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Epic Code LAB3525 APTIMA Trichomonas, NAAT, ThinPrep, Swab, Urine

Important Note

  • Please review complete specimen collection for each specimen type, making note of the important notes within the specimen requirements.
  • This testing is not approved for patients under the age of 14.
    • Please order a Reference Miscellaneous test (LAB848) on these patients so the specimen can be forwarded to a reference laboratory to perform the testing.
    • Indicate the complete test name and source when pediatric testing is necessary.
  • This test cannot be added to a previous Pap test order.

Test Name Alias

Trichomonas NAAT Aptima | Trich | ThinPrep | 7043 | STI | TV

Interface Order Alias

11774

Clinical Information

Trichomonas vaginalis (TV) is the most common curable sexually transmitted disease (STD) agent in the United States.  Infection with the protozoa in women can cause vaginitis, urethritis, and cervicitis.  Complications can include premature labor, low-birth-weight offspring, premature rupture of membranes, and post-abortion or post-hysterectomy infection.

 

Cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution, APTIMA vaginal swabs, APTIMA endocervical unisex swabs, and male and female urine specimens from symptomatic and asymptomatic individuals are approved for testing.  Other specimen types are not acceptable.

 

Improper collection of the specimen may results in invalid results.  If the lab receives a swab specimen transport tube with no swabs, two swabs, a cleaning swab, or a swab not supplied by Hologic the specimen must be rejected.

 

A negative test result does not preclude the presence of a TV infection because results are dependent on adequate specimen collection, absence on inhibitors, and sufficient rRNA to be detected.

 

If a specimen has a small number of TV organisms, uneven distribution may occur which may affect the ability to detect TV rRNA in the collected material.  If negative results from the specimen do not fit with the clinical impression, a new specimen may be necessary.

 

The presence of Trichomonas tenax or Pentatrichomonas hominis in a specimen may affect the ability to detect TV rRNA due to cross-reactivity in the presence of these microorganisms.

Icons & Photos

 

 

Specimen Requirements

Submit  only ONE of the following specimens:

Cervical Cytology Specimens

Specimen Type: Cervical cytology specimen

Container/Tube: ThinPrep Vial

Collection Instructions:

Brush collection:

  1. Obtain an adequate sampling from the ectocervix using a plastic spatula. If desired, use lukewarm water to warm and lubricate the speculum. Water-soluble gel lubricant sparingly applied to the posterior blade of the speculum can be used if necessary. Select contoured end of plastic spatula and rotate it 360 degrees around the entire exocervix while maintaining tight contact with exocervical surface.
  2. Rinse the spatula as quickly as possible into the PreservCyt solution in the ThinPrep vial by swirling the spatula vigorously in the vial 10 times. Discard the spatula.
  3. Obtain as adequate sampling from the endocervix using an endocervical brush device. Insert the brush into the cervix until only the bottom-most fibers are exposed. Slowly rotate 1/4 or 1/2 turn in one direction. Do not over-rotate.
  4. Rinse the brush as quickly as possible into the PreservCyt solution in the ThinPrep vial by rotating the device in the solution 10 times while pushing against the PreservCyt vial wall. Swirl the brush vigorously to further release material. Discard the brush
  5. Tighten the cap so that the torque line on the cap passes the torque line on the vial
  6. Record the patient’s name and date of birth on the vial.

Broom collection:

  1. Obtain an adequate sampling from the cervix by inserting the central bristles of the broom into the endocervical canal deep enough to allow the shorter bristles to fully contact the ectocervix.  Push gently, and rotate the broom in a clockwise direction five times.
  2. Rinse the broom in the PreservCyt solution in the ThinPrep vial by pushing the broom into the bottom of the vial 10 times, forcing the bristles apart.
  3. As a final step, swirl the broom vigorously to further release the material.
  4. Discard the collection device.
  5. Tighten the cap on the ThinPrep vial so that the torque line on the cap passes the torque line on the vial.
  6. Record the patient’s name and date of birth on the vial.

 

Vaginal Specimens

Specimen Type: Vaginal specimens

Container/Tube: APTIMA Mutitest (Vaginal) Swab

Collection Instructions:

  1. Partially peel open the swab package.  Do not touch the soft tip or lay the swab down.
  2. Hold the swab so that the thumb and forefinger are positioned in the middle of the 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 past the introitus 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.  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.  Do not touch the top of the cap.
  5. Immediately place the swab in 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. Discard the top portion of the swab shaft.
  8. Tightly screw the cap onto the tube, being careful not to touch the top of the cap.
  9. Record the patient’s name and date of birth on the vial.

Important Note: Collect the specimen using only the APTIMA Multitest (Vaginal) Swab Collection Kit when requesting Trichomonas NAAT (APTIMA)  testing on a vaginal specimens.  Other swabs are not acceptable for use with this assay when testing a vaginal specimen.

 

Endocervical Specimens

Specimen Type: Endocervical specimens

Container/Tube: APTIMA Unisex Swab for Endocervical Specimens

 

Collection Instructions:

  1. Peel open the swab package.  Do not touch the soft tips or lay the swabs down.
  2. Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab with the white shaft.  Discard this swab.
  3. Carefully insert the specimen collection swab (with the blue shaft) into the endocervical canal.  Gently rotate the swab 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. While holding the swab in the same hand, unscrew the cap from the tube.  Do not spill the contents of the tube.  Do not touch the top of the cap.
  6. Immediately place the swab in the transport tube so that the score line is at the top of the tube.
  7. Carefully break the swab shaft at the score line against the side of the tube.
  8. Discard the top portion of the swab shaft.
  9. Tightly screw the cap onto the tube, being careful not to touch the top of the cap.
  10. Record the patient’s name and date of birth on the vial.

Important Note: Collect the specimen using only the APTIMA Unisex Swab Collection Kit for Endocervical Specimens when requesting Trichomonas NAAT (APTIMA) testing.  Other swabs are not acceptable for use with this assay when testing on an endocervical specimen. 

 

Male Urethral Specimens

Specimen Type: Male Urethral Specimens

Container/Tube: APTIMA Unisex Swab for Male Urethral Specimens

Collection Instructions:

  1. The patient should not have urinated for at least 1 hour priro to sample collection.
  2. Peel open the swab package. Do not touch the soft tips or lay the swabs down.
  3. Carefully insert the specimen collection swab (with the blue shaft) 2 to 4 cm into the urethra. Gently rotate the swab clockwise for 2 to 3 seconds in the urthra to ensure adequate sampling.
  4. Withdraw the swab carefully.
  5. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. Do not touch the top of the cap.
  6. Immediately place the swab in the transport tube so that the score line (black line) is at the top of the tube. 
  7. Carefully break the swab shaft at the score line against the side of the tube.
  8. Discard the top portion of the swab shaft.
  9. Tightly screw the cap onto the tube, being careful not to touch the top of the cap.
  10. Record the patient's name and date of birth on the vial.

Important Note: Collect the specimen using only the APTIMA Unisex Swab Collection Kit for Male Urethral Specimens when requesting APTIMA Chlamydia NAAT Testing. Other swabs are not acceptable for use with this assay when testing male urethral specimens.

 

Urine-Sterile Urine Cup

Specimen Type: Urine

Container/Tube: Sterile urine cup

Volume: 20 to 30 mL

Collection Instructions:

  1. The patient should not have urinated for at least 1 hour prior to specimen collection.
  2. The patient should be directed to provide a first-catch urine (approximately 20 to 30 mL of the initial urine stream) into a sterile urine cup free of any preservatives.  Female patients should not clean the labial area prior to providing the specimen.
  3. Record the patient’s name and date of birth on the cup.

 

Urine Specimen-Aptima Urine Transport Tube

Specimen Type: Urine

Container/Tube: APTIMA Urine Transport Tube

Volume: 20 to 30 mL collected in a sterile urine collection cup

Collection Instructions:

  1. The patient should not have urinated for at least 1 hour prior to specimen collection.
  2. The patient should be directed to provide a first-catch urine (approximately 20 to 30 mL of the initial urine stream) into a sterile urine cup free of any preservatives.  Female patients should not clean the labial area prior to providing the specimen.
  3. Remove the cap of the APTIMA urine specimen transport tube.
  4. Transfer 2 mL of urine from the collection cup to the urine specimen transport tube using the disposable pipette provided.  The correct volume of urine has been added when the fluid level is between the black fill lines on the urine specimen transport tube label.
  5. Re-cap the urine specimen transport tube tightly.
  6. Record the patient’s name and date of birth on the vial.

Important Note: Urine specimens should be submitted using only a sterile urine cup or the APTIMA Urine Transport Tube when requesting Trichomonas NAAT (APTIMA) testing.  Other urine collection tubes are not acceptable for use with this assay.

Specimen Transport Temperature

ThinPrep vial: After collection, the PreservCyt Solution in the ThinPrep liquid Pap vial is transported and stored at room temperature or refrigerated until tested.

 

Swab Specimens: After collection, the multitest (vaginal) or unisex swab is transported and stored at room temperature or refrigerated until tested.

 

Urine specimens: Urine specimens still in the sterile urine cup must be transported to the laboratory stored at room temperature or refrigerated within 24 hours of collection.  Urine specimens transferred to the APTIMA Urine Transport Tube is transported and stored at room temperature until tested.

Special Instructions

See any Important Notes with specimen type above.

Best practice to avoid specimen contamination: Do not touch top of cap, make sure all caps are secured, individually bag specimens, change gloves if contaminated.

Rejection Criteria

  • Improper collection of the specimen may results in invalid results.  If the lab receives a swab specimen transport tube with no swabs, two swabs, a cleaning swab, or a swab not supplied by Hologic the specimen must be rejected.
  • If specimens are bagged together and a specimen leaks, all specimens in the bag will be canceled and a request for recollection will be made.
  • Invalid specimen types
  • Improper labeling of specimen - Spectrum Health Laboratory requires 2 patient identifiers (Name and Date of Birth or SH MRN)

Specimen Stability

ThinPrep vial: Specimens submitted in the ThinPrep liquid Pap vial must be transferred to an APTIMA Specimen Transfer Tube within 30 days of collection.  Once an aliquot of the PreservCyt Solution in the ThinPrep vial has been transferred to the APTIMA Specimen Transfer Tube, the specimen is stable for 14 days from the date of transfer if stored refrigerated.

 

Swab Specimens: The multitest (vaginal) or unisex swab specimens will be stored at room temperature for 14 days from collection

 

Urine specimens: Urine specimens still in the sterile urine cup must be transferred to an APTIMA Urine Transport Tube within 24 hours of collection.  Urine specimens transferred to the APTIMA Urine Transport Tube are stable for 14 days from the date of transfer when stored at room temperature.

Test Frequency

Available Monday through Friday; usual TAT 1 to 2 days

Reference Range

Negative

Performing Department

CYTOLOGY

Performing Department Laboratory Location

Spectrum Health Regional Laboratory, Grand Rapids, MI

Methodology

The APTIMA Nucleic Acid Amplification Test (NAAT) utilizes target capture, Transcription-Mediated Amplification (TMA) and Dual Kinetic Assay (DKA) technologies for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis (TV). 

CPT

87661 - LAB TRICHOMONAS PCR

CDM Code

3900403

Epic Test ID

1230101239

LOINC

TRICHOMONAS NAAT APTIMA: 46154-1

Mayo Access Code

SHO11774

Reviewed Date

7/2/2021