Trichomonas vaginalis RNA, Qualitative, TMA, Males

Test Code
90801


CPT Codes
87661

Preferred Specimen
1 male urethral swab in Aptima® Transport Tube or
2 mL male urine in Aptima® Transport Tube


Patient Preparation
Male urine: Patient should not have urinated within one hour prior to collection

Minimum Volume
2 mL urine


Other Acceptable Specimens
2 mL male urine (no preservatives) received within 24 hours collected in an Aptima® Urine Transport Medium


Instructions
Urethral swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit for Endocervical and Urethral Swab Specimens package insert.

Male 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
Urine
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 6 months

Swab
Room temperature: 60 days
Refrigerated: 60 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 fill lines • Female specimens


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
The Trichomonas vaginalis RNA, Qualitative Transcription- Mediated Amplification, Males assay is a nucleic acid amplification test that uses TMA for detection of T. vaginalis RNA in male urethral swabs or urine. It is used in the screening and diagnosis of trichomoniasis [1].

Trichomoniasis is one of the most prevalent sexually transmitted infections (STIs) in the United States, with an estimated 1.1 million new cases each year [2]. 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 men, symptoms include genital itching or irritation, burning after urination or ejaculation, and penile discharge [3].

In men, T. vaginalis is associated with nongonococcal urethritis and chronic prostatitis. T. vaginalis is also a risk factor for HIV transmission and infection in men, as it increases HIV excretion in semen [4,5]. Because of the high rate of reinfection, individuals infected with T. vaginalis should return 3 months post-treatment to be retested [1].

Men with urethritis and other symptoms of T. vaginalis, as well as those who are clinically suspected of having T. vaginalis, should be tested. In a study of 298 men, TMA-based testing for T. vaginalis had a sensitivity of 91.7%, using either urine or urethral swab specimens; specificity was 91.9% for urine and 86.7% for urethral swab specimens [6].

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. Satterwhite CL, et al. Sex Transm Dis. 2013;40:187-193.
3. CDC. Trichomoniasis-CDC fact sheet. Published 7/2017.
https://www.cdc.gov/std/trichomonas/stdfact-trichomoniasis.htm. Accessed August 14, 2019.
4. Soper D. Am J Obstet Gynecol. 2004;190:281-290.
5. Hobbs MM, et al. Sex Transm Dis. 1999;26:381-387.
6. 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



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.