Trichomonas vaginalis RNA, Qualitative, TMA

Test Code
TVD/TVPAP


CPT Codes
87661

Preferred Specimen
The Aptima Trichomonas vaginalis Assay is designed to detect the presence of T.vaginalis in clinician-collected endocervical and vaginal swab specimens, and Preservcyt liquid Pap specimens.  Tufts Medical Center Clinical Laboratory has further validated the use of female and male urine specimens by in-house testing.
 
Tufts Medical Center accepts the following specimen types:
  • Aptima Unisex Swab Collection Kit
  • Aptima Specimen Transfer Kit (PreservCyt)
  • Urine specimens
Urine specimens are preferably in the Aptima urine specimen transport tube but it is not essential.  A urine cup is also acceptable.
For urine collection, the patient should not have urinated for at least one hour prior to specimen collection. Direct patient to provide a first-catch urine (approximately 20 mL to 30 mL of the initial urine stream) into a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity; lesser volumes may not adequately rinse organisms into the specimen. Female patients should not cleanse the labial area prior to providing the specimen.
 


Minimum Volume
1 mL of cervical specimen in PreserCyt solution,
or
2 mL of urine


Transport Container
Swab specimens: After collection, transport and store the swab in the swab specimen transport tube at 2°C to 30°C for up to 60 days.
 
Specimens collected in PreservCyt Solution: Transport and store the PreservCyt Solution specimen at 2°C to 30°C for up to 30 days.
 
Urine specimens:  Urine specimens that are still in the primary collection container must be transported to the lab at 2ºC to 30ºC. Transfer the urine specimen into the Aptima urine specimen transport tube within 24 hours of collection.
 


Transport Temperature
Room temperature


Specimen Stability
Swab specimens:
     Refrigerated or room temp; 60 days
     Frozen; up to 24 months 

Urine specimens:
     Refrigerated or room temp in the Aptima urine transport tube; 60 days
     Frozen; up to 24 months 

Specimens collected in PreservCyt Solution
     Refrigerated or room temp in the PreservCyt solution; 60 days (After transfer to an Aptima specimen transfer tube, specimens may be stored an additional 14 days at 15ºC to 30ºC or 30 days at 2ºC to 8ºC)    
     Forzen in Aptima transfer tube; up to 24 months


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Urine specimens showing visible hemolysis should be rejected, as they can be associated with a false negative test result.


Methodology
Transcription-Mediated Amplification (TMA)

FDA Status
The assay has been cleared by the FDA for the following specimens:

Setup Schedule
Setup: 4 – 5 days per week, Monday - Friday
 


Report Available
Report available: 1-2 days


Reference Range
Negative


Clinical Significance
Trichomonas vaginalis (TV) is the most common curable sexually transmitted disease (STD) agent in the United States, with an estimated 7.4 million new cases occurring annually. Infections in women cause vaginitis, urethritis, and cervicitis. Discharge and small hemorrhagic lesions may be present in the genitourinary tract. Complications can include premature labor, low-birth-weight offspring, premature rupture of membranes, and post-abortion or post hysterectomy infection. An association with pelvic inflammatory disease, tubal infertility, and cervical cancer with previous episodes of trichomoniasis has been reported. Symptomatic women with trichomoniasis usually complain of vaginal discharge, vulvovaginal soreness, and/or irritation. Dysuria is also common. However, it has been estimated that 10 to 50% of T. vaginalis infections in women are asymptomatic, and in men the proportion may even be higher.


Performing Laboratory
Performed in Chemistry Laboratory, Tufts Medical Center X5820



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.