Trichomonas vaginalis, NAAT
Test Mnemonic
TRVAMP
CPT Codes
- 87661 - QTY (1)
LOINC ®
46154-1
Aliases
- T. vaginalis amplification
- Trich amplification
- Trichomonas amplification
- T. vaginalis
- Trich
- Trichomonas
- Trichomonas vaginalis
- Trich vag
- Trich vag.
Performing Laboratory
Cleveland Clinic Laboratories
FDA Category
Laboratory Developed Test
Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 2 mL | Urine, first-catch | APTIMA Urine specimen collection kit | Ambient | Ambient | The patient should not have urinated for at least 1 hour prior to specimen collection. The patient should collect first portion of random voided urine (first part of stream) into a sterile, plastic, preservative-free container. Transfer 2 mL of urine into the Aptima urine specimen transport tube using the disposable pipette provided within 24 hours of collection. Close the tube tightly. Work with one specimen at a time. The correct volume of urine has been added when the fluid level is between the black fill lines (window) on the urine transport tube. Do not overfill or underfill the APTIMA Urine transport tube. |
| One | Vaginal | Aptima Multitest Collection Kit | Ambient | Ambient | Vaginal Multitest (orange tube pink swab): A vaginal swab is the recommended specimen for female patients due to this being a specimen type ideal for sharing with other testing. Carefully insert the swab into the vagina about 2 inches past the introitus and gently rotate the swab for 10-30 seconds. Make sure the swab touches the vaginal walls so that moisture is absorbed by the swab. Place swab into Aptima transport tube. Snap off swab at the score line, and close the tube tightly. |
| 2 mL | Urine, first-catch | Sterile container | Ambient | Ambient | The patient should not have urinated for at least 1 hour prior to specimen collection. The patient should collect first portion of random voided urine (first part of stream) into a sterile, plastic, preservative-free container. |
Alternate Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| One | Endocervical | APTIMA Collection Unisex swab | Ambient | Ambient | Endocervical Unisex (white tube blue swab): Remove excess mucus from cervical os and surrounding mucosa using the white cleaning swab, then DISCARD. Insert blue swab into the endocervical canal and gently rotate clockwise for 10-30 seconds. Place swab into Aptima transport tube. Snap off swab at the score line, and close the tube tightly. |
| One | Cervical | Cytyc PreservCyt solution (Thin Prep) | Ambient | Ambient | PreservCyt Solution (ThinPrep) is an acceptable specimen when added onto a ThinPrep Pap Test and no dedicated vaginal or endocervical swab specimens are available. It is not a recommended due to lower test sensitivity for gonorrhea and chlamydia detection (often ordered on the same swab) compared to other specimen types. Due to this reason, it is not available as a selectable specimen source/type during order entry, only as a laboratory add-on. In order to place an order on this specimen type, you must place a call to lab client services. If consulted prior to specimen collection, lab client services should advise the provider to collect a separate dedicated Vaginal Multitest Swab for optimal test performance characteristics. If consulted after specimen collection, lab client services should assist the provider in placing an add on order with "Fluid, Cervix" as the specimen source, and have cytology perform the aliquot as below prior to cytology testing. Prior to cytology testing and within 30 days of collection, cytology will transfer a 1 mL aliquot into an APTIMA Specimen Transfer Tube. The specimen must have been stored at 2-30C. |
Stability
| Environmental Condition | Description |
|---|---|
| Ambient | 15⁰C to 30⁰C. Swab in Aptima transport media: 60 days; Urine in Aptima transport media: 30 days; Urine unprocessed: 24 hours; ThinPrep PreservCyt solution in Aptima transport media: 14 days; ThinPrep PreservCyt unprocessed: 30 days |
| Frozen | -20⁰C to -70⁰C. Swab in Aptima transport media: 24 months; Urine in Aptima transport media: 12 months; Urine unprocessed: unacceptable; ThinPrep PreservCyt solution in Aptima transport media: 12 months; ThinPrep PreservCyt unprocessed: unacceptable |
| Refrigerated | 2⁰C to 8⁰C. Swab in Aptima transport media: 60 days; Urine in Aptima transport media: 30 days; Urine unprocessed: 24 hours; ThinPrep PreservCyt solution in Aptima transport media: 30 days; ThinPrep PreservCyt unprocessed: 30 days |
Days Performed
Mon - Sun
Turnaround Time
1 - 4 days
Methodology
| Name | Description |
|---|---|
| Transcription-Mediated Amplification |
Reference Range
Special Info
Microbiology Preanalytic Guidance: http://portals.ccf.org/plmi/Laboratory-Medicine/Microbiology-Specimen-Collection-Transport-Information. Up to two tests can be run on a single Aptima Multitest Swab specimen (ie. GCCT+TRVAMP) - if specimen sources have been correctly selected, the shared tests will print on the same label. Do not place more than one label on a single collection tube. Common reasons for specimen rejection: 1. Inappropriate collection device for source selected. 2. Transport tubes containing a cleaning swab or more than 1 swab. 3. Overfilled or underfilled urine transport tubes. 4. Collection device expired prior to specimen collection. Related alternative orders: 1. TRICHO: in-house trichomonas vaginalis rapid antigen test (lower patient cost than NAAT, but with lower sensitivity; should not be used for asymptomatic screening).
Clinical Info
Trichomonas vaginalis is a protozoan parasite that is a common cause of vaginitis and the most common nonviral sexually transmitted infection worldwide. The majority of persons who have trichomoniasis (70%–85%) either have minimal or no genital symptoms, and untreated infections might last from months to years, and have been associated with reproductive morbidity. Symptomatic patients can present with vaginitis, vaginal discharge, cervicitis, urethritis, and/or other genitourinary symptoms. The CDC recommends diagnostic testing for T. vaginalis in patients seeking care for vaginal discharge, as well as considering asymptomatic screening in certain high risk groups. T. vaginalis can be diagnosed via wet mount, culture, rapid antigen testing, and nucleic acid amplification testing (NAAT), with the latter having the highest sensitivity. The Aptima Trichomonas vaginalis Assay is an in vitro FDA-cleared qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Panther System. The assay uses target capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA) technologies. The assay may be used to test the following specimens from symptomatic or asymptomatic individuals: clinician-collected endocervical swabs, clinician-collected and patient-collected vaginal swabs (in a clinical setting), female and male urine, and specimens collected in PreservCyt Solution.
Clinical Limitation
1. The performance of the assay has not been evaluated in patients <14 years of age. 2. Therapeutic failure or success cannot be determined with the assay since nucleic acid may persist following appropriate antimicrobial therapy. 3. 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, technical error, specimen mix-up, or target levels below the assay limit of detection. 4. The effects of tampon use, douching, and specimen collection variables have not been assessed for their impact on assay detection. 5. Competitive interference may preclude detection of T. vaginalis in low quantities if Trichomonas tenax or Pentatrichomonas hominis are present in high quantities (commensals of the oral cavity and large intestine respectively).
Clinical Reference
Workowski KA, Bachmann LH, Chan PA, Johnston CM, Muzny CA, Park I, Reno H, Zenilman JM, Bolan GA. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. doi: 10.15585/mmwr.rr7004a1. PMID: 34292926; PMCID: PMC8344968.