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Test Code GCSW/LAB5460 Neisseria gonorrhoeae (GC) DNA Probe

Important Note

EPIC order code is LAB5460

Preferred Media: Cobas PCR ® media

 

Performing Laboratory

Asante Rogue Regional Medical Center

Specimen Requirements

Specimen: GC swab for Females

Female cervical, endocervical or vaginal swab specimens are collected and transported in Cobas ® PCR media.

This test is also approved for female self-collected vaginal specimens using the Cobas ® PCR media swab collect kit. 

 

Specimen: GC  Urine (male or female) collection

 

For females, urine is also an acceptable specimen. 

For males, only urine is acceptable. Not an approved method for male  urogenital samples.

 

ONLY SAMPLE SWABS PROVIDED IN THE COBAS PCR ® MEDIA OR  RESPECTIVE COLLECTION KITS ARE APPROVED FOR SAMPLE COLLECTION AND TESTING. . DO NOT COLLECT SAMPLES ON WOODEN SHAFT, COTTON TIP SWABS OR ANY OTHER UNAPPROVED SAMPLING DEVICE.

 

Acceptable:

Collection  in Cobas ® PCR media preferred :

      GC swab for Females

      GC Urine (male or female) collection

 

Sterile Urine Cup

     Sterile collection cup


Neisseria gonorrhoeae SWAB sample:


Female (provider collected):Remove excess mucus from endocervix with 1 large tipped swab and discard swab. Insert another large swab into the endocervical canal.  Rotate 3-5 seconds and withdraw.  Transfer specimen collection swab to a tube of Cobas ® PCR media.  Swab is easily broken off at the scored (black line).  Swab must remain in the transport media.  Close the transport media tube securely. Date and label the tube with appropriate patient identification information. 

 

This method is also approved  for female self-collection. Refer to specific instructions on each Cobas ® PCR media kit.

 

Neisseria gonorrhoeae  URINE sample- Male/Female:  GC  Urine (male or female) collection

 

Dirty catch urine, preferred collection after 1 hour of not-voiding, volume between 15-50 mls, (dirty catch, first part of the stream, not mid-stream) into a clean, polypropylene container without preservatives. (You may want to mark the outside of the cup to show the desired volume.)  Too much urine volume causes a dilution effect and can yield negative results. Caution the patient not to begin urinating until the collection cup is in position. 

 

Urine can be submitted directly to ARRMC lab. Aliquot urine into Cobas PCR ® media to only fill between the lines (do not overfill) within 24 hours of collection. Office may submit urine already aliquoted  in Cobas PCR ® media. DO NOT OVERFILL the Cobas PCR media vial; fill ONLY in between the lines. NOTE: Given that collection of larger volumes of urine may reduce test sensitivity, emphasis should be placed on the FIRST voided part of the stream.

Date and label the tube with appropriate patient identification information. 
 

Also include specimen source information on transport tube and on test requisition. 

Specimens collected  and transported with the Cobas® PCR® Sample Kit may be stored at 2°-30°C for up to 12 months once the specimens have been stabilized in Cobas® PCR ® Media.  Refrigerate urines  and transport to the laboratory as soon as possible. Stability of urine, not stabilized in Cobas PCR ® media is 24 hours.

 

 

 

Specimen Transport Temperature and Stability

Neisseria gonorrhoeae SWAB sample:

Transport to the laboratory as soon as possible. 

Stability limit for Cobas ® PCR media: 1 year at 2°-30°C, i.e. room temperature or refrigerated temperature.
 

Neisseria gonorrhoeae URINE sample:

Refrigerate (2°-8°C) urine sample and transport to the laboratory as soon as possible. 

Stability limit:  24 hours  refrigerated; or 12 months if stabilized in Cobas ® PCR  transport media.

 

Day(s) Test Set Up

Monday - Friday, A.M. shift.  All positive samples results are phoned to the physician.  Positive results also require Public Health reporting and follow-up.

Additional Information

Testing at RRMC is for 14 years and OLDER. 13 and under are collected in GenProbe Aptima II media and sent to Mayo  or Specialty Labs - check with Central Processing to obtain special collection media.

 

Use:  Qualitative detection of DNA for Neisseria gonorrhoeae in urogenital samples.  PCR method should not be
used as a “test for cure.”

 

Urine: Given that collection of larger volumes of urine may reduce test sensitivity, urine collected in volumes greater than 50 mls may cause false negative results.

 

Grossly bloody samples are unacceptable and may yield false positive results.  Grossly mucoid samples are not acceptable and may yield false negative results.  Avoid sample contamination, the presence of spermicide, lubricants or feminine hygiene powders. 


USE OF WOODEN SHAFT, COTTON TIP SWABS OR ANY SWAB WHICH HAS NOT BEEN PROVIDED IN THE PCR COLLECTION KITS IS CAUSE FOR REJECTION

 
 

Methodology

PCR (Polymerase Chain Reaction)

Performing Department

Special Chemistry

Test Classification and CPT Coding

87591  Infectious agent detection by nucleic acid (DNA or RNA); Neisseria gonorrhoeae, amplified probe technique

Billing Code

2030849