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Test Code LAB1376 Chlamydia and Neisseria gonorrhoeae Nucleic Acid Detection, Genital, Urine, Throat or Rectal

Important Note

NOTE: The Cepheid Xpert Swab Specimen Collection Kit  for CT/NG testing is the same swab kit currently in use for the Cepheid Multiplex Vaginal Panel (MVP) assay. Please collect individual samples, one for each test, if both tests are ordered by the provider. This will ensure that we have enough sample in the lab for instances when repeat testing is warranted.

Useful For

 Aid in the diagnosis of infections caused by Chlamydia trachomatis and Neisseria gonorrhoeae

Methodology

Real-Time PCR

Performing Laboratory

Bozeman Health Laboratory Services

Specimen Requirements

Submit only 1 of the following specimens.  Specimens must be collected with one the following specimen collection kits:

Specimen Type: Urine (dirty catch)

Container/Tube: Xpert Urine Transport Reagent Tube or Urine Cup

Collection Instructions:

Note: Specimen must be a "dirty catch".  Patient should not have urinated for at least 1 hour prior to specimen collection.

  1. Direct patient to provide dirty catch urine (approximately 20 to 30 mL of initial urine stream) into urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity. Female patients should not cleanse labial area prior to providing specimen.
  2. Remove cap from Xpert Urine Transport Reagent Tube and transfer 7 mL of urine into urine specimen transport tube using the disposable transfer pipette provided. The correct volume of urine has been added when the fluid level has reached the black-dashed fill lines on Xpert Urine Transport Reagent Tube label.  
  3. Re-cap Xpert Urine Transport Reagent Tube tightly. Invert reagent tube 3 to 4 times to ensure that the specimen and reagent are well mixed. 
  4. Tightly recap the Xpert Urine Transport Reagent Tube and label with patient’s full name, date of birth, and date/time of collection.
  5. Alternatively, urine can be collected in a sterile urine cup and sent to the lab within 24 hours ambient or 3 days refrigerated. 

Specimen Rejection:

  1. Clean catch urine specimens will be rejected.
  2. Urine transport tubes that have not been properly filled. 

Bozeman Health Outpatient Labs are not considered to be a clinical setting.

Specimen Type: Vaginal, Endocervical, Throat, and Rectal

Container/Tube: Xpert Swab Transport Reagent Tube

Specimen Volume: Entire specimen

Collection Instructions: 

Vaginal:

  1. Vaginal samples can either be Patient (self) collected, or Clinician collected. Patient collected swabs must be obtained within a clinical environment. 

  2. Touch the swab to the walls of the vagina and gently rotate for 10-30 seconds to ensure adequate sampling.
  3. Carefully withdraw the swab. (Do not put the swab down or allow it to touch to another surface.)
  4. Remove the cap from the Xpert Swab Transport Reagent Tube and immediately lower the swab into the tube.
  5. Carefully break the swab shaft at the scoreline, using care not to splash the contents of the transport tube.
  6. Tightly recap the Xpert Swab Transport Reagent Tube and label with patient’s full name, date of birth, and date/time of collection.

Endocervical:

Note: Do not use lubricant on speculum.

  1. Visualize cervix with a speculum.
  2. Obtain an adequate sampling from endocervix using swab provided. Insert device into cervix. Slowly rotate one quarter or one half turn in 1 direction. Do not over-rotate. Additional rotation may cause bleeding and contaminate specimen.
  3. Remove the cap from the Xpert Swab Transport Reagent Tube and immediately lower the swab into the tube.
  4. Carefully break the swab shaft at the scoreline, using care not to splash the contents of the transport tube.
  5. Tightly recap the Xpert Swab Transport Reagent Tube and label with patient’s full name, date of birth, and date/time of collection.

Throat:

  1. Hold the swab placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
  2. Swab the back of the throat and tonsils and withdraw the swab without touching the inside of the cheeks or tongue.
  3. While holding the swab in the same hand, unscrew the cap from the Xpert Swab Transport Reagent Tube.  Do not spill the contents of the tube.
  4. Immediately place the swab into the Xpert Swab Transport Reagent Tube so that the score line is at the top of the tube.
  5. Carefully break the swab shaft at the score line against the side of the tube and discard the top portion of the swab shaft. Tightly screw the cap onto the Xpert Swab Transport Reagent Tube.
  6. Label tube with patient’s name (first and last), date and actual time of collection, and specimen source.

Rectal:

  1. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
  2. Carefully insert the swab into the rectum about 1-2 inches (3-5 cm) past the anal margin and gently rotate the swab for 5 to 10 seconds. Withdraw the swab without touching the skin.
  3. Immediately place the swab into the Xpert Swab Transport Reagent Tube so that the score line is at the top of the tube.
  4. Carefully break the swab shaft at the score line against the side of the tube and discard the top portion of the swab shaft. Tightly screw the cap onto the Xpert Swab Transport Reagent Tube.
  5. Label tube with patient’s name (first and last), date and actual time of collection, and specimen source.

Specimen Stability

Specimen Type Temperature Time
Xpert Swab Collection Kit

Ambient or Refrigerated

(2 - 30°C) 

60 days
Xpert Urine Collection Kit

Ambient or Refrigerated

(2 - 15°C) 

45 days
Urine Cup (Unpreserved) Refrigerated 3 days
Ambient 24 hours

Specimen Transport Temperature

Refrigerated Preferred 

Reference Values

Not detected

 

A positive result indicates the presence of Chlamydia trachomatis or Neisseria gonorrhoeae

Day(s) Test Set Up

Sunday through Saturday

Test Classification and CPT Coding

87491-Chlamydia trachomatis

87591-Neisseria gonorrhoeae