Sexually-Transmitted Infections (STIs) Male Urethritis Panel, Expanded

Sexually-Transmitted Infections (STIs) Male Urethritis Panel, Expanded

Test Code

38288
87494, 87661, 87798 (x2), 87563
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
38288
87494, 87661, 87798 (x2), 87563
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
In-home collection may be available in your area for purchase through Quest Mobile.

Clinical Significance

Sexually-Transmitted Infections (STIs) Male Urethritis Panel, Expanded - 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.

Test 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.

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

Alternative Name(s)

Urethritis,STD,STI,Urethral discharge,Dysuria,Penile itching,Penile tingling

LOINC® Codes, Performing Laboratory

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)
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.

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

Alternative Name(s)

Urethritis,STD,STI,Urethral discharge,Dysuria,Penile itching,Penile tingling

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

Setup Schedule

1 urethral swab collected in an Aptima® Transport Tube or
2 mL male urine collected in an Aptima® Transport Tube
2 mL urine
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.
Aptima® Transport Tube
Room temperature
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 30 days
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
In-home collection may be available in your area for purchase through Quest Mobile.
Test Details

Clinical Significance

Test Resources

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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