Test Catalog

Test Id : TVRNA

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Trichomonas vaginalis, Nucleic Acid Amplification, Varies

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Method Name
A short description of the method used to perform the test

Transcription-Mediated Amplification

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Trichomonas vaginalis Amplified RNA

Aliases
Lists additional common names for a test, as an aid in searching

Trichomonas RNA

T. Vag

Trich

Specimen Type
Describes the specimen type validated for testing

Varies

Necessary Information

Specimen source is required.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
SRC29 SOURCE:

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Submit only 1 of the following specimens:

 

Specimen Type: Endocervix/Cervix

Supplies: Aptima Unisex Swab Collection Kit (T583)

Container/Tube: Aptima Unisex Swab

Specimen Volume: Swab

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.

 

Specimen Type: Vaginal

Supplies: Aptima Multitest Swab Collection Kit (T584)

Container/Tube: Aptima Multitest Swab

Specimen Volume: Swab

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.

 

Specimen Type: ThinPrep Specimen (Endocervix/Cervix)

Supplies: Aptima Thin Prep Transport Tube (T652)

Container/Tube: Thin Prep Transport Tube

Specimen Volume: 1 mL

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.

3. Label Aptima transfer tube with appropriate label.

4. Use remainder of ThinPrep specimen for Pap testing.

5. 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.

 

Specimen Type: Urine

Supplies: Aptima Urine Transport Tube (T582)

Container/Tube: Aptima urine specimen transport tube

Specimen Volume: 15 to 20 mL

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.

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

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 		Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) APTIMA VIAL
Frozen 180 days APTIMA VIAL
Ambient APTIMA VIAL

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Interpretation
Provides information to assist in interpretation of the test results

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.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187

2. Andrea SB, Chapin KC. Comparison of Aptima Trichomonas vaginalis transcription-mediated amplification assay and BD affirm VPIII for detection of T. vaginalis in symptomatic women: performance parameters and epidemiological implications. J Clin Microbiol. 2011;49(3):866-9. doi:10.1128/JCM.02367-10

3. Chernesky M, Jang D, Gilchrist J, et al. Ease and comfort of cervical and vaginal sampling for Chlamydia trachomatis and Trichomonas vaginalis with a new Aptima specimen collection and transportation kit. J Clin Microbiol. 2014;52(2):668-70. doi:10.1128/JCM.02923-13

Method Description
Describes how the test is performed and provides a method-specific reference

The APTIMA Trichomonas vaginalis assay combines the technologies of target capture, transcription-mediated amplification, and hybridization protection assay for detection of 16S ribosomal RNA from T vaginalis.(Package insert: APTIMA Trichomonas vaginalis Assay. Hologic, Inc; Rev. 003, 06/2023)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87661

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
TVRNA Trichomonas vaginalis Amplified RNA 46154-1
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
34810 Trichomonas vaginalis amplified RNA 46154-1
SRC29 SOURCE: 31208-2

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports