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Chlamydia Trachomatis (CT), Qualitative by Aptima COMBO® 2 TMA

Test Code

CT

Associations

The CDC recommends that all sexually active adolescent women be screened for chlamydia trachomatis at least once a year. Close to half of chlamydia cases (46%) occur in women ages 15-19 and another 33% of infections occur in females between 20 and 24. Of all reported neisseria gonorrhoeae cases, 75% occur in individuals between 15 and 29 years of age.

Methodology

Transcription-Mediated Amplification (TMA)

Turnaround Time

1-3 days

Specimen Requirements

3.0 mL ThinPrep® PAP or SurePath™ Test Pack
1.0 mL liquid cytology media (ThinPrep or SurePath) media
One cervical or urethral swab collected with APTIMA Unisex Swab Specimen Collection (WHITE) Kit
20.0-30.0 mL (first catch) urine collected in preservative-free urine collection cup or 2.0 mL urine transferred to APTIMA urine specimen transport (YELLOW) tube

Specimen Stability
ThinPrep/SurePath - 30 days from collection at 18-25°C. Specimens are kept for 21 days after receipt.
Swabs - 60 days from collection
Urine - 24 hours from collection; 30 days after transfer to APTIMA urine transport (YELLOW) tube
Storage & Handling

Transport and store all specimens at 2-30°C

Causes for Rejection

Insufficient specimen volume
No swab in transport tube
Urine specimens >24 hours old unless transferred to APTIMA urine transport (YELLOW) tube

Reference Range

Detected/Not Detected

Description

Intended for use as a screening test for evidence of Chlamydia trachomatis infection.

References
  1. Welch DF (2007).  Screening for Chlamydial and Gonorrheal infections: Current laboratory applications.  Infect Med. 24:266-278.
  2. Chernesky M et al. (2006). High analytical sensitivity and low rates of inhibition may contribute to detection of Chlamydia trachomatis in significantly more women by the APTIMA Combo 2 assay. J Clin Micro. 44:400-405.
  3. GEN-PROBE APTIMA Combo 2 Assay.
Trademarks

APTIMA Combo 2 is a trademark of Gen-Probe, Inc.
ThinPrep is a registered trademark of Cytyc Corporation.
SurePath is a trademark of Becton, Dickinson and Company.