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Test Code GPCRU Neisseria gonorrhoeae, PCR, Urine

Important Note

This test has not been validated for patients <14 year old. Please contact the laboratory or collect with an Aptima swab if testing is needed for this age range.

Additional Codes

Epic: LAB262

Specimen Required

Specimen Type: Urine

Collection Container/Type: COBAS media urine

Submission Container/Tube: COBAS media vial

Specimen Volume: 5.5 mL Urine (sample volume must be between the two indicator lines on the tube).

Collection Instructions: 

  1. 1) Prior to sampling, the patient should not have urinated for at least one hour.
  2. Direct patient to provide first-catch urine (approximately 10 to 50 mL of the initial urine stream) into a urine collection cup.
  3. Immediately transfer the urine into the COBAS® PCR Media tube using the provided disposable pipette.
    NOTE: If the urine specimen cannot be transferred immediately, it can be stored at 2°C to 30°C for up to 24 hours.
  4. The correct volume of urine has been added when the fluid level is between the two black lines on the tube label. Do not over or under fill.
  5. Tightly re-cap the cobas® PCR Media tube.
  6. Invert the tube 5 times to mix. The specimen is now ready for transport.

Specimen Stability

Room temperature: 1 month

Refrigerated: 1 month

Frozen: 1 month

Reference Range

Negative for Neisseria gonorrhoeae DNA

Rejection Due To

  • Urine fill level is above or below the two black lines on the cobas PCR media tube label window.
  • Bloody specimens are unacceptable for testing.

Report Available

2-3 days

Clinical Significance

Results depend on adequate specimen collection, absence of inhibitors, and sufficient DNA for detection.
This test should not be used to determine therapeutic success as nucleic acids may be present, and detected, after antimicrobial therapy.
A negative result does not necessarily rule out Chlamydia trachomatis and/or Neisseria gonorrhoeae infection. Specimens containing mucus, gels, lubricants, or creams may give invalid or false negative results.

Method Name

Real-time polymerase chain reaction (PCR) 

Limitations

CT/GC testing with this instrument is not available for patients <14 years old. However, molecular testing can be performed using a different platform. Please contact your laboratory for the alternative transport media required for these samples.

This test is not recommended for evaluation of suspected sexual abuse and for other medico-legal indication

Day(s) Performed

Monday, Wednesday, Friday