Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital

Test Code
CH GC RNA(11363)

Quest Code
11363

CPT Codes
87491, 87591

Includes
Chlamydia trachomatis, Neisseria gonorrhoeae

Preferred Specimen
1 mL liquid cytology (Preservcyt®) preservative (ThinPrep®) collected in APTIMA® specimen transfer tube (green label) or APTIMA® Vaginal Collection Kit or Multi-test Collection Kit (orange label) or APTIMA® Unisex Swab Specimen Collection Kit.

0.5 mL of SurePath® preservative fluid collected in APTIMA® specimen transfer tube (green label) or APTIMA® Vaginal Collection Kit or Multi-test Collection Kit (orange label).

Endocervical or urethral swabs in APTIMA® Combo 2 Assay Unisex Swab Specimen Collection Kit.

Vaginal swabs in the APTIMA® Combo 2 Assay Vaginal Swab Collection Kit or Multi-test Collection Kit.

2 mL urine using APTIMA® Urine Specimen Collection Kit

Patient Preparation
Urine specimens: The patient should not have urinated for at least one hour prior to specimen collection. Female patients should not cleanse the labial area prior to providing the specimen.

Other Acceptable Specimens
Urine (no preservatives): 2 mL of urine, specimen must be transferred into the APTIMA® Urine Transport Medium within 24 hours of collection and before being assayed • ThinPrep® vial • SurePath® vial

Instructions
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.
Labs performing cytology: Aliquot Preservcyt® or SurePath® solution before performance of liquid based cytology testing.

Preservcyt®: Transfer 1 mL to Preservcyt® solution into APTIMA® specimen transfer tube (green label) or APTIMA® Vaginal Collection or Multi-Test Collection Kit. Ship to lab.

SurePath®: SurePath® fluid must be transferred to APTIMA® STM within 4 days of collection. Transfer 0.5 mL of SurePath® preservative fluid to APTIMA® specimen transfer tube (green label) or APTIMA® Vaginal Collection or Multi-Test Collection kit (orange label). Ship to lab.

Endocervical or urethral swabs: Follow instructions in the APTIMA® Combo 2 Assay Unisex Swab Specimen Collection Kit. In females, to insure collection of cells infected with c. Trachomatis, columnar epithelial cells lining the endocervix should be obtained. To that effect, excess mucus should be removed prior to sampling.

Vaginal swabs: Follow instructions in the APTIMA® Combo 2 Assay Vaginal Collection or Multi-Test Collection Kit.

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. 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 within 24 hours of collection and before being assayed. Use tube provided in the urine specimen collection kit for urine specimens. The fluid (urine plus transport media) level in the urine tube must fall within the clear pane on the tube label.

Transport Temperature
Room temperature

Specimen Stability
Liquid cytology (Preservcyt®) preservative (ThinPrep®)
Room temperature: 14 days
Refrigerated: 30 days
Frozen: Not established

SurePath® preservative fluid
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Not established

Urine in APTIMA® transport medium
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year

Cervical/vaginal swabs in APTIMA® transport tube
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 1 year

Urethral swabs in APTIMA® transport tube
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 6 months

Methodology
Dual Kinetic Assay (DKA) • Target Capture • Transcription-Mediated Amplification (TMA)

Setup Schedule
Mon-Sat

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.

Performing Laboratory
Quest Diagnostics Nichols Institute Valencia
27027 Tourney Road
Valencia, CA 91355-5386



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.