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Test Name:
Neisseria gonorrhoeae, by Nucleic Acid Amplification, Urine


  • SBMF No:
    21152
  • Performance Lab Name:
    Microbiology
  • Test Mnemonic:
    GC U
  • ABN:
    Not required
  • CPT Code:
    87591
  • LOINC Code:
    60256-5
  • Also Known As:
    APTIMA® GC Assay
    GC NAAT
  • Also See:
    21150 – Chlamydia trachomatis and Neisseria gonorrhoeae, by Nucleic Acid Amplification, Urine
  • Spec Type:
    "First voided" urine (first part of urine stream) – first morning specimen preferred
  • Spec Container:
    Plastic, preservative-free, sterile container with tightly fitting lid
    APTIMA® "Urine Transport Tube"
  • Pref Vol:
    30.0 mL
  • Min Vol:
    20.0 mL
  • Fasting:
    No
  • Patient Prep:
    Instruct patient not to urinate for at least 1 hour prior to time of specimen collection
    First morning specimen is preferred
  • Spec Collect:

    Instruct patient to collect "first-voided" urine, consisting of 20.0-30.0 mL of first part of urine stream, into plastic, preservative-free, sterile urine container
        Note: collection of larger urine volumes may result in specimen dilution that may reduce test sensitivity
    Female patients should not cleanse labial area prior to providing urine specimen
  • Spec Process:

    After collection, use disposable pipette from APTIMA® "Urine Specimen Collection Kit" to transfer 2.0 mL of urine into yellow-labeled APTIMA® "Urine Specimen Transport Tube"
        Note: Urine must be transferred to specimen transport tube within 24 hours of collection
    Correct volume of urine has been added to transport tube when fluid rises to a level within "fill area" window indicated on transport tube
    Tightly recap processed specimen in transport tube taking care not to disrupt foil portion of cap
    Label tube with patient identification and collection date
  • Spec Store Transport:
    Room temperature (unprocessed up to 24 hours) or refrigerated
  • Spec Stability:
    Unprocessed specimen (not transferred to APTIMA® "Urine Specimen Transport Tube"):
    – 24 hours room temperature (20-30°C)
    Processed specimen (transferred to APTIMA® "Urine Specimen Transport Tube" within 24 hours of collection):
    – 1 month room temperature (20-30°C)
    – 1 month refrigerated (2-8°C)
    – 3 months frozen (-20°C) – Do not use frost-free units that undergo repeated freeze/thaw cycles
  • Spec Reject:
    Processed specimen with fluid level above or below "fill area" window indicated on transport tube
    Unprocessed specimen not transferred to APTIMA® "Urine Specimen Transport Tube" within 24 hours of collection
  • Methodology:
    Target Capture
  • Use:
    Detect Neisseria gonorrohoeae
  • Clinical Significance:
    Sexually Transmitted Disease (STD)
    Reportable Disease
  • Reference Range:
    Negative for Neisseria gonorrhoeae
  • Critical High Value:
    Positive for Neisseria gonorrhoeae
  • Additional Test Info:
    Positives are confirmed by repeat testing.
       Note: Culture is recommended for Chlamydia trachomatis detection in cases of suspected sexual abuse or suspected failure of therapy.
  • Day Run:
    Mon, Wed, Fri
  • Time Run:
    7:00 am
  • Time Reported:
    5:00 pm
  • Test Type:
    INFECTIOUS ORGANISM