GC/Chlamydia by PCR

Test Code
LAB6483


Alias/See Also
Gonorrhea and Chlamyida by PCR Probe
GC and Chlamydia by PCR Probe


Preferred Specimen
First catch Urine (dirty urine) in sterile container is optimal, can also collect in Xpert urine collection tube (yellow top).
Endocervical, Pharyngeal, or Rectal swab in Xpert transport tube (pink top).
 


Minimum Volume
Urine - 10 ml


Instructions
• Endocervical, Pharyngeal and Rectal swabs - follow instructions for the Xpert collection system. Rectal swabs that are highly soiled with fecal material should not be used.
• Urine - without cleaning or wiping the labia or urethral opening, have patient collect the first 20 - 50 ml of their urine stream. 


Transport Container
Urine - Sterile urine container or Xpert urine transport container
Endocervical, Pharyngeal or Rectal - Xpert swab transfer container


Transport Temperature
Room temperature


Specimen Stability
Endocervical, Pahryngeal or Rectal - 2 - 30o, stable for 60 days if in Xpert system transport media
Urine - Female: 24 hrs at room temperature  or  8 days at 4o       Male: 3 days at room temperature  or  8 days at 4o


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Sources other than urine, endocervical, pharyngeal or rectal; collection devices other than sterile container (urine) or Xpert collection kit (endocervical, pharyngeal or rectal)
Specimens exceeding stability limits.


Methodology
Cepheid Xpert CT/NG molecular assay for DNA by PCR

Setup Schedule
Every day 7am to 9pm


Limitations
The test has not been validated in patients less than 14 years of age, in pregnant women or in patients with a history of hysterectomy.

Endocervical - interference may be caused by:
  •  blood at a concentration greater than 1% v/v
  • Mucin at a concentration greater than 0.8% w/v
Urine - interference may be caused by:
  • Blood at a concentration greater than 0.3% v/v
  • Mucin at a concentration greater than 0.2%w/v
  • Bilirubin at a concentration greater than 0.2 mg/ml
  • Vagisil feminine powder at a concentration greater than 0.2% w/v


Reference Range
Negative




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.