Trichomonas vaginalis

Brief Description

The Aptima Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the selection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Panther system. The Aptima Trichomonas vaginalis Assay involves the technologies of target capture Transcription-Mediated Amplification (TMA), and Hybridization Protection Assay (HPA). 

Before submitting specimens for testing, you must arrange to purchase reagent kits deliverable to GPHL or WPHL.

Laboratory Unit

  • Virology GPHL
  • Virology WPHL

Methodology

Nucleic acid amplification test (NAAT), combines the technologies of Target capture, Transcription-Mediated Amplification (TMA) and Hybridization Protection assay (HPA).

Specimen Collection

  • Vaginal Swab:
    • Use only the Hologic Aptima specimen collection swab to collect the specimen.
  • Endocervical Swab:
    • Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white shaft swab in the package with red printing). Discard this swab. Use only the Hologic Aptima specimen collection swab to collect the specimen. 
  • Male Urethral Swab:
    • The patient should not have urinated for at least 1 hour prior to sample collection. Use only the Hologic Aptima specimen collection swab to collect the specimen. 
  • Urine: 
    • Specimen must be assayed within 30 days of collection. The patient should not have urinated for at least one hour prior to specimen collection. Provide first catch urine (approximately 20 to 30 ml of the initial urine stream) into a urine collection cup.  

Storage/Transport

  • Swabs specimens: 
    • After collection, transport and store the swab in the swab specimen transport tube at ambient (2-30 °C) temperatures until tested. Must be received within 60 days of collection.  
  • Urine: 
    • Transport and store urine specimens at ambient (2-30 °C) temperatures after collection. Urine specimens can be frozen (-20 °C or colder) for up to 24 months after transfer. Specimens must be assayed with the Aptima Combo 2 assay within 30 days of collection.  
  • Download this pdf file. FRM-QA 4 Refrigeration Outfit Guide

Acceptable Specimen Type(s)

  • Aptima Unisex Swab Specimen Collection kit: clinician collected endocervical, vaginal, and urethral swabs
  • Aptima Urine Specimen Collection kit: urine

Test Request

Possible Results

  • Positive
  • Negative
  • Indeterminate
  • Unsatisfactory

Reference Range

Negative

Unacceptable Conditions

  • Missing written testing requisition form
  • Missing minimum of 2 patient identifiers
  • Unidentified specimen
  • No name on specimen
  • Improper storage/transport of specimen
  • No Swab in Collection Device (excluding urine) or 2 Swabs Present
  • Improper labeling
  • Low volume samples
  • Urine Collection Device Too Full (must fall between the two black indicator lines)
  • Specimen type collected in outfit other than those listed in acceptable specimen outfits and types
  • Unapproved source – any specimen type other than those listed above in acceptable specimen outfits and types
  • Receipt of Swabs > 60 Days after Collection Date
  • Receipt of Urines > 30 Days after Collection Date
  • Medical/Legal test requested (This assay is not intended for medical/legal cases.)
  • Specimen damaged, broken, or leaking upon arrival
  • Turbid or contaminated specimens
  • Swab other than the specimen collection swab provided in the acceptable specimen outfit kits
  • Patient name/identifier on specimen does not match requisition
  • Expired collection outfit
  • Incorrect or missing collection date on requisition
  • Specimens collected from patients less than 14 years of age
  • Unapproved submitter – any specimen received from a submitter than has not provided a reagent kit

Interfering Substances

Excess endocervical mucus

Result Reported

  • 3-5 business days GPHL
  • 1-3 business days WPHL

Fees

Download this pdf file. Fee schedule

LOINC/Order Codes

46154-1 (Order code: 100100 Decatur, W100100 Waycross)