Trichomonas NAAT

TEST DESCRIPTION

Nucleic acid amplification test (NAAT) for the detection of Trichomonas vaginalis. This test is a target amplification nucleic acid probe test that uses target capture for the qualitative detection of Trichomonas vaginalis ribosomal RNA to aid in the diagnosis of trichomoniasis.

Methodology

Transcription-mediated amplification

Reference range

Negative

TEST FREQUENCY & RESULT AVAILABILITY

Performed 3 times weekly. Results are typically available two business days after specimen receipt.

ACCEPTABLE SPECIMEN TYPES AND COLLECTION

• Urine

1. 2 mL of urine transferred into an Aptima urine transport tube

• Vaginal swab 
  1. Multitest swab (pink) placed in an Aptima transport tube; patient or clinician collected
• Endocervical swab 
  1. Unisex swab (blue) placed in an Aptima transport tube; clinician collected
• Detailed collection instructions appear below

SPECIMEN STORAGE & TRANSPORT

Store and transport at room temperature or refrigerated   (2–30 °C/36–86 °F) for up to 30 days for urine and up to 60 days for swabs. 

REJECTION CRITERIA

• Collection tube expired prior to date of collection
• Holding time greater than 30 days for urine; 60 days for swabs
• Specimen tube has leaked or is not sealed properly
• Urine specimens with a volume level outside the acceptable range indicated with black arrows
• Swab specimens that are missing the swab, contain multiple swabs, or contain the wrong swab

CODES

CPT: 87661

LOINC: 46154-1

Test code: 2850

TEST FEE

Refer to the current fee schedule.

DETAILED SPECIMEN COLLECTION INSTRUCTIONS

• Verify that the kit is not expired.
• Use Universal Precautions when handling specimens.
• Avoid cross-contamination during the specimen handling steps. Specimens can contain extremely high levels of organisms. Ensure that specimen containers do not contact one another, and discard used materials without passing over any container. Change gloves if they touch the specimen.
• If tube transport media is spilled, discard and replace with a new Aptima transport tube.
• Place the transport tube inside the zippered portion of the biohazard specimen bag and seal tightly. 
• Fill out the requisition form completely. Fold it in half once (no staples please) and place in the outer pocket of the biohazard specimen bag (not inside the zippered pouch with the specimen).

 Urine

Patient Instructions

1. Do not urinate for at least one hour prior to collection.
2. Do not cleanse genitals prior to collection.
3. Collect only the first, most concentrated part of the urine stream (about 20 mL to 30 mL) into a collection cup that is free of any preservatives.

Clinic Staff Instructions

1. Using the disposable pipette provided, transfer 2 mL of urine into the transport tube, aiming for the middle of the fill area between the two black arrows.
   1. If the volume is outside of the acceptable range indicated with black arrows, the specimen will be rejected. If urine is under the line, add more. If urine is over the line, discard and replace with a new Aptima urine transport tube. 
   2. Urine specimens must be transferred into the transport tube within 24 hours of collection; however, we find within 2 hours to be optimal.
2. Tightly screw the cap onto the tube.

IF ORDERING THREE OR MORE APTIMA AMPLIFICATION TESTS, COLLECT AND SUBMIT TWO URINE COLLECTION TUBES

 Swab – Endocervical

1. Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white shaft swab). Discard this swab. If excess mucus remains, an additional large-tipped swab (not provided) may be used for cleaning.
2. Insert the Unisex Swab (blue shaft swab) into the endocervical canal.
3. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal.
4. Withdraw the swab carefully; avoid any contact with the vaginal mucosa.
5. Remove the tube cap and immediately place the 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.

Multitest Swab – Vaginal 

Note: Vaginal swabs can be collected by the clinician or by the patient. Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use. 

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) and gently rotate the swab 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.