Trichomonas Vaginalis DNA by PCR


Sunquest Code:TVPCR  
Epic Code:LAB6959Epic Name:Trichomonas Vaginalis DNA PCR
Synonyms:Bacterial Vaginosis; BV; Trich PCR, Wet Prep
Methodology:Real-Time PCR
Turnaround Time:Performed daily; results are reported within 24 hours of receipt in IDDL.
Special Instructions:Specimen must be collected/sent to IDDL using the Cepheid Xpert Urine Collection Kit or the Cepheid Xpert Vaginal/Endocervical Collection Kit.


Collection Instructions

Container:GeneXpert Pink Vaginal Endocervical, GeneXpert Yellow Urine
Collection Instructions:Urine Female or Male First Catch Collection
Note: First catch urine must be transferred to Xpert Urine Transport Reagent tube within 4 hours of collection.
  1. The patient should not have urinated for at least 1 hour prior to collecting the specimen. Female patients should not cleanse the labial area prior to specimen collection. Male patients should not cleanse the tip of the penis prior to specimen collection.
  2. Patient should collect first 20-50 mL of the initial urine stream into a sterile, plastic, preservative-free container. Collection of larger volumes may result in specimen dilution that may reduce test sensitivity.
  3. Ensure the urine is well mixed in the urine cup before transferring sample to the Xpert Urine Transport Reagent tube.
  4. Using the disposable transfer pipet in the Xpert Urine Collection kit, transfer approximately 7 mL of urine into the transport tube. The correct amount of urine has been added when the level reaches the black dashed line  on the label. Urine must be transferred to the transport tube within 4 hours of collection.
  5. Replace the cap on the Xpert Urine Transport Reagent tube, tighten securely and invert 3-4 times to mix.
  6. Label the transport tube with appropriate patient information.


Female Endocervical Specimens
Note: Samples must be collected using the flocked collection swab and transport tube in the Cepheid Xpert Vaginal/Endocervical collection kit.
  1. Remove excess mucus from the cervical os and surrounding mucosa using the large, individually wrapped cleaning swab. Discard this large swab once cervical mucus has been removed!
  2. Insert the flocked specimen collection swab (white shaft flocked swab in the package labeled FLOQSwabs) into the endocervical canal.
  3. Gently rotate the swab for 10-30 seconds in the endocervical canal to ensure adequate sampling.
  4. Withdraw the swab carefully.
  5. While holding the swab in the same hand, unscrew the cap from the Xpert Swab Transport Reagent tube. (Do not spill tube contents! If the contents of the tube are spilled, then use a new collection kit.)
  6. Immediately place the swab in the transport reagent tube.
  7. 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.
  8. Re-cap the swab transport reagent tube and tighten cap securely. Invert or gently shake the tube 3-4 times to elute material from this swab. Avoid foaming.
  9. Label the transport tube with the appropriate patient informaiton.


Female Vaginal Self-Collect Specimens
  1. Open the outer peel-pack (which contains the two package kit); identify the larger cleaning swab and discard it.
  2. Open the package that contains the pink-capped Xpert Swab Transport Reagent tube and individually wrapped collection swab. Open the collection swab wrapper and remove the swab taking care not to touch the tip or lay it down.
  3. Hold the swab shaft across the scoreline.
  4. Carefully insert the swab into the vagina about 2 inches past the opening of the vagina and gently rotate the swab for 10-30 seconds. Make sure the swab touches the walls of the vagina so that the moisture is absorbed by the swab and then withdraw the swab.
  5. While holding the swab in the same hand, unscrew the pink cap from the Xpert Swab Transport Reagent tube. (Do not spill the contents! If the contents of the tube are spilled, then use a new collection kit.)
  6. Immediately place the swab in the transport reagent tube.
  7. 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 the contents. Wash with soap and water if exposed.
  8. Re-cap the swab transport tube and tighten cap securely.
  9. Return the tube as instructed by lab staff or provider for appropriate patient labeling.
Causes for Rejection:Midstream or catheterized urine samples; urine in preservative; overfillled or underfilled urine transport tubes; transport tubes containing a cleaning swab or more than 1 swab; swab specimens not collected using the correct Cepheid collection device. Specimens from pregnant women or women with a known history of hysterectomy.


Processing and Shipping

Specimen Processing:Urine: Must be transferred to a Cepheid Xpert Urine Transport tube within 4 hours of collections.
Swabs: Must be collected using the flocked collection swab and transport tube in the Cepheid Xpert Vaginal/Endocervical collection kit.
Specimen
Type
Collection
Device
Stability
Urine: First-catch,
male or female
Sterile cup
Unprocessed urine
4 days at 2-8°C
4 hours at 15-30°C
Urine: First-catch
male or female
Xpert Urine Specimen
Collection Kit
28 days at 2-8°C
14 days at 15-30°C
Endocervical swab Xpert Vaginal
Endocervical Collection Kit
60 days at 2-30°C
Patient-Collect
vaginal swab
Xpert Vaginal
Endocervical Collection Kit
60 days at 2-30°C
 
Shipping Instructions:Ship at room temperature or refrigerated.
Test Performed at or Referral Lab Infectious Diseases Diagnostic Laboratory  (Range, UMMC-East Bank)


Interpretive

Reference Range:Trichomonas vaginalis DNA not detected.
Limitations:
  • With endocervical and patient-collected vaginal specimens, assay interference may be observed in the presence of blood (>60 v/v).
  • Xpert TV assay performance has not been evaluated in pregnant women or in patients with a history of hysterectomy.
  • Trichomonas tenax was found to cross-react with the Xpert TV Assay at levels above 1.0 x 102cells/mL T.tenax is a commensal of the oral cavity.
  • This assay has not been validated by the manufacturer or the Infectious Diseases Diagnostic Laboratory for patients less than 18 years of age, or older than 78 years of age. Clinical judgement and correlation are necessary for interpretation of this result.
Use:This assay is intended to aid in the clinical diagnosis of trichomonas in symptomatic or asymptomatic individuals. It is a qualitative diagnostic test for the detectionof Trichomonas vaginalis genomic DNA in female and male urine specimens, endocervical swab specimens or patient collected vaginal swab specimens (collected in the clinical setting) when collected using the appropriate Cepheid collection device.


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