Sexually-Transmitted Infections (STIs) Male Urethritis Panel, Expanded
Test code
CPT code(s)*
Test resources
Details
Includes
Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital
Trichomonas vaginalis RNA, Qualitative, TMA, Males
Mycoplasma genitalium, rRNA, TMA
SureSwab®, Ureaplasma species, Real-Time PCR
Methodology
Transcription-Mediated Amplification (TMA) • Real-Time Polymerase Chain Reaction (PCR)
Assay category
Trichomonas vaginalis RNA, Qualitative, TMA, Males: 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.
SureSwab®, Ureaplasma species, Real-Time PCR: This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Alternative name(s)
Urethritis,STD,STI,Urethral discharge,Dysuria,Penile itching,Penile tingling
Specimen requirements | |
|---|---|
| Patient preparation | None Specified |
| Preferred specimen(s) | 1 urethral swab collected in an Aptima® Transport Tube or 2 mL male urine collected in an Aptima® Transport Tube |
| Minimum volume | 2 mL urine |
| Collection instructions | Urethral swabs: Follow instructions in the Aptima Unisex Swab Specimen Collection Kit (white label). 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 on the tube label. |
| Transport container | Aptima® Transport Tube |
| Transport temperature | Room temperature |
| Specimen stability | Room temperature: 14 days Refrigerated: 14 days Frozen: 30 days |
| Reject criteria | Transport tube with 2 swabs • Transport tubes with non-Aptima swabs • Swab transport tubes with no swab • Swab submitted in non-Aptima transport containers • Urine samples where the fluid level is not between the black fill lines • Urine submitted in non-Aptima transport container • Female urine • Patients less than 15 years of age |
Reference Range(s)
| C. trachomatis, RNA, TMA, Urogenital | Not Detected |
| N. gonorrhoeae RNA, TMA, Urogenital | Not Detected |
| T. vaginalis RNA, Qualitative, TMA, Males | Not Detected |
| Mycoplasma genitalium, rRNA, TMA | Not Detected |
| SureSwab®, Ureaplasma species, Real-Time PCR | |
| U. parvum DNA | Not Detected |
| U. urealyticum DNA | Not Detected |
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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