"Clinical Significance
Chlamydia trachomatis RNA, TMA, Throat - Chlamydia trachomatis may infect the oral/pharyngeal cavity of sexually active individuals. Detection of this organism may be important for determining the risk for disease progression or transmission.

Preferred Specimen(s)
Throat swab in APTIMA® Combo 2 Transport Media

Collection Instructions
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
Use the ATPIMA® Unisex Swab Specimen Collection kit (white label) or APTIMA® Vaginal Swab Specimen Collection kit (orange label). Using a tongue depressor, insert the small, blue shafted collection swab (Unisex kit, NOT the larger white shafted cleansing swab) or the small pink shafted collection swab (Vaginal kit) and vigorously rub the tonsils and the posterior pharynx. Carefully remove the swab without touching any area of the mouth. 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.

 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 • Specimens in broken containers • Swab submitted in M4 transport media • Swabs submitted in Viral Culture Media (V-C-M)

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)
Not detected

Alternative Name(s)
CT APTIMA®,CT TMA