Sexually-Transmitted Infections (STIs) Male Urethritis Panel

Test Code

36964

CPT Codes
87491, 87591, 87661, 87563

Includes

Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital
Trichomonas vaginalis RNA, Qualitative, TMA, Males
Mycoplasma genitalium, rRNA, TMA

Preferred Specimen

2 mL urine collected in an Aptima® transport tube or
Urethral swab collected in an Aptima® transport tube

Patient Preparation
Male urine: Patient should not have urinated within one hour prior to collection.

Instructions

Male urine: Direct patient to provide 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 tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine tube must fall within the clear pane on the tube label.

Male urethral swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit for Endocervical and Urethral Swab Specimens package insert.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 14 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 or urine submitted in Non-Aptima® transport tube • Urine samples where the fluid level is not between the black fill lines • Raw urine • Female urine

Methodology
Transcription-Mediated Amplification (TMA)

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.

Setup Schedule

Sets up 6 days a week.

Report Available

Reports in 3 to 5 days.

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. The symptoms are a burning sensation while urinating, itching or burning near the opening of the penis, presence of blood in the semen or urine and discharge from the penis. A panel will help the clinician identify the cause of these symptoms.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.