Transcription-Mediated Amplification (TMA)
The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
T. vaginalis,Urine Trichomonas,Trichomonas Urine
Specimen requirements | |
|---|---|
| Patient preparation | Male urine: Patient should not have urinated within one hour prior to collection |
| Preferred specimen(s) | 1 male urethral swab in Aptima® Transport Tube or 2 mL male urine in Aptima® Transport Tube |
| Alternative specimen(s) | Urine (no preservatives): 2 mL of urine, specimen must be transferred into the Aptima® Urine Transport Medium within 24 hours of collection and before being assayed |
| Minimum volume | 1 male urethral swab in Aptima® Transport • 2 mL random urine (male) in Aptima® Transport |
| Collection instructions | For a complete list of limitations we recommend you review the manufacturers package insert: https://www.hologic.com/package-inserts/diagnostic-products/aptima-trichomonas-vaginalis-assay Urethral swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit for Endocervical and Urethral Swab Specimens package insert. Male urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima® Specimen Transport within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label. |
| Transport container | APTIMA® Unisex Swab Specimen Collection kit |
| Transport temperature | Room temperature |
| Specimen stability | Urine Room temperature: 30 days Refrigerated: 30 days Frozen: 6 months Swab Room temperature: 60 days Refrigerated: 60 days Frozen: 6 months |
| Reject criteria | Transport tubes with 2 swabs • Transport tubes with non-Aptima® swabs • Swab transport tubes with no swab • Specimens in broken containers • Swab submitted in viral transport media • Urine samples where the fluid level is not between the fill lines • Female specimens |
Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.
*The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.
This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.
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