Chlamydia trachomatis/Neisseria gonorrhoeae RT-PCR Assay

Message

For patients under the age of 14 - Order #NAT CT/GC-QNI

Test Code

CT/GC RT-PCR Assay

CPT Codes
87491, 87591

Includes

Assay Detects: Chlamydia trachomatis and Neisseria gonorrhoeae

Preferred Specimen

Endocervical swab collected in Xpert CT/NG Vaginal Endocervical Specimen Collection Kit (Pink Transport Reagent Tube)
Urine specimen collected and placed in Xpert CT/NG Urine Specimen Collection Kit (Yellow Transport Reagent Tube). Refer to Urine Instructions below for collection details.
Urine may be tested for either male or females. Specimens should be "dirty" (not necessary to have a clean catch specimen).
Volume of urine collected should be between 20 - 50 mL

Other Acceptable Specimens

None

Instructions

Female Vaginal Endocervical Specimens: Specimen must be collected using the swab from the Xpert CT/NG Vaginal Endocervical Collection Kit and transported in the pink transport reagent tube.
Urine Specimens: Patient must not have urinated for at least one hour prior to collection. Collect first 20-50mL of urine into a sterile cup. Mix the urine well before transferring approximately 7mL of sample to the Xpert CT/NG Urine Transport Reagent Tube using the CT/NG Urine Specimen Collection Kit supplied. Urine must be filled to the level of the black dashed line on the label, otherwise the sample will be rejected.

Transport Container

Xpert CT/NG Vaginal Endocervical Collection Kit (Pink Transport Reagent Tube)
Xpert CT/NG Urine Specimen Collection Kit (Yellow Transport Reagent Tube)

Transport Temperature

Ambient / Room temperature

Specimen Stability

The Xpert CT/NG urine specimen collection kit allows for an extended range of time and temperature conditions for
specimen storage and transport when testing for the presence of Chlamydia trachomatis and Neisseria gonorrhoeae.

First catch female urine specimen must be transferred to the Transport Reagent tube within 24 hours of collection if shipped and/or stored at room temperature.
First catch female urine specimen that is transferred to the Transport Reagent tube can be shipped and/or stored up to 45 days at 2^oC to 15^oC, or up to 3 days at 2^oC to 30^o C before testing.
First catch male urine must be transferred to the Transport Reagent tube within 3 days of collection if shipped and/or stored at room temperature.
First catch male urine specimen that is transferred to the Transport Reagent tube can be shipped and/or stored up to 45 days at 2^oC to 30^oC before testing.
First catch male and female urine specimen NOT transferred to the Transport Reagent tube can be shipped and/or stored for up to 8 days at 4^oC.

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Swabs received with the following sources:

Throat/Oral
Rectal/Anal
Eye/Occular/Conjunctival

Any collection devices other than Xpert CT/NG collection devices.
Urine submitted in sterile cups.
Urine not filled to the level of the black dashed line on the label.
Xpert CT/NG devices submitted without collection swab.

Methodology
An automated in-vitro diagnostic test for qualitative detection and differentiation of DNA from Chlamydia trachomatis and
Neisseria gonorrhoeae by real-time PCR. The test is performed on the Cepheid GeneXpert Instrument Systems.

Setup Schedule

Daily

Report Available

Turnaround time is 4 hours

Reference Range

Chlamydia trachomatis / Neisseria gonorrhoeae: Negative

Performing Laboratory
Wyoming Medical Center

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.