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Trichomonas vaginalis RNA, Qualitative, TMA
Test Code19550
CPT Codes
87661
Preferred Specimen
1 vaginal or endocervical swab collected in an Aptima® transport tube, or
2 mL Female or Male urine in collected in an Aptima® transport tube
2 mL Female or Male urine in collected in an Aptima® transport tube
Patient Preparation
Urine: Patient should not have urinated within one hour prior to collection. Female patients should not cleanse the labial area prior to providing the specimen.
Minimum Volume
2 mL urine
Other Acceptable Specimens
2 mL Female or Male Urine (no preservatives) collected in an Aptima® urine transport medium within 24 hours of collection and before being assayed
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
Vaginal swab: Follow instructions in the Aptima® Vaginal Swab Collection or Multitest Collection Kit (orange label).
Endocervical swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label). Excess mucus should be removed prior to sampling.
Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima® Specimen Transport within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube 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
Vaginal swab: Follow instructions in the Aptima® Vaginal Swab Collection or Multitest Collection Kit (orange label).
Endocervical swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label). Excess mucus should be removed prior to sampling.
Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima® Specimen Transport within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label.
Transport Temperature
Room temperature
Specimen Stability
Swab
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 6 months
Urine
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 6 months
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 6 months
Urine
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 6 months
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Transport tubes with 2 swabs • Transport tubes with non-Aptima® swabs • Swab transport tubes with no swab • Specimens in broken containers • Swab submitted in viral transport media • Urine samples where the fluid level is not between the black fill lines • Pap vials
Methodology
Transcription-Mediated Amplification (TMA)
Setup Schedule
Set up: Daily; Report available: 1-2 days
Reference Range
Not detected
Clinical Significance
Trichomonas vaginalis RNA, Qualitative Transcription-Mediated Amplification (TMA) assay is a nucleic acid amplification test that uses TMA for detection of T. vaginalis RNA in vaginal swabs (preferred), female or male urine, or endocervical swabs. It is used in the screening and diagnosis of trichomoniasis. When the clinical performance of this assay was evaluated, sensitivity was 100% in vaginal swab, endocervical swab, and PreservCyt® Solution liquid PAP specimens. Specificity was 98.2% in vaginal swab specimens and 98.1% in endocervical swab specimens [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 of HIV infection in women, as well as increased risk of preterm labor [1].
The Centers for Disease Control and Prevention (CDC) recommends T. vaginalis testing for women with vaginal discharge or cervicitis [4]. Because of the high rate of reinfection in individuals treated for T. vaginalis, CDC also recommends 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].
In a study of 933 symptomatic and asymptomatic women tested for T. vaginalis using a TMA-based assay, clinical sensitivity and specificity for various specimens were as follows: 100% and 99%, respectively, for vaginal swabs; 95.2% and 98.9% for urine; and 100% and 99.4% for endocervical swabs [3].
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. Satterwhite Cl, et al. Sex Transm Dis. 2013;40:187-193.
2. CDC. Trichomoniasis-CDC fact sheet. Published 7/2017. https://www.cdc.gov/std/trichomonas/stdfact- trichomoniasis.htm. Accessed August 14, 2019.
3. Workowski KA, et al. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015;64:1-137.
4. Nye MB, et al. Am J Obstet Gynecol. 2009;200:188.e1-188.e7.
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 of HIV infection in women, as well as increased risk of preterm labor [1].
The Centers for Disease Control and Prevention (CDC) recommends T. vaginalis testing for women with vaginal discharge or cervicitis [4]. Because of the high rate of reinfection in individuals treated for T. vaginalis, CDC also recommends 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].
In a study of 933 symptomatic and asymptomatic women tested for T. vaginalis using a TMA-based assay, clinical sensitivity and specificity for various specimens were as follows: 100% and 99%, respectively, for vaginal swabs; 95.2% and 98.9% for urine; and 100% and 99.4% for endocervical swabs [3].
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. Satterwhite Cl, et al. Sex Transm Dis. 2013;40:187-193.
2. CDC. Trichomoniasis-CDC fact sheet. Published 7/2017. https://www.cdc.gov/std/trichomonas/stdfact- trichomoniasis.htm. Accessed August 14, 2019.
3. Workowski KA, et al. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015;64:1-137.
4. Nye MB, et al. Am J Obstet Gynecol. 2009;200:188.e1-188.e7.
Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153
