Trichomonas vaginalis and Mycoplasma genitalium, Qualitative PCR
ID: LAB3471
Last Review: 01/28/2026
Components
Mycoplasma genitalium Qual PCR
Trichomonas vaginalis Qual PCR
 
Specimen Sources
Cervical/Endocervical 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 or urethral sources.
Collect in Cobas PCR Dual Swab for cervical/endocervical source.
Collection cannot be shared with other tests.

Refer to the Electronic Test Catalog, LAB3471 "Additional Information" for further details.
Shipping And Handling
Shipping/Handling Instructions: Submit to the Clinical Microbiology Lab as soon as possible at ambient or refrigeration temperature.

Refer to the Electronic Test Catalog, LAB3471 "Additional Information" for further details.
Performing Labs, Collection Containers and TATs
▷  Duke Microbiology Laboratory
Clinical Indications
The T. vaginalis and M. genitalium Qual PCR Test (LAB3471) is validated for urine, vaginal, and endocervical 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, and endocervical swab. 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 < 18 years of age (T. vaginalis or M. genitalium 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 TV/MG assays. 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   


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 collection:**  
• Roche PCR Uni Swab Kit  
• Vendor Cat#: 7958030190  
• SAP#: 178653  


**Endocervical collection:**  
• Roche PCR Dual Swab Kit  
• Vendor Cat#: 7980241190  
• SAP#: 35551
Critical Values
No Critical Values