Trichomonas Vaginalis DNA by PCR


Sunquest Code:TVPCR  
Epic Code:LAB6959Epic Name:Trichomonas Vaginalis DNA PCR
Synonyms:BV; Bacterial Vaginosis; Wet Prep; Trich PCR
Methodology:Real-Time PCR
CPT Code:----------CPTCODES HERE----------
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

Specimen:Female or Male Urine; vaginal/endocervical swab
Container:GeneXpert Yellow Urine (GeneXpert Pink Vaginal Endocervical)
Collection Instructions:

Urine-Female or Male First Catch Collection

Note: First catch urine must be transferred to an 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 information.

 

Female Vaginal Self-Collect Specimens

1.     Open the outer peelpack (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 an gently rotate the swab for 10-30 seconds. Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab and then withdraw the swab.

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 of 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, overfilled or under filled 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 patients that are less than 18 years of age or older than 78 years of age. Specimens from pregnant women or women with a know history of hysterectomy.


Processing and Shipping

Specimen Processing:

Urine: Must be transferred to a Cepheid Xpert Urine Transport tube within 4 hours of collection.

 

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 Lab-Microbiology  (Fairview Range - FRMC, UMMC-East Bank)


Interpretive

Reference Range:Trichomas 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 evaulated in pregnant women or in patients with a history of hysterectomy.

·          Xpert TV Assay performance has not been evaluated in patients less than 18 years of age or older than 78 years of age.

·          Trichomonas tenax was found to cross-react with the Xpert TV Assay at levels above 1.0 x 102 cells/mL. T. tenax is a commensal of the oral cavity.

 

 

Use:This assay is intended to aid in the clinical diagnosis of trichomonas's in symptomatic or asymptomatic individuals. It is a qualitative diagnostic test for the detection of 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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