| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
Trichomonas vaginalis RNA, Qualitative, TMA, Pap Vial
Test Code90521
CPT Codes
87661
Preferred Specimen
1 mL Liquid Cytology (PreservCyt®) Preservative (ThinPrep®) in Aptima® Transfer Tube (green label) or
0.5 mL SurePath™ Preservative Fluid in Aptima® Transfer Tube (green label)
0.5 mL SurePath™ Preservative Fluid in Aptima® Transfer Tube (green label)
Minimum Volume
1 mL PreservCyt® (ThinPrep®) in Aptima® Transfer Tube • 0.5 mL SurePath™ Fluid in Aptima® Transfer Tube
Other Acceptable Specimens
20 mL PreservCyt® (ThinPrep®) • 10 mL SurePath™ Fluid
Instructions
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® transfer tube (green label).
SurePath™: SurePath™ fluid must be transferred to APTIMA® tube within 4 days of collection. Transfer 0.5 mL SurePath™ solution into APTIMA® transfer tube (green label).
Labs performing cytology: Aliquot PreservCyt® solution before performance of liquid-based cytology testing.
PreservCyt®: Transfer 1 mL PreservCyt® solution into APTIMA® transfer tube (green label).
SurePath™: SurePath™ fluid must be transferred to APTIMA® tube within 4 days of collection. Transfer 0.5 mL SurePath™ solution into APTIMA® transfer tube (green label).
Transport Temperature
Room temperature
Specimen Stability
Liquid cytology (PreservCyt®), preservative (ThinPrep®) in APTIMA® transfer tube
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 year
SurePath™ preservative fluid in APTIMA® transfer tube
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
Liquid cytology (PreservCyt®) preservative (ThinPrep®) collected in original ThinPrep® vial
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year
SurePath™ preservative fluid collected in original SurePath™ vial
Room temperature: 4 days
Refrigerated: 4 days
Frozen: Unacceptable
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 year
SurePath™ preservative fluid in APTIMA® transfer tube
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
Liquid cytology (PreservCyt®) preservative (ThinPrep®) collected in original ThinPrep® vial
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year
SurePath™ preservative fluid collected in original SurePath™ vial
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 performance characteristics of this assay when used to test SurePath™ specimens have been determined by Quest Diagnostics. Performance characteristics refer to the analytical performance of the test.
Setup Schedule
Set up: Daily; Report available: 1-2 days
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.
