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HelpTest Code CHLAMYDIA/GC DNA PCR CHLAMYDIA/GC DNA PCR
Additional Codes
LAB8639
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
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
87491
Days Test Set Up
7 days a week
Group Components
Chlamydia trachomatis DNA PCR
GC DNA PCR
Collection Instructions
For patients less than 14 years of age, collect a minimum of 5 ml urine in a sterile container and send to the laboratory immediately. Patients younger than 14 will automatically be ordered by Epic as Chlamydia Trachomatis and Neisseria Gonorrheae (CT/GC) Nucleic Acid Amplification Testing. Specimen must be aliquoted into the Aptima Urine Specimen Transport tube and sent to Viracor for testing.
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.
- Do not prewet swab in media before collection.
- 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.
- Carefully leverage the swab against the rim to break the swab shaft at the scoreline.
- 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.
Clinical Information
Chlamydia, caused by Chlamydia trachomatis, and gonorrhea, caused by Neisseria gonorrhoeae, are among the most common bacterial sexually transmitted infections in the United States.
Both infections 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 Chlamydia trachomatis and 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 C. trachomatis and 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 C. trachomatis and 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 C. trachomatis and/or N. gonorrhoeae DNA. However, the viability of organisms cannot be inferred. A negative result indicates C. trachomatis and/or N. gonorrhoeae DNA was not detected.