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

Important Note

Order this test for genital, urine, throat, rectal and liquid PAP specimens. 

For ocular sources, order sendout test NBLD0615 to Mayo Medical Laboratories

Useful For

Diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae infection

Methodology

Polymerase Chain Reaction (PCR) using rRNA via the PANTHER System

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: Endocervical (Females) or Urethra (Males)

Container/Tube: APTIMA Unisex Swab Collection Kit vial

Collection Instructions:  APTIMA Unisex Collection Instructions

Endocervical:

  1. Use cleaning swab (white shaft swab with red printing) to remove excess mucus from cervical os and surrounding mucosa. Discard this swab.
  2. Insert collection swab (blue shaft swab with green printing) into endocervical canal. Gently rotate swab clockwise for 10 to 30 seconds to ensure adequate sampling. Withdraw swab carefully; avoid any contact with vaginal mucosa.
  3. While holding swab in hand, unscrew the tube cap. Do not spill tube contents. If the tube contents are spilled, discard and get a new APTIMA Unisex swab transport tube. Immediately place swab into transport tube so that the tip of the swab is visible below tube label. Carefully break swabs shaft at the score line against the side of the tube. Discard top portion of swab shaft.
  4. Re-cap swab specimen transport tube tightly

Urethral:

Note: Patient should not have urinated for at least 1 hour prior to specimen collection.

  1. Discard cleaning swab (white shaft with red print on label). The cleaning swab is NOT needed for male specimen collection.
  2. Insert specimen collection swab (blue shaft swab in package with green printing) 2 cm to 4 cm into urethra. Gently rotate swab clockwise for 2 to 3 seconds in urethra to ensure adequate sampling. Withdraw swab carefully.
  3. While holding swab in hand, unscrew the tube cap. Do not spill tube contents. If the tube contents are spilled, discard and get a new APTIMA Unisex swab transport tube. Immediately place swab into transport tube so that the tip of the swab is visible below tube label. Carefully break swabs shaft at the score line against the side of the tube. Discard top portion of swab shaft.
  4. Re-cap swab specimen transport tube tightly

Specimen Rejection: If the lab receives a swab specimen transport tube with no swab, two swabs, a cleaning swab, or a swab not supplied by APTIMA, the specimen must be rejected.

 

 

 

Specimen Type: Urine (Males and Females)

Container/Tube: APTIMA processed urine specimen

Collection Instructions:  APTIMA Urine 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 first-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 urine specimen transport tube and transfer 2 mL of urine into urine specimen transport tube using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black fill lines on urine specimen transport tube label.  Urine sample must be transferred into Aptima urine specimen transport tube within 24 hours of collection.
  3. Re-cap urine specimen transport tube tightly. This is now known as the “processed urine specimen.”

Specimen Rejection:

  1. Clean catch urine specimens will be rejected.
  2. After urine has been added in the urine transport tube, the liquid level must fall between the two black indicator lines on the tube label.  Otherwise, the specimen must be rejected.

 

 

 

Specimen Type: Vaginal, Rectal, or Throat

Container/Tube: APTIMA Multitest Swab Collection Kit vial

Collection Instructions: Aptima Multitest Swab Collection Instructions

Vaginal:

  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 vagina about 2 inches (5 cm) past the introitus and gently rotate the swab for 10 to 30 seconds. Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab and then withdraw the swab without touching the skin.
  3. While holding the swab in the same hand, unscrew the cap from the tube.  Do not spill tube contents. If the tube contents are spilled, discard and get a new APTIMA Unisex swab transport tube.
  4. Immediately place the swab into the transport 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 tube.

 

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. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection Kit.
  4. Immediately place the swab into the transport 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 tube.
  6. Label tube with patient’s name (first and last), date and actual time of collection, and specimen source.

 

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 tube.  Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection Kit.
  4. Immediately place the swab into the transport 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 tube.
  6. Label tube with patient’s name (first and last), date and actual time of collection, and specimen source.

 

 

Specimen Type: Endocervix

Container/Tube: ThinPrep vial

Specimen Volume: Entire specimen

Collection Instructions:

Note: Do not use lubricant on speculum.

  1. Visualize cervix with a speculum.
  2. Obtain an adequate sampling from endocervix using an endocervical brush, broom, or spatula device. 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. Rinse brush in PreservCyt Solution vial by rotating device in solution 10 times while pushing against PreservCyt vial wall. Swirl brush VIGOROUSLY to further release material.
  4. Discard collection device after depositing cellular material in vial. Do not send collection device in vial.
  5. Tighten cap so torque line on cap passes torque line on vial.
  6. Label vial with patient’s name (first and last), date and actual time of collection, and type of specimen. 

Specimen Transport Temperature

Ambient/Refrigerated

Specimen Stability

Specimen Type Temperature Time
APTIMA Unisex Swab Collection Kit Ambient or Refrigerated 60 days
APTIMA Multitest Swab Collection Kit Ambient or Refrigerated 60 days
Urine, Sterile Container Refrigerated 24 hours
APTIMA Urine Collection Vial Ambient or Refrigerated 30 days
ThinPrep vial (PreservCyt Solution) Ambient or Refrigerated 30 days
APTIMA Transfer Kit for ThinPrep vials Ambient or Refrigerated

14 days

Reference Values

Not detected

 

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

Additional Infomation

A negative result does not exclude the possibility of infection. Improper specimen collection, the presence of inhibitors, or low organism yield may cause false-negative results.

Day(s) Test Set Up

Monday through Friday

Test Classification and CPT Coding

87491-Chlamydia trachomatis

87591-Neisseria gonorrhoeae