Chlamydia/Neisseria gonorrhoeae RNA, TMA, Rectal

Test Code
GENP CT-GC RNA TMA RECTAL (16506)

Quest Code
16506

CPT Codes
87491, 87591

Preferred Specimen
1 rectal swab collected in an Aptima® Transport Tube

Instructions
Use the Aptima® Unisex Swab Specimen Collection Kit (white label) or Aptima® Vaginal Swab Specimen Collection Kit or Multi-test Collection Kit (orange label). Insert the small, blue-shafted collection swab (unisex kit, not the larger white-shafted cleansing swab) or the small, pink-shafted swab (vaginal kit) approximately 3-5 cm into the rectum. Rotate swab against the rectal wall at least 3 times. Withdraw the swab carefully. Swabs that are grossly contaminated with feces should be discarded and the collection repeated. Remove the cap from the swab specimen transport tube and immediately place the swab into the transport tube. Carefully break the swab shaft at the score line. Re-cap the swab specimen transport tube tightly, label and ship to the lab.

Note: Results from the Aptima® Combo 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician.

The Aptima® Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications.

For a complete list of assay limitations we recommend that you review the manufacturers package insert, https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng


Transport Temperature
Room temperature

Specimen Stability
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 30 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Transport tubes with 2 swabs • Transport tubes with non-Aptima® swabs • Swab submitted in viral transport media

Methodology
Transcription-Mediated Amplification (TMA)

FDA Status
The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Mon, Wed, Fri

Report Available
1 to 2 Day(s)

Reference Range
C. trachomatis TMA, Rectal Not detected
N. gonorrhoeae TMA, Rectal Not detected


Clinical Significance
Both Chlamydia trachomatis and Neisseria gonorrhoeae may infect the anal/rectal canal of sexually active individuals. Detection of this organism may be important for determining the risk for disease progression or transmission.

Performing Laboratory
Quest Diagnostics Infectious Disease, Inc.
33608 Ortega Highway, Bldg B-West Wing
San Juan Capistrano, 92675-2042



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.