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Trichomonas vaginalis RNA, Qualitative TMA, UROGENITAL : 19550
Test CodeTVURO or 19550
CPT Codes
87661
Transport Container
Vaginal swab: Follow instructions in the Aptima® Multitest Collection Kit (orange label).
Endocervical swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label).To ensure collection of cells infected with N. gonorrhoeae/C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling.
Urethral swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit for Endocervical and Urethral Swab Specimens package insert.
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 Female or Male 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.
Note: Patient should not have urinated within one hour prior to collection. Female patients should not cleanse the labial area prior to providing the specimen.
Endocervical swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label).To ensure collection of cells infected with N. gonorrhoeae/C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling.
Urethral swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit for Endocervical and Urethral Swab Specimens package insert.
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 Female or Male 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.
Note: Patient should not have urinated within one hour prior to collection. Female patients should not cleanse the labial area prior to providing the specimen.
Transport Temperature
Room temperature.
Specimen Stability
Urine in Aptima® Transport Medium
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 30 days
Swabs in Aptima® Transport
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 6 months
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 30 days
Swabs in Aptima® Transport
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 6 months
Methodology
Transcription-Mediated Amplification (TMA)
Setup Schedule
Monday - Saturday
Report Available
1-3 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), urine, or endocervical/ urethral swabs. It is used in the screening and diagnosis of trichomoniasis.
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 [1,2,3]. 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. 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. e.1-188.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 [1,2,3]. 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. 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. e.1-188.e7.
Performing Laboratory
med fusion
