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Test Code LAB5461 Neisseria gonorhoease (GC) DNA Probe, Urine

Important Note

EPIC order code is LAB5461

Preferred Media: Cobas PCR ® media

If under 14 years old, see Additional Notes below

Performing Laboratory

Asante Rogue Regional Medical Center (ARRMC)

 

Performing Department

Microbiology

Special Instructions

Testing at RRMC is for 14 years and OLDER. Thirteen (13) and under are collected in GenProbe Aptima II media and sent to Lab Corp; Order as MISCELLANEOUS, Lab Corp test # 183194 - 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.

Specimen Required

Male or female non-clean catch (“dirty”) urine specimens collected in a sterile, polypropylene container without preservatives, or transported in cobas®  PCR media (instructions follow).

 

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

 

Acceptable:

Sterile Urine Cup    

    Sterile collection cup

 

Neisseria gonorrhoeae  URINE sample-Male/Female: GC-Chlamydia 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.

Specimen Minimum Volume

10 mL

Specimen Stability Information

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.

 

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.

 

Reject Due To

Clean-catch urine; this methodology has not been evaluated for this specimen type

Day(s) Performed

Monday - Friday, A.M. shift. 

All positive samples results are phoned to the physician.  Positive results also require Public Health reporting and follow-up.

Method Name

PCR (Polymerase Chain Reaction)

CPT Code Information

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

Billing Code

2030849