Test Code: 11363
Includes: Chlamydia trachomatis, Neisseria gonorrhoeae
Methodology: Dual Kinetic Assay (DKA) • Target Capture • Transcription-Mediated Amplification (TM)
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
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
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.
APTIMA Urine Collection Device
Supply: A01 - APTIMA Urine Collection
Test Code:
11636, CT/NG
19550(X), SureSwab Trichomonas vaginalis
Patient should not have urinated for at least 1 hour prior to specimen collection. Female patients should not cleanse the labial area prior to providing the specimen.
Direct patient to provide first-catch urine (approximately 20 to 30 mL of initial urine stream) into 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 labial area prior to providing specimen.
Remove cap from urine specimen transport tube and transfer 2 mL of urine into urine specimen transport tube using disposable pipette provided. The correct volume of urine has been added when fluid level is between black fill lines on urine specimen transport tube label.
Re-cap urine specimen transport tube tightly. This is now known as the “processed urine specimen.”
Specimen Transport and Storage: Transfer urine sample into APTIMA Urine specimen transport tube within 24 hours of collection.
Transport container: APTIMA® Urine transport tube
Transport temperature: Room temperature
Specimen stability:
Room Temperature: 30 days
For additional supply or collection device information, please contact DLO's Customer Services at (800) 891-2917, option 2.