Test Details
Mnemonic
CHGTM
Ordering Code
3091010
CPT-4 Code(s)
Chlamydia - 87491; Neisseria - 87591
Specimen Information
Collect
Variable specimen types
Specimen Preparation
Specimen source required for testing.
Endocervical, vaginal or male urethral swab specimens in APTIMA Combo II or Aptima Multitest transport medium.
First catch urine in APTIMA Combo II Urine Transport Tube. Liquid level must fall between the two black indicator lines. Minimum 2.0 mL
Aptima Combo II Urine transport media is currently unavailable.
Endocervical, vaginal or male urethral swab specimens in APTIMA Combo II or Aptima Multitest transport medium.
First catch urine in APTIMA Combo II Urine Transport Tube. Liquid level must fall between the two black indicator lines. Minimum 2.0 mL
Aptima Combo II Urine transport media is currently unavailable.
Minimum Volume
Determined by specimen type
Transport Temperature
Varies, see stability
Rejection Criteria
Specimens submitted with the white cleaning swab or with two swabs, transports without swabs. Swabs in gel, wooden swabs, dry swabs other than BD Dry Swab system. Swabs in bacterial transport medium (e.g., Culturettes). Urine specimens where the liquid level in the urine transport tube does not fall between the two black indicator lines will not be tested. Urine specimens in sterile containers that have exceeded the 24 hour stability. Specimens collected in liquid cytology containers or media will not be tested.
Specimens collected in Universal Transport Medium (UTM).
Specimens collected in Universal Transport Medium (UTM).
Stability
Swab in APTIMA Combo II or Aptima Multitest transport medium, Urine in Aptima Combo II urine transport tube
Refrigerated: 30 days
Room temperature: 30 days
Frozen (-20°C): 90 days
Urine in a sterile screw capped plastic container. (For increased stability, transfer urine sample to APTIMA Combo II Urine Transport tube within 24 hours of collection.) If sending primary urine, transfer urine to a sterile IATA-approved screw-capped plastic container.
Refrigerated: 24 hours
Room temperature: Unacceptable
Frozen (-20°C): 4 days
Swab in M4 Viral Transport tube
Refrigerated: 4 days
Room temperature: 24 hours
Frozen (-20°C): 4 days
Swab in Gen-Probe Pace 2 swab transport tubes
Refrigerated: 7 days
Room temperature: 7 days
Frozen (-20°C): Unacceptable
Swab in BD ProbeTec ET CT/GC Diluent, BD ProbeTec Dry Swab
Refrigerated: 4 days
Room temperature: 4 days
Frozen (-20°C): Unacceptable
Refrigerated: 30 days
Room temperature: 30 days
Frozen (-20°C): 90 days
Urine in a sterile screw capped plastic container. (For increased stability, transfer urine sample to APTIMA Combo II Urine Transport tube within 24 hours of collection.) If sending primary urine, transfer urine to a sterile IATA-approved screw-capped plastic container.
Refrigerated: 24 hours
Room temperature: Unacceptable
Frozen (-20°C): 4 days
Swab in M4 Viral Transport tube
Refrigerated: 4 days
Room temperature: 24 hours
Frozen (-20°C): 4 days
Swab in Gen-Probe Pace 2 swab transport tubes
Refrigerated: 7 days
Room temperature: 7 days
Frozen (-20°C): Unacceptable
Swab in BD ProbeTec ET CT/GC Diluent, BD ProbeTec Dry Swab
Refrigerated: 4 days
Room temperature: 4 days
Frozen (-20°C): Unacceptable
Methodology
Transcription Mediated Amplification nucleic acid amplification. Positive specimens are retested using a different TMA assay (different target) before reporting. The analytical sensitivity of the Chlamydia trachomatis assay is 7 inclusion-forming units per swab or 5 inclusion-forming units per milliliter of urine.
The analytical sensitivity of the Neisseria gonorrhoeae assay is 362 organisms per swab or 250 organisms per milliliter of urine.
The analytical sensitivity of the Neisseria gonorrhoeae assay is 362 organisms per swab or 250 organisms per milliliter of urine.
Reference Range
Negative
Performing Laboratory
Warde Medical Laboratory