Aptima® Trichomonas Vaginalis Test (ATV)

The most common curable STI

Despite being the most common curable STI, Trichomonas vaginalis (TV) is as prevalent as Chlamydia (CT) and Gonorrhea (NG) combined.1 The latest CDC estimates reported more than 26 million new sexually transmitted infections in 2018, which includes 6.9 million incidences from trichomoniasis.1 Many different conditions may cause symptoms similar to TV, and co-infections can be common, making accurate diagnosis imperative for effective TV treatment.2-9

similar-symptoms-img

Up to 45% of trichomoniasis infections are missed by wet mount10

Wet mount testing results can be unreliable due to the following reasons11,12 :

1. Sensitivity and Timing

  • Relies on detecting motile forms, leading to potential false negatives.
  • Delayed testing reduces accuracy as trichomonas motility decreases over time.

2. Interpretation Challenges

  • Variability in clinician skills affects accuracy.
  • Non-motile forms may be confused with vaginal cells.
trichomoniasis-infections-img

Motile organisms decrease rapidly13

Nucleic acid amplification testing (NAAT) is recommended for the diagnosis of trichomoniasis.13

ACOG

NAATs testing are highly sensitive, detecting more T. vaginalis infections than wet-month microscopy.4

CDC
Current ACOG and CDC Guidelines for TV4,13
  • Nucleic acid amplification testing (NAAT) is recommended for the diagnosis of TV.
  • Patients should be retested approximately 3 months after treatment because of the high rates of infection recurrence.
  • For persistent infections in women, resistance testing should be considered.
  • Current partners should be referred for presumptive treatment to avoid reinfection.
Additional CDC Guidance4
  • All women seeking care for vaginal discharge or who report other symptoms should be tested for TV.
  • All women with HIV infection are recommended to be tested.
  • Women receiving care in high-prevalence settings (e.g., STD clinics and correctional facilities) should consider screening.
  • Asymptomatic persons at increased risk for infections should consider screening.
  • Women with TV should be tested for other STIs, including HIV, syphilis, chlamydia and gonorrhea.

Accurate TV detection, with or without symptoms

Our Aptima Trichomonas vaginalis assay is an FDA-cleared nucleic acid amplified test (NAAT) for trichomoniasis detection. Along with detecting trichomoniasis in both symptomatic and asymptomatic cases, it requires only a fraction of one organism to detect up to 100% of TV infections.15
Performance data by sample type15
Specimen TypeSensitivitySpecificity
Aptima® Multitest Swab
(Clinician Collected Vaginal Sample)
100.0%98.2%
Aptima® Multitest Swab
(Patient Collected Vaginal Sample)
98.8%99.4%
Aptima® Unisex Swab
(Endocervical Sample)
100.0%98.1%
ThinPrep® Vial100.0%98.6%
Aptima® Urine
(Female Sample)
100.0%100.0%
Aptima® Urine
(Male Sample)
100.0%99.8%

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1. CDC. Incidence, Prevalence, and Cost of Sexually Transmitted Infection in the United States. Last reviewed: March 16, 2022. Accessed July 7, 2022. https://
www.cdc.gov/nchhstp/newsroom/ fact-sheets/std/STI-Incidence-Prevalence-Cost-Factsheet.html 2. Kent HL. Epidemiology of vaginitis. Am J Obstet Gynecol. 1991;165(4 Pt 2):1168-1176. 3. Thomason JL and Gelbart SM. Trichomonas vaginalis. Obst Gynecol. 1989;74(3)2:536-541 4. Workowski KA, Bachmann LH, Chan PA, Johnston CM, Muzny CA, Park I, Reno H, Zenilman JM, Bolan GA. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. doi: 10.15585/mmwr.rr7004a1 5. CDC. Trichomonas Fact Sheet. Center for Disease Control and Prevention website. Last reviewed February 15, 2023. Accessed February 15, 2023. https://www.cdc.gov/std/trichomonas/stdfact-trichomoniasis.htm 6. CDC. Bacterial Vaginosis Fact Sheet. Center for Disease Control and Prevention website. Last reviewed February 15, 2023. Accessed February 15, 2023. https://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm 7. CDC. Candida Fact Sheet. Center for Disease Control and Prevention website. Last reviewed February 15, 2023. Accessed February 15, 2023. https://www.cdc.gov/fungal/diseases/candidiasis/genital/index.html 8. CDC. Chlamydia Fact Sheet. Center for Disease Control and Prevention website. Last reviewed February 15, 2023. Accessed February 15, 2023. https://www.cdc.gov/std/chlamydia/stdfact-chlamydia.htm 9. CDC. Gonorrhea Fact Sheet. Center for Disease Control and Prevention website. Last reviewed February 15, 2023. Accessed February 15, 2023. https:/www.cdc.gov/std/gonorrhea/stdfact-gonorrhea.htm 10. Nye MB, 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. doi: 10.1016/j.ajog.2008.10.005. 11. Garber G, et al. The laboratory diagnosis of Trichomonas Vaginalis. Can J Infect Dis Med Microbiol. 2005; 6(1):35-38. 12. Kingston MA, et al. ‘Shelf life’ of Trichomonas vaginalis. Intl J STD AIDS. 2003; 14(1):28-29. 13. ACOG. Vaginitis in Nonpregnant Patients. ACOG Practice Bulletin. Number 215. Obstet Gynecol. 2020;135(1):e1-e17. 14. Aptima Trichomonas vaginalis Assay [package insert]. 503684 Rev. 008. San Diego, CA: Hologic, Inc.; 2020