| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
Chlamydia/Neisseria gonorrhoeae RNA, TMA, Throat
Test Code70051
Alias/See Also
LAB01101
CT/GC THROAT
CT/GC THROAT
CPT Codes
87491, 87591
Preferred Specimen
1 throat swab submitted in Aptima® Multitest transport tube
Minimum Volume
1 throat swab submitted in Aptima Multitest transport tube
Other Acceptable Specimens
Aptima Unisex Swab Specimen Collection Kit (white label)
Instructions
Use the Aptima Multitest transport tube (orange label). Using a tongue depressor, insert the swab 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.
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
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 Container
Aptima Multitest transport tube (orange label)
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 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 transport tubes with no swab • Specimens in broken containers • Swab submitted in 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
Daily
Report Available
1-2 days
Reference Range
| C. trachomatis TMA, Throat | Not detected |
| N. gonorrhoeae TMA, Throat | Not detected |
Clinical Significance
Both Chlamydia trachomatis and Neisseria gonorrhoeae 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.
Performing Laboratory
| Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
| 33608 Ortega Highway |
| San Juan Capistrano, CA 92675-2042 |