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Trichomonas Vaginalis by Aptima

Test Code

TV

Associations

Pregnant women with STI, including trichomonas infection may result in premature or low birth weight. Symptoms and final diagnosis do not always correlate and treatment may not resolve symptoms.Vaginitis symptoms or suggestive history of STI and the Gen-Probe TMA APTIMA assay for Trichomoniasis detected a prevalence of 5.1% in a current study of 766 patients versus currently available methodologies that indicate a lower rate of 3.2%.

Trichomonas vaginalis (TV) is primarily asymptomatic and associated with concurrent STIs in the general population. Screening for Trichomonas is limited today in part due to the shortfalls of current testing techniques. Most testing currently is done via culture methods, which are slower and less sensitive than molecular tests, or "wet mount," which requires the microscopic examination of a sample shortly after it is collected.

Methodology

Aptima by Transcription-Mediated Amplification (TMA)

Turnaround Time

3-5 days

Specimen Requirements

3.0 mL ThinPrep® PAP media or SurePath™ TestPack solution
1.0 mL liquid cytology media media transferred to APTIMA specimen transfer (GREEN) tube
One cervical swab collected with APTIMA Unisex Swab Specimen Collection Kit (blue swab)
20.0-30.0 mL (first catch) urine (female) collected in preservative-free urine collection cup or 2.0 mL urine transferred to APTIMA urine specimen transport (YELLOW) tube

Specimen Stability
ThinPrep/SurePath - 30 days from collection at 18-25°C. Specimens are kept for 21 days after receipt.
Swabs - 60 days from collection
Urine - 24 hours from collection; 30 days after transfer to APTIMA urine transport (YELLOW) tube
Storage & Handling

Transport and store all specimens at 2-30°C

Causes for Rejection

Insufficient specimen volume
No swab in transport tube
Urine specimens >24 hours old unless transferred to APTIMA urine transport (YELLOW) tube

Reference Range

Detected/Not Detected

Description

The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test cleared by the FDA for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the TIGRIS DTS System.
The assay may be used to test specimens from symptomatic or asymptomatic women.

References
  1. Allsworth J et al.(2009). Trichomoniasis and other Sexually Transmitted Infections: Results from the 2001-2004 National Health and Nutrition Examination Surveys. Sexually transmitted diseases 36: 7238-744
  2. Andrea SB, Chapin KC. J. (2011). Comparison of Aptima Trichomonas vaginalis Transcription-Mediated Amplification Assay and BD Affirm VPIII for Detection of T. vaginalis in Symptomatic Women: Performance Parameters and Epidemiological Implications. Clin Microbiol.49(3):866-9. Epub 2011 Jan 19
Trademarks

APTIMA s a trademark of Gen-Probe, Inc.
ThinPrep is a registered trademark of Cytyc Corporation