"Clinical Significance
Chlamydia/Neisseria gonorrhoeae RNA, TMA, Rectal - 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.

Preferred Specimen(s)
1 rectal swab in Aptima® Transport Tube

Minimum Volume
1 rectal swab in Aptima® Transport

Collection 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

 IMPORTANT: Please review the Specimen Collection instructions SPECIMEN COLLECTION GUIDES FOR APTIMA for this test

Transport Container
Aptima® transport tube

Transport Temperature
Room temperature

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

Reject Criteria
Transport tubes with 2 swabs • Transport tubes with non-Aptima® swabs • Swab transport tubes with no swab • Specimens in broken containers • Swabs submitted in viral transport media

Methodology
Transcription-Mediated Amplification (TMA)

Assay Category
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.

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

Alternative Name(s)
CT/NG Aptima,CT/GC Aptima,CT/GC TMA,CT/NG TMA