Chlamydia trachomatis and Neisseria gonorrhoeae, PCR, Swab, Varies

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Important Note



This test has not been validated for patients <14 year old. Please contact the laboratory or collect with an Aptima swab if testing is needed for this age range.
 


Test Code
SCTGC


Alias/See Also
Epic: LAB2240

LAB3020
CGDS
Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital
LAB9822
CTNGT
Chlamydia/Neisseria gonorrhoeae RNA, TMA, Throat
LAB13867
CTREC
Chlamydia trachomatis RNA, TMA, Rectal


Includes
Chlamydia trachomatis
Neisseria gonorrhoeae


Preferred Specimen

Submit only 1 of the following specimens:

Specimen Type: Endocervix
Collection Container: COBAS media swab
Specimen Volume: Swab

Specimen Type: Vaginal
Collection Container: COBAS media swab
Specimen Volume: Swab




Specimen Type: Anorectal
Collection Container: COBAS media swab
Specimen Volume: Swab

Specimen Type: Oropharyngeal (Throat)
Collection Container: COBAS media swab
Specimen Volume: Swab




Instructions
Endocervix
  1. Using the woven cleaning swab, remove excess mucus from the cervical os and surrounding mucosa. DISCARD THIS WOVEN SWAB AFTER USE.
  2. NOTE: Cleaning excess mucus from the cervical os is required to assure adequate target cells are obtained for processing.
  3. To collect the specimen, insert the flocked swab provided into the endocervical canal. Gently rotate the swab 5 times in one direction in the endocervical canal. Do not over rotate. Carefully withdraw the swab, avoiding contact with the vaginal mucosa.
  4. Remove the cap from the cobas PCR media tube and lower the swab specimen into the tube until the visible dark line in the swab shaft is aligned with the tube rim. The tip of the swab should be just above the media surface near the hexagonal Roche logo
  5. Carefully leverage the swab against the tube rim to break the swab shaft at the dark line; discard the top portion of the swab
  6. Tightly re-cap the cobas PCR media tube.
Vaginal
  1. If present in the collection kit, discard the flocked swab.
  2. To collect the specimen, insert the polyester woven swab about 5 cm (2 inches) into the vaginal opening. Gently turn the swab for about 30 seconds while rubbing the swab against the walls of the vagina. Withdraw the swab carefully. Do not let the swab touch any surface before placing it into the collection tube.
  3. Remove the cap from the cobas® PCR Media tube and lower the swab specimen into the tube until the visible dark line on the swab shaft is aligned with the tube rim. The tip of the swab should be just above the media surface near the hexagonal Roche logo.
  4. Carefully leverage the swab against the tube rim to break the swab shaft at the dark line; discard the top portion of the swab.
  5. Tightly re-cap the cobas® PCR Media tube. The specimen is now ready for transport. 
  6. WARNING: DO NOT PRE-WET SWAB IN Cobas® PCR MEDIA BEFORE COLLECTION
Anorectal
  1. If present in the collection kit, discard the flocked swab.
  2. Collect specimen with the polyester woven swab only.
  3. To collect the specimen, hold the woven swab with the scoreline above your hand and insert the swab about 3 to 5 cm (1-2 inches) into the anal canal.
  4. Gently turn the swab in a clockwise direction for about 5-10 seconds while running the swab against the walls of the rectum.
    NOTE: If the swab is grossly contaminated with feces, discard and repeat the collection.
  5. Withdraw the swab carefully. Do not let the swab touch any surface before placing it into the collection tube.
  6. Remove the cap from the cobas® PCR Media tube and lower the swab specimen into the tube until the visible dark line on the swab shaft is aligned with the tube rim. The tip of the swab should be just above the media surface near the hexagonal Roche logo.
  7. Carefully leverage the swab against the tube rim to break the swab shaft at the dark line; discard the top portion of the swab.
  8. Tightly re-cap the cobas® PCR Media tube.

Oropharyngeal (Throat)
  1. If present in the collection kit, discard the flocked swab.
  2. Collect specimen with the polyester woven swab only.
  3. Hold the woven swab with the scoreline above your hand and insert the swab into the mouth and collect the specimen from the bilateral posterior pharynx, both tonsils and the uvula.
  4. Withdraw the swab carefully. Do not let the swab touch any surface before placing it into the collection tube.
  5. Remove the cap from the cobas® PCR Media tube and lower the swab specimen into the tube until the visible dark line on the swab shaft is aligned with the tube rim. The tip of the swab should be just above the media surface near the hexagonal Roche logo.
  6. Carefully leverage the swab against the tube rim to break the swab shaft at the dark line; discard the top portion of the swab.
  7. Tightly re-cap the cobas® PCR Media tube


Transport Container
cobas® PCR Media Uni Swab Sample Kit or cobas® PCR Media Dual Swab Sample Kit


Specimen Stability

Room temperature: 1 month
Refrigerated: 1 month
Frozen: 1 month




Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
  • Bloody specimens are unacceptable for testing
  • Endocervical and vaginal specimen tubes with no swabs or with two swabs have not been collected according to the instructions in the COBAS® PCR Female Swab Sample Kit and are unacceptable


Methodology

Real-time polymerase chain reaction (PCR) 



Setup Schedule

Monday, Wednesday, Friday




Report Available

2-3 days




Limitations

CT/GC testing with this instrument is not available for patients <14 years old. However, molecular testing can be performed using a different platform. Please contact your laboratory for the alternative transport media required for these samples.



This test is not recommended for evaluation of suspected sexual abuse and for other medico-legal indication




Reference Range
Negative for Chlamydia trachomatis DNA
Negative for Neisseria gonorrhoeae DNA


Clinical Significance
Results depend on adequate specimen collection, absence of inhibitors, and sufficient DNA for detection.
This test should not be used to determine therapeutic success as nucleic acids may be present, and detected, after antimicrobial therapy.
A negative result does not necessarily rule out Chlamydia trachomatis and/or Neisseria gonorrhoeae infection. Specimens containing mucus, gels, lubricants, or creams may give invalid or false negative results.



Performing Laboratory

Inova Laboratories

2832 Juniper Street

Fairfax, VA 22031



Additional Information
Inova Laboratory Specimen Transport Guide: Inova Women’s Health

Last Updated: August 21, 2023
Last Review: N. Wolford, July 19, 2023


The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.