 10.1136/sextrans-2015-052126.290 on 18 May 2015. 8. Nye M, et al. Comparison of APTIMA Trichomonas vaginalis transcription-mediated amplification to wet mount microscopy, culture, and polymerase chain reaction for diagnosis of trichomoniasis in men and women. Am J Obstet Gynecol. 2009;200(2):188.e1-7. 9. Schwebke JR, et al. Diagnostic Performance of a Molecular Test Versus Clinician Assessment of Vaginitis. J Clin Microbiol. 2018; 56. doi:10.1128/JCM.00252-18. 10. Schwebke JR, et al. Vaginitis and risk of sexually transmitted infections: results of a multi-center U.S. clinical study using STI nucleic acid amplification testing. J Clin Microbiol. 2024 Sep 11;62(9):e0081624. A Hologic sponsored study. 11. Schwebke JR, et al. Clinical validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: results from a prospective multi-center clinical study. J Clin Microbiol. 2019; 58. doi:10.1128/JCM.01643-19.