OVERVIEW

Purpose: The Aptima® Trichomonas vaginalis Assay is an in vitro 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 may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician-collected vaginal swabs, female urine specimens and specimens collected in PreservCyt Solution.

SPECIMEN COLLECTION

Specimen Requirements: One swab, 2 mL of a 20 mL to 30 mL urine collection, or entire liquid cytology vial.

Specimen Source: Endocervical and vaginal swab specimens, female urine specimens and PreservCyt liquid Pap specimens.

Minimum Volume: One swab, 2 mL of a 20 mL to 30 mL urine collection, or entire liquid cytology vial.

Collection Method: Refer to the appropriate specimen collection kit package insert for specific collection instructions.

TEST DETAILS

Methodology: The Aptima Trichomonas vaginalis Assay is a nucleic acid test that utilizes target capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA) technologies. When the Aptima Trichomonas vaginalis Assay is performed in the laboratory, the target rRNA is isolated from the specimens by the use of a specific capture oligomer and magnetic microparticles, the Hologic TMA reaction amplifies a specific region of the small ribosomal subunit from T. vaginalis via DNA and RNA intermediates and generates RNA amplicon molecules. A single-stranded chemiluminescent DNA probe, complementary to a region of the target amplicon, combines with amplicon to form stable RNA:DNA hybrids. The selection reagent differentiates hybridized from unhybridized probe, eliminating the generation of signal from unhybridized probe. During the detection step, light emitted from the labeled RNA:DNA hybrids is measured as photon signals in a luminometer and are reported as relative light units (RLU). Assay test results are automatically interpreted by the Panther System Aptima Trichomonas Assay software. A test result may be negative, positive or invalid as determined by total RLU in the detection step.

Compliance Category: FDA approved test.

Reference Interval: No Trichomonas detected.

Limitations:

• The Aptima Trichomonas vaginalis Assay provides qualitative results. Therefore, a correlation cannot be drawn between the magnitude of a positive assay signal and the number of organisms in a specimen
• TV-positive mucoid samples may exhibit decreased RLU values. To ensure proper endocervical sampling, excess mucus should be removed
• Urine, 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
• This assay has been tested using only the specimen types indicated. Performance with other specimen types has not been evaluated
• Reliable results are dependent on adequate specimen collection. 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
• Therapeutic failure or success cannot be determined with the Aptima Trichomonas vaginalis Assay since nucleic acid may persist following appropriate antimicrobial therapy
• Results from the Aptima Trichomonas vaginalis Assay should be interpreted in conjunction with other clinical data available to the clinician
• If a specimen has a small number of T. vaginalis organisms, uneven distribution of the trichomonads may occur, which may affect the ability to detect T. vaginalis rRNA in the collected material. If negative results from the specimen do not fit with the clinical impression, a new specimen may be necessary

Sample Stability: 7 days at 37°C and 50°C, 14 days at room temperature, as well as refrigerated and frozen temperatures.

Turnaround Time: 98% < 72 hours, 50% < 24 hours

Directorship: Cheryl Hanau, MD; Garth Ehrlich, PhD, FAAAS, FAAM; Donald Hall Jr., PhD; Yinghua Qiu, PhD, DABCC

CPT Code: 87661

Review Date: 08/28/2023

SPECIMEN PROCESSING

Specimen Transport and Storage:

• Swab specimens
  • After collection, transport and store the swab in the swab specimen transport tube at 2°C to 30°C until tested
  • Assay specimens within 60 days of collection. If longer storage is needed, freeze the specimen transport tube at ≤ –20°C for up to 24 months
• Urine specimens
  • Urine specimens that are still in the primary collection container must be transported to the lab at 2°C to 30°C. Transfer the urine specimen into the Aptima urine specimen transport tube within 24 hours of collection
  • Store processed urine specimens at 2°C to 30°C and assay within 30 days after transfer. If longer storage is needed, store the processed urine specimen at ≤ –20°C for up to 24 months after transfer
• Specimens collected in PreservCyt Solution
  • Transport and store the PreservCyt Solution specimen at 2°C to 30°C for up to 30 days
  • Specimens collected in PreservCyt Solution must be transferred into an Aptima specimen transfer tube according to the instructions in the Aptima Specimen Transfer kit package insert
  • After transferring to an Aptima specimen transfer tube, specimens may be stored an additional 14 days at 15°C to 30°C or 30 days at 2°C to 8°C
  • If longer storage is needed, the PreservCyt Solution specimen or the PreservCyt Solution liquid Pap specimen diluted into the specimen transfer tube may be stored at ≤ –20°C for up to 24 months after transfer

Rejection Criteria:

• Inappropriate specimen condition:
  • Incorrect patient identification
  • Unlabeled specimen
• Inappropriate specimen transport conditions:
  • Specimen leaked in transit
  • Specimen in expired transport or incorrect transport device
• ThinPrep liquid cytology specimens containing less than 1 mL
• Specimen stability limits exceeded

The information on these pages is provided for general information only and should not be used for diagnosis or treatment, or as a substitute for consultation with a physician or health care professional. If you have specific questions or concerns about your health, you should consult your health care professional.

 
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