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Test Code SCGMT Genital-Chlamydia/Neisseria/M. genitalium/Trich PCR 

Important Note

This test has not been validated for patients <18 year old. Please contact the laboratory or collect with an Aptima swab if testing is needed for this age range.

Additional Codes

Epic: LAB14701

Specimen Required

Patient Preparation: Products containing carbomer(s), including vaginal lubricants, creams and gels may interfere with the test and cause invalid or false negative results. These products should not be used during or prior to collecting urogenital specimens.

 

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.
  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.

Additional Information:  

 

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:

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

Specimen Minimum Volume

Swab

Specimen Stability

Room temperature: 1 month

Refrigerated: 1 month

Reference Range

Neisseria gonorrhoeae: Negative

Chlamydia trachomatis: Negative

Trichomonas vaginalis: Negative

Mycoplasma genitalium: Negative

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

Day(s) and Time(s) Performed

Monday, Wednesday, Friday

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 infection. Specimens containing mucus, gels, lubricants, or creams may give invalid or false negative results.

Method Name

Real-time polymerase chain reaction (PCR) 

Performing Laboratory

Inova Laboratories

2832 Juniper Street

Fairfax, VA 22031

Includes

Neisseria gonorrhoeae

Chlamydia trachomatis

Trichomonas vaginalis

Mycoplasma genitalium

Limitations

A vaginal swab is the preferred specimen type for Mycoplasma genitalium testing in females due to higher sensitivity compared to endocervical swabs and urine. If the preferred specimen type is not used, further testing with the preferred specimen type may be indicated if M. genitalium infection is strongly suspected.                    

Testing with this instrument is not available for patients <18 years old.
This test is not recommended for evaluation of suspected sexual abuse and for other medico-legal indication