Chlamydia trachomatis/Neisseria gonorrhoeae (TMA)
Biopharma: This test is available for use in clinical trials or research purposes only.
Expected Turnaround Time
1-3 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.
Clinical Information
The APTIMA Combo 2 Assay for Chlamydia trachomatis/Neisseria gonorrhoeae Assay is an in vitro qualitative nucleic acid amplification test cleared by the FDA for the detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) in clinician collected specimens for screening of symptomatic and asymptomatic individuals for evidence of chlamydial and/or gonococcal urogenital disease.
Specimen Requirements
Specimen Requirements
- Cervical Cells: 3mL, ThinPrep® or SurePath™
- Cervical or Urethral Swab: One Swab, APTIMA Unisex Swab Specimen Collection
- Urine in preservative-free urine collection cup: 20-30 mL in preservative-free urine collection cup
- Urine: 2 mL APTIMA urine tube
- Throat Swab: One Swab, Aptima Multitest Swab
- Anal Swab: One Swab, Aptima Multitest Swab
Specimen Stability
- Cervical Cells: 21 Days
- Cervical or Urethral Swab: 60 Days
- Urine in preservative-free urine collection cup: 24 Hours
- Urine: 30 Days
- Throat Swab: 60 Days
- Anal Swab: 60 Days
Storage Requirements
- Cervical Cells: 2°C to 25°C
- Cervical or Urethral Swab: 2°C to 25°C
- Urine in preservative-free urine collection cup: 2°C to 8°C
- Urine: 15°C to 25°C
- Throat Swab: 15°C to 25°C
- Anal Swab: 4°C to 25°C
Shipping Recommendations
- Cervical Cells: AMBIENT
- Swabs: AMBIENT
- Urine in preservative-free urine collection cup: REFRIGERATED
- Urine: AMBIENT
Specimen Rejection Criteria
Insufficient specimen volume; No swab in transport tube; Urine specimens >24 hours old unless transferred to APTIMA urine transport (YELLOW) tube
Test Details
Keywords
Molecular Diagnostics, Women's Health, STI
Test Method
Transcription-Mediated Amplification (TMA)
Methodology Category
Molecular
Regulatory Status
IVD
Special Considerations
Urine in preservative-free urine collection cup: Void first 10mL.