Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital

Test Code

11363

CPT Codes
87491, 87591

Includes

Chlamydia trachomatis RNA, TMA, Urogenital
Neisseria gonorrhoeae RNA, TMA, Urogenital

Preferred Specimen

1 vaginal swab in Aptima® Transport Tube or
1 endocervical or urethral swab in Aptima® Transport Tube or
2 mL urine in Aptima® Transport Tube or
1 mL liquid cytology (PreservCyt®) Preservative (ThinPrep®) in Aptima® Transfer Tube or
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 • 1 endocervical or urethral swab in Aptima® Transport • 2 mL urine in Aptima® Transport • 1 mL PreservCyt® (ThinPrep®) 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 N. gonorrhoea/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.

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® Transport Tube

Transport Temperature

Room temperature

Specimen Stability

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

Liquid cytology (Preservcyt® Preservative (ThinPrep®)
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year

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

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

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

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 • PreservCyt® ThinPrep® material previously processed for cytology • PreservCyt® ThinPrep® with excess mucus

Methodology
Transcription-Mediated Amplification (TMA)

FDA Status
The analytical performance characteristics of this assay, when used to test SurePath™ specimens 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

Set up: Daily; Report available: 1-2 days

Reference Range

C. trachomatis RNA, TMA, Urogenital	Not detected
N. gonorrhoeae RNA, TMA, Urogenital	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.
⁠⁠⁠⁠⁠⁠⁠
Neisseria gonorrhoeae (gonococci) is the causative agent of gonorrhea. In men, this disease generally results in anterior urethritis accompanied by purulent exudate. In women, the disease is most often found in the cervix, but the vagina and uterus may also be infected.

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.