"Clinical Significance
Chlamydia/Neisseria Gonorrhoeae RNA, TMA, Urine - 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.

Preferred Specimen(s)
2 mL random urine submitted in Aptima® transport tube

Minimum Volume
2 mL

Collection Instructions
2 mL of urine specimen must be transferred into the Aptima® specimen transport within 24 hours of collection. Use tube provided in the urine specimen collection kit for urine specimens. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane on the tube 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 manufacturer's package insert, https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng

Transport Container
Aptima® Urine Collection kit

Transport Temperature
Room temperature

Specimen Stability
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year

Includes
Chlamydia trachomatis, RNA, TMA
Neisseria gonorrhoeae, RNA, TMA
Patient Preparation
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.

Methodology
Target Capture

Reference Range(s)
C. trachomatis RNA, TMA    Not detected
N. gonorrhoeae RNA, TMA    Not detected