26610 Trichomonas vaginalis, Nucleic Acid Amplification, Varies

​Trichomonas RNA, T. Vag, Trich​​

Detecting Trichomonas vaginalis in urine, cervical/endocervical or vaginal specimen types .

This test should only be used for urine (male and female) and female urogenital specimens on prepubescent children (<14 years). Primary test for patients >14 years of age is the in-house test code TRICNAM. For post-prostatic massage fluid and male urethral swab specimens from prepubescent children (<14 years) refer to test code MTRNASO (Trichomonas vaginalis, Nucleic Acid Amplification, Varies)

 ​Submit only 1 of the preferred specimens types:

Endocervix/Cervix Collection Instructions:

1. Specimens must be collected using the Aptima Unisex Swab Collection Kit.
2. Use cleaning swab (white shaft) to remove excess mucus from endocervix/cervix.
Discard the cleaning swab.
3. Insert second swab (blue shaft) 1 to 1.5 cm into endocervical canal, and rotate swab gently for 30 seconds. Avoid touching vaginal wall when removing swab.
4. Place second swab (blue shaft) into Aptima transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.
5. Cap tube securely and label tube with patient's entire name and collection date and time.
6. Maintain swab container at 2 to 30 degrees C (refrigerate temperature is preferred), transport within 60 days of collection.

Vaginal Collection Instructions:
1. Specimens must be collected using the Aptima Multitest Swab Collection Kit.
2. Insert swab (pink shaft) about 5 cm past introitus and rotate gently for 30 seconds.
3. Place swab into Aptima transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.
4. Cap tube securely and label tube with patient's entire name and collection date and time.
5. Maintain swab container at 2 to 30 degrees C (refrigerate temperature is preferred), transport within 60 days of collection.

ThinPrep Specimen (Endocervix.Cervix) Collection Instructions:
1. Collect ThinPrep sample as per normal collection process.
2. ThinPrep specimen must be aliquoted (as outlined below) before it is processed/tested for Pap smear.
3. Vortex ThinPrep/PreservCyt vial 3 to 10 seconds. Within 1 minute of vortexing: 
     a. Transfer 1 mL of specimen into the Aptima specimen transfer tube using a disposable transfer pipette or a pipette tip containing a filter (aerosol barrier or                hydrophobic plug).
     b. Process only 1 ThinPrep and transfer tube set at a time.
     c. Recap Aptima specimen transfer tube tightly and gently invert 3 times to mix.
4. Label Aptima transfer tube with appropriate label.
5. Use remainder of ThinPrep specimen for Pap testing.
6. Maintain specimen transport tube at 2 to 30 degrees C (refrigerate temperature is preferred), transport within 30 days of collection when stored at 2 to 14 degrees C or                 within ​14 days when stored at 15 to 30 degrees C.​

Urine Collection Instructions:
1. Patient should not have urinated for at least 1 hour prior to specimen collection.
2. Patient should collect first portion of random voided urine (first part of stream) into a sterile, plastic, preservative-free container.
3. Within 24 hours of collection, transfer 2 mL of urine into the Aptima urine specimen transport tube using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black fill lines on the Aptima urine transport tube.

Midstream urine specimen
Clean catch urine specimen
Over-filled or under-filled urine transport tubes
Specimen collected into a SurePath device
Transport tubes containing a cleaning swab or more than 1 swab

​The effects of tampon use, douching, and specimen collection variables have not been assessed for their impact on the detection of Trichomonas vaginalis.

To ensure proper endocervical sampling, excess mucus should first be removed.

 Vaginal swab and PreservCyt Solution liquid Pap specimen sampling is not designed to replace cervical exams and endocervical specimens for diagnosis of female urogenital infections. Patients may have cervicitis, urethritis, urinary tract infections, or vaginal infections due to other causes or concurrent infections with other agents.

This assay has only been approved by the US Food and Drug Administration for the specimen types indicated. Performance with other specimen types has not been evaluated by the manufacturer.

Reliable results are dependent on adequate specimen collection. Because the transport system used for this assay does not permit microscopic assessment of specimen adequacy, training clinicians in proper specimen collection techniques is necessary.

Therapeutic failure or success cannot be determined with the Aptima T vaginalis assay since nucleic acid may persist following appropriate antimicrobial therapy.

Results from the Aptima T vaginalis assay should be interpreted in conjunction with other clinical data and symptoms.

A negative result does not preclude a possible infection because results are dependent on adequate specimen collection. Test results may be affected by improper specimen collection, preanalytical errors, technical errors, or target levels below the assay limit of detection. Furthermore, a negative result does not preclude a possible infection because the presence of Trichomonas tenax or Pentatrichomonas hominis in a specimen may affect the ability to detect T vaginalis RNA.

Assay performance of the Aptima T vaginalis assay has not been evaluated in the presence of Dientamoeba fragilis.

The Aptima T vaginalis assay has not been validated for use with vaginal swab specimens collected by patients.

Performance of the vaginal swab specimen has not been evaluated in pregnant women or girls younger than 14 years.

​Trichomonas vaginalis is a protozoan parasite that commonly infects the genital tract of men and women. It is considered to be the most common nonviral sexually transmitted infection (STI), with an estimated 2.6 million cases documented in 2020 in the United States. Although up to 70% of infected individuals are asymptomatic, infections may be associated with vaginitis, urethritis, and cervicitis in women and urethritis and prostatitis in men. Patients that are infected with T vaginalis have an increased risk of acquiring other STIs, such as HIV, while infections in pregnant women are associated with premature labor, low birth-weight offspring, premature rupture of membranes, and post-hysterectomy/post-abortion infection.

Symptoms of T vaginalis overlap considerably with other STIs; therefore, laboratory diagnosis is required for definitive diagnosis. The most frequently used method for detection is microscopic examination of a wet-mount preparation of vaginal secretions. However, this method has only 35% to 80% sensitivity compared with culture. Culture also suffers from relatively low sensitivity (38%-82%) when compared to molecular methods. Culture is technically challenging and takes 5 to 7 days to complete. Molecular methods, such as the Aptima T vaginalis assay, offer high sensitivity and specificity for detection of trichomoniasis. The Aptima test utilizes target capture, transcription-mediated amplification, and hybridization protection assay technologies for detection of T vaginalis ribosomal RNA.

Negative

A positive result indicates the presence of nucleic acid from Trichomonas vaginalis and is strongly supportive of a diagnosis of trichomoniasis.

A negative result indicates the absence of nucleic acid from T vaginalis.

 A negative result does not exclude the possibility of infection. If clinical indications strongly suggest gonococcal or chlamydial infection, additional specimens should be collected for testing.

A result of indeterminate indicates that a new specimen should be collected.

 The predictive value of an assay depends on the prevalence of the disease in any specific population. In settings with a high prevalence of sexually transmitted infections, positive assay results have a high likelihood of being true-positive results. In settings with a low prevalence of sexually transmitted infections, or in any setting in which a patient's clinical signs and symptoms or risk factors are inconsistent with infection, positive results should be carefully assessed, and the patient retested by other methods if appropriate.