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Test Code TVBYPC Trichomonas vaginalis rPCR LAB921

Important Note

  • The Xpert TV assay performance has not been evaluated for patients <18 year and >78 years of age.
  • The Xpert TV assay performance has not been evaluated in pregnant women or in patients with a history of hysterectomy.

Test Method

Reverse Polymerase Chain Reaction

Performance

Testing is performed Monday through Sunday.

Routine: Typically completed within 4 hours after the specimen
arrives at the testing site.

STAT: Typically completed within 1 hour, 10 minutes after
the specimen arrives at the testing site.

Specimen Requirement

Vaginal or endocervical swab collected using Xpert Swab
Collection Kit [#SWAB/G-50] is required.

 

OR

 

First catch urine collected from a female or male subject using
the Xpert Urine Specimen Collection Kit [Cepheid #URINE/A-50]
(yellow cap) is required.

Useful For

The Xpert TV assay is a qualitative in vitro diagnostic test for
the detection of Trichomonas vaginalis genomic DNA on
clinician-collected endocervical swab specimens or
patient-collected vaginal swab specimens (collected in the clinical
setting) intended to aid in the diagnosis of trichomoniasis in
symptomatic or asymptomatic individuals.

Reference Values

Negative

CPT Code Information

87661  Trichomonas vaginalis, amplified probe technique

LOINC Code Information

62491-9  Trichomonas vaginalis DNA Vag Ql PCR: Trichomonas
vaginalis DNA [Presence] in Vaginal fluid by Probe and target
amplification method

Additional Specimen Collection Information

Physician-Collected Endocervical Swab
Collection Instructions:

  1. Obtain an Xpert Swab Collection Kit.
  2. Remove excess mucus from the cervix and surrounding area using
    the large individually wrapped cleaning swab.
  3. Open the package that contains the pink-capped Xpert Swab
    Transport Reagent tube and individually wrapped collection swab.
    Set the tube aside. Do not expose swab to Xpert Swab Transport
    Reagent prior to collection.
  4. Open the collection swab wrapper by peeling open the top of the
    wrapper.
  5. Hold the swab in your hand, placing your thumb and forefinger
    in the middle of the swab shaft.
  6. Insert the collection swab into the endocervical canal. Rotate
    the swab clockwise for 10-30 seconds in the endocervical canal.
    Withdraw the swab carefully.
  7. Unscrew the cap from the transport tube and immediately place
    the specimen collection swab into the transport reagent tube.
  8. Identifying the score-line, break the swab shaft against the
    side of the tube. Discard the top portion of the swab shaft.
  9. Recap the swab transport reagent tube and tighten the cap
    securely. Invert the tube 3-4 times to elute material from the
    swab.
  10. Label the plastic transport tube with the patient name, patient
    identification number, date and time of collection and the
    initials of the nurse who collected the specimen. 

Patient-Collected Vaginal Swab
Collection Instructions:

  1. Obtain an Xpert Swab Collection Kit. Swabs are not to
    be sent home with patients. They must be collected at the
    healthcare facility.
  2. Open the package that contains the pink-capped Xpert Swab
    Transport Reagent tube and individually wrapped collection swab.
    Set the tube aside. Do not expose swab to Xpert Swab
    Transport Reagent prior to collection.
  3. Open the collection swab wrapper by peeling open the top of the
    wrapper. Remove the swab, taking care not to touch the tip or lay
    it down.
  4. Hold the swab in your hand, placing your thumb and forefinger
    in the middle of the swab shaft across the score-line.
  5. Carefully insert the swab into your vagina about two inches
    inside the opening of the vagina.
  6. Gently rotate the swab for 10-30 seconds. Ensure the swab
    touches the walls of the vagina so that moisture is absorbed onto
    the swab. Withdraw the swab and continue to hold it in your
    hand.
  7. Unscrew the cap from the transport tube and immediately place
    the specimen collection swab into the transport reagent tube.
  8. Identifying the score-line, break the swab shaft against the
    side of the tube. Discard the top portion of the swab shaft.
  9. Recap the swab transport reagent tube and tighten the cap
    securely.
  10. Return the tube as instructed to your doctor, nurse, or
    care-provider. The Health Care Provider should label the plastic
    transport tube with the patient name, patient identification
    number, date and time of collection and the initials of
    employee who assisted with the collected the specimen.

Storage:
Swab specimens in transport tubes can be stored at room temperature
or refrigerated for up to 60 days.

 

Urine Collection

Collection Instructions:

  1. Ensure that the urine is well mixed in the urine cup before
    transferring a sample to the Xpert Urine Transport Reagent Tube
    (yellow cap).
  2. Open a disposable transfer pipette provide in the kit. Insert
    the transfer pipette into the urine cup so that the tip is near the
    bottom of the cup.
  3. Transfer urine to the Xpert Urine Transport Reagent Tube until
    the liquid level reaches the black dashed line on the label. This
    is approximately 7 mL of urine.
  4. Invert the specimen 3-4 times.
  5. Label the plastic transport tube with the patient name, patient
    identification number, date & time of collection and the
    initials of the nurse who collected the specimen.

Storage:

  1. Urine not in transport tubes: 4 hours at room temperature, 4
    days refrigerated.
  2. Urine in Xpert Transport Tube: 14 days at room temperature, 28
    days refrigerated.