See Specimen Submission Instructions for test requisition, specimen labeling and specimen packaging requirements. 

Test Description

The Aptima Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis. The Aptima Trichomonas vaginalis Assay is a nucleic acid test that utilizes Target Capture, Transcription-Mediated Amplification (TMA), and Hybridization Protection Assay (HPA) technologies.

Indications

The assay may be used to test specimens from symptomatic and asymptomatic individuals.

Results from the Aptima Trichomonas vaginalis Assay should be interpreted in conjunction with other clinical data available to the clinician.

Acceptable specimens

• ThinPrep^® Pap Test PreservCyt Solution* vial
• Aptima^® Unisex Swab (Endocervical Source)
• Aptima^® Multitest Swab Specimen (Vaginal Source)

Collection Procedure

• ThinPrep® Pap Test PreservCyt Solution* vial collected with a Broom type device (Rovers Cervex® Brush, Wallach Papette®), or Endocervical Brush/Spatula
  • Gynecologic specimens collected using routine pap specimen collection technique. Collect gynecologic specimens in ThinPrep Pap Test vials containing PreservCyt Solution with broom-type or cytobrush/spatula collection devices according to the manufacturer’s instructions.
• Aptima® Unisex Swab Specimen Collection Kit for Endocervical Specimens
  • Endocervical swab Specimen Collection
    1. Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white shaft swab in the package with red printing). Discard this swab. Note: To remove excess mucus from the cervical os, a large-tipped swab (not provided) may be used.
    2. Insert the specimen collection swab (blue shaft swab in the package with the green printing) into the endocervical canal.
    3. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling.
    4. Withdraw the swab carefully; avoid any contact with the vaginal mucosa.
    5. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube.
    6. Carefully break the swab shaft against the side of the tube at the scoreline and discard the top portion of the swab shaft; use care to avoid splashing of contents.
    7. Re-cap the swab specimen transport tube tightly.
• Aptima Multitest Swab Specimen Collection Kit for Vaginal Swab Specimens
  • Vaginal Swab Specimen Collection:
    1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima Multitest Swab Specimen Collection Kit.
    2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
    3. Carefully insert the swab into the vagina about 2 inches (5 cm) past the introitus and gently rotate the swab clockwise for 10 to 30 seconds. Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab and then withdraw the swab without touching the skin
    4. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection Kit.
    5. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
    6. Carefully break the swab shaft at the score line against the side of the tube.
    7. Immediately discard the top portion of the swab shaft.
    8. Tightly screw the cap onto the tube.

Stability

ThinPrep® collection vials are stable for 30 days at ambient temperatures for Trichomonas vaginalis (TV) testing. Transfer to

Urogenital, extragenital (throat, rectal) Swab specimens must be testing within 60 days of collection if stored at ambient temperatures.

Reference Range

Test is reported as:

1. Trich Neg Negative for Trichomonas vaginalis – (Normal Reference value)
2. Trich Pos Positive for Trichomonas vaginalis.
3. Invalid Indeterminate, a new specimen should be collected

CPT Code

Trichomonas vaginalis (TV)           87661