Aptima Trichomonas vaginalis assay

Furthering our commitment to protecting the reproductive health of women through early detection of sexually transmitted infections (STI's), Hologic offers the Aptima Trichomonas vaginalis (ATV) assay. Expanding on the same trusted Aptima technology as the Aptima Combo 2 assay for CT/NG the Aptima Trichomonas vaginalis assay provides a new standard of performance in the detection of trichomoniasis infections with the first nucleic acid amplification test (NAAT) cleared for screening both symptomatic and asymptomatic patients.

About

Trichomoniasis is the most prevalent non-viral sexually transmitted infection (STI) caused by the protozoan parasite Trichomonas vaginalis.1 It is estimated that 3.7 million people in the United States are currently infected with Trichomonas vaginalis with a worldwide incidence of 276.4 million new cases each year making it more prevalent than chlamydia and gonorrhea combined.1,2

The Most Common Non-viral STI1

The Aptima Trichomonas vaginalis assay overcomes the challenges associated with traditional, less sensitive methodologies. Requiring only a fraction of a single organism3 and detecting up to 50% more than the most commonly used method makes it the most reliable test to diagnose Trichomonas infections.4

The Advantage Is in the Technology

Only Aptima detects up to 100% of Trichomonas infections.3,4,5,6

Features

Aptima Trichomonas vaginalis is a highly specific assay

Studies have shown ATV to detect up to 50% Trichomonas infections than wet mount.4,6

Studies referenced in the chart above document performance of Trichomonas vaginalis ASR assay.

One sample, multiple STI results

  • Multiple sample types makes it easy to order as a standalone test or in addition to Aptima Combo 2 for CT/NG
    • Vaginal swab - Clinician or patient-collected
    • Unisex swab - Female endocervical/male urethral
    • Female urine
    • The ThinPrep Pap test vial

Industry-leading automation

  • Panther system
  • Tigris DTS system
Performance Data

Performance Data on Panther System3

Specimen Type
Sensitivity % (95%CI)
Specificity % (95% CI)
Vaginal Swab
100 (94.7-100)
98.2 (96.7-100)
Endocervical Swab
100 (94.6-100)
98.1 (96.7-100)
PreservCyt Solution
100 (95.6-100)
98.6 (97.4-100)

 

Performance Data on Tigris DTS System3

Specimen Type Sensitivity % (95%CI) Specificity % (95% CI)
Vaginal Swab
100 (96.7-100)
99.0 (97.9-99.5)
Endocervical Swab
100 (96.7-100)
99.4 (98.6-99.7)
PreservCyt Solution
100 (96.0-100)
98.6 (98.8-99.9)
Female Urine
95.2 (88.4-98.1)
98.9 (97.8-99.5)
Regulatory

The Aptima Trichomonas vaginalis assay is FDA-cleared for in vitro diagnostic use.

For additional availability in other countries beyond the U.S., please contact your local sales representative or distributor,

References
  1. CDC Fact Sheet: Incidence, Prevalence and Cost of Sexually Transmitted Infections in the United States. http://www.cdc.gov/std/stats/sti-estimates-fact-sheet-feb-2013.pdf.
  2. World Health Organization (WHO) Global Prevalence and incidence of selected curable sexually transmitted infections - 2008.
  3. Aptima Trichomonas vaginalis Assay [package insert], San Diego, CA; Gen-Probe, 2011.
  4. Huppert, et al., CID2007:45 (15 July).
  5. Andrea, et al., J. Clin. Microbiol. 2011, 49(3):866.
  6. Nye MB, Schwebke JR, Body BA. C Am J Obstet Gynecol 2009; 200:188.e1-188.e7.
  7. Wendel, KA, et al. CID 2005:35 (1 September).