Chlamydia trachomatis RNA, TMA, Urogenital

Test Code

11361

CPT Codes
87491

Preferred Specimen

1 vaginal swab in Aptima® Transport Tube
1 endocervical or urethral swab in Aptima® Transport Tube
2 mL urine in Aptima® Transport Tube
1 mL liquid cytology ThinPrep® PreservCyt® in Aptima® Transfer Tube
0.5 mL SurePath™ preservative fluid in Aptima® Transfer Tube

Patient Preparation
Urine: Patient should not have urinated within one hour prior to collection. Female patients should not cleanse the labial area prior to providing the specimen.

Minimum Volume

1 vaginal swab in Aptima® Transport Tube
1 endocervical or urethral swab in Aptima® Transport Tube
2 mL urine in Aptima® Transport Tube
1 mL ThinPrep® PreservCyt® in Aptima® Transfer Tube
0.5 mL SurePath™ fluid in Aptima® Transfer Tube

Instructions

Vaginal Swab: Follow instructions in the Aptima® Multitest Collection Kit (orange label).

Endocervical or Urethral Swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label). In females, to ensure collection of cells infected with C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling.

Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima® Specimen Transport Tube within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label.

Labs performing cytology: Aliquot ThinPrep® PreservCyt® solution before performance of liquid-based cytology testing.

ThinPrep® PreservCyt®: Transfer 1 mL ThinPrep® PreservCyt® solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Tube (white label).

SurePath™: SurePath™ fluid must be transferred to Aptima® tube within 4 days of collection. Transfer 0.5 mL SurePath™ solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Tube (white label).

Note: Results from the Aptima® combo 2 assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician.

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® Transport Tube

Transport Temperature

Room temperature

Specimen Stability

Swabs in Aptima® Transport Tube
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 1 year

Urine in Aptima®Transport Tube
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year

Liquid cytology ThinPrep®PreservCyt® Preservative
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year

ThinPrep®PreservCyt® in Aptima® Transport Tube
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 year

SurePath™ Preservative Fluid
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable

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 viral transport media • Urine samples where the fluid level is not between the black fill lines • ThinPrep® PreservCyt® material previously processed for cytology • ThinPrep® PreservCyt® with excess mucus

Methodology
Transcription-Mediated Amplification (TMA)

Setup Schedule

Day shift Daily

Report Available

1 day

Reference Range

Not detected

Clinical Significance

C. trachomatis infections are the leading cause of sexually transmitted diseases in the united states. C. trachomatis is known to cause cervicitis, pelvic inflammatory disease (PID), epididymitis and proctitis. It is also the most frequent cause of non-gonococcal urethritis in men. Among women, the consequences of chlamydial infections are severe if left untreated. Approximately half of chlamydial infections are asymptomatic.

Performing Laboratory

Quest Diagnostics-Seattle

1737 Airport Way S Suite 200

Seattle, WA 98134-1636

Last Updated: November 6, 2024

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.