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Test Code LAB921 TRICH VAGINALIS DNA

Performing Lab

Arnot Ogden Medical Center Laboratory

Ordering Recommendations

This assay is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. This test uses female and male urine specimens, endocervical swab specimens or patient-collected vaginal swab specimens and is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals.

Collect

Specimen Types:

  • First-catch female or male urine
  • Endocervical swab in GeneXpert Swab Transport Reagent
  • Self-collected vaginal swab in GeneXpert Swab Transport Reagent

Collection Device

  • Urine: Sterile cup
  • Endocervical swab: GeneXpert Vaginal/Endocervical Collection Kit
  • Self-collected vaginal swab: GeneXpert Vaginal/Endocervical Collection Kit

Specimen Volume

Minumum volume (Urine): 7 ml

Stability (from collection to initiation)

Specimen Specimen Transport and Storage Temperature Specimen Storage Time
Female and Male Urine (NEAT) 15-30C 4 hours
2-8C 4 days
Endocervical Swab in Xpert Swab Transport Reagent 2-30C 60 days
Vaginal Swab in Xpert Swab Transport Reagent 2-30C 60 days

Storage/Transport Temperature

Specimen Specimen Transport and Storage Temperature Specimen Storage Time
Female and Male Urine (NEAT) 15-30C 4 hours
2-8C 4 days
Endocervical Swab in Xpert Swab Transport Reagent 2-30C 60 days
Vaginal Swab in Xpert Swab Transport Reagent 2-30C 60 days

Methodology

Automated real-time PCR

Start Date

6/13/2018

Last Review Date

6/19/2025

Performed

Daily

Reference Interval

Expected Result: Not Detected

Lab Section

Microbiology

Collection Instructions

  1. For collection of endocervical swab specimens and patient-collected vaginal swab specimens, use only the GeneXpert Vaginal/Endocervical Collection Kit.
  2. For collection of urine specimens, use neat (unpreserved) urine with first-catch urine only.
  3. Transport materials must be within date.
  4. All specimens must be labelled as per the current laboratory SOP on specimen labeling.

 
 

Remarks

  • This assay has only been validated with the following specimen types, collected with Xpert Specimen Collection Kits:
    • Endocervical swabs
    • Patient-collected vaginal swabs
    • Female and male first-catch urine
  • A negative test result does not exclude the possibility of infection because test results may be affected by improper specimen collection, technical error, sample mix-up, or because the number of organisms in the sample is below the limit of detection of the test.
  • Careful compliance with the package insert instructions for both test and collection materials is necessary to avoid erroneous results.
  • Because the detection of Trichomonas vaginalis is dependent on the organism’s DNA being present in the sample, reliable results are dependent on proper sample collection, handling and storage.
  • Trichomonas tenax was found to cross-react with Xpert TV Assay at levels above 1.0 x 102 cells/mL. T. tenax is a commensal of the oral cavity. See Xpert TV Analytical Specificity for more details.
  • With endocervical and patient-collected vaginal specimens, assay interference may be observed in the presence of blood (>60% v/v).
  • As with many diagnostic tests, results from this assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician.
  • The patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated.
  • This assay has not been validated for use with vaginal swab specimens collected by patients at home. The patient collected vaginal swab specimen application is limited to healthcare facilities where support/counseling is available to explain procedures and precautions.
     
  • This assay provides qualitative results and does not provide the quantitative value of organism detected in the specimen. No correlation can be drawn between the magnitude of the Ct value and the number of cells in an infected sample.
  • This test should not be used for the evaluation of suspected sexual abuse or for other medico-legal indications.
  • The predictive value of the assay depends on the prevalence of the disease in any particular population.
  • Mutations or nucleotide polymorphisms in primer or probe binding regions may affect detection of new or unknown Trichomonas vaginalis variants resulting in a false negative result.
  • Xpert TV Assay performance has not been evaluated in pregnant women, or in patients with a history of hysterectomy.
  • This assay has not been evaluated in patients less than 18 or more than 78 years of age.

CPT Codes

87661