Chlamydia / N. Gonorrhoeae RNA, TMA - Unisex Collection

Supply #180030 APTIMA Unisex Collection

Test Code: 11363

CPT Code(s): 87491, 87591

Includes: Chlamydia trachomatis, Neisseria gonorrhoeae

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

Reference Range(s):
C.trachomatis RNA, TMA - Not detected

N.gonorrhoeae RNA, TMA - Not detected

This test was performed using the APTIMA® COMBO2 Assay (GEN-PROBE).

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.

Test FAQ: Chlamydia trachomatis and Neisseria gonorrhoeae RNA, TMA

Alternative Name(s): CT/NG APTIMA®, CT/GC APTIMA®, Hologic, CT/GC TMA, CT/NG TMA

Additional Preferred Specimens Collection for Test Code 11363:
1 ml liquid cytology collected through Thinprep® Broom or Brush/Spatula
0.5 ml of Surepath® preservative fluid collected using Broom or Brush/Spatula
Vagina Swabs in APTIMA® Combo 2 Assay Vaginal Swab Specimen Collection Kit
2 ml urine using APTIMA® Urine Specimen Collection Kit

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, http://www.hologic.com/package-inserts/clinical-diagnostics- blood-screening/assays-and-tests/aptima-combo-2-assay-ctng.

Collection Guide: 

Supply: 180030 APTIMA Unisex Collection

Additional Tests with APTIMA Unisex as Preferred Specimen Colleciton Device
19550, SURESWAB® TRICHOMONAS VAGINALIS RNA, QL, TMA
16898, SURESWAB®, BACTERIAL VAGINOSIS DNA, QUANTITATIVE, REAL-TIME PCR
16494, SURESWAB®, CANDIDIASIS, PCR

Follow instructions listed below for the APTIMA® Combo 2 Assay Unisex Swab Specimen Collection Kit. In females, to insure collection of cells infected with n. Gonorrhoeae, columnar epithelial cells lining the endocervix should be obtained. To that effect, excess mucus should be removed prior to sampling.

Collection for Vaginal Swab Specimen

Unisex Female 1
Use cleaning swab (white shaft swab with red printing) to remove excess mucus from cervical os and surrounding mucosa. Discard this swab.*

Unisex Female 2
Insert collection swab (blue shaft swab with green printing) into endocervical canal. Gently rotate swab clockwise for 10 to 30 seconds to ensure adequate sampling. Withdraw swab carefully; avoid any contact with vaginal mucosa.

Unisex Female 3
While holding swab in hand, unscrew the tube cap. Do not spill tube contents. If the tube contents are spilled, discard and get a new APTIMA Unisex swab transport tube. Immediately place swab into transport tube so that the tip of the swab is visible below tube label. Carefully break swabs shaft at the score line against the side of the tube. Discard top portion of swab shaft.

Unisex Female 4
Re-cap swab specimen transport tube tightly.

Collection for Male Urtheral Swab Specimen
Patient should not have urinated within an hour prior to specimen collection.

Unisex Male 1
Discard cleaning swab (white shaft with red print on label). The cleaning swab if NOT needed for male specimen collection. Insert specimen collection swab (blue shaft swab in package with green printing) 2 cm to 4 cm into urethra. Gently rotate swab clockwise for 2 to 3 seconds in urethra to ensure adequate sampling. Withdraw swab carefully.

Unisex Male 2
While holding swab in hand, unscrew the tube cap. Do not spill tube contents. If the tube contents are spilled, discard and get a new APTIMA Unisex swab transport tube. Immediately place swab into transport tube so that the tip of the swab is visible below tube label. Carefully break swabs shaft at the score line against the side of the tube. Discard top portion of swab shaft.

Unisex Male 3
Re-cap swab specimen transport tube tightly.

Specimen stability
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 6 months

For additional supply or collection device information, please contact DLO's Customer Services at (800) 891-2917, option 2.

The CPT codes provided 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.