Test Code LAB7166 Chlamydia trachomatis and Neisseria gonorrhea PCR
Performing Section
Microbiology
Purpose/Principle
The Xpert CT/NG Assay is performed on the Cepheid GeneXpert Instrument Systems. The Xpert CT/NG Assay is cleared by the FDA to test the following specimens from symptomatic and asymptomatic individuals: first-catch male urine, female urine, and vaginal or endocervical swab specimens. The assay has been validated off-label to test throat and rectal swabs as well as eye swabs.
Special Collection Notes
If using Chain of Custody, please make sure all appropriate steps are followed. If possible, notify lab of Chain of Custody.When collecting one urine specimen for multiple urine orders, make sure all orders have the same specimen source.
Collect specimen per standard operating procedure
Specimen Type
Endocervical, vaginal, throat, and rectal swabs: Xpert CT/NG Vaginal/Endocervical Specimen Collection KitUrine: Sterile Container (Default) Xpert Urine
Specimen Volume
Urine:
Optimal volume: 20 – 50 mL
Minimum volume: 7 mL
Processing Instructions
Transport specimen at ambient temperature.
Urine specimens in sterile container must be received within 24 hours if stored at ambient temperature or within 8 days if stored/shipped refrigerated.
Temperature
Ambient (Endocervical/Vaginal/Throat/Rectal Swabs )Refrigerated (Eye Swab)
Refrigerated if greater than 24hrs (Urine)
Test Components
CHLAMYDIA TRACHOMATIS PCR
NEISSERIA GONORRHEA PCR
Reference Range
CHLAMYDIA TRACHOMATIS PCRNot Detected
NEISSERIA GONORRHEA PCR
Not Detected
TAT
48 Hours
Sample Stability
Urine (sterile container)
Ambient: 24hrs
Refrigerated : 8 Days
Urine (Xpert)
Ambient: 3 Days
Refrigerated: 45 days
Endocervical/Vaginal/Throat/Rectal Swabs
Ambient: 60 days
Additional Notes
Unacceptable Specimens:
1. Urine specimens that contain less than 7 mL
2. Swab not received in transport media
Aliases
CTNG PCR
CT PCR
GC PCR
CPT
87491
87591