Test Code TVBYPC Trichomonas vaginalis rPCR LAB921
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:
- Obtain an Xpert Swab Collection Kit.
- Remove excess mucus from the cervix and surrounding area
using
the large individually wrapped cleaning swab. - 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. - Open the collection swab wrapper by peeling open the top of
the
wrapper. - Hold the swab in your hand, placing your thumb and
forefinger
in the middle of the swab shaft. - Insert the collection swab into the endocervical canal.
Rotate
the swab clockwise for 10-30 seconds in the endocervical canal.
Withdraw the swab carefully. - Unscrew the cap from the transport tube and immediately
place
the specimen collection swab into the transport reagent tube. - Identifying the score-line, break the swab shaft against
the
side of the tube. Discard the top portion of the swab shaft. - Recap the swab transport reagent tube and tighten the cap
securely. Invert the tube 3-4 times to elute material from the
swab. - 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:
- Obtain an Xpert Swab Collection Kit. Swabs are not
to
be sent home with patients. They must be collected at the
healthcare facility. - 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. - 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. - Hold the swab in your hand, placing your thumb and
forefinger
in the middle of the swab shaft across the score-line. - Carefully insert the swab into your vagina about two inches
inside the opening of the vagina. - 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. - Unscrew the cap from the transport tube and immediately
place
the specimen collection swab into the transport reagent tube. - Identifying the score-line, break the swab shaft against
the
side of the tube. Discard the top portion of the swab shaft. - Recap the swab transport reagent tube and tighten the cap
securely. - 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:
- Ensure that the urine is well mixed in the urine cup before
transferring a sample to the Xpert Urine Transport Reagent Tube
(yellow cap). - 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. - 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. - Invert the specimen 3-4 times.
- 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:
- Urine not in transport tubes: 4 hours at room temperature,
4
days refrigerated. - Urine in Xpert Transport Tube: 14 days at room temperature,
28
days refrigerated.