Chlamydia Trachomatis and Neisseria Gonorrhoeae, Qualitative PCR
ID: LAB3477
Last Review: 09/22/2025
Components
Chlamydia trachomatis Qual PCR
Neisseria gonorrhoeae Qual PCR
 
Specimen Sources
Cervical/Endocervical Swab
Pharyngeal Swab
Rectal Swab
Urine
Vaginal Swab
Collection Requirements
Urine:  collect clean catch urine sample. Transfer urine to Cobas PCR Urine Sample Kit
Swabs:  
Collect in Cobas PCR Uni Swab for vaginal, urethral, throat or rectal sources.
Collect in Cobas PCR Dual Swab for cervical/endocervical source.
Collection cannot be shared with other tests.


Refer to the Electronic Test Catalog, LAB3477  "Additional Information" for further details
Shipping And Handling
Submit to the Clinical Microbiology Lab as soon as possible at ambient or refrigeration temperature.

Refer to the Electronic Test Catalog, LAB3477  "Additional Information" for further details
Turn Around Time (TATs for Specific Labs Below May Differ)
Turn Around Time:
  • ASAP: 5760 Minute(s)
  • STAT: 5760 Minute(s)
  • ROUTINE: 5760 Minute(s)
Performing Labs, Collection Containers and TATs
▷  DHLN Clinical Laboratory
▷  Duke Microbiology Laboratory
Clinical Indications
The C. trachomatis and N. gonorrheae Qual PCR Test (LAB3477) is validated for urine, vaginal, endocervical, throat, and rectal sources. See “Additional Information” below for more details.
For current screening and testing guidelines, please refer to US Center for Disease Control and Prevention documents on testing recommendations:
-Guidelines: https://www.cdc.gov/std/treatment-guidelines/default.htm
-Screening Recommendations: https://www.cdc.gov/std/treatment-guidelines/screening-recommendations.htm
Limitations
• This assay is FDA approved and validated for urine (both male and female), vaginal swab, endocervical swab, and throat and rectal swab (both male and female). Orders with any other source will be cancelled.
• While there is no FDA packet insert-specific age restriction, the performance of this assay has not been evaluated for individuals < 14 years of age (C. trachomatis or N. gonorrheae detection) by the manufacturer.
• This assay is ONLY compatible with the Roche PCR media collection kits. Specimen collected with any other collection kits, including the Aptima collection kit, will be cancelled.
Methodology
This test is performed using the FDA approved Roche Cobas 8800 CT/NG assay. The performance of the assay has been verified in the DUHS Clinical Microbiology Laboratory, and performed in accordance with the FDA packet insert.
Additional Information
For additional ordering information and instructions on collection, please visit the DUHS Clinical Microbiology Laboratory video links for:
Urine Source: https://duke.app.box.com/s/24c3cmrbzbwcxgz55u8ucdfl9l9a3ln0
Vaginal Source: https://duke.box.com/s/0j1lzsnetalc44prguwvghod4un0gjgp
Endocervical Source: https://duke.box.com/s/pq1iydd3upbaixlt5e6g4a9gdtqev601
Throat and Rectal Sources: https://duke.box.com/s/im0hocz8j3xzmvh4281v9yumgtop5u08
Collection tip sheet: https://prodduke.sharepoint.com/:b:/s/MicrobiologySharepoint/EWCwcgUkrdREhViNrUilkHMBf6nrqsLxAGwuAvtPLenJcg?e=XNsMrb
Collection Kit Information:
Urine collection:
• Roche PCR Urine Kit
• Vendor Cat#: 5170486190
• SAP#: 220617
Vaginal, throat and rectal collection:
• Roche PCR Uni Swab Kit
• Vendor Cat#: 7958030190
• SAP#: 178653
Endocervical collection:
• Roche PCR Dual Swab Kit
• Vendor Cat#: 7980241190
• SAP#: 35551
For conjunctival swab source:
• Chlamydia trachomatis: order the referral lab send out test to LabCorp: https://testcatalog.duke.edu/Home/ProcedureDetails?ProcedureID=d2d443fc-b66c-4897-806a-f92ac2a3cce3
o Must be collected using an Aptima collection kit.
Critical Values
No Critical Values