Chlamydia trachomatis/Neisseria gonorrhoeae, DNA, SDA

Test Code

17305X

CPT Codes
87491; 87591

Includes

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

Preferred Specimen

Liquid Cytology (PreservCyt® Preservative (ThinPrep®) or TriPath SurePathâ„¢ vials)-post-processing of the PAP smear

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

Use the following transports only when also submitting for liquid cytology. Residual SurePath vial-2 mL post-processing of the PAP smear. ThinPrep vial-6 mL post-processing of the PAP smear. No add on's to regularly processed SurePath or ThinPrep samples

Transport Container

Aptima® Transport Tube

Transport Temperature

Room temperature, stable 6 days

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
Strand Displacement Amplification

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

Chlamydia trachomatis infections are recognized as the leading cause of sexually transmitted diseases (STD) in the United States. C. trachomatis is known to cause cervicitis, pelvic inflammatory disease (PID), urethritis, epididymitis an

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153

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.