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Trichomonas vaginalis RNA, Qualitative TMA, Pap Vial : 90521
Test CodeTVPAPV or 90521
CPT Codes
87661
Transport Container
1 mL Liquid Cytology (PreservCyt® Preservative (ThinPrep®) in APTIMA® Transfer Tube
or
0.5 mL SurePath(TM) Preservative Fluid in APTIMA(®) Transfer Tube
Instructions:
PreservCyt(®) or SurePath(TM) 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)
SurePath(TM): SurePath(TM) fluid must be transferred to APTIMA(®) tube within 4 days of collection. Transfer 0.5 mL SurePath(TM) solution into APTIMA(®) Specimen Transfer Tube (green label).
or
0.5 mL SurePath(TM) Preservative Fluid in APTIMA(®) Transfer Tube
Instructions:
PreservCyt(®) or SurePath(TM) 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)
SurePath(TM): SurePath(TM) fluid must be transferred to APTIMA(®) tube within 4 days of collection. Transfer 0.5 mL SurePath(TM) solution into APTIMA(®) Specimen Transfer Tube (green label).
Transport Temperature
Room temperature.
Specimen Stability
PreservCyt® (ThinPrep®) in Aptima® Transport
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 12 months
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: 12 months
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 already processed for cytology or PAP; Multitest Collection tube (orange label)
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 PreservCyt® (ThinPrep®) and SurePath™ specimens in Aptima® Transfer Tube Solution. It is used in the screening and diagnosis of trichomoniasis.
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 PreservCyt® (ThinPrep®) and SurePath™ specimens in Aptima® Transfer Tube Solution. 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.
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 PreservCyt® (ThinPrep®) and SurePath™ specimens in Aptima® Transfer Tube Solution. 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.
Performing Laboratory
med fusion
