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Chlamydia trachomatis RNA, TMA, UROGENITAL: 11361
Test CodeCTRNA2 or 11361
CPT Codes
87491
Preferred Specimen
1 vaginal swab in Aptima® Transport Tube
1 endocervical or urethral swab in Aptima® Transport Tube
2 mL urine in Aptima® Transport Tube
1 mL liquid cytology (PreservCyt®) preservative (ThinPrep®) in Aptima® Transfer Tube
0.5 mL SurePath™ preservative fluid in Aptima® Transfer Tube
1 endocervical or urethral swab in Aptima® Transport Tube
2 mL urine in Aptima® Transport Tube
1 mL liquid cytology (PreservCyt®) preservative (ThinPrep®) in Aptima® Transfer Tube
0.5 mL SurePath™ preservative fluid in Aptima® Transfer Tube
Minimum Volume
1 vaginal swab in Aptima® Transport Tube
1 endocervical or urethral swab in Aptima® Transport Tube
2 mL urine in Aptima® Transport Tube
1 mL PreservCyt® (ThinPrep®) in Aptima® Transfer Tube
0.5 mL SurePath™ fluid in Aptima® Transfer Tube
1 endocervical or urethral swab in Aptima® Transport Tube
2 mL urine in Aptima® Transport Tube
1 mL PreservCyt® (ThinPrep®) in Aptima® Transfer Tube
0.5 mL SurePath™ fluid in Aptima® Transfer Tube
Instructions
Vaginal Swab: Follow instructions in the Aptima® Multitest Collection Kit (orange label).
Endocervical or Urethral Swab: Follow instructions in the Aptima Unisex Swab Specimen Collection Kit (white label).
In females, to ensure collection of cells infected with C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling.
Urine: 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. 2 mL of urine specimen must be transferred into the Aptima Specimen Transport tube within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label.
Labs performing cytology: Aliquot ThinPrep® PreservCyt® solution before performance of liquid-based cytology testing.
ThinPrep PreservCyt: Transfer 1 mL ThinPrep PreservCyt solution into Aptima Specimen Transfer Tube (green label) or Aptima Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Tube (white label).
SurePath™: SurePath fluid must be transferred to Aptima tube within 4 days of collection. Transfer 0.5 mL SurePath solution into Aptima Specimen Transfer Tube (green label) or Aptima Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Tube (white label).
Endocervical or Urethral Swab: Follow instructions in the Aptima Unisex Swab Specimen Collection Kit (white label).
In females, to ensure collection of cells infected with C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling.
Urine: 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. 2 mL of urine specimen must be transferred into the Aptima Specimen Transport tube within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label.
Labs performing cytology: Aliquot ThinPrep® PreservCyt® solution before performance of liquid-based cytology testing.
ThinPrep PreservCyt: Transfer 1 mL ThinPrep PreservCyt solution into Aptima Specimen Transfer Tube (green label) or Aptima Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Tube (white label).
SurePath™: SurePath fluid must be transferred to Aptima tube within 4 days of collection. Transfer 0.5 mL SurePath solution into Aptima Specimen Transfer Tube (green label) or Aptima Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Tube (white label).
Transport Temperature
Room temperature.
Specimen Stability
(ThinPrep) in APTIMA(R) Transport Tube
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 year
Liquid cytology Preservative (ThinPrep®)
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 12 months
SurePath™ Preservative Fluid
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
Urine in Aptima® Transport Medium
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 12 months
Swabs in Aptima® Transport
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 12 months
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 year
Liquid cytology Preservative (ThinPrep®)
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 12 months
SurePath™ Preservative Fluid
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
Urine in Aptima® Transport Medium
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 12 months
Swabs in Aptima® Transport
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 12 months
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Transport tubes with 2 swabs; Transport tubes with Non-Aptima® swabs; Swab transport tubes with no swab; Specimens in broken containers; Swab submitted in viral transport media; Urine samples where the fluid level is not between the black fill lines; PreservCyt® ThinPrep® material previously processed for cytology; PreservCyt® ThinPrep® with excess mucus
Methodology
Transcription-Mediated Amplification (TMA)
Setup Schedule
Monday - Saturday
Report Available
1-3 days
Limitations
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.
The APTIMA® Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications.
Reference Range
NOT DETECTED
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.
Performing Laboratory
med fusion
