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Test Code GC DNA PCR GC DNA PCR

Important Note

This test is not validated for patients under 14 years of age. 

Department

Molecular

Specimen Type

Endocervical, Vaginal, anorectal, oropharyngeal, urine and cervical specimens in PreservCyt® Solution.

Method

Roche Cobas 6800 System Real-time PCR

Container

Cobas collection kit or urine cup

Special Requirements

Do not use this test for eye sources.

For eyes, refer to: Chlamydia trachomatis, Miscellaneous Sites, Nucleic Acid Amplification, Varies - Orlando Health

Minimum Volume

5 mLs for urine

Collection Instructions

For patients less than 14 years of age, refer to CHLAMYDIA/GC DNA PCR - Orlando Health

 

Endocervical: Collect specimen with FLOCKED Swab using cobas® PCR Dual Swab Sample Kit.  Vaginal, Oropharyngeal or Anorectal: Collect specimen with WOVEN Swab using cobas® PCR Dual Swab Sample Kit. 

  1. Do not prewet swab in media before collection. 
  2. Remove the cap from the cobas® PCR Media Tube and lower the swab specimen into the tube until the visible scoreline on the swab shaft is aligned with the tube rim.  The bud of the swab should not be submerged into liquid prior to breaking the shaft.
  3. Carefully leverage the swab against the rim to break the swab shaft at the scoreline.
  4. Tightly re-cap the cobas® PCR Media Tube

Urine: Collect urine in sterile cup.  If the cobas® PCR Urine Sample Kit is available, then immediately transfer specimen into the cobas® PCR media Media Tube using the provided disposable pipette.  A minimum of 5 mL of urine is required to fill the cobas® PCR urine Media Tube.

Cervical Specimens in PreservCyt® Solution: Follow the manufacturer's instructions for collecting cervical specimens into PreservCyt® Solution.

Ship Temperature

Swabs: Room Temperature (25-30°C) or Refrigerated temperature (2-4°C)

Urine: Room Temperature (25-30°C) or Refrigerated temperature (2-4°C)

Stability Room Temp

Swabs in cobas® PCR Media Tube: 12 months

Urine in sterile cup: 24 hours

Urine in cobas® PCR Media Tube: 12 months

CPT Code

87591

Days Test Set Up

7 days a week

Group Components

GC DNA PCR

Clinical Information

Gonorrhea, caused by Neisseria gonorrhoeae, is among the most common bacterial sexually transmitted infections in the United States. 

This infection can lead to vaginal, urethral, or rectal discharge and may cause dysuria. It's important to note that infections can also be asymptomatic. In women, complications can include pelvic inflammatory disease. Prompt diagnosis and treatment of these infections are essential.

Test Use

The Roche Cobas 6800 System uses Real-Time Polymerase Chain Reaction (PCR) technology for the direct, qualitative detection of Neisseria gonorrhea DNA in vaginal, rectal, and oropharyngeal swabs, and urine.

Cautions

Interfering substances include, but are not limited to, the presence of blood and bilirubin. Detection of  N. gonorrhoeae is dependent on the number of organisms present. It may be affected by specimen collection methods, patient factors (age, history of STD, presence of symptoms), infection stage, and/or infecting N. gonorrhoeae  strains.  This test should not be used to determine therapeutic success, as nucleic acids may be present after antimicrobial therapy.

Interpretation

A positive result indicates the detection of N. gonorrhoeae DNA. However, the viability of organisms cannot be inferred. A negative result indicates N. gonorrhoeae DNA was not detected.