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Test Code PCRGC Neisseria gonorrhoeae, PCR, Genital Swab

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.

Additional Codes

Epic: LAB262

Specimen Required

Submit only 1 of the following specimens:

 

Specimen Type: Endocervix

Collection Container/Type: COBAS media swab

Submission Container/Tube: COBAS media vial

Specimen Volume: Swab

Collection Instructions: 

  1. Using the woven cleaning swab, remove excess mucus from the cervical os and surrounding mucosa. DISCARD THIS WOVEN SWAB AFTER USE.
    NOTE: Cleaning excess mucus from the cervical os is required to assure adequate target cells are obtained for processing.
  2. 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.
  3. 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
  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.

 

Specimen Type: Vaginal

Collection Container/Type: COBAS media swab

Submission Container/Tube: COBAS media vial

Specimen Volume: Swab

Collection Instructions:

  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. 

Additional Information:

  1. WARNING: DO NOT PRE-WET SWAB IN Cobas® PCR MEDIA BEFORE COLLECTION

Specimen Stability

Room temperature: 1 month

Refrigerated: 1 month

Frozen: 1 month

Reference Range

Negative for Neisseria gonorrhoeae DNA

Rejection Due To

  • 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

Report Available

2-3 days

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.

Method Name

Real-time polymerase chain reaction (PCR) 

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

Day(s) Performed

Monday, Wednesday, Friday

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