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Trichomonas vaginalis RNA, Qualitative, TMA, Pap Vial
Test Code90521
CPT Codes
87661
Preferred Specimen
1 mL liquid cytology (PreservCyt®) Preservative (ThinPrep®) collected in an Aptima® transfer tube or
0.5 mL SurePath™ Preservative Fluid collected in an Aptima® transfer tube
0.5 mL SurePath™ Preservative Fluid collected in an Aptima® transfer tube
Minimum Volume
1 mL liquid cytology • 0.5 mL SurePath™ Preservative fluid • 20 mL PreservCyt® • 10 mL SurePath™ fluid
Other Acceptable Specimens
20 mL PreservCyt® (ThinPrep®) • 10 mL SurePath™ Fluid
Instructions
Performance has not been evaluated in women less than 14 years of age.
For a complete list of assay limitations we recommend that you review the manufacturers package insert: https://www.hologic.com/package-inserts/diagnostic-products/aptima-trichomonas-vaginalis-assay
PreservCyt® or SurePath™ material already processed for cytology or PAP are not acceptable.
Labs performing cytology: Aliquot PreservCyt® solution before performance of liquid based cytology testing.
PreservCyt®: Transfer 1 mL PreservCyt® solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label).
SurePath™: SurePath™ fluid must be transferred to Aptima® tube within 4 days of collection. Transfer 0.5 mL SurePath™ solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label).
For a complete list of assay limitations we recommend that you review the manufacturers package insert: https://www.hologic.com/package-inserts/diagnostic-products/aptima-trichomonas-vaginalis-assay
PreservCyt® or SurePath™ material already processed for cytology or PAP are not acceptable.
Labs performing cytology: Aliquot PreservCyt® solution before performance of liquid based cytology testing.
PreservCyt®: Transfer 1 mL PreservCyt® solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label).
SurePath™: SurePath™ fluid must be transferred to Aptima® tube within 4 days of collection. Transfer 0.5 mL SurePath™ solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label).
Transport Temperature
Room temperature
Specimen Stability
PreservCyt® (ThinPrep®) in Aptima® Transport
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 year
SurePath™ Fluid in Aptima® Transport
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
PreservCyt® (ThinPrep®)
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year
SurePath™ Fluid
Room temperature: 4 days
Refrigerated: 4 days
Frozen: Unacceptable
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 year
SurePath™ Fluid in Aptima® Transport
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
PreservCyt® (ThinPrep®)
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year
SurePath™ Fluid
Room temperature: 4 days
Refrigerated: 4 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
PreservCyt® or SurePath™ material previously processed for cytology • PreservCyt® with excess mucus
Methodology
Transcription-Mediated Amplification (TMA)
FDA Status
The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Daily; Report available: 1-2 days
Reference Range
Not detected
Clinical Significance
Trichomonas vaginalis RNA, Qualitative Transcription- Mediated Amplification, Pap Vial test is a nucleic acid amplification test that uses transcription-mediated amplification for detection of T. vaginalis RNA, using a ThinPrep® or SurePath™ Pap sample as the specimen. It is used in the screening and diagnosis of trichomoniasis. When the clinical performance of this assay was evaluated, sensitivity was 100% in PreservCyt Solution liquid Pap specimens, while specificity was 98.6% [1,2].
Trichomoniasis is one of the most common sexually transmitted infections (STIs) in the United States, with an estimated 1.1 million new cases each year [3]. It is curable. About 70% of people infected with T. vaginalis are asymptomatic, though symptoms may show up after the infection has been present for some time. In women, symptoms include vaginal and/or urethral discharge, painful urination, and genital burning and discomfort [4].
In women, untreated T. vaginalis infection can lead to infertility, pelvic inflammatory disease, and cervical neoplasia. T. vaginalis infection is associated with a 2- to 3-fold increased risk for HIV infection in women, as well as increased risk of preterm labor [1].
T. vaginalis testing is recommended for women with vaginal discharge or cervicitis [4]. Because of the high rate of reinfection in individuals treated for T. vaginalis, repeat testing 3 months after treatment is recommended. Additionally, screening is recommended for HIV-infected women at the first HIV-related visit, with follow-up T. vaginalis testing annually. For pregnant women with HIV infection, T. vaginalis screening is recommended at the first prenatal visit [1].
A "detected" result is consistent with T. vaginalis infection. False-positive results could be obtained from sampling less than 2 weeks after cessation of therapy, since TMA-based tests can detect nucleic acids from dead organisms. A "not detected" result is consistent with the absence of T. vaginalis infection. False-negative results could be obtained due to an organism concentration below the assay detection limit [1].
References
1. Workowski, KA et al. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015;64:1-137.
2. Aptima trichomonas vaginalis assay [package insert]. San Diego, CA:Hologic;2019.
3. Satterwhite CL, et al. Sex Transm Dis. 2013;40:187-193.
4. CDC. Trichomoniasis-CDC fact sheet. Published 7/2017.
https://www.cdc.gov/std/trichomonas/stdfact-trichomoniasis.htm. Accessed August 14, 2019.
Trichomoniasis is one of the most common sexually transmitted infections (STIs) in the United States, with an estimated 1.1 million new cases each year [3]. It is curable. About 70% of people infected with T. vaginalis are asymptomatic, though symptoms may show up after the infection has been present for some time. In women, symptoms include vaginal and/or urethral discharge, painful urination, and genital burning and discomfort [4].
In women, untreated T. vaginalis infection can lead to infertility, pelvic inflammatory disease, and cervical neoplasia. T. vaginalis infection is associated with a 2- to 3-fold increased risk for HIV infection in women, as well as increased risk of preterm labor [1].
T. vaginalis testing is recommended for women with vaginal discharge or cervicitis [4]. Because of the high rate of reinfection in individuals treated for T. vaginalis, repeat testing 3 months after treatment is recommended. Additionally, screening is recommended for HIV-infected women at the first HIV-related visit, with follow-up T. vaginalis testing annually. For pregnant women with HIV infection, T. vaginalis screening is recommended at the first prenatal visit [1].
A "detected" result is consistent with T. vaginalis infection. False-positive results could be obtained from sampling less than 2 weeks after cessation of therapy, since TMA-based tests can detect nucleic acids from dead organisms. A "not detected" result is consistent with the absence of T. vaginalis infection. False-negative results could be obtained due to an organism concentration below the assay detection limit [1].
References
1. Workowski, KA et al. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015;64:1-137.
2. Aptima trichomonas vaginalis assay [package insert]. San Diego, CA:Hologic;2019.
3. Satterwhite CL, et al. Sex Transm Dis. 2013;40:187-193.
4. CDC. Trichomoniasis-CDC fact sheet. Published 7/2017.
https://www.cdc.gov/std/trichomonas/stdfact-trichomoniasis.htm. Accessed August 14, 2019.
Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153
