Test Overview
Test Methodology

Transcription mediated amplification (TMA).

Test Usage

Detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium in male or female urine specimens.

Reference Range *

Negative

Test Limitations

Adequate specimen collection is important. Test should be performed on a first catch random urine specimen. Some feminine sprays, powders, spermicidal agents, and lubricants may interfere with the assay and should not be used prior to specimen collection. A negative result does not exclude the possibility of infection. Predictive value of test will vary depending on disease prevalence. Nucleic acids may persist for up to 4 weeks following appropriate antimicrobial therapy.

Test Details
Days Set Up
Tuesday-Friday and Sunday
Analytic Time

Tuesday-Friday and Sunday TAT 1 day
Specimens received on Friday or Sunday afternoon TAT 2 days

Soft Order Code
CGTMU
MiChart Code
STI Panel + Mycoplasma genitalium, Urine
Synonyms
  • MGENU
  • Chlamydia trachomatis RNA, Urine
  • Neisseria gonorrhoeae RNA, Urine
  • Trichomonas vaginalis RNA, Urine
  • TVAGU
  • CHLU
  • GCU
  • Mycoplasma genitalium RNA, Urine
Laboratory
Microbiology
Section
Microbiology
Specimen Requirements
Collection

Use the APTIMA Urine Specimen Collection Kit. 1. The patient should not have urinated for at least 1 hour prior to sample collection. Female patients should not cleanse the labial area prior to collection. 2. Instruct patient to provide 20 to 30 mL of the initial urine stream (NOT midstream) into a urine cup free of any preservatives. Collection of larger volumes of urine may result in rRNA target dilution that may reduce test sensitivity. 3. Remove the cap and transfer 2 mL of urine into the Urine Transport Tube using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black lines on the urine transport tube label. 4. Re-cap the urine specimen transport tube tightly and label with two identifiers. Store and transport at room temperature or refrigerated. See http://www.pathology.med.umich.edu/handbook/Tables/Aptima_Urine.pdf for collection procedure guide.

Rejection Criteria
All specimens must be received in Aptima urine transport tube. Preserved urine in grey-top tube is unacceptable.
Contraindications
This assay should not be used for the evaluation of suspected sexual abuse or other medico-legal investigations where chain of custody is required. MLabs does not offer chain of custody testing.
Aptima Urine Collection kit
Normal Volume
2 mL urine
Minimum Volume
2 mL urine
Storage Temperature
Urine specimens collected in the primary collection container must be transferred to Aptima urine transport tube within 24 hours of collection. Aptima urine transport specimens can be stored at 2ºC to 30ºC for up to 30 days.
Additional Information

Test includes Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium.

Billing
CPT Code
87491, 87591, 87661, 87563
Fee Code
32301, 32302, LA008, LA022
NY State Approved
No