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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 Kit

 

Urine: 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 PCR

Not 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