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Test Code Trich by NAAT Trichomonas vaginalis by NAAT

Aliases

Trichomonas vaginalis by APTIMA®, Nucleic Acid Amplification, Aptima Trichomonas Vaginalis Assay, Trichomonas vaginalis (TV)

Useful For

Trichomonas vaginalis is the parasite responsible for trichomoniasis, the most common curable sexually transmitted infection worldwide. Sex between women or between men and women can effectively transmit the parasite. The CDC estimates there are approximately 7.4 million new cases of Trichomonas infection in the United States each year. The CDC has set the U.S. prevalence rate at 3.1%.
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.
T. vaginalis infections can cause vaginitis, urethritis, and cervicitis. Untreated Trichomonas infections are also linked to pelvic inflammatory disease (PID) and tubal infertility. In pregnancy, complications include premature membrane rupture, low birth weight, and preterm birth. T. vaginalis infections may also increase a patient’s risk of acquiring and transmitting HIV.

Patient Preparation

No special patient preparation required

Special Collection Instructions

Swab specimens must be submitted with the correct swab provided in the APTIMA collection kit. Instructions for collection are provided on the kit packaging.
Urine specimens must be aliquotted in to APTIMA transport media within 24 hours of collection.

Collection Method

  • Clinician collected endocervical, vaginal and male urogenital swabs.
  • Self-collect swabs using the APTIMA vaginal self collect kit.
  • Urine specimens.
  • Clinician collected gynecological specimens collected into PreserveCyt solution.

Minimum Volume

  • 1 APTIMA swab specimen
  • 2 mL of urine
  • 2 mL PreserveCyt solution
  • 2mL M4 transport media with swab.

Container

For endocervical and urethral specimens collect APTIMA Swab:

Preferred Specimen

  • Urine
  • Cervix
  • Vaginal
  • Urethral
  • Penile
  • Endocervical

Acceptable Specimens

  • Urine
  • Cervix
  • Vaginal
  • Urethral
  • Penile

Reference or Target Ranges

Negative

Reportable Units

Positive/Negative

Critical Value

Not defined for this assay

Reasons for Rejection

Hemolysis Threshold N/A
Icterus Threshold N/A
Lipemia Threshold N/A
Interfering Subtances/Other
  • If the lab receives an APTIMA swab specimen transport tube with no swab, two swabs, a cleaning swab, or a swab not supplied by Gen-Probe, the specimen must be rejected.
  • If urine specimens are not aliquotted into the APTIMA transport media within 24 hours of collection, the specimen must be rejected.
  • Performance with specimens other than those collected with the following specimen collection kits has not been evaluated.
    • APTIMA Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens
    • APTIMA Vaginal Swab Specimen Collection Kit
    • APTIMA Specimen Transfer Kit (for use with gynecological samples collected in PreservCyt Solution
  • Swab specimens collected in any media other than APTIMA transport media or M4/Viral Transport Media may be rejected.

Specimen Stability

Ambient APTIMA swabs: 60 Days

Raw urine specimens: 24 Hours

Processed urine specimens: 30 Days

Viral Media specimens: See Note
Refrigerated (4°C to 8°C) APTIMA swabs: 60 Days

Raw urine specimens: 24 Hours

Processed urine specimens: 30 Days

Viral Media specimens: See Note
Frozen(-70°C to 0°C) APTIMA Swabs: 12 Months

Raw urine specimens: N/A

Processed Urine specimens: 90 Days

Viral Media specimens: See Note


Note regarding specimens in viral transport media:
Specimens received in M4 and M4RT intended for Trichomonas testing should be stored and transported at 2°C to 30°C for up to 24 hours. Specimens that will not arrive in the laboratory within 24 hours should be stored at -20°C to 8°C. Mix specimens well by vortexing and transfer 1mL of the M4 or M4RT media into the APTIMA specimen transfer tube. Once the specimen is transferred to the APTIMA Specimen Transfer tube, the specimen must be assayed within 30 days when stored at 2°C to 8°C or 14 days when stored at 15°C to 30°C. If longer storage is needed, freeze at -20°C to -70°C for up to 90 days after transfer.

Performance Information

Days and Time Performed Daily Monday – Friday
Expected Turn Around Time 1 -3 days on receipt in lab
Stat Availabilty No
Performing Bench Molecular Pathology
Methodology/Method Description Hologic Panther – Nucleic Acid Amplification

Special Handling

Refrigerate urine prior to aliquotting.

Additional Information/Important Notes

Accurate diagnosis of Trichomoniasis has been limited by lack of sensitive diagnostic tests. While highly specific, traditional methods used for the diagnosis of T. vaginalis, including wet mount, culture, and Pap smear have poor sensitivity compared to the APTIMA® Trichomonas vaginalis Nucleic Acid Amplification assay

CPT Codes

87661

Panel Components

APTIMA Trichomonas vaginalis assay may be ordered with N.gonorrhoeae and C. trachomatis by NAAT on the same specimen.