Neisseria gonorrhoeae PCR


Sunquest Code:GCPCR  
Epic Code:LAB3497Epic Name:Neisseria gonorrhoeae PCR
Synonyms:Gonococcus; GC by PCR; Gen-Probe; Uniprobe; Genprobe; GC/Chlamydia DNA Probe; GCPCR
Methodology:Transcription mediated amplification technology
CPT Code:----------CPTCODES HERE----------
Turnaround Time:Performed Sun-Fri; results reported within 2-3 days.
Special Instructions:PCR testing is performed on genitourinary, urine, eye, throat, rectum (perirectal acceptable) specimens only. Refer to Neisseria gonorrhoeae culture for other sources.
Associated Links:

IDDL (Microbiology/Virology) Collection Container Guidelines



Collection Instructions

Specimen:Female: endocervical swab, vaginal swab, or urine; Male: urethral swab or urine. Also available for eye, throat, rectum (perirectal acceptable) specimens.
Collection Instructions:
Follow manufacturer's collection instructions on the collection kit package:

Swab specimen must be collected using an APTIMA Collection Unisex Swab or an APTIMA Collection Vaginal Swab. These swabs are contained in the APTIMA Collection Kit.  

Urine specimen must be collected into a sterile container and transferred to the APTIMA Urine Specimen Transport Tube. Alternatively, urine can be sent in a labeled, sterile container if it can arrive in the testing lab within 24 hours of collection.   NOTE: The same specimen can be used for Chlamydia and Gonorrhea testing.  

 Specimen type:  Endocervix
  Container/Tube: APTIMA Collection Unisex Swab
  Specimen Volume: Swab (blue shaft)
  Collection Instructions:
  1. Using swab (white shaft) to remove excess mucus from endocervix and discard.
  2. Insert collection swab (blue shaft) 1 to 1.5 cm into endocervical canal and rotate swab gently for 10-30 seconds. Avoid touching vaginal mucosa when removing swab.
  3. Place collection swab into transport tube provided in the collection kit. Snap on swab at score line so swab fits into closed tube.
  4. Cap securely and label with appropriate patient information.
   
 Specimen type:  Vagina (self collect OR clinician collect)
  Container/Tube: APTIMA Collection Vaginal Swab (self collect) or APTIMA Collection Unisex Swab (clinician collect)
  Specimen Volume: Swab (pink shaft or blue shaft in correct transport tube)
  Collection Instructions:
  1. Insert collection swab (pink or blue shaft) into the vagina about 2 inches past the introitus and gently rotate for 10-30 seconds.
  2. Place swab into transport tube provided in the collection kit. Snap off swab at score line so swab fits into closed tube. Discard the top portion of the swab shaft.
  3. Cap securely and label with appropriate patient information.
   
 Specimen type:  Urethra (Males Only)
  Container/Tube: APTIMA Collection Unisex Swab
  Specimen Volume: Swab (blue shaft)
  Collection Instructions:
  1. Patient should not have urinated for at least 1 hour prior to specimen collection.
  2. With a rotating movement, insert swab (blue shaft) 2 to 4 cm into urethra.
  3. Once inserted, rotate swab gently at least 1 rotation using sufficient pressure to ensure swab comes into contact with urethral surfaces. Allow swab to remain inserted 2-3 seconds.
  4. Place swab into transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.
  5. Cap securely and label with appropriate patient information.
   
 Specimen type: Urine (Males and Females)
  Container/Tube:  APTIMA Urine Specimen Transport Tube
  Specimen Volume: 20 mL
  Collection Instructions:
  1. Patient should not have urinated for at least 1 hour prior to specimen collection. Female patients should not cleanse the labial area prior to providing the specimens.
  2. Patient should collect first 20-30 mL of random voided urine (first catch) into a sterile, plastic, preservative-free container. Note: Collection of a larger volume may reduce test sensitivity.
  3. Transfer 2 mL of urine into the urine specimen transport tube using the disposable pipet provided within 24 hours of collection. The correct volume or urine has been added when the fluid level is between the black fill lines on the urine transport tube.
  4. Cap securely and label with appropriate patient information.
   

Specimen type:  Eye/Throat/Rectum

  Container/Tube:  APTIMA Collection Unisex Swab
  Specimen Volume:  Swab (blue shaft)
  Collection Instructions:
  1. Swab site using APTIMA Collection Unisex Swab (blue shaft) Note: The white swab in the collection kit is a cleaning swab and should NOT be used for collection. Discard the white cleaning swab.
  2. Place swab in transport tube provided in collection kite. Snap off swab at score line so swab fits into closed tube.
  3. Cap securely and label with appropriate patient information.
   
Causes for Rejection:
Follow manufacturer's collection instructions on the collection kit package. The following specimens will not be tested:
  • Midstream and catheterized urine specimens
  • Overfilled or under filled urine transport tubes
  • Urine in the grey top aliquoted tube (with preservative)
  • Transport tubes containing a large, white cleaning swab
  • Transport tubes containing more than 1 swab
  • Transport tubes with the absence of a collection swab
  • Transport tubes containing a swab not included in the collection kit

Note: Specimen source must be approved for the collection kit used. See collection instructions above for suitable sources for each type of APTIMA collection kit.    



Processing and Shipping

Specimen Processing:

Swab specimens:

After collection, transport and store swab in the swab transport tube at 2°C to 30°C. Specimens  must be assayed within 60 days of collection.

 

Urine specimens:

After collection, transport processed urine specimens in the APTIMA urine transport tube at 2°C to 30°C. Processed urine specimens must be assayed within 30 days of collection.

 

Urine samples that are still in the primary collection container must be transported to the testing lab at 2°C to 30°C. Urine must be transferred to the APTIMA urine specimen transport tube within 24 hours of collection.

 

Shipping Instructions:

Swab specimens:

After collection, transport and store swab in the swab transport tube at 2°C to 30°C. Specimens  must be assayed within 60 days of collection.

 

Urine specimens:

After collection, transport processed urine specimens in the APTIMA urine transport tube at 2°C to 30°C. Processed urine specimens must be assayed within 30 days of collection.

 

Urine samples that are still in the primary collection container must be transported to the testing lab at 2°C to 30°C. Urine must be transferred to the APTIMA urine specimen transport tube within 24 hours of collection.

 

Specimens should be sent in individual bags to limit the possibility of cross contamination.

 

Test Performed at or Referral Lab Infectious Diseases Diagnostic Lab-Microbiology  (UMMC-East Bank)


Interpretive

Reference Range:

Negative for Neisseria gonorrhoeae by PCR.

 

Limitations:As is true for all urine test methods, a negative urine result for a female patient who is clinically suspected of having chlamydial or gonococcal infection does not rule out the presence of CT or GC in the urogenital tract. Testing of an endocervical specimen is recommended in such cases.


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