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Sexually-Transmitted Infections (STIs) Male Urethritis Panel, Expanded
Test CodeLAB444712
Quest Code
38288
CPT Codes
87491, 87591, 87661, 87798 (x2), 87563
Includes
Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital
Trichomonas vaginalis RNA, Qualitative, TMA, Males
Mycoplasma genitalium, rRNA, TMA
SureSwab, Ureaplasma species, Real-Time PCR
Trichomonas vaginalis RNA, Qualitative, TMA, Males
Mycoplasma genitalium, rRNA, TMA
SureSwab, Ureaplasma species, Real-Time PCR
Preferred Specimen
1 urethral swab collected in an Aptima® Transport Tube, or
2 mL urine collected in an Aptima® Transport Tube
2 mL urine collected in an Aptima® Transport Tube
Minimum Volume
2 mL urine
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.
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 Temperature
Room temperature
Specimen Stability
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 30 days
Refrigerated: 14 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Transport tubes 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 containers • Female urine • Patients less than 15 years of age
Methodology
Transcription-Mediated Amplification (TMA) • Real-Time Polymerase Chain Reaction (PCR)
FDA Status
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.
Setup Schedule
Set up: Mon-Sat; Report available: 3-5 days
Reference Range
| 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 |
Clinical Significance
Urethritis is an inflammation of the urethra and is often due to sexually transmitted infections. It may be caused by Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and/or Mycoplasma genitalium and Ureaplasma spp. A panel will help the clinician?s ability to precisely identify the cause of these symptoms.
Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153
