This is a qualitative Transcription-Mediated Amplification Test intended to aid in the diagnosis of Trichomonas vaginalis urogenital disease.

This assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications.

This assay has not been evaluated for patients under the age of 14.

This test requires prior authorization (PA) and should be placed as a future order in the outpatient setting.  If unable to obtain PA, please have patient sign a financial waiver.

TRICHOMONAS VAGINALIS NAT, AMPLIFIED (LAB921)

Patients should avoid urinating for at least one hour prior to sample collection.

Swab

• Swab placed in an Aptima Specimen Transport Tube at 2-30°C.

• Transfer 2.0mL of urine from the primary collection container to the Aptima Urine Specimen Collection Kit within 24hrs and transport at 2-30°C.  Liquid level must be between fill lines on tube.

• Urine collected at the AWH campus may be transported to the laboratory in the primary collection container.

• Transport specimen in an Aptima Specimen Transfer Tube at 2-30°C.  

• Swabs not in an Aptima Specimen Collection Kit.
• Swab specimen transport tube without a swab, two swabs, a cleaning (white) swab or a swab not supplied by Hologic.

• Urine outside of an Aptima Urine Specimen Transport Container >24hrs
• Urine outside of the indicated fill volume.

• Specimens other than ThinPrep or SurePath liquid based cytology.

Swab in Aptima Swab Transport Tube

• Ambient or refrigerated 2 months
• Frozen 1 year

Urine in Aptima Urine Specimen Transport Tube

• Ambient or refrigerated 1 month
• Frozen 1 year

Liquid Cytology Specimen in Aptima Transport Tube

• Ambient 14 days
• Refrigerated 1 month
• Frozen 1 year

• Specimens intended for TV testing must be transferred to an Aptima Specimen Transfer tube within 30 days of collection when stored at 2ºC to 30ºC.
• Specimens must be transferred before cytology processing if using a processor other than the ThinPrep 2000/3000 system.
• Specimens transferred to an Aptima Specimen Transfer tube post analysis on the ThinPrep 2000/3000 System must adhere to the cytology processing procedure in the Aptima Specimen Transfer Kit package insert which involves bleaching and removing filters in between specimens.

Negative / Positive

This test is performed on Hologic's Panther system using Aptima Trichomonas vaginalis assay which replicates a specific region of the small ribosomal subunit from T. vaginalis.

A negative result does not preclude the presence of T. vaginalis infection because results are dependent upon adequate specimen collection, absence of inhibitors and sufficient rRNA to be detected.  A positive result obtained from a patient after therapeutic treatment cannot be interpretated as indicating the presence of viable T. vaginalis.

Performance has not been evaluated in women less than 14 years of age.

>30 mL of urine collected may decrease the sensitivity of the assay.

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