Critical Ordering Information

  • Use this test for ANORECTAL specimens only
  • Test may be ordered as one of the following specimen types:
    • “CLINICIAN-COLLECTED ANORECTAL SWAB”
    • “SELF-COLLECTED ANORECTAL SWAB”
      • Note: CT/NG testing on self-collected anorectal swabs is not approved by the FDA. This method is considered a laboratory developed test and its performance has been validated by the UCDH Molecular Laboratory. A detailed statement regarding this test’s status as a laboratory developed test will be appended to each result. 
  • Test has not been validated for patients under the age of 14 years. Medical director approval required for this patient demographic. Results may be delayed.

Performed

Monday-Friday, variable weekends

Methodology

Roche Cobas 6800

Reported

Within 3 days

Synonyms

  • GC/Chlamydia
  • CTGC
  • CTNG

Collect

Anorectal Swabs may be collected using:
  • Cobas PCR Media Uni Swab Sample Kit
  • Cobas PCR Media Dual Swab Sample Kit (use woven swab only, do not use the flocked swab)
ANORECTAL COLLECTION (clinician collection or self collection)
NOTE: Can be collected using Dual or Uni Swab Sample Kit
  1. Collect: Hold the WOVEN swab (Swab A) with the scoreline above your hand and insert the swab about 3 to 5 cm (1-2 inches) into the anal canal. Gently turn the swab in the clockwise direction for about 5-10 seconds while running the swab against the walls of the rectum. If the swab is grossly contaminated with feces, discard and repeat the collection. Withdraw the swab carefully. Do NOT let the swab touch any surface before placing it into the collection tube.
  2. Align: Remove the cap form the Cobas PCR Media Tube and lower the swab specimen into the tube until the visible scoreline on the swab is aligned with the tube rim. The tip of the swab should not be submerged into the liquid prior to breaking the shaft.
  3. Break: Carefully leverage the swab against the tube rim to break the swab shaft at the scoreline.
  4. Close: Tightly re-cap the Cobas PCR Media Tube. Discard the top portion of the swab.

Storage/Transport Temperature

Store and transport at 2-30 oC

Unacceptable Conditions

  • Primary swab specimen tubes with no swabs, multiple swabs, or improper swabs (e.g., flocked swab, wood shaft swabs, etc.)
  • Thinprep vials
  • Any other swab collection media (e.g. Aptima, BD eSwab, UTM/VTM, etc.)

Stability (from collection to initiation)

2-30 0C for up to 12 months

Remarks

Do NOT prewet the collection swab in the Cobas PCR media before collection.

Reference Interval

Negative

Interpretive Data

  • Test Sensitivity for anorectal swab collections:
    • Chlamydia Trachomatis:  20 elementary bodies/mL​​​​​​
    • Neisseria Gonorrhoeae:  0.2 colony forming units/mL

CPT Codes

  • Chlamydia Trachomatis - 87491
  • Neisseria Gonorrhoeae - 87591

URL link

https://www.testmenu.com/UCDavis/Tests/1198306
Ordering

Critical Ordering Information

  • Use this test for ANORECTAL specimens only
  • Test may be ordered as one of the following specimen types:
    • “CLINICIAN-COLLECTED ANORECTAL SWAB”
    • “SELF-COLLECTED ANORECTAL SWAB”
      • Note: CT/NG testing on self-collected anorectal swabs is not approved by the FDA. This method is considered a laboratory developed test and its performance has been validated by the UCDH Molecular Laboratory. A detailed statement regarding this test’s status as a laboratory developed test will be appended to each result. 
  • Test has not been validated for patients under the age of 14 years. Medical director approval required for this patient demographic. Results may be delayed.

Performed

Monday-Friday, variable weekends

Methodology

Roche Cobas 6800

Reported

Within 3 days

Synonyms

  • GC/Chlamydia
  • CTGC
  • CTNG
Collection

Collect

Anorectal Swabs may be collected using:
  • Cobas PCR Media Uni Swab Sample Kit
  • Cobas PCR Media Dual Swab Sample Kit (use woven swab only, do not use the flocked swab)
ANORECTAL COLLECTION (clinician collection or self collection)
NOTE: Can be collected using Dual or Uni Swab Sample Kit
  1. Collect: Hold the WOVEN swab (Swab A) with the scoreline above your hand and insert the swab about 3 to 5 cm (1-2 inches) into the anal canal. Gently turn the swab in the clockwise direction for about 5-10 seconds while running the swab against the walls of the rectum. If the swab is grossly contaminated with feces, discard and repeat the collection. Withdraw the swab carefully. Do NOT let the swab touch any surface before placing it into the collection tube.
  2. Align: Remove the cap form the Cobas PCR Media Tube and lower the swab specimen into the tube until the visible scoreline on the swab is aligned with the tube rim. The tip of the swab should not be submerged into the liquid prior to breaking the shaft.
  3. Break: Carefully leverage the swab against the tube rim to break the swab shaft at the scoreline.
  4. Close: Tightly re-cap the Cobas PCR Media Tube. Discard the top portion of the swab.

Storage/Transport Temperature

Store and transport at 2-30 oC

Unacceptable Conditions

  • Primary swab specimen tubes with no swabs, multiple swabs, or improper swabs (e.g., flocked swab, wood shaft swabs, etc.)
  • Thinprep vials
  • Any other swab collection media (e.g. Aptima, BD eSwab, UTM/VTM, etc.)

Stability (from collection to initiation)

2-30 0C for up to 12 months

Remarks

Do NOT prewet the collection swab in the Cobas PCR media before collection.
Result Interpretation

Reference Interval

Negative

Interpretive Data

  • Test Sensitivity for anorectal swab collections:
    • Chlamydia Trachomatis:  20 elementary bodies/mL​​​​​​
    • Neisseria Gonorrhoeae:  0.2 colony forming units/mL
Administrative

CPT Codes

  • Chlamydia Trachomatis - 87491
  • Neisseria Gonorrhoeae - 87591

URL link

https://www.testmenu.com/UCDavis/Tests/1198306