Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital

Test 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 - no preservative

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

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.

Endocervical/Urethral Swabs: Follow instructions in the Aptima® Combo 2 Assay Unisex Swab Specimen Collection Kit for Endocervical and Urethral Swab Specimens package insert. In females, to ensure collection of cells infected with C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. To that effect, excess mucus should be removed before sampling. Collection Container: Tube in the APTIMA Unisex Swab Specimen Collection Kit for Endocervical and Urethral Swab Specimens.

Vaginal Swabs:
Follow instructions in the APTIMA® Vaginal Collection or Multi-Test Collection kit package insert. Collection Container: Tube in the APTIMA® Vaginal Collection or Multi-Test Collection kit or APTIMA® Unisex Swab Specimen Collection Kit.

Urine:
The patient should not have urinated for at least 1 hour before specimen collection. Direct patient to provide a first-catch urine (approximately 20-30 mL of the initial urine stream) into a leakproof urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity. Female patients should not cleanse the labial area before providing the specimen. Thus, a urine sample collected from a female for Chlamydia/GC TMA cannot be collected at the same voiding event as that urine which would be intended for bacterial culture (the latter needs to be a clean catch). Minimum 2 mL of urine specimens must be transferred into the APTIMA® specimen transport tube within 24 hours of collection, and before being assayed. Collection Container: Tube in the APTIMA® Urine Specimen Collection Kit for Urine Specimens. The fluid (urine plus transport medium) level in the urine transport tube must fall within the clear pane on the tube label.

PreservCyt®:
Transfer minimum 1 mL of PreservCyt® solution into APTIMA® Specimen Transfer tube (green label) or APTIMA® Vaginal Collection or Multi-Test Collection Kit (orange label). 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.

Transport Container
APTIMA® Transport Tube/Medium

Transport Temperature
Room temperature

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

Liquid cytology (Preservcyt®) APTIMA® transport tube:
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 yaer

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/urethral swabs in APTIMA® transport medium
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 1 year

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Transport tubes with Non-APTIMA® swabs

Methodology
Dual Kinetic Assay (DKA) • Target Capture • 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.

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.

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.